Trial Outcomes & Findings for PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers (NCT NCT02936323)

Last Updated: 2021-12-14

Results Overview

MTD was determined by testing increasing doses up to 25 mg flat dose IV over 1 hour on an every 3 week cycle on dose escalation cohorts 1 to 7 with 2 participants in cohort 1 and 3-6 participants each in cohorts 2-7. The MTD was defined as the highest drug dosage not causing a Dose Limiting Toxicity (DLT) in \> 33% of the treated participants during the first cycle of treatment. DLTs were defined as any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.03 occurring within the first 4 weeks for cohort 1 and within 3 weeks for each subsequent cohort that was not related to underlying disease, disease progression, intercurrent illness, or concomitant medications. The RP2D was established by achieving the Maximum Tolerated Dose (MTD). The RP2D may be equal to or below the MTD.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

89 participants

Primary outcome timeframe

Up to 4 weeks in the first cohort and up to 3 weeks for each subsequent cohort

Results posted on

2021-12-14

Participant Flow

Participants enrolled with SSTR2 expressing advanced gastroenteropancreatic or lung or thymus or other NETs or SCLC or LCNEC of the lung. A total of 23 participants enrolled into the Phase 1 Dose Escalation stage of the study receiving at least one dose of PEN-221 and a total of 66 patients enrolled into the Phase 2a Disease-Specific Dose Expansion stage of the study receiving at least one dose of PEN-221.

Each eligible participant must have demonstrated a tumor that was positive for expression of SSTR2 by historical or study-related somatostatin analog radioimaging (SARI). Participants who discontinued treatment entered a follow-up period (Disease Progression Follow-up and/or Long-Term Follow-up). Results for data collected up to cut-off 31 July 2020 are reported here.

Participant milestones

Participant milestones
Measure	Phase 1 Dose Escalation (Cohort 1) Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 2) Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (GI Mid-gut NET Cohort) Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade gastrointestinal mid-gut Neuroendocrine Tumor (GINET). Participants in the GINET cohort were enrolled into one of two groups which included 25 participants without prior Peptide Receptor Radionuclide Therapy \[PRRT\] (GINET PRRT Naïve) and 7 participants with prior PRRT (GINET PRRT Recurrent).	Phase 2a Dose Expansion (PNET Cohort) Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade pancreatic Neuroendocrine Tumor (PNET).	Phase 2a Dose Expansion (SCLC Cohort) Participants were enrolled with advanced or metastatic Small Cell Lung Cancer (SCLC).
Phase 1 Dose Escalation STARTED	2	3	3	3	3	6	3	0	0	0
Phase 1 Dose Escalation COMPLETED	0	1	0	1	0	1	0	0	0	0
Phase 1 Dose Escalation NOT COMPLETED	2	2	3	2	3	5	3	0	0	0
Phase 2a Dose Expansion STARTED	0	0	0	0	0	0	0	32	15	19
Phase 2a Dose Expansion COMPLETED	0	0	0	0	0	0	0	15	2	5
Phase 2a Dose Expansion NOT COMPLETED	0	0	0	0	0	0	0	17	13	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 Dose Escalation (Cohort 1) Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 2) Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (GI Mid-gut NET Cohort) Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade gastrointestinal mid-gut Neuroendocrine Tumor (GINET). Participants in the GINET cohort were enrolled into one of two groups which included 25 participants without prior Peptide Receptor Radionuclide Therapy \[PRRT\] (GINET PRRT Naïve) and 7 participants with prior PRRT (GINET PRRT Recurrent).	Phase 2a Dose Expansion (PNET Cohort) Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade pancreatic Neuroendocrine Tumor (PNET).	Phase 2a Dose Expansion (SCLC Cohort) Participants were enrolled with advanced or metastatic Small Cell Lung Cancer (SCLC).
Phase 1 Dose Escalation Informed Consent Withdrawn	0	1	0	1	1	1	0	0	0	0
Phase 1 Dose Escalation Death	2	1	3	1	2	3	3	0	0	0
Phase 1 Dose Escalation Study Discontinued at Site	0	0	0	0	0	1	0	0	0	0
Phase 2a Dose Expansion Informed Consent Withdrawn	0	0	0	0	0	0	0	11	4	2
Phase 2a Dose Expansion Physician Decision	0	0	0	0	0	0	0	0	0	1
Phase 2a Dose Expansion Lost to Follow-up	0	0	0	0	0	0	0	2	1	0
Phase 2a Dose Expansion Change(s) to patient's condition	0	0	0	0	0	0	0	0	0	1
Phase 2a Dose Expansion Death	0	0	0	0	0	0	0	4	8	10

Baseline Characteristics

PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Dose Escalation (Cohort 1) n=2 Participants Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 2) n=3 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 Participants Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 Participants Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 Participants Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=3 Participants Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (GI Mid-gut NET Cohort) n=32 Participants Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade gastrointestinal mid-gut Neuroendocrine Tumor (GINET). Participants in the GINET cohort were enrolled into one of two groups which included 25 participants without prior Peptide Receptor Radionuclide Therapy \[PRRT\] (GINET PRRT Naïve) and 7 participants with prior PRRT (GINET PRRT Recurrent).	Phase 2a Dose Expansion (PNET Cohort) n=15 Participants Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade pancreatic Neuroendocrine Tumor (PNET).	Phase 2a Dose Expansion (SCLC Cohort) n=19 Participants Participants were enrolled with advanced or metastatic Small Cell Lung Cancer (SCLC).	Total n=89 Participants Total of all reporting groups
Age, Continuous	48.5 Years n=5 Participants	57.0 Years n=7 Participants	67.0 Years n=5 Participants	46.0 Years n=4 Participants	67.0 Years n=21 Participants	63.5 Years n=10 Participants	52.0 Years n=115 Participants	66.0 Years n=24 Participants	58.0 Years n=42 Participants	65.0 Years n=42 Participants	65 Years n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	15 Participants n=24 Participants	8 Participants n=42 Participants	10 Participants n=42 Participants	43 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	1 Participants n=115 Participants	17 Participants n=24 Participants	7 Participants n=42 Participants	9 Participants n=42 Participants	46 Participants n=42 Participants
Race/Ethnicity, Customized Caucasian/White	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants	3 Participants n=115 Participants	27 Participants n=24 Participants	10 Participants n=42 Participants	19 Participants n=42 Participants	76 Participants n=42 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Native American or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Not collected	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants
Ethnicity Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants	2 Participants n=115 Participants	30 Participants n=24 Participants	13 Participants n=42 Participants	19 Participants n=42 Participants	81 Participants n=42 Participants
Ethnicity Not collected	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks in the first cohort and up to 3 weeks for each subsequent cohort

Population: All Phase 1 participants who received at least one dose of PEN-221 and either experienced a DLT or had been followed for the full DLT evaluation period.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=23 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 1: Maximum Tolerated Dose of PEN-221 and Recommended Phase 2a Dose (RP2D)	18.0 mg	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 4 weeks in the first cohort and up to 3 weeks for each subsequent cohort

Population: All Phase 1 participants who received at least one dose of PEN-221 and either experienced a DLT or had been followed for the full DLT evaluation period.

DLTs were defined as any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.03 occurring within the first 4 weeks for cohort 1 and within 3 weeks for each subsequent cohort that was not related to underlying disease, disease progression, intercurrent illness, or concomitant medications. Grade 3 is a severe AE and Grade 4 is a life-threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which \> 33% of participants experienced a DLT during the first cycle of treatment.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=2 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=3 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 Participants Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 Participants Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 Participants Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=3 Participants Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants	—	—	—

PRIMARY outcome

Timeframe: Baseline and every 9 weeks up to time of disease progression (per RECIST 1.1) or death, up to data cut-off (31 Jul 2020).

Population: Outcome measured by cancer type. GI mid-gut NET or PNET participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment.

Efficacy of PEN-221 in gastrointestinal mid-gut NETs and pancreatic NETs using clinical benefit rate (CBR) defined as the best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 using the investigator assessment.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=26 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=12 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 2a: Percentage of Gastrointestinal Mid-gut NETs and Pancreatic NETs Participants Who Achieved Clinical Benefit as Determined by RECIST 1.1	88.5 percentage of participants Interval 69.8 to 97.6	50 percentage of participants Interval 21.1 to 78.9	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and every 6 weeks up to time of disease progression (per RECIST 1.1) or death, up to data cut-off (31 Jul 2020).

Population: Outcome measured by cancer type. SCLC participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment.

Efficacy of PEN-221 in Small Cell Lung Cancer (SCLC) using objective response rate (ORR) as defined as the best overall response of CR or PR using tumor response criteria defined by RECIST 1.1.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=12 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 2a: Number of Small Cell Lung Cancer (SCLC) Participants Who Achieved an Objective Response of Complete Response (CR) or Partial Response (PR) as Defined by RECIST 1.1. Partial Response	0 Participants	—	—	—	—	—	—	—	—	—
Phase 2a: Number of Small Cell Lung Cancer (SCLC) Participants Who Achieved an Objective Response of Complete Response (CR) or Partial Response (PR) as Defined by RECIST 1.1. Complete Response	0 Participants	—	—	—	—	—	—	—	—	—
Phase 2a: Number of Small Cell Lung Cancer (SCLC) Participants Who Achieved an Objective Response of Complete Response (CR) or Partial Response (PR) as Defined by RECIST 1.1. Stable Disease	3 Participants	—	—	—	—	—	—	—	—	—
Phase 2a: Number of Small Cell Lung Cancer (SCLC) Participants Who Achieved an Objective Response of Complete Response (CR) or Partial Response (PR) as Defined by RECIST 1.1. Progressive Disease	9 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From the date of first treatment through the date of first documented progression, assessed up to data cut-off (31 Jul 2020).

Population: Outcome measured by cancer type. SCLC participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment. No participants in the SCLC cohort had an objective response, so no data is presented for this Outcome Measure.

Duration of Response (DOR) is defined as the time from the first documented response (CR or PR), as assessed by the investigator, to the date of first documented disease progression or death due to underlying cancer. If patient did not progress or die before the data cutoff date (31-July-2020), DOR was censored at the date of last adequate tumor assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first treatment/trial entry until 28 days after last treatment for each participant, up to data cut-off (31 Jul 2020).

Population: The Safety Analysis population was comprised of all enrolled participants who received any amount of study drug and had at least 1 post-baseline safety evaluation. All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.

Phase 1 and Phase 2a participants who experienced any Treatment-Emergent Adverse Event (TEAE) to determine the safety and tolerability of PEN-221. TEAEs are any AE that occurred after first dose of study drug through 28 days after the last dose of study drug, any event considered study drug related regardless of start date of the event, or any event that was present at baseline but worsened in intensity or was subsequently considered study drug related by the Investigator. Phase 2a TEAEs were collected for reporting in the BSA dosing format only.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=2 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=3 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 Participants Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 Participants Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 Participants Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=3 Participants Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) n=12 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) n=34 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) n=20 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Number of Study Participants Who Experienced Treatment-Emergent Adverse Events Any TEAE	2 Participants	3 Participants	3 Participants	3 Participants	3 Participants	6 Participants	3 Participants	12 Participants	32 Participants	20 Participants
Number of Study Participants Who Experienced Treatment-Emergent Adverse Events Dose Limiting Toxicity	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Study Participants Who Experienced Treatment-Emergent Adverse Events Serious TEAEs	2 Participants	1 Participants	3 Participants	0 Participants	0 Participants	2 Participants	2 Participants	3 Participants	7 Participants	15 Participants
Number of Study Participants Who Experienced Treatment-Emergent Adverse Events Treatment Related TEAEs	0 Participants	3 Participants	3 Participants	3 Participants	3 Participants	6 Participants	3 Participants	10 Participants	29 Participants	19 Participants
Number of Study Participants Who Experienced Treatment-Emergent Adverse Events TEAEs leading to Discontinuation of Study Drug	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	7 Participants	6 Participants
Number of Study Participants Who Experienced Treatment-Emergent Adverse Events TEAEs leading to Death	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Phase 1: Day 1 of Cycles 1 and 3 pre-start of infusion (SOI), at 0.5, 1, 1.5, 2, 4, 6, 8, 10 hours post-start of infusion. Phase 2a: Day 1 Cycle 1 pre-start of infusion, at 0.5,1, 1.5, 2, 4, 6, 8, 24 hours post-SOI; once at Day 8 Cycle 1.

Population: The Pharmacokinetic Analysis set comprises all participants who received any amount of study drug and provided adequate PK samples. Phase 2a participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.

Blood samples were obtained and plasma concentrations were determined using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Phase 2a data were collected for reporting in the BSA dosing format only.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=2 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=3 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 Participants Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 Participants Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 Participants Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=3 Participants Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) n=12 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) n=28 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) n=20 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Maximum Concentration (Cmax) of PEN-221, DM1, and Peptide Plasma PK	18.96 ng/mL Standard Deviation 9.56	50.20 ng/mL Standard Deviation 24.30	150.40 ng/mL Standard Deviation 51.99	359.70 ng/mL Standard Deviation 92.42	592.50 ng/mL Standard Deviation 149.66	2802 ng/mL Standard Deviation 5068.6	1324 ng/mL Standard Deviation 519.94	451.4 ng/mL Standard Deviation 174.14	1533 ng/mL Standard Deviation 3356.9	1064 ng/mL Standard Deviation 2298.7
Maximum Concentration (Cmax) of PEN-221, DM1, and Peptide Total Peptide	16.38 ng/mL Standard Deviation 3.7112	40.03 ng/mL Standard Deviation 15.807	129.8 ng/mL Standard Deviation 5.7813	261.4 ng/mL Standard Deviation 49.269	420.2 ng/mL Standard Deviation 69.703	1925 ng/mL Standard Deviation 3246.8	926.9 ng/mL Standard Deviation 279.02	350.0 ng/mL Standard Deviation 102.28	1041 ng/mL Standard Deviation 2061.0	831.5 ng/mL Standard Deviation 1721.0
Maximum Concentration (Cmax) of PEN-221, DM1, and Peptide Unconjugated DM1	4.758 ng/mL Standard Deviation 0.78830	13.79 ng/mL Standard Deviation 6.1768	42.23 ng/mL Standard Deviation 12.295	78.63 ng/mL Standard Deviation 6.2100	112.0 ng/mL Standard Deviation 22.186	218.3 ng/mL Standard Deviation 73.574	266.3 ng/mL Standard Deviation 46.561	101.0 ng/mL Standard Deviation 26.560	164.5 ng/mL Standard Deviation 74.435	146.3 ng/mL Standard Deviation 74.755
Maximum Concentration (Cmax) of PEN-221, DM1, and Peptide Total DM1	11.11 ng/mL Standard Deviation 2.7669	29.88 ng/mL Standard Deviation 14.304	94.01 ng/mL Standard Deviation 2.7951	198.6 ng/mL Standard Deviation 37.848	340.4 ng/mL Standard Deviation 87.602	1327 ng/mL Standard Deviation 2157.2	691.3 ng/mL Standard Deviation 165.22	261.2 ng/mL Standard Deviation 70.449	762.3 ng/mL Standard Deviation 1388.0	505.9 ng/mL Standard Deviation 734.05
Maximum Concentration (Cmax) of PEN-221, DM1, and Peptide Free Sulfhydryl DM1	0.09568 ng/mL Standard Deviation 0.034873	0.2441 ng/mL Standard Deviation 0.17198	0.6778 ng/mL Standard Deviation 0.02297	1.975 ng/mL Standard Deviation 0.46462	2.739 ng/mL Standard Deviation 0.90804	14.12 ng/mL Standard Deviation 18.151	11.04 ng/mL Standard Deviation 5.011	2.174 ng/mL Standard Deviation 0.82698	5.214 ng/mL Standard Deviation 8.2827	6.225 ng/mL Standard Deviation 12.276

SECONDARY outcome

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=2 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=3 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 Participants Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 Participants Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 Participants Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=3 Participants Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) n=12 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) n=28 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) n=20 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Area Under the Curve (AUC) of PEN-221, DM1, and Peptide Total Peptide	87.20 (ng/mL)*h Standard Deviation 30.636	189.2 (ng/mL)*h Standard Deviation 64.194	548.0 (ng/mL)*h Standard Deviation 156.34	1080 (ng/mL)*h Standard Deviation 197.69	1730 (ng/mL)*h Standard Deviation 475.69	3147 (ng/mL)*h Standard Deviation 1211.0	4402 (ng/mL)*h Standard Deviation 938.17	2988 (ng/mL)*h Standard Deviation 847.68	4203 (ng/mL)*h Standard Deviation 1837.2	4558 (ng/mL)*h Standard Deviation 1474.5
Area Under the Curve (AUC) of PEN-221, DM1, and Peptide Plasma PK	38.34 (ng/mL)*h Standard Deviation 15.88	89.95 (ng/mL)*h Standard Deviation 33.64	192.40 (ng/mL)*h Standard Deviation 48.66	643.60 (ng/mL)*h Standard Deviation 224.39	1119 (ng/mL)*h Standard Deviation 330.86	2323 (ng/mL)*h Standard Deviation 2267.7	2357 (ng/mL)*h Standard Deviation 798.60	867.7 (ng/mL)*h Standard Deviation 329.9	1667 (ng/mL)*h Standard Deviation 1638.6	1463 (ng/mL)*h Standard Deviation 1141.8
Area Under the Curve (AUC) of PEN-221, DM1, and Peptide Total DM1	65.59 (ng/mL)*h Standard Deviation 16.501	179.7 (ng/mL)*h Standard Deviation 97.376	454.8 (ng/mL)*h Standard Deviation 136.89	981.1 (ng/mL)*h Standard Deviation 74.477	1780 (ng/mL)*h Standard Deviation 652.3	1996 (ng/mL)*h Standard Deviation 489.18	3980 (ng/mL)*h Standard Deviation 1335.4	2153 (ng/mL)*h Standard Deviation 526.06	3328 (ng/mL)*h Standard Deviation 1881.7	3419 (ng/mL)*h Standard Deviation 1277.9
Area Under the Curve (AUC) of PEN-221, DM1, and Peptide Unconjugated DM1	54.18 (ng/mL)*h Standard Deviation 15.810	163.9 (ng/mL)*h Standard Deviation 86.594	444.5 (ng/mL)*h Standard Deviation 100.94	720.6 (ng/mL)*h Standard Deviation 86.063	1384 (ng/mL)*h	1776 (ng/mL)*h Standard Deviation 660.31	4316 (ng/mL)*h	1765 (ng/mL)*h Standard Deviation 415.63	2384 (ng/mL)*h Standard Deviation 522.17	2781 (ng/mL)*h Standard Deviation 1057.1
Area Under the Curve (AUC) of PEN-221, DM1, and Peptide Free Sulfhydryl DM1	—	—	—	16.86 (ng/mL)*h	17.63 (ng/mL)*h Standard Deviation 7.6946	37.40 (ng/mL)*h Standard Deviation 12.335	131.4 (ng/mL)*h Standard Deviation 109.56	32.06 (ng/mL)*h Standard Deviation 20.012	62.05 (ng/mL)*h Standard Deviation 35.792	69.48 (ng/mL)*h Standard Deviation 58.396

SECONDARY outcome

Blood samples were obtained and plasma concentrations were determined using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Phase 2a data collected for reporting in the BSA dosing format only.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=2 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=3 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 Participants Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 Participants Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 Participants Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=3 Participants Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) n=12 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) n=28 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) n=20 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Half-life (t1/2) of PEN-221, DM1, and Peptide Free Sulfhydryl DM1	—	—	—	4.57 hours	4.93 hours Interval 4.4 to 5.47	3.87 hours Interval 2.57 to 4.21	9.01 hours Interval 7.1 to 10.8	10.1 hours Interval 6.22 to 38.1	20.9 hours Interval 7.21 to 46.9	14.3 hours Interval 8.16 to 47.2
Half-life (t1/2) of PEN-221, DM1, and Peptide Plasma PK	1.46 hours Interval 1.15 to 1.77	1.41 hours Interval 1.31 to 1.8	1.77 hours Interval 0.86 to 2.69	1.70 hours Interval 1.59 to 2.32	1.94 hours Interval 1.8 to 3.76	1.61 hours Interval 1.26 to 3.64	3.06 hours Interval 2.5 to 3.45	4.259 hours Interval 1.04 to 9.01	4.180 hours Interval 1.64 to 12.9	4.526 hours Interval 1.27 to 6.93
Half-life (t1/2) of PEN-221, DM1, and Peptide Total Peptide	5.33 hours Interval 3.87 to 6.8	4.61 hours Interval 4.15 to 5.29	5.25 hours Interval 2.56 to 6.5	4.33 hours Interval 3.61 to 5.57	5.63 hours Interval 3.03 to 8.07	4.89 hours Interval 2.27 to 11.2	7.49 hours Interval 7.32 to 7.67	27.9 hours Interval 10.1 to 35.0	28.7 hours Interval 6.71 to 35.8	30.9 hours Interval 22.9 to 38.6
Half-life (t1/2) of PEN-221, DM1, and Peptide Total DM1	4.78 hours Interval 3.61 to 5.94	4.48 hours Interval 3.85 to 7.35	5.87 hours Interval 2.94 to 6.13	4.43 hours Interval 4.19 to 4.49	5.69 hours Interval 3.25 to 9.13	5.43 hours Interval 3.67 to 6.38	6.32 hours Interval 5.66 to 6.98	25.3 hours Interval 7.26 to 28.4	24.2 hours Interval 5.57 to 27.6	25.5 hours Interval 19.9 to 34.1
Half-life (t1/2) of PEN-221, DM1, and Peptide Unconjugated DM1	5.77 hours Interval 3.61 to 7.92	7.80 hours Interval 6.38 to 9.0	6.07 hours Interval 5.58 to 6.56	5.36 hours Interval 4.73 to 5.98	8.49 hours Interval 8.49 to 8.49	6.89 hours Interval 4.67 to 9.6	8.94 hours Interval 8.94 to 8.94	25.9 hours Interval 6.98 to 29.4	24.5 hours Interval 8.03 to 29.2	25.0 hours Interval 19.8 to 34.8

SECONDARY outcome

Timeframe: Baseline, every 6 or 9 weeks depending on the tumor type, up to time of disease progression (per RECIST 1.1) or death, up to data cut-off (31 Jul 2020).

Population: Phase 1 participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

Assess the potential of preliminary anti-tumor activity of PEN-221 using tumor response criteria as defined by RECIST 1.1.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=2 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=3 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=2 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 Participants Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 Participants Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 Participants Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=2 Participants Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 1: Number of Participants With a Best Response of an Objective Response, Stable Disease, or Progressive Disease. Complete Response (Confirmed or Unconfirmed)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Phase 1: Number of Participants With a Best Response of an Objective Response, Stable Disease, or Progressive Disease. Partial Response (Confirmed)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Phase 1: Number of Participants With a Best Response of an Objective Response, Stable Disease, or Progressive Disease. Partial Response (Unconfirmed)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Phase 1: Number of Participants With a Best Response of an Objective Response, Stable Disease, or Progressive Disease. Stable Disease	1 Participants	3 Participants	1 Participants	3 Participants	2 Participants	2 Participants	2 Participants	—	—	—
Phase 1: Number of Participants With a Best Response of an Objective Response, Stable Disease, or Progressive Disease. Progressive Disease	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	4 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From date of first treatment/trial entry until 28 days after last treatment for each Phase 2a participant, up to data cut-off (31 Jul 2020)

Population: All Phase 2a participants who received any amount of study drug and had at least 1 post-baseline safety evaluation. SRC reviewed all Phase 1 and 31 Phase 2a participants and changed flat dose (mg) to Body Surface Area (BSA) based dose of 8.8 mg/m\^2 due to correlation between BSA and drug exposure associated with higher rate of participant discontinuation. Calculated BSA capped at 2.0 m\^2 so not to exceed Phase 1 MTD of 18 mg. Phase 2a data collected for reporting in the BSA dosing format only.

Confirm the MTD identified during the dose-escalation phase and further investigate the safety and tolerability of the RP2D and schedule of PEN-221. Initial Phase 2a PEN-221 start dose at Phase 1 MTD and RP2D was determined at 18 mg flat dose. The MTD was defined as the highest drug dosage not causing a Dose Limiting Toxicity (DLT) in \> 33% of the treated participants during the first cycle of treatment. DLTs were defined as any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.03 occurring within the first 4 weeks for cohort 1 and within 3 weeks for each subsequent cohort that was not related to underlying disease, disease progression, intercurrent illness, or concomitant medications. The RP2D was established by achieving the Maximum Tolerated Dose (MTD). The RP2D may be equal to or below the MTD.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=66 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 2a: Maximum Tolerated Dose (MTD) and Recommended Phase 2a Dose (RP2D) Based on Body Surface Area	8.8 mg/m^2	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first treatment/trial entry until first documented progression or date of death from any cause, whichever came first, assessed up to data cutoff of 31 Jul 2020

Population: Outcome measured by cancer type. GI mid-gut NET, PNET, and SCLC participants enrolled into the study and who received any amount of study drug.

Progression free survival (PFS) is defined as the time from the date of first dose of PEN-221 to the date of first documented disease progression per RECIST 1.1, or death due to any cause. If a participant had not progressed or died before the analysis cutoff date (31 Jul 2020), PFS was censored at the date of last adequate tumor assessment. Results based on Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=32 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=15 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=19 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 2a: Progression Free Survival (PFS)	9.0 Months Interval 5.0 to 16.5	3.2 Months Interval 2.0 to 5.9	1.4 Months Interval 1.2 to 1.8	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: For each GI mid-gut NET, PNET, and SCLC, from date of first treatment/trial entry until the date of death from any cause, assessed up to data cutoff of 31 Jul 2020

Population: Outcome measured by cancer type. GI mid-gut NET, PNET, and SCLC patients enrolled into the study and who received any amount of study drug.

Overall survival (OS) was defined as the time from the first dose of PEN-221 to the date of death due to any cause. If the participant had not died before data lock (31 Jul 2020), OS was censored at the date of last contact.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=32 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=15 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=19 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 2a: Overall Survival (OS)	NA Months Interval 13.1 to Median Overall Survival was not estimable at time of data lock (7 patients died and 25 were censored)	21.0 Months Interval 4.9 to 24.0	3.9 Months Interval 1.8 to 5.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: For each GI mid-gut NET and PNET participant from the date of first treatment through the date of first documented progression, assessed up to data cutoff 31 Jul 2020

Population: Outcome measured by cancer type. GI mid-gut NET and PNET participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment (RECIST 1.1).

The Objective Response Rate (ORR) is defined as the proportion of patients with a best overall CR or PR as defined by RECIST 1.1 using the investigator assessment captured on the electronic Case Report Form.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=26 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=12 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Phase 2a: ORR for Gastrointestinal Mid-gut NETs (GI Mid-gut NET) and Pancreatic NETs (PNET) Responder	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Phase 2a: ORR for Gastrointestinal Mid-gut NETs (GI Mid-gut NET) and Pancreatic NETs (PNET) Non-Responder	26 Participants	12 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: For each GI mid-gut NET and PNET participant, from the date of first treatment through the date of first documented progression, assessed up to data cutoff (31 Jul 2020)

Population: Outcome measured by cancer type. GI mid-gut NET cohort and PNET cohort participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment (RECIST 1.1). No participants in the GI mid-gut NET cohort or PNET cohort had an objective response, so no data is presented for this Outcome Measure

Duration of Response (DOR) is defined as the time from the first documented response (CR or PR), as assessed by the investigator, to the date of first documented disease progression or death due to underlying cancer. If a patient did not progress or die before the data cutoff date (31 Jul 2020), DOR was censored at the date of last adequate tumor assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every 6 weeks up to end of treatment for each patient.

Population: All participants who received any dose of study drug with at least 1 post-baseline immunogenicity assessment. Phase 2a participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.

Plasma Samples Using an Electrochemiluminescent Method for the Detection of Anti-PEN-221 Antibodies in Human Serum.

Outcome measures

Outcome measures
Measure	All Participants in Phase 1 Dose Escalation (Cohorts 1-7) n=2 Participants All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.	Phase 1 Dose Escalation (Cohort 2) n=3 Participants Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 Participants Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 Participants Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 Participants Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 Participants Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=2 Participants Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) n=11 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) n=22 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) n=15 Participants Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose.
Anti-PEN-221 Antibodies (ADA) Baseline ADA Positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Anti-PEN-221 Antibodies (ADA) Baseline ADA Negative	2 Participants	3 Participants	3 Participants	3 Participants	3 Participants	6 Participants	2 Participants	11 Participants	20 Participants	15 Participants
Anti-PEN-221 Antibodies (ADA) ADA Positive On-Study Treatment	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants
Anti-PEN-221 Antibodies (ADA) Persistent Positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Anti-PEN-221 Antibodies (ADA) Only Last Sample Positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Anti-PEN-221 Antibodies (ADA) Other Positive	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Anti-PEN-221 Antibodies (ADA) ADA Negative On-Study Treatment	2 Participants	3 Participants	3 Participants	2 Participants	3 Participants	6 Participants	2 Participants	11 Participants	19 Participants	13 Participants

Adverse Events

Phase 1 Dose Escalation (Cohort 1)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Phase 1 Dose Escalation (Cohort 2)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1 Dose Escalation (Cohort 3)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 1 Dose Escalation (Cohort 4)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1 Dose Escalation (Cohort 5)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase 1 Dose Escalation (Cohort 6)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Phase 1 Dose Escalation (Cohort 7)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 2a Dose Expansion (<8.8 mg/m^2)

Serious events: 3 serious events

Other events: 12 other events

Deaths: 4 deaths

Phase 2a Dose Expansion (8.8 mg/m^2)

Serious events: 7 serious events

Other events: 32 other events

Deaths: 8 deaths

Phase 2a Dose Expansion (>8.8 mg/m^2)

Serious events: 15 serious events

Other events: 20 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 Dose Escalation (Cohort 1) n=2 participants at risk Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 2) n=3 participants at risk Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 participants at risk Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 participants at risk Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 participants at risk Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 participants at risk Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=3 participants at risk Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) n=12 participants at risk Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m2 or \> 8.8 mg/m2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) n=34 participants at risk Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) n=20 participants at risk Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m2 or \> 8.8 mg/m2 dose groups based on the BSA conversion of the initial study dose.
Gastrointestinal disorders Abdominal Pain	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Constipation	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Nausea	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Vomiting	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Colitis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Diarrhea	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Fatigue	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Influenza like illness	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Asthenia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Malaise	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Mucosal inflammation	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Non-cardiac chest pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Oedema	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Sepsis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Urinary tract infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Device related infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Kidney infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Lung infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Pneumonia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Pulmonary sepsis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Cerebrovascular accident	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Hemorrhage intercranial	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Headache	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Metabolic encephalopathy	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Hepatobiliary disorders Gallbladder pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Hepatobiliary disorders Hepatic hemorrhage	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Blood bilirubin increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Alanine aminotransferase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Amylase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Lipase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor necrosis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Hypertension	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Thrombophlebitis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Blood and lymphatic system disorders Anemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Cardiac disorders Myocardial infarction	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Confusional state	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.

Other adverse events

Other adverse events
Measure	Phase 1 Dose Escalation (Cohort 1) n=2 participants at risk Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 2) n=3 participants at risk Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 3) n=3 participants at risk Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 4) n=3 participants at risk Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 5) n=3 participants at risk Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 6) n=6 participants at risk Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 1 Dose Escalation (Cohort 7) n=3 participants at risk Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg1 on an every 3-week cycle (21 days +/-2 days).	Phase 2a Dose Expansion (<8.8 mg/m^2) n=12 participants at risk Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m2 or \> 8.8 mg/m2 dose groups based on the BSA conversion of the initial study dose.	Phase 2a Dose Expansion (8.8 mg/m^2) n=34 participants at risk Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days)	Phase 2a Dose Expansion (>8.8 mg/m^2) n=20 participants at risk Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m\^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m2 or \> 8.8 mg/m2 dose groups based on the BSA conversion of the initial study dose.
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	100.0% 3/3 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	83.3% 5/6 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 6/12 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	47.1% 16/34 • Number of events 21 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 10/20 • Number of events 17 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Diarrhea	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	100.0% 3/3 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	100.0% 6/6 • Number of events 15 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	75.0% 9/12 • Number of events 15 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	44.1% 15/34 • Number of events 22 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	30.0% 6/20 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	38.2% 13/34 • Number of events 17 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	45.0% 9/20 • Number of events 13 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Abdominal Pain	50.0% 1/2 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 8 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 4/6 • Number of events 13 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	41.7% 5/12 • Number of events 8 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.6% 7/34 • Number of events 8 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 5/20 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 4/12 • Number of events 8 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	23.5% 8/34 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.0% 4/20 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Abdominal distension	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.8% 3/34 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Dry mouth	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Dysphagia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Stomatitis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Flatulence	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Ascites	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Enteritis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Hiatus hernia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Melaena	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Gastrointestinal disorders Mouth ulceration	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Fatigue	100.0% 2/2 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	100.0% 3/3 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	83.3% 5/6 • Number of events 11 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 6/12 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	47.1% 16/34 • Number of events 26 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 10/20 • Number of events 17 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Oedema peripheral	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 4/12 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.8% 3/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Asthenia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Pyrexia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Chills	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Mucosal inflammation	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Chest pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Non-cardiac chest pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Gait disturbance	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Infusion site erythema	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Infusion site reaction	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Infusion site swelling	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Oedema	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Extravasation	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Infusion site pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Infusion site pruritus	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
General disorders Injection site pruritus	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	100.0% 3/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 6/12 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	32.4% 11/34 • Number of events 13 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	35.0% 7/20 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	29.4% 10/34 • Number of events 15 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	30.0% 6/20 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.6% 7/34 • Number of events 8 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 13 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	14.7% 5/34 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 13 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	11.8% 4/34 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	14.7% 5/34 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.8% 3/34 • Number of events 8 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.0% 4/20 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypercholesterolemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Neuropathy peripheral	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 4/6 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 4/12 • Number of events 12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	29.4% 10/34 • Number of events 13 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.0% 4/20 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Headache	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 3/6 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	23.5% 8/34 • Number of events 11 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.0% 4/20 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Dysgeusia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	17.6% 6/34 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Dizziness	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 3/12 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	11.8% 4/34 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Paraesthesia	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Hypoesthesia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Somnolence	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Syncope	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Ageusia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Aphasia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Balance disorder	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Cognitive disorder	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Seizure	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Sensory disturbance	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Sinus headache	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Tremor	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Nervous system disorders Sixth nerve paralysis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Alanine aminotransferase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 3/6 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 3/12 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	26.5% 9/34 • Number of events 12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	45.0% 9/20 • Number of events 17 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 3/6 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.6% 7/34 • Number of events 13 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	45.0% 9/20 • Number of events 17 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 3/12 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	29.4% 10/34 • Number of events 13 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 5/20 • Number of events 8 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Blood creatinine increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.6% 7/34 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Weight decreased	50.0% 1/2 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	41.7% 5/12 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations White blood cell count decreased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	17.6% 6/34 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Amylase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Blood bilirubin increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	11.8% 4/34 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Neutrophil count decreased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Lipase increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Electrocardiogram T wave inversion	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations International normalized ratio increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Platelet count decreased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Blood glucose increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Blood pressure increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Blood urea increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Escherichia test positive	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Glucose urine present	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Lymphocyte count decreased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Pupil dilation procedure	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations Weight increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Investigations White blood cell count increased	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	100.0% 3/3 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 3/12 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	17.6% 6/34 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.0% 4/20 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	17.6% 6/34 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	15.0% 3/20 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.6% 7/34 • Number of events 11 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.0% 4/20 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Urinary tract infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	14.7% 5/34 • Number of events 9 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Lung infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Sinusitis	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Skin infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Bronchitis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Oral candidiasis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Conjunctivitis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Escherichia urinary tract infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Genital infection fungal	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Helicobacter gastritis	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Influenza	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Lower respiratory tract infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Infections and infestations Wound infection	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Flushing	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 3/12 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	14.7% 5/34 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 5/20 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Hypotension	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	14.7% 5/34 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Hypertension	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Hot flush	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Thrombophlebitis superficial	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	11.8% 4/34 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Phlebitis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Vascular disorders Embolism	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 3/6 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.6% 7/34 • Number of events 10 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Sleep apnea syndrome	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 3/6 • Number of events 6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	11.8% 4/34 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 3/12 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.8% 3/34 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Night sweats	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Skin tightness	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Blood and lymphatic system disorders Anemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	50.0% 3/6 • Number of events 12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 2/12 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.6% 7/34 • Number of events 11 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	25.0% 5/20 • Number of events 12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 4/12 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.6% 7/34 • Number of events 16 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	30.0% 6/20 • Number of events 11 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Injury, poisoning and procedural complications Contusion	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Injury, poisoning and procedural complications Laceration	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Injury, poisoning and procedural complications Skin wound	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Insomnia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 2/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.8% 3/34 • Number of events 4 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	30.0% 6/20 • Number of events 7 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Anxiety	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	20.0% 4/20 • Number of events 5 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Restlessness	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.9% 2/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Depressed mood	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Depression	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Mental status changes	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Hallucination	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Nightmare	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Psychiatric disorders Sleep disorder	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.8% 3/34 • Number of events 3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Renal and urinary disorders Dysuria	50.0% 1/2 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Renal and urinary disorders Hematuria	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Renal and urinary disorders Nocturia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Renal and urinary disorders Proteinuria	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 8 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Cardiac disorders Palpitations	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	66.7% 2/3 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Cardiac disorders Bradycardia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Cardiac disorders Tachycardia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Hepatobiliary disorders Cholelithiasis	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Hepatobiliary disorders Hepatomegaly	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Endocrine disorders Hypothyroidism	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	10.0% 2/20 • Number of events 2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Endocrine disorders Cushing's syndrome	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Eye disorders Vision blurred	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	8.3% 1/12 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	2.9% 1/34 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Eye disorders Diplopia	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	16.7% 1/6 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Reproductive system and breast disorders Pelvic pain	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	33.3% 1/3 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/20 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.
Immune system disorders Hypersensitivity	0.00% 0/2 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/6 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/3 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/12 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	0.00% 0/34 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.	5.0% 1/20 • Number of events 1 • From time of first dose of study drug through 28 days after the last dose of study drug for each participant up to data cut-off 31 Jul 2020. The Safety Analysis population was comprised of all enrolled patients who received any amount of study drug and have at least 1 post-baseline safety evaluation (AE, clinical laboratory assessments, vital signs, ECG (electrocardiogram), ECOG scores, physical examination). Participants were analyzed according to treatment received. Dose levels reported for Phase 2a Arms/Groups were collected for reporting in BSA format only.

Additional Information

Tarveda Clinical Information Center

Tarveda Therapeutics, Inc.

Phone: (617) 923-4100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institute and/or Principal Investigator may submit for publication or public disclosure based on the results of the study only after one of the following occurs as specified in the Clinical Trial Agreement: 1. Sponsor publication of the multi-center clinical trial results; 2. Sponsor notification that the multi-center clinical trial results submission is no longer planned; or 3. The eighteenth (18) month anniversary of the completion or early termination of the multi-center clinical trial.
Publication restrictions are in place

Restriction type: OTHER