Trial Outcomes & Findings for A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors (NCT NCT04157517)

Last Updated: 2024-12-27

Results Overview

Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

From signing of the informed consent form (ICF) through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)

Results posted on

2024-12-27

Participant Flow

Participants took part in the study at 17 investigative sites in the United States and Australia from 12 December 2019 to 20 December 2023.

Participants were enrolled to Phase 1b (Dose Escalation) to receive single agent modakafusp alfa, and combination therapy of modakafusp alfa and pembrolizumab in Phase 2 (Safety lead-in, and Expansion with 3 Cohorts \[Cohorts I, II and III). Cohort III had no enrolment due to strategic reason, therefore, no data was collected and reported for Cohort III in this report.

Participant milestones

Participant milestones
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.1 milligrams per kilogram (mg/kg), infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Overall Study STARTED	3	3	3	3	3	6	3	9	12
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	3	3	3	6	3	9	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.1 milligrams per kilogram (mg/kg), infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Overall Study Death	1	2	2	3	3	4	1	2	4
Overall Study Withdrawal by Subject	1	1	1	0	0	1	0	0	1
Overall Study Other	1	0	0	0	0	1	2	7	7

Baseline Characteristics

A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=9 Participants Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=12 Participants Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Total n=45 Participants Total of all reporting groups
Age, Continuous	74.0 years STANDARD_DEVIATION 5.20 • n=5 Participants	51.3 years STANDARD_DEVIATION 11.37 • n=7 Participants	68.0 years STANDARD_DEVIATION 10.44 • n=5 Participants	62.0 years STANDARD_DEVIATION 8.19 • n=4 Participants	55.0 years STANDARD_DEVIATION 4.58 • n=21 Participants	61.8 years STANDARD_DEVIATION 9.13 • n=8 Participants	74.3 years STANDARD_DEVIATION 4.04 • n=8 Participants	53.4 years STANDARD_DEVIATION 17.91 • n=24 Participants	60.3 years STANDARD_DEVIATION 12.11 • n=42 Participants	60.7 years STANDARD_DEVIATION 13 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	1 Participants n=42 Participants	16 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	5 Participants n=24 Participants	11 Participants n=42 Participants	29 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	7 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants	2 Participants n=8 Participants	8 Participants n=24 Participants	8 Participants n=42 Participants	33 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants
Race (NIH/OMB) American Indian 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Native 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	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=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	8 Participants n=24 Participants	9 Participants n=42 Participants	38 Participants n=42 Participants
Race (NIH/OMB) More than one race	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants

PRIMARY outcome

Timeframe: From signing of the informed consent form (ICF) through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	6 Participants	3 Participants	—	—

PRIMARY outcome

Timeframe: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs	2 Participants	1 Participants	2 Participants	2 Participants	3 Participants	4 Participants	2 Participants	—	—

PRIMARY outcome

Timeframe: Cycle 1 (Cycle length is equal to [=] 21 days)

Population: DLT evaluable analysis set included participants who received all Cycle 1 doses of modakafusp alfa or experience a DLT in Cycle 1 in the dose-escalation portion of the study; or participants who received all Cycle 1 doses of modakafusp alfa in combination with pembrolizumab or experience a DLT in Cycle 1 in the safety lead-in portion of the study.

A DLT was defined as any of the following AEs that occurred in the escalation phase or in the combination safety lead-in phase during Cycle 1 unless they were considered by the investigator to be clearly unrelated to therapy with modakafusp alfa according to NCI CTCAE version 5.0. Any Grade 5 TEAE. Febrile neutropenia: Grade \>=3 or 4 neutropenia. Grade 4 thrombocytopenia. Grade \>=3 thrombocytopenia. Any Grade 3 immune-related AEs such as pericarditis, pneumonitis, cardiotoxicity, hepatitis, or neurotoxicity. Delay in the initiation of Cycle 2 by more than 14 days from the calculated start date due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities. Any Grade \>=3 nonhematologic toxicity with some exception. Any Grade 2 nonhematologic toxicity that was considered by the investigator to be related to study drug and dose-limiting.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Serious Adverse Event (SAEs)	3 Participants	1 Participants	2 Participants	1 Participants	2 Participants	4 Participants	0 Participants	—	—

PRIMARY outcome

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations TEAEs Leading to Treatment Discontinuations	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—
Phase 1b and Phase 2 Safety Lead-in: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations TEAEs Leading to Dose Modifications	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	4 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of treatment or end of study (up to 2 years)

Population: The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation.

ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=9 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: Overall Response Rate (ORR) Based on RECIST v1.1	0.0 percentage of participants Interval 0.0 to 33.6	16.7 percentage of participants Interval 2.1 to 48.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (Cycle length = 21 days)

Population: DLT evaluable analysis set included participants who received all Cycle 1 doses of modakafusp alfa or experience a DLT in Cycle 1 in the dose-escalation portion of the study.

The MTD was selected as the highest dose which has maximum probability of being in targeted toxicity interval.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=21 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b: Maximum Tolerated Dose (MTD) of Modakafusp Alfa	NA milligrams per kilograms (mg/kg) MTD was not determined because criteria was not met.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (Cycle length = 21 days)

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

The RP2D of modakafusp alfa as a single agent or in combination with pembrolizumab was determined based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v5.0.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=21 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Recommended Phase 2 Dose (RP2D) for Single Agent (SA) Modakafusp Alfa in Phase 1b and in Combination With Pembrolizumab in Phase 2 Safety Lead-in	1.0 mg/kg	1.0 mg/kg	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month)

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=9 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: Number of Participants Reporting One or More TEAEs	8 Participants	12 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month)

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=9 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs	6 Participants	7 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 2 years 1 month)

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=9 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: Number of Participants Reporting One or More SAEs	2 Participants	6 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month)

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=9 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations TEAEs Leading to Dose Modifications	1 Participants	9 Participants	—	—	—	—	—	—	—
Phase 2 Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations TEAEs Leading to Treatment Discontinuations	0 Participants	1 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days)

Population: Pharmacokinetic (PK) analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "number analyzed" signified participants who were evaluable at specified timepoints.

Cmax for modakafusp alfa was reported.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Maximum Observed Serum Concentration (Cmax) for Modakafusp Alfa Cycle 1 Day 1	261 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 85.0	2770 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 51.4	4920 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 42.9	17000 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 26.1	17700 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 60.1	37200 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 29.9	21200 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 18.7	—	—
Phase 1b and Phase 2 Safety Lead-in: Maximum Observed Serum Concentration (Cmax) for Modakafusp Alfa Cycle 2 Day 1	336 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 540.2	2790 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 14.2	3560 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 99.9	9420 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 52.7	14400 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 136.2	25400 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 84.5	—	—	—
Phase 1b and Phase 2 Safety Lead-in: Maximum Observed Serum Concentration (Cmax) for Modakafusp Alfa Cycle 3 Day 1	—	—	—	—	—	—	13900 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	—	—

SECONDARY outcome

Population: PK analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable at specified timepoints.

Tmax for modakafusp alfa was reported.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Time to Reach the Cmax (Tmax) for Modakafusp Alfa Cycle 2 Day 1	1.28 hour Interval 1.05 to 1.5	1.03 hour Interval 1.0 to 1.05	1.05 hour Interval 0.92 to 3.92	1.07 hour Interval 1.03 to 3.18	1.77 hour Interval 1.6 to 1.93	1.97 hour Interval 1.03 to 2.72	—	—	—
Phase 1b and Phase 2 Safety Lead-in: Time to Reach the Cmax (Tmax) for Modakafusp Alfa Cycle 1 Day 1	1.53 hour Interval 1.48 to 1.72	1.17 hour Interval 1.03 to 1.17	1.05 hour Interval 0.98 to 1.2	1.18 hour Interval 1.17 to 2.12	1.52 hour Interval 1.12 to 2.02	1.97 hour Interval 1.03 to 2.72	3.13 hour Interval 2.6 to 3.42	—	—
Phase 1b and Phase 2 Safety Lead-in: Time to Reach the Cmax (Tmax) for Modakafusp Alfa Cycle 3 Day 1	—	—	—	—	—	—	2.90 hour Interval 2.9 to 2.9	—	—

SECONDARY outcome

Population: PK analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "number analyzed" signified participants who were evaluable at specified timepoints.

AUClast for modakafusp alfa was reported.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) for Modakafusp Alfa Cycle 1 Day 1	458 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 135.8	8450 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 70.0	33100 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 72.4	183000 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 74.1	262000 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 61.5	897000 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 57.1	455000 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 21.8	—	—
Phase 1b and Phase 2 Safety Lead-in: Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) for Modakafusp Alfa Cycle 2 Day 1	535 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 1101.2	8030 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 9.3	20300 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 153.2	86300 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 81.7	159000 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 219.2	360000 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 112.5	—	—	—
Phase 1b and Phase 2 Safety Lead-in: Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) for Modakafusp Alfa Cycle 3 Day 1	—	—	—	—	—	—	165000 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	—	—

SECONDARY outcome

AUCinf of modakafusp alfa was reported.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=1 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Modakafusp Alfa Cycle 1 Day 1	1470 h*ng/mL Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	8780 h*ng/mL Geometric Coefficient of Variation 66.3	33100 h*ng/mL Geometric Coefficient of Variation 72.2	217000 h*ng/mL Geometric Coefficient of Variation 60.2	263000 h*ng/mL Geometric Coefficient of Variation 61.5	1060000 h*ng/mL Geometric Coefficient of Variation 62.1	455000 h*ng/mL Geometric Coefficient of Variation 21.8	—	—
Phase 1b and Phase 2 Safety Lead-in: Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Modakafusp Alfa Cycle 2 Day 1	2540 h*ng/mL Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	8840 h*ng/mL Geometric Coefficient of Variation 7.1	21100 h*ng/mL Geometric Coefficient of Variation 140.1	86400 h*ng/mL Geometric Coefficient of Variation 81.6	160000 h*ng/mL Geometric Coefficient of Variation 218.7	372000 h*ng/mL Geometric Coefficient of Variation 121.3	—	—	—
Phase 1b and Phase 2 Safety Lead-in: Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Modakafusp Alfa Cycle 3 Day 1	—	—	—	—	—	—	165000 h*ng/mL Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	—	—

SECONDARY outcome

T1/2z of modakafusp alfa was reported.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=1 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Terminal Disposition Phase Half-life (t1/2z) for Modakafusp Alfa Cycle 1 Day 1	1.07 hour Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	1.97 hour Geometric Coefficient of Variation 33.9	5.25 hour Geometric Coefficient of Variation 13.7	5.60 hour Geometric Coefficient of Variation 28.5	6.23 hour Geometric Coefficient of Variation 14.4	15.5 hour Geometric Coefficient of Variation 71.8	6.44 hour Geometric Coefficient of Variation 11.0	—	—
Phase 1b and Phase 2 Safety Lead-in: Terminal Disposition Phase Half-life (t1/2z) for Modakafusp Alfa Cycle 2 Day 1	0.832 hour Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	1.85 hour Geometric Coefficient of Variation 9.1	3.08 hour Geometric Coefficient of Variation 38.6	6.43 hour Geometric Coefficient of Variation 11.3	6.15 hour Geometric Coefficient of Variation 7.7	14.1 hour Geometric Coefficient of Variation 85.6	—	—	—
Phase 1b and Phase 2 Safety Lead-in: Terminal Disposition Phase Half-life (t1/2z) for Modakafusp Alfa Cycle 3 Day 1	—	—	—	—	—	—	6.15 hour Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	—	—

SECONDARY outcome

CL was total clearance of the drug from the serum. CL of modakafusp alfa was reported.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=1 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Total Clearance (CL) After Intravenous Administration for Modakafusp Alfa Cycle 1 Day 1	0.0682 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	0.0228 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 66.2	0.0121 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 72.4	0.00345 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 61.0	0.00383 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 61.1	0.00142 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 61.1	0.00220 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 21.3	—	—
Phase 1b and Phase 2 Safety Lead-in: Total Clearance (CL) After Intravenous Administration for Modakafusp Alfa Cycle 2 Day 1	0.0394 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	0.0226 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 7.2	0.0190 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 139.6	0.00872 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 81.1	0.00632 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 214.5	0.00407 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation 118.5	—	—	—
Phase 1b and Phase 2 Safety Lead-in: Total Clearance (CL) After Intravenous Administration for Modakafusp Alfa Cycle 3 Day 1	—	—	—	—	—	—	0.00610 liters per hour per kilograms (L/h/kg) Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	—	—

SECONDARY outcome

Vss of modakafusp alfa was reported.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=1 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: Volume of Distribution at Steady State (Vss) for Modakafusp Alfa Cycle 1 Day 1	0.119 liters per kilograms (L/kg) Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	0.0567 liters per kilograms (L/kg) Geometric Coefficient of Variation 49.7	0.0562 liters per kilograms (L/kg) Geometric Coefficient of Variation 58.2	0.0276 liters per kilograms (L/kg) Geometric Coefficient of Variation 13.5	0.0369 liters per kilograms (L/kg) Geometric Coefficient of Variation 48.1	0.0331 liters per kilograms (L/kg) Geometric Coefficient of Variation 33.1	0.0313 liters per kilograms (L/kg) Geometric Coefficient of Variation 13.3	—	—
Phase 1b and Phase 2 Safety Lead-in: Volume of Distribution at Steady State (Vss) for Modakafusp Alfa Cycle 2 Day 1	0.0546 liters per kilograms (L/kg) Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	0.0565 liters per kilograms (L/kg) Geometric Coefficient of Variation 15.6	0.0794 liters per kilograms (L/kg) Geometric Coefficient of Variation 135.8	0.0562 liters per kilograms (L/kg) Geometric Coefficient of Variation 72.9	0.0514 liters per kilograms (L/kg) Geometric Coefficient of Variation 107.2	0.0629 liters per kilograms (L/kg) Geometric Coefficient of Variation 33.4	—	—	—
Phase 1b and Phase 2 Safety Lead-in: Volume of Distribution at Steady State (Vss) for Modakafusp Alfa Cycle 3 Day 1	—	—	—	—	—	—	0.0453 liters per kilograms (L/kg) Geometric Coefficient of Variation NA Here "NA" means Geometric Coefficient of Variation could not be calculated for a single participant.	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2)

Population: The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation.

ORR was defined as the percentage of participants who achieved CR or PR as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=4 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2 Safety Lead-in: ORR Based on RECIST v1.1	0.0 percentage of participants Interval 0.0 to 84.2	0.0 percentage of participants Interval 0.0 to 84.2	0.0 percentage of participants Interval 0.0 to 84.2	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 84.2	0.0 percentage of participants Interval 0.0 to 60.2	0.0 percentage of participants Interval 0.0 to 70.8	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2)

Population: The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation.

DCR was defined as the percentage of participants who achieved CR, PR, or stable disease (SD) (determined by the investigator) as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD), taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=4 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=9 Participants Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=12 Participants Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2: Disease Control Rate (DCR) Based on RECIST v1.1	0 percentage of participants Interval 0.0 to 84.2	50.0 percentage of participants Interval 1.3 to 98.7	0 percentage of participants Interval 0.0 to 84.2	33.3 percentage of participants Interval 0.8 to 90.6	0 percentage of participants Interval 0.0 to 84.2	50.0 percentage of participants Interval 6.8 to 93.2	33.3 percentage of participants Interval 0.8 to 90.6	33.3 percentage of participants Interval 7.5 to 70.1	41.7 percentage of participants Interval 15.2 to 72.3

SECONDARY outcome

Timeframe: From the date of first documentation of a CR or PR until PD or death, whichever occurred first (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2])

Population: The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Here, "overall number of participants analyzed" signified participants who had CR or PR.

DOR was defined as the time from the first documentation of a response (CR or PR) until PD or death, whichever occurred first as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=2 Participants Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2: Duration of Response (DOR) Based on RECIST v1.1	—	—	—	—	—	—	—	—	NA months Here "NA" means median and 95% confidence interval could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From the date of the first dose of study drug to the date of the first documentation of PD (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2])

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD according to RECIST v1.1. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=1 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=4 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=8 Participants Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=7 Participants Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2: Time to Progression (TTP) Based on RECIST v1.1	2.4 months Interval 1.41 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	4.5 months Interval 1.41 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.7 months Interval 0.79 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.4 months Interval 1.38 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.5 months Here "NA" means upper and lower limits of 95% confidence interval could not be estimated due to insufficient events.	2.3 months Interval 1.35 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.7 months Interval 1.31 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	2.8 months Interval 1.28 to 6.01	2.3 months Interval 1.35 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From the date of the first dose of study drug to the date of first documentation of PD or death, whichever occurred first (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2])

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

PFS was defined as the time from the date of the first dose of study drug to the date of first documentation of PD according to RECIST v.1.1, or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=9 Participants Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=12 Participants Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2: Progression Free Survival (PFS) Based on RECIST v1.1	2.4 months Interval 1.41 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.6 months Interval 1.41 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.7 months Interval 0.79 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.4 months Interval 1.38 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.8 months Interval 1.48 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.9 months Interval 0.95 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	1.7 months Interval 1.31 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	4.8 months Interval 1.31 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	2.6 months Interval 1.38 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From the date of first dose of study drug to the date of death due to any cause (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2])

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

OS was defined as the time from the date of first dose of study drug to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=9 Participants Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=12 Participants Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2: Overall Survival (OS) Based on RECIST v1.1	NA months Interval 3.61 to Here "NA" means median and upper limit of 95% confidence interval could not be estimated due to insufficient events.	9.8 months Interval 1.64 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	7.0 months Interval 0.99 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	6.3 months Interval 2.99 to Here "NA" means the upper limit of 95% confidence interval could not be estimated due to small number of death events resulting large variability and therefore the upper 95% confidence limits of Kaplan-Meier survival estimate remaining above 50%.	4.3 months Interval 1.84 to Here "NA" means the upper limit of 95% confidence interval could not be estimated due to small number of death events resulting large variability and therefore the upper 95% confidence limits of Kaplan-Meier survival estimate remaining above 50%.	3.1 months Interval 0.95 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	NA months Interval 5.13 to Here "NA" means median and upper limit of 95% confidence interval could not be estimated due to insufficient events.	NA months Interval 5.62 to Here "NA" means median and upper limit of 95% confidence interval could not be estimated due to insufficient events.	NA months Interval 2.6 to Here "NA" means median and upper limit of 95% confidence interval could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From date of first dose of study drug until confirmed iCR or iPR (up to end of treatment or end of study [up to 2 years])

Population: The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation.

ORR was defined as the percentage of participants whose BOR was immune CR (iCR) or immune PR (iPR), according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions immune confirmed progressive disease (iCPD). (iCPD): immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. iSD: immune stable disease in the absence of iCR or immune PD (iPD). iUPD: immune unconfirmed progressive disease (iUPD) when iCPD is unconfirmed NE: not evaluable.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=8 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: ORR Based on Based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)	0.0 percentage of participants Interval 0.0 to 36.9	16.7 percentage of participants Interval 2.1 to 48.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first dose of study drug until confirmed iCR or iPR (up to end of treatment or end of study [up to 2 years])

Population: The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation.

DCR was defined as percentage of participants who have achieved the best response of iCR, iPR, iSD based on iRECIST as per investigator assessment. iCR: achieved with disappearance of all target lesions, iPR: achieved with disappearance of partial target lesions. iSD: in the absence of iCR or iCPD. iUPD: when iPD is unconfirmed NE: not evaluable.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=8 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: DCR Based on iRECIST	37.5 percentage of participants Interval 8.5 to 75.5	41.7 percentage of participants Interval 15.2 to 72.3	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first documented confirmed iCR or iPR until first documentation of iCPD or death (up to end of treatment or end of study [up to 2 years])

DOR was defined as time from date of first observation of response (iPR or iCR) to date of the first observation of progression (iCPD) based on iRECIST as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: DOR Based on iRECIST	—	NA months Here "NA" means median and 95% confidence interval could not be estimated due to insufficient events.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of the first dose of study drug to the date of the first documentation of iCPD (up to end of treatment or end of study [up to 2 years])

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of iCPD based on iRECIST as per investigator assessment. iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=9 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: TTP Based on iRECIST	4.8 months Interval 1.31 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	NA months Interval 1.38 to Here "NA" means median and upper limit of 95% confidence interval could not be estimated due to insufficient events.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug until confirmed iCPD or death (up to end of treatment or end of study [up to 2 years])

Population: The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.

PFS was defined as the time from the first dose date to the date of iCPD or date of death (whichever occurred first) based on iRECIST as per investigator assessment. iCPD was defined as immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=9 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=12 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 2 Expansion: PFS Based on iRECIST	4.8 months Interval 1.31 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	2.6 months Interval 2.6 to Here "NA" means upper limit of 95% confidence interval could not be estimated due to insufficient events.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2)

Population: Immunogenicity-evaluable analysis set included participants with a baseline and at least one post-baseline immunogenicity assessment.

ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=4 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=9 Participants Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=10 Participants Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2: Number of Participants With Positive Anti-Modakafusp Alfa Antibodies (ADA) Status	2 Participants	2 Participants	3 Participants	3 Participants	3 Participants	4 Participants	3 Participants	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2)

Population: Immunogenicity-evaluable analysis set included participants with a baseline and at least one post-baseline immunogenicity assessment.

ADA titers were assessed by confirmatory assay.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=2 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=4 Participants Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg n=3 Participants Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=9 Participants Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg n=10 Participants Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Phase 1b and Phase 2: Titer of Anti-Modakafusp Alfa Antibodies (ADA)	150.0 titers Interval 75.0 to 225.0	164000.0 titers Interval 2020.0 to 1480000.0	6070.0 titers Interval 675.0 to 492000.0	6070.0 titers Interval 75.0 to 164000.0	6070.0 titers Interval 2020.0 to 54700.0	109350.0 titers Interval 2020.0 to 492000.0	273350.0 titers Interval 225.0 to 1480000.0	492000.0 titers Interval 225.0 to 4430000.0	164000.0 titers Interval 225.0 to 1480000.0

Adverse Events

Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab

Serious events: 2 serious events

Other events: 8 other events

Deaths: 2 deaths

Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab

Serious events: 6 serious events

Other events: 12 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 participants at risk Participants received modakafusp alfa 0.1mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab n=3 participants at risk Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab n=9 participants at risk Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab n=12 participants at risk Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Nervous system disorders Dysarthria	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations Encephalitis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Cardiac disorders Cardiac tamponade	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Chest pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Confusional state	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Death	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Injury, poisoning and procedural complications Infusion related reaction	100.0% 3/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 2/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Intussusception	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Nausea	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Pyrexia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Seizure	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Vomiting	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)

Other adverse events

Other adverse events
Measure	Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg n=3 participants at risk Participants received modakafusp alfa 0.1mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg n=3 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg n=3 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg n=3 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg n=3 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg n=6 participants at risk Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.	Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab n=3 participants at risk Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab n=9 participants at risk Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.	Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab n=12 participants at risk Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 3/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 4/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Alanine aminotransferase increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	22.2% 2/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Anxiety	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	25.0% 3/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	25.0% 3/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Bell's palsy	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Blood alkaline phosphatase decreased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Blood bilirubin increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Blood creatinine increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Vascular disorders Blood pressure fluctuation	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Blood thyroid stimulating hormone increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Blood uric acid increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Body temperature increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Brain fog	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations C-reactive protein increased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations CD4 lymphocytes decreased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations COVID-19	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Chest discomfort	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	25.0% 3/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Chest pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Chills	100.0% 3/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	50.0% 3/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 3/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	41.7% 5/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Renal and urinary disorders Chronic kidney disease	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Confusional state	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations Conjunctivitis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Constipation	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 2/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	22.2% 2/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 4/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Immune system disorders Cytokine release syndrome	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Depression	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Disturbance in attention	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Dizziness	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Dysgeusia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Dysphagia	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 2/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	25.0% 3/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Ear and labyrinth disorders Ear pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Eye disorders Eye pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Face oedema	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Fatigue	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 2/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	44.4% 4/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	58.3% 7/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Flatulence	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Vascular disorders Flushing	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	58.3% 7/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Hallucination	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Injury, poisoning and procedural complications Hand fracture	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Headache	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	44.4% 4/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	75.0% 9/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Hemiparesis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Immune system disorders Hypersensitivity	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Vascular disorders Hypertension	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	25.0% 3/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Vascular disorders Hypotension	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Hypoxia	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Metabolism and nutrition disorders Increased appetite	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Influenza like illness	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 2/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	50.0% 6/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Infusion site extravasation	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Insomnia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	25.0% 3/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Intensive care unit delirium	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	22.2% 2/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 4/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Libido decreased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Lymphocyte count decreased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 2/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Renal and urinary disorders Micturition urgency	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	25.0% 3/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Nausea	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	50.0% 3/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	44.4% 4/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	58.3% 7/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Non-cardiac chest pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Oedema peripheral	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations Orchitis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Paraesthesia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations Pneumonia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Renal and urinary disorders Proteinuria	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 4/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Pyrexia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 3/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Psychiatric disorders Restlessness	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations Sepsis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations Sinusitis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
General disorders Swelling face	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Syncope	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Cardiac disorders Tachycardia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	66.7% 2/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 2/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	22.2% 2/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 4/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Toothache	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Nervous system disorders Tremor	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Infections and infestations Urinary tract infection	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Renal and urinary disorders Urinary tract obstruction	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Ear and labyrinth disorders Vestibular disorder	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Eye disorders Vision blurred	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	11.1% 1/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Gastrointestinal disorders Vomiting	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 1/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 3/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	16.7% 2/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Investigations Weight decreased	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	33.3% 1/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/6 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/3 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	0.00% 0/9 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)	8.3% 1/12 • From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place