Trial Outcomes & Findings for A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (NCT NCT05160168)

NCT ID: NCT05160168

Last Updated: 2024-06-05

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Up to 24 months after first dose

Results posted on

2024-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Escalation (3 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Overall Study STARTED	3	7	3	3	3	7	6
Overall Study COMPLETED	3	7	3	3	3	7	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation (3 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).	Expansion Cohort 1 Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase.	Expansion Cohort 2 Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase.	Expansion Cohort 3 Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	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=42 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	—	—	—	20 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	—	—	—	12 Participants n=42 Participants
Age, Continuous	56.3 years STANDARD_DEVIATION 13.01 • n=5 Participants	57.7 years STANDARD_DEVIATION 10.66 • n=7 Participants	57.7 years STANDARD_DEVIATION 15.04 • n=5 Participants	49.0 years STANDARD_DEVIATION 6.00 • n=4 Participants	62.7 years STANDARD_DEVIATION 9.29 • n=21 Participants	64.6 years STANDARD_DEVIATION 9.07 • n=8 Participants	60.8 years STANDARD_DEVIATION 18.32 • n=8 Participants	—	—	—	59.3 years STANDARD_DEVIATION 12.05 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	—	—	—	15 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	—	—	—	17 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	—	—	—	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants	5 Participants n=8 Participants	—	—	—	30 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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=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=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	1 Participants n=8 Participants	0 Participants n=8 Participants	—	—	—	1 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	—	—	—	1 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	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	—	—	—	1 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	—	—	—	29 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=42 Participants
Race (NIH/OMB) Unknown or Not Reported	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=42 Participants
Region of Enrollment United States	3 participants n=5 Participants	7 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	3 participants n=21 Participants	7 participants n=8 Participants	6 participants n=8 Participants	—	—	—	32 participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 24 months after first dose

Population: Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630.

Outcome measures

Outcome measures
Measure	Dose Escalation (3 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Dose Escalation (Phase 1): Safety Analysis - Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	3 Participants	7 Participants	3 Participants	3 Participants	3 Participants	7 Participants	6 Participants

PRIMARY outcome

Timeframe: 28 days

Population: DLT-Evaluable Analysis Set (Phase 1 only), which includes patients enrolled in the Dose Escalation (Phase 1) portion who completed at least 75% of the planned total dose during Cycle 1 (DLT evaluation period, i.e. 21 of 28 days) and patients who experienced a protocol-defined DLT, regardless of dosing adherence in Cycle 1.

Outcome measures

Outcome measures
Measure	Dose Escalation (3 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=6 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Dose Escalation (Phase 1): Safety Analysis - Number of Participants With Dose-limiting Toxicities (DLTs) Following Oral Administration of THE-630	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: 28 days

The MTD is defined as the highest dose at which ≤1 of 6 DLT-assessment eligible patients experience a DLT within the first 28 days of treatment (end of Cycle 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (3 mg Once Daily) n=27 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Dose Escalation (Phase 1): Safety Analysis - Maximum Tolerated Dose (MTD) of Orally Administered THE-630	NA mg The MTD could not be identified because (1) the 18 mg once daily dose level did not enroll 6 DLT-assessment eligible patients and (2) the 27 mg once daily dose level was shown to exceed the MTD.	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days

The RP2D was expected to be equal to the MTD or less than the MTD, if aspects of tolerability or efficacy not encompassed by the MTD determination suggested utilizing a lower dose.

Outcome measures

Outcome measures
Measure	Dose Escalation (3 mg Once Daily) n=27 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Dose Escalation (Phase 1): Recommended Phase 2 Dose (RP2D) of Orally Administered THE-630	NA mg The RP2D was not determined, in part because the MTD could not be identified. The study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study.	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 24 months after first dose

Population: The Sponsor terminated the study due to early dose-limiting toxicities and not initiate Expansion Cohort 1, Expansion Cohort 2 or Expansion Cohort 3 (Phase 2).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days)

Population: The scope of planned analyses and data reporting was reduced (per statistical analysis plan \[SAP\] v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available.

Cmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days)

Population: The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available.

Tmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days)

AUC 0-24 of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days)

AUC 0-t of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Population: Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630.

Outcome measures

Outcome measures
Measure	Dose Escalation (3 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Dose Escalation (Phase 1): Efficacy Assessment - Confirmed ORR, According to Modified RECIST 1.1	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 41.0	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 41.0	0 percentage of participants Interval 0.0 to 45.9

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Population: Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630.

Outcome measures

Outcome measures
Measure	Dose Escalation (3 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Dose Escalation (Phase 1): Efficacy Assessment - Best Overall Response, According to Modified RECIST 1.1 Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Dose Escalation (Phase 1): Efficacy Assessment - Best Overall Response, According to Modified RECIST 1.1 Parital Response (PR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Dose Escalation (Phase 1): Efficacy Assessment - Best Overall Response, According to Modified RECIST 1.1 Stable Disease (SD)	0 Participants	1 Participants	1 Participants	3 Participants	3 Participants	3 Participants	4 Participants
Dose Escalation (Phase 1): Efficacy Assessment - Best Overall Response, According to Modified RECIST 1.1 Progressive Disease (PD)	3 Participants	3 Participants	2 Participants	0 Participants	0 Participants	3 Participants	2 Participants
Dose Escalation (Phase 1): Efficacy Assessment - Best Overall Response, According to Modified RECIST 1.1 Not Evaluable (NE)	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Population: Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630.

Outcome measures

Outcome measures
Measure	Dose Escalation (3 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Dose Escalation (Phase 1): Efficacy Assessment - Disease Control Rate (DCR), According to Modified RECIST 1.1	0 percentage of participants Interval 0.0 to 70.8	14.3 percentage of participants Interval 0.4 to 57.9	33.3 percentage of participants Interval 0.8 to 90.6	100 percentage of participants Interval 29.2 to 100.0	100 percentage of participants Interval 29.2 to 100.0	42.9 percentage of participants Interval 9.9 to 81.6	66.7 percentage of participants Interval 22.3 to 95.7

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630.

Outcome measures

Outcome measures
Measure	Dose Escalation (3 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=7 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 Participants Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Dose Escalation (Phase 1): Efficacy Assessment - Clinical Benefit Rate (CBR) at 16 Weeks, According to Modified RECIST 1.1	0 percentage of participants Interval 0.0 to 70.8	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 70.8	66.7 percentage of participants Interval 9.4 to 99.2	66.7 percentage of participants Interval 9.4 to 99.2	14.3 percentage of participants Interval 0.4 to 57.9	50.0 percentage of participants Interval 11.8 to 88.2

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Population: No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months after first dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days)

Cmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days)

Tmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days)

AUC 0-24 of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days)

AUC 0-t of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Outcome measures

Outcome data not reported

Adverse Events

Dose Escalation (3 mg Once Daily)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Escalation (4 mg Once Daily)

Serious events: 5 serious events

Other events: 7 other events

Deaths: 6 deaths

Dose Escalation (6 mg Once Daily)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Dose Escalation (9 mg Once Daily)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation (12 mg Once Daily)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Dose Escalation (18 mg Once Daily)

Serious events: 5 serious events

Other events: 7 other events

Deaths: 2 deaths

Dose Escalation (27 mg Once Daily)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation (3 mg Once Daily) n=3 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=7 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=7 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Cardiac disorders Myocardial infarction	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Parainfluenzae virus infection	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Encephalopathy	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Hepatic encephalopathy	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Other adverse events

Other adverse events
Measure	Dose Escalation (3 mg Once Daily) n=3 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (4 mg Once Daily) n=7 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (6 mg Once Daily) n=3 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (9 mg Once Daily) n=3 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (12 mg Once Daily) n=3 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (18 mg Once Daily) n=7 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles).	Dose Escalation (27 mg Once Daily) n=6 participants at risk Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 2/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Cardiac disorders Sinus bradycardia	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Cardiac disorders Pericardial effusion	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Cardiac disorders Sinus tachycardia	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Eye disorders Visual impairment	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Eye disorders Blepharospasm	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Eye disorders Vision blurred	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	100.0% 3/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 4/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Constipation	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 4/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Nausea	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 2/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Dry mouth	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Abdominal pain upper	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 2/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Abdominal discomfort	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Abdominal pain lower	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Abdominal tenderness	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Retching	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Gastrointestinal disorders Saliva altered	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
General disorders Fatigue	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	50.0% 3/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
General disorders Oedema peripheral	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
General disorders Thirst	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
General disorders Chills	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
General disorders Pyrexia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
General disorders Chest pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
General disorders Early satiety	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations COVID-19	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Candida infection	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Folliculitis	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Gingivitis	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Infectious pleural effusion	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Oral candidiasis	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Rash pustular	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Infections and infestations Sinusitis	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Aspartate aminotransferase increased	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	57.1% 4/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 2/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Weight decreased	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 2/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Alanine aminotransferase increased	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	42.9% 3/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 2/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Amylase increased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Platelet count decreased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations White blood cell count decreased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Blood bilirubin increased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Blood cholesterol increased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Ejection fraction decreased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Lipase increased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Serum ferritin decreased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Investigations Troponin increased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 4/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 2/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Arthralgia	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 2/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Muscle tightness	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Headache	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Balance disorder	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Cognitive disorder	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Dizziness	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Nervous system disorders Trigeminal nerve disorder	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Psychiatric disorders Insomnia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Psychiatric disorders Depression	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Psychiatric disorders Anxiety	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Psychiatric disorders Confusional state	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Psychiatric disorders Irritability	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Psychiatric disorders Libido decreased	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Renal and urinary disorders Haematuria	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Renal and urinary disorders Proteinuria	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Renal and urinary disorders Micturition urgency	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Reproductive system and breast disorders Oedema genital	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	66.7% 2/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	28.6% 2/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	50.0% 3/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Vascular disorders Hypertension	100.0% 3/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	57.1% 4/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	16.7% 1/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Vascular disorders Flushing	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	33.3% 1/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Vascular disorders Hot flush	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/3 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	14.3% 1/7 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	0.00% 0/6 • Up to 24 months after first dose Dose Escalation (Phase 1): Safety Analysis - Number of participants with treatment-emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Additional Information

Stew Kroll

Theseus Pharmaceuticals (a subsidiary of Concentra Biosciences)

Phone: (650) 576-9679

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Agreements between Theseus Pharmaceuticals and individual investigators may vary. Theseus has the right to review results disclosures prior to public release and can embargo results disclosures for \>60 days but ≤180 days from the date of submission for review. Theseus supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER