Trial Outcomes & Findings for A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013) (NCT NCT04521621)

Last Updated: 2024-10-01

Results Overview

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Up to approximately 30 months

Results posted on

2024-10-01

Participant Flow

76 participants were allocated and 75 participants received study intervention. The study was terminated before any participants were enrolled into Cohorts D and E.

Participant milestones

Participant milestones
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Overall Study STARTED	22	14	17	6	3	14
Overall Study Treated	21	14	17	6	3	14
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	22	14	17	6	3	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Overall Study Death	17	8	8	5	2	7
Overall Study Study Terminated by Sponsor	4	6	8	0	1	7
Overall Study Withdrawal by Subject	0	0	1	1	0	0
Overall Study Allocated in error without study intervention	1	0	0	0	0	0

Baseline Characteristics

A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=22 Participants Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases n=6 Participants Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases n=3 Participants Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases n=14 Participants Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Total n=76 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 11.5 • n=5 Participants	59.7 years STANDARD_DEVIATION 13.1 • n=7 Participants	80.6 years STANDARD_DEVIATION 12.8 • n=5 Participants	54.7 years STANDARD_DEVIATION 12.5 • n=4 Participants	58.3 years STANDARD_DEVIATION 8.3 • n=21 Participants	57.8 years STANDARD_DEVIATION 14.1 • n=10 Participants	62.4 years STANDARD_DEVIATION 15.7 • n=115 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	10 Participants n=10 Participants	45 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants	31 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=10 Participants	65 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 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=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	14 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=10 Participants	55 Participants n=115 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	5 Participants n=115 Participants

PRIMARY outcome

Timeframe: Up to approximately 30 months

Population: The analysis population consisted of all allocated participants in Part 1 with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 Participants Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Part 1: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator	0.0 Percentage of Participants Interval 0.0 to 16.1	35.7 Percentage of Participants Interval 12.8 to 64.9	64.7 Percentage of Participants Interval 38.3 to 85.8	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 (28-day cycle)

Population: The analysis population included all allocated participants in Part 2 who received at least 1 dose of study treatment who met the criteria for DLT evaluability (e.g. finished Cycle 1 without a DLT or experienced a DLT in Cycle 1). Cohorts D and E in Part 2 did not enroll any participants.

The following toxicities during DLT evaluation period were considered a DLT, if assessed by investigator to be possibly, probably, or definitely related to treatment: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 3 thrombocytopenia (if associated with clinically significant bleeding) or any grade febrile neutropenia; nonhematologic adverse event (AE) ≥ Gr 3 (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention is required, leads to hospitalization, or persists for \>1 week); drug-related toxicity that causes a \>2 week delay in Cycle 2 initiation; drug-related toxicity that causes treatment discontinuation or missed dosage of gebasaxturev; or Gr 5 toxicity. Per protocol, only the participants in Part 2 were analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases n=6 Participants Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases n=3 Participants Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases n=14 Participants Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	—	—	—	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all allocated participants in Part 2 who received study intervention. Cohorts D and E in Part 2 did not enroll any participants.

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 2 were analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases n=6 Participants Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases n=3 Participants Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases n=14 Participants Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Part 2: Number of Participants Who Experienced One or More Adverse Events (AEs)	—	—	—	6 Participants	2 Participants	14 Participants

PRIMARY outcome

Timeframe: Up to approximately 10 months

Population: The analysis population included all allocated participants in Part 2 who received study intervention. Cohorts D and E in Part 2 did not enroll any participants.

An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 2 were analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases n=6 Participants Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases n=3 Participants Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases n=14 Participants Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Part 2: Number of Participants Who Discontinued Study Intervention Due to an AE	—	—	—	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: The analysis population included all allocated participants in Part 1 who received study intervention. Cohorts D and E in Part 2 did not enroll any participants.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 Participants Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Part 1: Number of Participants Who Experienced One or More AEs	19 Participants	14 Participants	17 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 23 months

Population: The analysis population included all allocated participants in Part 1 who received study intervention. Cohorts D and E in Part 2 did not enroll any participants.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 Participants Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Part 1: Number of Participants Who Discontinued Study Intervention Due to an AE	1 Participants	3 Participants	3 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 30 months

PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by investigator. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 Participants Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator	2.1 Months Interval 1.5 to 3.1	3.3 Months Interval 1.7 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	15.4 Months Interval 2.4 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: The analysis population consisted of all allocated participants in Part 1 who experienced a confirmed CR or PR with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. No participants in Part 1, Cohort A were eligible for analysis. Cohorts D and E in Part 2 did not enroll any participants.

For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death, whichever occurs first. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection did not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=5 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=11 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator	—	NA Months Interval 4.4 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	NA Months Interval 4.6 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 30 months

PFS was defined as the time from first dose of study treatment to the first documented immune-based confirmed progressive disease (iCPD) or death due to any cause, whichever occurs first as assessed by investigator. Per iRECIST, iCPD was defined as worsening of any existing cause of progression, or the appearance of any other cause of progression, relative to the initial appearance of progressive disease by RECIST 1.1. Per protocol, only participants in Part 1 were analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 Participants Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
PFS Per Response Evaluation Criteria in Solid Tumors 1.1 for Immune-Based Therapeutics (iRECIST) as Assessed by Investigator	3.3 Months Interval 1.3 to 4.3	8.2 Months Interval 2.1 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	20.4 Months Interval 3.3 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: The analysis population consisted of all allocated participants in Part 1 who experienced a confirmed response (CR, PR, iCR or iPR) with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. No participants in Part 1, Cohort A were eligible for analysis. Cohorts D and E in Part 2 did not enroll any participants.

For participants who demonstrated confirmed CR (disappearance of all target lesions and non-target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 or immune-based Complete Response (iCR: Disappearance of all target lesions) or immune-based Partial Response (iPR: ≥30% decrease in the sum of diameters of target lesions) after a single PD per iRECIST, DOR was defined as the time from the first documented CR or PR, or iCR or an iPR, as assessed by investigator, until progressive disease or death, whichever occurs first. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection did not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=6 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=11 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
DOR Per iRECIST as Assessed by Investigator	—	NA Months Interval 4.4 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	NA Months Interval 4.6 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: The analysis population consisted of all participants with a baseline scan that demonstrated measurable disease and who were administered at least one dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants.

ORR was defined as the percentage of participants who had confirmed responses assessed using RECIST 1.1 before PD or an immune-based Complete Response (iCR: Disappearance of all target lesions) or an immune-based Partial Response (iPR: ≥30% decrease in the sum of diameters of target lesions) after a single PD per iRECIST as assessed by investigator.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 Participants Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases n=6 Participants Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases n=3 Participants Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases n=14 Participants Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
ORR Per iRECIST as Assessed by Investigator	0.0 Percentage of Participants Interval 0.0 to 16.1	42.9 Percentage of Participants Interval 17.7 to 71.1	64.7 Percentage of Participants Interval 38.3 to 85.8	16.7 Percentage of Participants Interval 0.4 to 64.1	0.0 Percentage of Participants Interval 0.0 to 70.8	0.0 Percentage of Participants Interval 0.0 to 23.2

SECONDARY outcome

Timeframe: Up to approximately 30 months

OS was defined as the time from first dose of study intervention to death due to any cause. Per protocol, only participants in Part 1 were analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 Participants Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 Participants Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 Participants Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Overall Survival (OS)	7.5 Months Interval 4.3 to 15.0	11.8 Months Interval 3.0 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	20.4 Months Interval 3.3 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population consisted of all allocated participants in Part 2 with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 2 were analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases n=6 Participants Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases n=3 Participants Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases n=14 Participants Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Part 2: ORR Per RECIST 1.1 as Assessed by Investigator	—	—	—	16.7 Percentage of Participants Interval 0.4 to 64.1	0.0 Percentage of Participants Interval 0.0 to 70.8	0.0 Percentage of Participants Interval 0.0 to 23.2

Adverse Events

Part 1, Cohort A: Triple-Negative Breast Cancer

Serious events: 4 serious events

Other events: 18 other events

Deaths: 18 deaths

Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma

Serious events: 8 serious events

Other events: 14 other events

Deaths: 8 deaths

Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma

Serious events: 6 serious events

Other events: 17 other events

Deaths: 8 deaths

Part 2 Dose Level 1, Solid Tumors + Liver Metastases

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Part 2 Dose Level 2, Solid Tumors + Liver Metastases

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Part 2 Dose Level 3, Solid Tumors + Liver Metastases

Serious events: 3 serious events

Other events: 14 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 participants at risk Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 participants at risk Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 participants at risk Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases n=6 participants at risk Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases n=3 participants at risk Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases n=14 participants at risk Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Cardiac disorders Cardiac arrest	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Cardiac disorders Cardiac failure congestive	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Abdominal pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Haematemesis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Vomiting	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders General physical health deterioration	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Pyrexia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Hepatobiliary disorders Cholestasis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations COVID-19 pneumonia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Cellulitis	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Diverticulitis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Liver abscess	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Pneumonia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Pneumonia aspiration	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Septic shock	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Head injury	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Hepatic seroma	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Troponin increased	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Encephalopathy	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Polyneuropathy	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.

Other adverse events

Other adverse events
Measure	Part 1, Cohort A: Triple-Negative Breast Cancer n=21 participants at risk Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10\^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma n=14 participants at risk Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma n=17 participants at risk Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 1, Solid Tumors + Liver Metastases n=6 participants at risk Participants with solid tumors with liver metastases received 3 X 10\^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 2, Solid Tumors + Liver Metastases n=3 participants at risk Participants with solid tumors with liver metastases received 1 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.	Part 2 Dose Level 3, Solid Tumors + Liver Metastases n=14 participants at risk Participants with solid tumors with liver metastases received 3 X 10\^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Blood and lymphatic system disorders Anaemia	23.8% 5/21 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Cardiac disorders Angina pectoris	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Cardiac disorders Atrial fibrillation	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Cardiac disorders Bradycardia	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Cardiac disorders Sinus tachycardia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Cardiac disorders Tachycardia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Ear and labyrinth disorders Deafness	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Ear and labyrinth disorders Ear discomfort	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Endocrine disorders Adrenal insufficiency	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Endocrine disorders Hyperthyroidism	23.8% 5/21 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Endocrine disorders Hypothyroidism	19.0% 4/21 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	42.9% 6/14 • Number of events 6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Endocrine disorders Thyroiditis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Eye disorders Dry eye	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Eye disorders Exophthalmos	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Eye disorders Lacrimation increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Eye disorders Vision blurred	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Abdominal pain	4.8% 1/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Ascites	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Constipation	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Diarrhoea	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	23.5% 4/17 • Number of events 12 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Dry mouth	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Dysphagia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Eructation	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Blood alkaline phosphatase increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Nausea	23.8% 5/21 • Number of events 8 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	35.7% 5/14 • Number of events 9 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Odynophagia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Oral pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Salivary gland pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Stomatitis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Tongue geographic	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Toothache	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Gastrointestinal disorders Vomiting	14.3% 3/21 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	28.6% 4/14 • Number of events 9 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Asthenia	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	23.5% 4/17 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Chills	19.0% 4/21 • Number of events 6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	50.0% 3/6 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Discomfort	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Face oedema	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Facial pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Fatigue	9.5% 2/21 • Number of events 8 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	23.5% 4/17 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	50.0% 3/6 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	28.6% 4/14 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Influenza like illness	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Injection site bruising	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Injection site erythema	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Injection site inflammation	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Injection site oedema	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Injection site pain	9.5% 2/21 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 2/6 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Injection site pruritus	4.8% 1/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Mucosal inflammation	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Oedema	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Oedema peripheral	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Pain	19.0% 4/21 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Pyrexia	28.6% 6/21 • Number of events 10 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	35.7% 5/14 • Number of events 8 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
General disorders Swelling face	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Bacteraemia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations COVID-19	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	35.7% 5/14 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	23.5% 4/17 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Conjunctivitis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Gingivitis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Herpes zoster	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Influenza	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Myiasis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Oral candidiasis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Pneumonia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Pneumonia aspiration	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Respiratory tract infection	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Rhinitis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Skin infection	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Upper respiratory tract infection	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Urinary tract infection	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Infections and infestations Viral infection	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Fall	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Limb injury	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Skin wound	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Injury, poisoning and procedural complications Stoma complication	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Alanine aminotransferase increased	19.0% 4/21 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Amylase increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Aspartate aminotransferase increased	19.0% 4/21 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	17.6% 3/17 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Bilirubin conjugated increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Blood bilirubin increased	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Blood creatine increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Blood creatine phosphokinase increased	14.3% 3/21 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Blood lactate dehydrogenase increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Blood urea increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations C-reactive protein increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations CD4 lymphocytes increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Gamma-glutamyltransferase increased	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Lymphocyte count decreased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Neutrophil count decreased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Neutrophil count increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Platelet count decreased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Protein total decreased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Thyroxine free increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Thyroxine increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Troponin T increased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations Weight decreased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Investigations White blood cell count decreased	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Decreased appetite	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	23.5% 4/17 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Hypokalaemia	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Hypomagnesaemia	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Hyponatraemia	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Metabolism and nutrition disorders Hypophosphataemia	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	23.5% 4/17 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	28.6% 4/14 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Back pain	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Muscle spasms	4.8% 1/21 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Myalgia	9.5% 2/21 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Musculoskeletal and connective tissue disorders Pain in extremity	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of spleen	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	17.6% 3/17 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Cerebrovascular accident	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Dizziness	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Encephalopathy	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Headache	9.5% 2/21 • Number of events 6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	23.5% 4/17 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Hypoaesthesia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Neuropathy peripheral	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Post herpetic neuralgia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Nervous system disorders Somnolence	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Psychiatric disorders Anxiety	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Psychiatric disorders Confusional state	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Psychiatric disorders Depression	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Psychiatric disorders Hallucination, visual	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Psychiatric disorders Insomnia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Renal and urinary disorders Chronic kidney disease	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Renal and urinary disorders Nocturia	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Renal and urinary disorders Pollakiuria	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Reproductive system and breast disorders Breast pain	19.0% 4/21 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Reproductive system and breast disorders Pelvic discomfort	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Reproductive system and breast disorders Perineal pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Cough	23.8% 5/21 • Number of events 5 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 2/6 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	14.3% 2/14 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 3/21 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Hiccups	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Acne	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Blister	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Pruritus	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	28.6% 4/14 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	11.8% 2/17 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Rash	4.8% 1/21 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 4 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	33.3% 1/3 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	21.4% 3/14 • Number of events 3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Vascular disorders Embolism	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Vascular disorders Hypertension	9.5% 2/21 • Number of events 2 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	5.9% 1/17 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	16.7% 1/6 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
Vascular disorders Hypotension	0.00% 0/21 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	7.1% 1/14 • Number of events 1 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/17 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/6 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/3 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.	0.00% 0/14 • Up to approximately 30 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER