Trial Outcomes & Findings for A Study to Learn About the Study Medicine (Called Ontorpacept or TTI-621) Given Alone and in Combination With Doxorubicin in People With Leiomyosarcoma (NCT NCT04996004)

Last Updated: 2024-12-11

Results Overview

An adverse event (AE) was any untoward medical occurrence or worsening of a pre-existing medical condition following or during exposure to pharmaceutical product, whether or not considered causally related to product. A serious adverse event (SAE) was an adverse event occurred during any study at any dose of the investigational products that fulfils one or more of following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. TEAEs were those events with onset date occurred during on-treatment period. AEs included SAEs and all Non-SAEs. On-treatment period was defined as time from first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer therapy). Participant with at least one TEAE and one serious TEAEs are reported in this outcome measure.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

From first dose of study treatment (Day 1) up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)

Results posted on

2024-12-11

Participant Flow

The study consisted of two phases: Phase I (dose escalation) and Phase II (dose expansion). Phase I enrolled participants with high-grade leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma and epithelioid sarcoma. Phase II enrolled participants with high-grade leiomyosarcoma. Participants were treated with ontorpacept (TTI-621) in combination with doxorubicin for the first 6 cycles and ontorpacept alone thereafter.

A total of 76 participants were enrolled and treated in the study (Phase I: 9 participants and Phase II: 67 participants).

Participant milestones

Participant milestones
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin Participants received ontorpacept, 0.2 milligram per kilogram (mg/kg) as Intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 milligram per meter square (mg/m\^2) was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Phase I STARTED	3	3	3	0	0	0
Phase I COMPLETED	0	0	0	0	0	0
Phase I NOT COMPLETED	3	3	3	0	0	0
Phase II STARTED	0	0	0	32	13	22
Phase II COMPLETED	0	0	0	0	0	0
Phase II NOT COMPLETED	0	0	0	32	13	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin Participants received ontorpacept, 0.2 milligram per kilogram (mg/kg) as Intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 milligram per meter square (mg/m\^2) was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Phase I Death	1	2	1	0	0	0
Phase I Study terminated by sponsor	2	1	2	0	0	0
Phase II Study terminated by sponsor	0	0	0	20	10	10
Phase II Withdrawal by Subject	0	0	0	0	1	2
Phase II Death	0	0	0	12	2	9
Phase II Other	0	0	0	0	0	1

Baseline Characteristics

A Study to Learn About the Study Medicine (Called Ontorpacept or TTI-621) Given Alone and in Combination With Doxorubicin in People With Leiomyosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Total n=76 Participants Total of all reporting groups
Age, Customized Less than (<) 40 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Age, Customized 40 - <65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	25 Participants n=4 Participants	7 Participants n=21 Participants	12 Participants n=8 Participants	49 Participants n=8 Participants
Age, Customized 65 - <75 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	18 Participants n=8 Participants
Age, Customized 75 - <85 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	23 Participants n=4 Participants	10 Participants n=21 Participants	16 Participants n=8 Participants	55 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	21 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	9 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	29 Participants n=4 Participants	10 Participants n=21 Participants	19 Participants n=8 Participants	64 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	24 Participants n=4 Participants	10 Participants n=21 Participants	22 Participants n=8 Participants	64 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)

Population: The safety analysis set (SAS) included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs: Phase I Participants with TEAEs	3 Participants	3 Participants	3 Participants	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs: Phase I Participants with Serious TEAEs	0 Participants	1 Participants	1 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline, 30 minutes post dose on Day 1 of Cycle 1

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Blood pressure included diastolic blood pressure (DBP) and systolic blood pressure (SBP). Mean change from baseline to 30 minutes post-dose on C1D1 were reported in this outcome measure. Baseline was defined as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 1 Day 1 (C1D1): Phase I DBP	-0.7 Millimeter of mercury (mmHg) Standard Deviation 5.86	-0.7 Millimeter of mercury (mmHg) Standard Deviation 3.51	1.0 Millimeter of mercury (mmHg) Standard Deviation 8.72	—	—	—
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 1 Day 1 (C1D1): Phase I SBP	1.7 Millimeter of mercury (mmHg) Standard Deviation 8.02	2.0 Millimeter of mercury (mmHg) Standard Deviation 3.61	-8.7 Millimeter of mercury (mmHg) Standard Deviation 4.73	—	—	—

PRIMARY outcome

Timeframe: Baseline, 60 minutes post dose on Day 1 of Cycle 1

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Blood pressure included DBP and SBP. Mean change from baseline to 60 minutes post-dose on C1D1 were reported in this outcome measure. Baseline was defined as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C1D1: Phase I DBP	2.3 Millimeter of mercury Standard Deviation 2.08	0.7 Millimeter of mercury Standard Deviation 3.21	1.7 Millimeter of mercury Standard Deviation 9.29	—	—	—
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C1D1: Phase I SBP	3.0 Millimeter of mercury Standard Deviation 5.00	-0.7 Millimeter of mercury Standard Deviation 2.89	-8.3 Millimeter of mercury Standard Deviation 10.12	—	—	—

PRIMARY outcome

Timeframe: Baseline, 30 minutes post dose on Day 8 of Cycle 1

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Blood pressure included DBP and SBP. Mean change from baseline to 30 minutes post-dose on C1D8 were reported in this outcome measure. Baseline was defined as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 1 Day 8 (C1D8): Phase I DBP	1.3 Millimeter of mercury Standard Deviation 10.02	2.7 Millimeter of mercury Standard Deviation 5.03	0.3 Millimeter of mercury Standard Deviation 2.89	—	—	—
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 1 Day 8 (C1D8): Phase I SBP	7.0 Millimeter of mercury Standard Deviation 11.36	5.0 Millimeter of mercury Standard Deviation 6.93	-7.3 Millimeter of mercury Standard Deviation 7.51	—	—	—

PRIMARY outcome

Timeframe: Baseline, 60 minutes post dose on Day 8 of Cycle 1

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Blood pressure included DBP and SBP. Mean change from baseline to 60 minutes post-dose on C1D8 were reported in this outcome measure. Baseline was defined as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C1D8: Phase I DBP	0.3 Millimeter of mercury Standard Deviation 9.81	-4.0 Millimeter of mercury Standard Deviation 7.94	0.7 Millimeter of mercury Standard Deviation 6.51	—	—	—
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C1D8: Phase I SBP	3.3 Millimeter of mercury Standard Deviation 9.07	2.3 Millimeter of mercury Standard Deviation 9.29	-1.0 Millimeter of mercury Standard Deviation 11.53	—	—	—

PRIMARY outcome

Timeframe: Baseline, 30 minutes post dose on Day 1 of Cycle 2

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Blood pressure included DBP and SBP. Mean change from baseline to 30 minutes post-dose on C2D1 were reported in this outcome measure. Baseline was defined as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 2 Day 1 (C2D1): Phase I DBP	3.0 Millimeter of mercury Standard Deviation 3.46	-2.0 Millimeter of mercury Standard Deviation 6.24	6.5 Millimeter of mercury Standard Deviation 3.54	—	—	—
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 2 Day 1 (C2D1): Phase I SBP	4.0 Millimeter of mercury Standard Deviation 5.29	-5.7 Millimeter of mercury Standard Deviation 6.51	3.5 Millimeter of mercury Standard Deviation 16.26	—	—	—

PRIMARY outcome

Timeframe: Baseline, 60 minutes post dose on Day 1 of Cycle 2

Blood pressure included DBP and SBP. Mean change from baseline to 60 minutes post-dose on C2D1 were reported in this outcome measure. Baseline was defined as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C2D1: Phase I DBP	3.0 Millimeter of mercury Standard Deviation 5.20	-3.7 Millimeter of mercury Standard Deviation 8.02	11.0 Millimeter of mercury Standard Deviation 1.41	—	—	—
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C2D1: Phase I SBP	5.0 Millimeter of mercury Standard Deviation 5.57	-2.0 Millimeter of mercury Standard Deviation 14.73	10.5 Millimeter of mercury Standard Deviation 24.75	—	—	—

PRIMARY outcome

Timeframe: Baseline, 30 minutes post dose on Day 1 of Cycle 3

Blood pressure included DBP and SBP. Mean change from baseline to 30 minutes post-dose on C3D1 were reported in this outcome measure. Baseline was defined as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=1 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 3 Day 1 (C3D1): Phase I DBP	-3.5 Millimeter of mercury Standard Deviation 6.36	-5.5 Millimeter of mercury Standard Deviation 4.95	2.0 Millimeter of mercury Standard Deviation NA Standard deviation (SD) could not be calculated as only 1 participant was analyzed.	—	—	—
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 3 Day 1 (C3D1): Phase I SBP	-6.5 Millimeter of mercury Standard Deviation 17.68	-14.0 Millimeter of mercury Standard Deviation 0.00	-8.0 Millimeter of mercury Standard Deviation NA SD could not be calculated as only 1 participant was analyzed.	—	—	—

PRIMARY outcome

Timeframe: Baseline, 60 minutes post dose on Day 1 of Cycle 3

Blood pressure included DBP and SBP. Mean change from baseline to 60 minutes post-dose on C3D1 were reported in this outcome measure. Baseline was defined as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=1 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C3D1: Phase I DBP	0.5 Millimeter of mercury Standard Deviation 6.36	-2.0 Millimeter of mercury Standard Deviation 2.83	6.0 Millimeter of mercury Standard Deviation NA SD could not be calculated as only 1 participant was analyzed.	—	—	—
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C3D1: Phase I SBP	-1.0 Millimeter of mercury Standard Deviation 7.07	-12.0 Millimeter of mercury Standard Deviation 4.24	-11.0 Millimeter of mercury Standard Deviation NA SD could not be calculated as only 1 participant was analyzed.	—	—	—

PRIMARY outcome

Timeframe: Baseline, Safety follow up (up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)

Blood pressure included DBP and SBP. Mean change from baseline to safety follow up visit were reported in this outcome measure. Baseline was considered as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure at Safety Follow up: Phase I DBP	7.0 Millimeter of mercury Standard Deviation 2.83	-10.3 Millimeter of mercury Standard Deviation 2.89	3.0 Millimeter of mercury Standard Deviation 13.08	—	—	—
Mean Change From Baseline in Blood Pressure at Safety Follow up: Phase I SBP	13.5 Millimeter of mercury Standard Deviation 14.85	-15.7 Millimeter of mercury Standard Deviation 10.07	8.7 Millimeter of mercury Standard Deviation 12.66	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1 of Cycle 3

Body weight was measured in kilograms (kg). Baseline was considered as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Body Weight at C3D1: Phase I	0.68 Kilograms Standard Deviation 0.962	-3.86 Kilograms Standard Deviation 2.885	-1.71 Kilograms Standard Deviation 0.148	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1 of Cycle 5

Body weight was measured in kilograms. Baseline was considered as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Body Weight at Cycle 5 Day 1 (C5D1): Phase I	-0.91 Kilograms Standard Deviation 0.000	-2.50 Kilograms Standard Deviation 5.452	-2.09 Kilograms Standard Deviation 1.534	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1 of Cycle 7

Body weight was measured in kilograms. Baseline was considered as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Body Weight at Cycle 7 Day 1 (C7D1): Phase I	-0.91 Kilograms Standard Deviation 0.636	-0.23 Kilograms Standard Deviation 2.249	-1.26 Kilograms Standard Deviation 0.785	—	—	—

PRIMARY outcome

Body weight was measured in kilograms. Baseline was considered as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1).

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Body Weight at Safety Follow up: Phase I	1.13 kilograms Standard Deviation 0.325	-3.48 kilograms Standard Deviation 1.889	-1.56 kilograms Standard Deviation 1.794	—	—	—

PRIMARY outcome

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Standard 12- lead ECGs, average of triplicate assessments were obtained in participant in supine position and within 10 minutes total time. ECG abnormalities included: PR interval (millisecond \[msec\]): value greater than or equal to (\>=) 220 and change from baseline \>=20; QRS interval (msec) value \>=120; uncorrected QT interval, QT correct by Bazzette's formula (QTcB) interval and QT correct by Frederica formula (QTcF) interval (msec): value greater than (\>) 450, value \> 480, value \> 500, change from baseline \> 30 and \> 60. Baseline was defined as the last assessment prior to the date or time of the first dose of study treatment. In this outcome measure number of participants with overall ECG abnormalities are reported.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Overall Electrocardiogram (ECG) Abnormalities: Phase I	3 Participants	2 Participants	2 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

The following hematology laboratory parameters were assessed: hemoglobin, hematocrit, platelets, white blood cells (WBC), neutrophils, lymphocytes, eosinophils, basophils, monocytes, WBC with automated 5-part differential, Red blood cells (RBC), absolute reticulocytes, reticulocytes percentage (%), Mean corpuscular hemoglobin (MCH), Mean corpuscular volume (MCV) and Red cell distribution width (RDW). Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. Baseline was defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants who had hematology parameter abnormality Grade \<=2 at baseline and shifted to \>=3 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Shift in National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v)5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase I Shift from baseline Grade to post-baseline Grade 3: Leukocytes (10^9/L) white blood cells decreased	1 Participants	2 Participants	1 Participants	—	—	—
Number of Participants With Shift in National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v)5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase I Shift from baseline Grade to post-baseline Grade 4: Leukocytes (10^9/L) white blood cells decreased	0 Participants	0 Participants	2 Participants	—	—	—
Number of Participants With Shift in National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v)5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase I Shift from baseline Grade to post-baseline Grade 3: Neutrophils (10^9/L) decreased	1 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Shift in National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v)5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase I Shift from baseline Grade to post-baseline Grade 4: Neutrophils (10^9/L) decreased	0 Participants	0 Participants	3 Participants	—	—	—
Number of Participants With Shift in National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v)5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase I Shift from baseline Grade to post-baseline Grade 3: Platelets (10^9/L) decreased	0 Participants	1 Participants	2 Participants	—	—	—

PRIMARY outcome

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

The following chemistry parameters were assessed: glucose, sodium, potassium, calcium, chloride, phosphate, bicarbonate, blood urea nitrogen or urea, creatinine, total protein, albumin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, indirect bilirubin, uric acid, calcium, magnesium, lactate dehydrogenase (LDH). Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death related to adverse event. Baseline was defined as last assessment prior to date/time of first dose of study treatment. Number of participants who had chemistry parameter abnormality Grade\<=2 at baseline and shifted to \>=3 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Chemistry Parameters: Phase I Shift from baseline Grade to post-baseline Grade 3: ALT (U/L) increased	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Chemistry Parameters: Phase I Shift from baseline Grade to post-baseline Grade 4: AST (U/L) increased	0 Participants	1 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: During study treatment (from first dose of study treatment [Day 1] to maximum treatment exposure of 74.1 weeks for ontorpacept and 20.1 weeks for doxorubicin)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Dose modifications included dose reduction, dose omitted, infusion interruption and cycle delayed.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Dose Modifications: Phase I Participants with dose reduction- Ontorpacept	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Dose Modifications: Phase I Participants with dose omitted- Ontorpacept	0 Participants	1 Participants	2 Participants	—	—	—
Number of Participants With Dose Modifications: Phase I Participants with infusion interruption-Ontorpacept	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants With Dose Modifications: Phase I Participants with cycle delayed- Ontorpacept	1 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Dose Modifications: Phase I Participants with dose reduction- Doxorubicin	0 Participants	1 Participants	2 Participants	—	—	—
Number of Participants With Dose Modifications: Phase I Participants with dose omitted- Doxorubicin	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Dose Modifications: Phase I Participants with infusion interruption-Doxorubicin	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Dose Modifications: Phase I Participants with cycle delayed- Doxorubicin	1 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: During study treatment (from first dose of study treatment [Day 1] to maximum treatment exposure of 74.1 weeks for ontorpacept and 20.1 weeks for doxorubicin)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Number of participants with treatment discontinuations during the study treatment were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Treatment Discontinuations: Phase I Ontorpacept	3 Participants	3 Participants	3 Participants	—	—	—
Number of Participants With Treatment Discontinuations: Phase I Doxorubicin	1 Participants	2 Participants	2 Participants	—	—	—

PRIMARY outcome

Timeframe: From the start of study treatment until disease progression (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

ORR: percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on investigator's assessment per response evaluation criteria in solid tumours RECIST version (v)1.1. BOR: best response recorded from start of treatment until disease progression (PD). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than(\< )10 mm. PR: at least 30 percent (%) decrease in sum of longest diameter of target lesions, taking as reference baseline sum longest diameter. PD: at least 20% increase in sum of longest diameter of target lesions, taking as reference of the smallest sum on study.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Objective Response Rate (ORR): Phase I and Phase II	0.0 Percentage of Participants Interval 0.0 to 70.8	0.0 Percentage of Participants Interval 0.0 to 70.8	33.3 Percentage of Participants Interval 0.8 to 90.6	18.8 Percentage of Participants Interval 7.2 to 36.4	0.0 Percentage of Participants Interval 0.0 to 24.7	4.5 Percentage of Participants Interval 0.1 to 22.8

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase II was 88 weeks; maximum follow up to approx. 92 weeks)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

An AE was any untoward medical occurrence or worsening of a pre-existing medical condition following or during exposure to pharmaceutical product, whether or not considered causally related to product. A SAE was an adverse event occurred during any study at any dose of the investigational products that fulfils one or more of following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. TEAEs were those events with onset date occurred during on-treatment period. AEs included SAEs and all Non-SAEs. On-treatment period was defined as time from first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer therapy). Participant with at least one TEAE and one serious TEAEs are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=13 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With TEAEs and Serious TEAEs: Phase II Participants with TEAEs	32 Participants	13 Participants	22 Participants	—	—	—
Number of Participants With TEAEs and Serious TEAEs: Phase II Participants with Serious TEAEs	9 Participants	8 Participants	15 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, 30 and 60min post dose of C1D1,C1D8,C2D1,C3D1 and safety follow up 30 Days post last dose of study treatment/start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure of Phase II:88 weeks;maximum follow up:92 weeks)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=13 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at safety follow up	-6.9 Millimeter of mercury Standard Deviation 16.86	-2.4 Millimeter of mercury Standard Deviation 26.30	0.2 Millimeter of mercury Standard Deviation 16.11	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at 30 minutes post dose on C1D1	-2.8 Millimeter of mercury Standard Deviation 7.46	-8.8 Millimeter of mercury Standard Deviation 5.37	-3.5 Millimeter of mercury Standard Deviation 11.31	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at 60 minutes post dose on C1D1	-1.4 Millimeter of mercury Standard Deviation 6.73	-7.8 Millimeter of mercury Standard Deviation 7.01	-4.5 Millimeter of mercury Standard Deviation 11.88	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at 30 minutes post dose on C1D1	-10.0 Millimeter of mercury Standard Deviation 12.82	-15.4 Millimeter of mercury Standard Deviation 15.06	-3.6 Millimeter of mercury Standard Deviation 14.04	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at 60 minutes post dose on C1D1	-5.0 Millimeter of mercury Standard Deviation 12.18	-18.3 Millimeter of mercury Standard Deviation 15.70	-6.5 Millimeter of mercury Standard Deviation 14.79	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at 30 minutes post dose on C1D8	-3.5 Millimeter of mercury Standard Deviation 10.78	-5.0 Millimeter of mercury Standard Deviation 6.63	6.3 Millimeter of mercury Standard Deviation 15.26	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at 60 minutes post dose on C1D8	-1.8 Millimeter of mercury Standard Deviation 9.08	-4.8 Millimeter of mercury Standard Deviation 5.81	1.7 Millimeter of mercury Standard Deviation 2.52	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at 30 minutes post dose on C1D8	-9.0 Millimeter of mercury Standard Deviation 14.23	-7.0 Millimeter of mercury Standard Deviation 16.52	15.5 Millimeter of mercury Standard Deviation 20.14	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at 60 minutes post dose on C1D8	-6.8 Millimeter of mercury Standard Deviation 12.26	-9.5 Millimeter of mercury Standard Deviation 14.54	11.7 Millimeter of mercury Standard Deviation 8.96	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at 30 minutes post dose on C2D1	-3.3 Millimeter of mercury Standard Deviation 6.58	0.8 Millimeter of mercury Standard Deviation 8.30	-7.6 Millimeter of mercury Standard Deviation 15.95	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at 60 minutes post dose on C2D1	-3.8 Millimeter of mercury Standard Deviation 7.27	-3.5 Millimeter of mercury Standard Deviation 8.23	-3.1 Millimeter of mercury Standard Deviation 13.36	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at 30 minutes post dose on C2D1	-9.1 Millimeter of mercury Standard Deviation 14.57	-3.3 Millimeter of mercury Standard Deviation 19.29	-9.9 Millimeter of mercury Standard Deviation 17.51	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at 60 minutes post dose on C2D1	-7.7 Millimeter of mercury Standard Deviation 11.62	-11.5 Millimeter of mercury Standard Deviation 5.80	-6.3 Millimeter of mercury Standard Deviation 13.41	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at 30 minutes post dose on C3D1	-4.4 Millimeter of mercury Standard Deviation 4.09	-6.8 Millimeter of mercury Standard Deviation 13.02	-2.3 Millimeter of mercury Standard Deviation 6.50	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at 60 minutes post dose on C3D1	-3.2 Millimeter of mercury Standard Deviation 6.16	-10.0 Millimeter of mercury Standard Deviation 9.90	-2.0 Millimeter of mercury Standard Deviation 1.00	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at 30 minutes post dose on C3D1	-14.1 Millimeter of mercury Standard Deviation 12.20	-7.3 Millimeter of mercury Standard Deviation 10.66	-7.3 Millimeter of mercury Standard Deviation 20.50	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II SBP: Change at 60 minutes post dose on C3D1	-14.3 Millimeter of mercury Standard Deviation 13.37	-11.8 Millimeter of mercury Standard Deviation 5.74	-8.0 Millimeter of mercury Standard Deviation 17.44	—	—	—
Mean Change From Baseline in Blood Pressure: Phase II DBP: Change at safety follow up	-2.3 Millimeter of mercury Standard Deviation 12.10	-1.3 Millimeter of mercury Standard Deviation 13.52	2.1 Millimeter of mercury Standard Deviation 12.95	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycle 3, 5, 7 and safety follow up (up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest [maximum treatment exposure for Phase II was 88 weeks; maximum follow up to 92 weeks])

Baseline was considered as the last measurement taken prior to the first infusion of study medication (Day 1 of Cycle 1)

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=13 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Mean Change From Baseline in Body Weight: Phase II Change at C3D1	-1.30 Kilograms Standard Deviation 1.765	-0.43 Kilograms Standard Deviation 2.122	-1.83 Kilograms Standard Deviation 1.637	—	—	—
Mean Change From Baseline in Body Weight: Phase II Change at C5D1	-1.23 Kilograms Standard Deviation 2.348	-1.03 Kilograms Standard Deviation 2.807	-2.44 Kilograms Standard Deviation 2.620	—	—	—
Mean Change From Baseline in Body Weight: Phase II Change at C7D1	-0.84 Kilograms Standard Deviation 2.836	1.03 Kilograms Standard Deviation 2.420	-2.57 Kilograms Standard Deviation 3.695	—	—	—
Mean Change From Baseline in Body Weight: Phase II Change at Follow up	-0.54 Kilograms Standard Deviation 3.757	0.18 Kilograms Standard Deviation 3.012	-3.55 Kilograms Standard Deviation 5.018	—	—	—

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase II was 88 weeks; maximum follow up to approx. 92 weeks)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Standard 12- lead ECGs, average of triplicate assessments was obtained in participant in supine position and within 10 minutes total time. ECG abnormalities included: PR interval (msec): \>= 220 and change from baseline \>=20; QRS interval (msec) value \>=120; uncorrected QT interval, QT correct by QTcB interval and QT correct by QTcF interval (msec): value \> 450, value \> 480, value \> 500, change from baseline \> 30 and \> 60. Baseline was defined as the last assessment prior to the date or time of the first dose of study treatment. In this outcome measure number of participants with overall ECG abnormalities are reported.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=13 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Overall ECG Abnormalities: Phase II	17 Participants	8 Participants	11 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase II was 88 weeks; maximum follow up to approx. 92 weeks)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

The following hematology laboratory parameters were assessed: hemoglobin, hematocrit, platelets, WBC, neutrophils, lymphocytes, eosinophils, basophils, monocytes, WBC with automated 5-part differential, RBC, absolute reticulocytes, reticulocytes %, MCH, MCV and RDW. Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. Baseline was defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants who had hematology parameter abnormality Grade \<=2 at baseline and shifted to \>=3 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=13 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase II Shift from baseline Grade to post-baseline Grade 3: Leukocytes (10^9/L) white blood cells decreased	12 Participants	3 Participants	7 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase II Shift from baseline Grade to post-baseline Grade 4: Leukocytes (10^9/L) white blood cells decreased	12 Participants	9 Participants	12 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase II Shift from baseline Grade to post-baseline Grade 3: Neutrophils (10^9/L) decreased	5 Participants	2 Participants	6 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase II Shift from baseline Grade to post-baseline Grade 4: Neutrophils (10^9/L) decreased	21 Participants	10 Participants	8 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase II Shift from baseline Grade to post-baseline Grade 3: Platelets (10^9/L) decreased	4 Participants	6 Participants	12 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase II Shift from baseline Grade to post-baseline Grade 4: Platelets (10^9/L) decreased	2 Participants	1 Participants	7 Participants	—	—	—

SECONDARY outcome

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

The following chemistry parameters were assessed: glucose, sodium, potassium, calcium, chloride, phosphate, bicarbonate, blood urea nitrogen or urea, creatinine, total protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin, indirect bilirubin, uric acid, calcium, magnesium and LDH. Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death related to adverse event. Baseline was defined as last assessment prior to date/time of first dose of study treatment. Number of participants who had chemistry parameter abnormality Grade\<=2 at baseline and shifted to \>=3 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=13 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Chemistry Parameters: Phase II Shift from baseline Grade to post-baseline Grade 3: ALT (U/L) increased	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Chemistry Parameters: Phase II Shift from baseline Grade to post-baseline Grade 3: Albumin; Hypoalbuminemia (g/L)	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Chemistry Parameters: Phase II Shift from baseline Grade to post-baseline Grade 3: Blood Bilirubin increased (umol/L)	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Chemistry Parameters: Phase II Shift from baseline Grade to post-baseline Grade 3: Magnesium; Hypermagnesemia (mmol/L)	1 Participants	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: During study treatment (from first dose of study treatment [Day 1] to maximum treatment exposure of 88 weeks for ontorpacept and 25 weeks for doxorubicin)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Dose modifications included dose reduction, dose omitted, infusion interruption and cycle delayed.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=13 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Dose Modifications: Phase II Participants with dose reduction- Ontorpacept	0 Participants	5 Participants	17 Participants	—	—	—
Number of Participants With Dose Modifications: Phase II Participants with dose omitted- Ontorpacept	14 Participants	7 Participants	19 Participants	—	—	—
Number of Participants With Dose Modifications: Phase II Participants with infusion interruption- Ontorpacept	2 Participants	7 Participants	11 Participants	—	—	—
Number of Participants With Dose Modifications: Phase II Participants with cycle delayed- Ontorpacept	15 Participants	5 Participants	5 Participants	—	—	—
Number of Participants With Dose Modifications: Phase II Participants with dose reduction- Doxorubicin	11 Participants	5 Participants	13 Participants	—	—	—
Number of Participants With Dose Modifications: Phase II Participants with dose omitted- Doxorubicin	1 Participants	0 Participants	3 Participants	—	—	—
Number of Participants With Dose Modifications: Phase II Participants with infusion interruption- Doxorubicin	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Dose Modifications: Phase II Participants with cycle delayed- Doxorubicin	8 Participants	4 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: During study treatment (from first dose of study treatment [Day 1] to maximum treatment exposure of 88 weeks for ontorpacept and 25 weeks for doxorubicin)

Population: The SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Number of participants with treatment discontinuations during the study treatment were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=13 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With Treatment Discontinuations: Phase II Ontorpacept	32 Participants	13 Participants	22 Participants	—	—	—
Number of Participants With Treatment Discontinuations: Phase II Doxorubicin	15 Participants	5 Participants	10 Participants	—	—	—

SECONDARY outcome

Timeframe: Time from the first ontorpacept infusion (Day 1 of Cycle 1) to PD or death of any cause or censoring, whichever occurred first (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

PFS was defined as the time from the first ontorpacept infusion (Day 1 of Cycle 1) to PD or death of any cause, whichever occurred first. PD was defined at least 20% increase in sum of longest diameter (LD) of target lesion, taking reference of smallest sum on study. Participants without PD or death or participants with an event after 2 or more missing/inadequate disease assessment or participants with an event after the start date of alternate anticancer therapy were censored at their last response assessment date or last assessment prior to the start date of alternate anti-cancer therapy, whichever is earlier. Kaplan-Meier method was used for analysis.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Progression Free Survival (PFS): Phase I and Phase II	7.9 Months Interval 1.2 to Upper limit of 95% confidence interval (CI) could not be calculated due to insufficient number of participants with events.	6.4 Months Interval 1.3 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	7.6 Months Interval 1.3 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	6.0 Months Interval 4.1 to 6.7	4.3 Months Interval 1.6 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	5.6 Months Interval 3.0 to 9.7

SECONDARY outcome

Timeframe: From the first ontorpacept infusion (Day 1 of Cycle 1) to death of any cause or censoring, whichever occurred first (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

OS was defined as the time from the first ontorpacept infusion (Day 1 of Cycle 1) to death of any cause. Participants last known to be alive were censored at their last known alive date. Kaplan-Meier method was used for analysis.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Overall Survival (OS): Phase I and Phase II	NA Months Interval 26.0 to Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	8.2 Months Interval 7.2 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Interval 4.1 to Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	20.5 Months Interval 15.7 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Interval 4.9 to Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	14.4 Months Interval 12.4 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From the first dose of study treatment until PD or death, whichever occurred first (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

DCR was defined as the percentage of participants who have achieved CR, PR, or SD lasting at least 4 weeks as per RECIST v1.1 CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: at least 30% decrease in sum of longest diameter of target lesions, taking as reference baseline sum longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started. PD: at least 20% increase in sum of longest diameter of target lesions, taking as reference of the smallest sum on study.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Disease Control Rate (DCR): Phase I and Phase II	66.7 Percentage of participants Interval 9.4 to 99.2	66.7 Percentage of participants Interval 9.4 to 99.2	66.7 Percentage of participants Interval 9.4 to 99.2	75.0 Percentage of participants Interval 56.6 to 88.5	84.6 Percentage of participants Interval 54.6 to 98.1	72.7 Percentage of participants Interval 49.8 to 89.3

SECONDARY outcome

Timeframe: Time from date of first documented response (CR or PR) to date of documented progression or death of any cause after achieving response or censoring, whichever occurred first (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment. Here "Number of Participants Analyzed" signifies participants who had CR or PR.

DOR was defined as time from date of first documented response (CR or PR) to date of documented progression or death of any cause after achieving response. DOR was calculated for participants who achieved CR or PR. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: at least 30% decrease in sum of longest diameter of target lesions, taking as reference baseline sum longest diameter. Participants without PD or death or participants with an event after 2 or more missing/inadequate disease assessment or participants with an event after the start date of alternate anticancer therapy were censored at their last response assessment date or last assessment prior to the start date of alternate anti-cancer therapy, whichever is earlier.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=1 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=6 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=1 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Duration of Response (DOR): Phase I and Phase II	—	—	9.7 Months Full range of 95% CI could not be calculated as only one participant was evaluable.	4.7 Months Interval 3.5 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	—	NA Months Median and full range of 95% CI could not be calculated as participant did not have event of interest.

SECONDARY outcome

Timeframe: Time from first ontorpacept infusion (Day 1 of Cycle 1) to date of documented progression/death of any cause or censoring, whichever occurred first (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)

DDC: participants who achieved BOR of SD, as time from first ontorpacept infusion (Day1 of Cycle1) to date of documented PD/death of any cause. Calculated for participants who achieved CR,PR/SD lasting at least 4weeks. CR:disappearance of all target lesion. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR:at least 30%decrease in sum of longest diameter of target lesions, taking as reference baseline sum longest diameter. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started. PD:at least 20% increase in sum of LD of target lesion, taking reference of smallest sum on study. Participants without PD/death/with an event after 2/more missing/inadequate disease assessment/with event after start date of alternate anticancer therapy were censored at last response assessment date/last assessment prior to start date of alternate anti-cancer therapy, whichever is earlier.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=2 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=24 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=11 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=16 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Duration of Disease Control (DDC): Phase I and Phase II	12.4 Months Interval 7.9 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Interval 6.4 to Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	10.6 Months Interval 7.6 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	6.1 Months Interval 5.9 to 9.7	4.7 Months Interval 2.1 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	6.1 Months Interval 4.1 to 11.8

SECONDARY outcome

Timeframe: Time from the first ontorpacept infusion (Day 1 of Cycle 1) to PD or death of any cause or censoring, whichever is first (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

TTP was defined as the time from the first ontorpacept infusion (Day 1 of Cycle 1) to PD or death of any cause, whichever is first; provided death was not considered as an event. PD: at least 20% increase in sum of longest diameter of target lesion, taking reference of smallest sum on study. Participants without PD or death or with an event after 2 or more missing or inadequate disease assessment or with event after start date of alternate anticancer therapy were censored at last response assessment date or last assessment prior to start date of alternate anti-cancer therapy, whichever is earlier.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Time to Progression (TTP): Phase I and Phase II	7.9 Months Interval 1.2 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	6.4 Months Interval 1.3 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	7.6 Months Interval 1.3 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	6.0 Months Interval 4.2 to 6.7	4.3 Months Interval 1.6 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	5.6 Months Interval 3.0 to 9.7

SECONDARY outcome

Timeframe: Time from the first ontorpacept infusion (Day 1 of Cycle 1) until the appearance of new lesion or death or censoring date, whichever occurred first (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Time to new metastasis was defined as the time from the ontorpacept infusion (Day 1 of Cycle 1) to a new lesion appearance. Participants without new lesion or participants with new metastases after 2 or more missing/inadequate disease assessment or participants with new metastases after the start date of alternate anti-cancer therapy were censored at their last response assessment date or last assessment prior to the start date of alternate anti-cancer therapy whichever was earlier.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Time to New Metastases: Phase I and Phase II	NA Months Interval 7.9 to Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and full range of 95% CI could not be calculated as no participant had event.	NA Months Median and full range of 95% CI could not be calculated as no participant had event.	NA Months Interval 6.0 to Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	4.7 Months Interval 1.6 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Interval 3.9 to Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From Baseline up to 30 Days post last dose of study treatment/start of new anti-cancer therapy whichever occurred first (maximum exposure upto 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively)

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

ECOG performance were classified as 5 grades: 0: fully active, able to carry on all pre-disease performance without restriction; 1: restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2: ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours; 3: capable of only limited selfcare, confined to bed or chair more than 50% of waking hours and 4: completely disabled, cannot carry on selfcare and totally confined to bed or chair. Higher score indicated lower health status. Worsening of ECOG was defined as a worsening from baseline (i.e., increase) in the ECOG assessment level and was recorded in two consecutive assessments.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With a Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status: Phase I and Phase II	0 Participants	0 Participants	0 Participants	6 Participants	2 Participants	4 Participants

SECONDARY outcome

Population: The FAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

QOL was assessed with European organisation for research and treatment of cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30) tool. The EORTC QLQ-C30 is self-administered, self-reported general cancer-specific questionnaire consisting of 30 items covered by one of 3 dimensions: global health status (2 items): functional scales(15 total items addressing either physical, emotional, cognitive/social functioning) and symptom scales(13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea/financial impact). Higher score indicated better overall QoL. Worsening of Global Health Status /QoL assessments was defined as at least a 10-point decrease from baseline in the standardized score (linear transformation) of Global Health Status/QoL.

Outcome measures

Outcome measures
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 Participants Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 Participants Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 Participants Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Number of Participants With a Worsening of Global Health Status / Quality of Life (QoL) Status: Phase I and Phase II	2 Participants	2 Participants	2 Participants	17 Participants	9 Participants	12 Participants

Adverse Events

Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A)

Serious events: 9 serious events

Other events: 24 other events

Deaths: 12 deaths

Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C)

Serious events: 8 serious events

Other events: 12 other events

Deaths: 2 deaths

Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B)

Serious events: 15 serious events

Other events: 21 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 participants at risk Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 participants at risk Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 participants at risk Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 participants at risk Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 participants at risk Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 participants at risk Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Cardiac disorders Myocardial infarction	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Cardiac disorders Myocardial ischaemia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations Sepsis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations Endocarditis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations COVID-19	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations Pelvic abscess	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations Staphylococcal sepsis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations Wound infection	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Colitis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Aphasia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Spinal cord compression	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Syncope	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Cardiac disorders Cardiac arrest	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Cardiac disorders Cardiac hypertrophy	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Cardiac disorders Cardiotoxicity	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Cardiac disorders Mitral valve disease	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Cardiac disorders Myocardial fibrosis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Vascular disorders Axillary vein thrombosis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Vascular disorders Subclavian vein thrombosis	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
General disorders Chills	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
General disorders Pyrexia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Neutrophil count decreased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Other adverse events

Other adverse events
Measure	Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin n=3 participants at risk Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin n=3 participants at risk Participants received ontorpacept, 0.7 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.7 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase I: Ontorpacept 2.0 mg/kg + Doxorubicin n=3 participants at risk Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 0.2 mg/kg + Doxorubicin (Cohort A) n=32 participants at risk Participants received ontorpacept, 0.2 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 0.2 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 1.0 mg/kg + Doxorubicin (Cohort C) n=13 participants at risk Participants received ontorpacept, 1.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 1.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.	Phase II: Ontorpacept 2.0 mg/kg + Doxorubicin (Cohort B) n=22 participants at risk Participants received ontorpacept, 2.0 mg/kg as IV infusion on Days 1 and 8 of each 21-day cycle up to Cycle 6. Doxorubicin 75 mg/m\^2 was administered as IV infusion on Day 1 of 21-day cycles for a maximum of 6 cycles. After Cycle 6, participants continued treatment with ontorpacept 2.0 mg/kg as IV infusion on Days 1 and 15 as monotherapy in 28-day cycles until documentation of disease progression or development of unacceptable toxicity and a long-term follow-up period for assessment of overall survival.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	40.6% 13/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	54.5% 12/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.2% 4/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	28.1% 9/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.2% 4/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	21.9% 7/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.2% 4/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations COVID-19	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	25.0% 8/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Renal and urinary disorders Dysuria	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	12.5% 4/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Vascular disorders Hypertension	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Vascular disorders Hot flush	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Psychiatric disorders Insomnia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	12.5% 4/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Eye disorders Vision blurred	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Paraesthesia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Nausea	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	62.5% 20/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	69.2% 9/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	63.6% 14/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Stomatitis	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	37.5% 12/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	38.5% 5/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	27.3% 6/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Constipation	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	34.4% 11/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	46.2% 6/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.2% 4/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Vomiting	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	21.9% 7/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	27.3% 6/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.8% 6/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	27.3% 6/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.2% 4/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.6% 5/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.2% 4/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	12.5% 4/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
General disorders Fatigue	100.0% 3/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	68.8% 22/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	69.2% 9/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	68.2% 15/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
General disorders Pyrexia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.6% 5/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
General disorders Chills	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	12.5% 4/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
General disorders Non-cardiac chest pain	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.2% 4/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
General disorders Oedema peripheral	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	23.1% 3/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	43.8% 14/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	61.5% 8/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	72.7% 16/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	25.0% 8/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	23.1% 3/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Platelet count decreased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	34.4% 11/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	69.2% 9/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	86.4% 19/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Neutrophil count decreased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	37.5% 12/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	53.8% 7/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	68.2% 15/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations White blood cell count decreased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	28.1% 9/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	53.8% 7/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	45.5% 10/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Lymphocyte count decreased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.8% 6/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	27.3% 6/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	12.5% 4/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Blood bilirubin increased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Blood creatinine increased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Weight decreased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Headache	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	40.6% 13/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	38.5% 5/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	27.3% 6/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Dizziness	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	21.9% 7/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.4% 2/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	22.7% 5/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Nervous system disorders Dysgeusia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	12.5% 4/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	31.2% 10/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	69.2% 9/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	63.6% 14/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	34.4% 11/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.6% 5/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	23.1% 3/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	13.6% 3/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	15.6% 5/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.2% 4/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	66.7% 2/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	18.8% 6/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Flank pain	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.4% 3/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	3.1% 1/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	4.5% 1/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	12.5% 4/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	7.7% 1/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	33.3% 1/3 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	6.2% 2/32 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	0.00% 0/13 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.	9.1% 2/22 • From first dose of study treatment (Day 1up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurs soonest (maximum exposure up to 74.1 and 88 weeks; maximum follow up to approx. 78.1 and 92 weeks for Phase I and II respectively) Same event may appear as both AE and SAE, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or a participant may have experienced both SAE and non-SAE. SAS included all participants who were enrolled, allocated to treatment, and received at least one non-zero dose of study treatment.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER