Trial Outcomes & Findings for Study of PF-07263689 in Participants With Selected Advanced Solid Tumors (NCT NCT05061537)

Last Updated: 2024-04-12

Results Overview

DLTs=occurrence of any of following adverse events (AEs) attributable to PF-07263689 in first cycle (cycle=28 days): Hematologic: grade(G)4 neutropenia lasting \>5 days; febrile neutropenia; G3 neutropenia with infection, thrombocytopenia with bleeding; G4 thrombocytopenia. Non-hematologic: any treatment-related G\>=3 toxicity; clinical events consistent with Hy's law; any G3 cytokine release syndrome (CRS) not improving to G\<=2 within 72 hours despite medical management; any G4 CRC; G\>=3 toxicity of any duration affecting vital organs; G4 vaccinia infection lasting \>=6 days; G\>=3 toxicities persisting for \>3 days despite medical therapy (e.g. nausea, vomiting, diarrhea, fatigue); G \>=3 rash not resolving to G\<2 within 21 days with supportive measures; G\>=3 lab abnormalities not controlled to G \<=2 with or without appropriate medical management within 3 days; treatment-related AE inducing a delay by 2 weeks in receiving next scheduled dose; clinically important or persistent toxicities.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2024-04-12

Participant Flow

Study was planned to be conducted in 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and combination with sasanlimab (Part 1B) and Part 2 dose expansion for the combination therapy. The study was terminated during Part 1A due to sponsor's business decision; hence, Part 1B and Part 2 were not conducted and no participants were enrolled in Part 1B and 2.

A total of 13 participants were enrolled in Part 1A of the study.

Participant milestones

Participant milestones
Measure	Part 1A PF-07263689 210^8 PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Treatment Phase STARTED	3	4	6
Treatment Phase COMPLETED	3	2	2
Treatment Phase NOT COMPLETED	0	2	4
Follow up STARTED	3	3	4
Follow up COMPLETED	1	3	0
Follow up NOT COMPLETED	2	0	4
Long-term Follow-up STARTED	2	3	2
Long-term Follow-up COMPLETED	0	0	0
Long-term Follow-up NOT COMPLETED	2	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1A PF-07263689 210^8 PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Treatment Phase Progressive disease	0	1	2
Treatment Phase Adverse Event	0	0	2
Treatment Phase Global deterioration of health status	0	1	0
Follow up Other	2	0	2
Follow up Study terminated by sponsor	0	0	2
Long-term Follow-up Study terminated by sponsor	2	2	2
Long-term Follow-up Death	0	1	0

Baseline Characteristics

Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1B: PF-07263689 + Sasanlimab Participants were planned to receive escalating doses of PF-07263689 in combination with sasanlimab.	Part 2: PF-07263689 + Sasanlimab Participants were planned to receive PF-07263689 in combination with sasanlimab at the preliminary combination recommended Phase 2 dose from Part 1B.	Total n=13 Participants Total of all reporting groups
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	9 Participants n=8 Participants
Age, Continuous	56.3 Years STANDARD_DEVIATION 6.43 • n=5 Participants	61.0 Years STANDARD_DEVIATION 6.78 • n=7 Participants	47.3 Years STANDARD_DEVIATION 9.40 • n=5 Participants	—	—	53.6 Years STANDARD_DEVIATION 9.74 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 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
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: DLT evaluable set included participants who received 3 of the 4 doses of PF-07263689 and had completed the scheduled safety assessments during the DLT observation period or had experienced a DLT. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months)

Population: Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that at any dose met 1 or more of the following criteria: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; an important medical event; required inpatient hospitalization or prolongation of existing hospitalization. TEAE was defined as any adverse event that occurred during the on-treatment period, on or after the first dose of study treatment. Relatedness was based on investigator's assessment.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events Treatment related SAEs	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events TEAEs	3 Participants	4 Participants	6 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events SAEs	0 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events Treatment related TEAEs	2 Participants	3 Participants	6 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months)

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE was defined as any AE that occurred during the on-treatment period, on or after the first dose of study treatment. AEs were graded using CTCAE version 5 where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening; urgent intervention indicated; and grade 5= death related to AE.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade Grade 1	3 Participants	2 Participants	1 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade Grade 3	0 Participants	2 Participants	4 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade Grade 5	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade Grade 2	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade Grade 4	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment until 1 month follow-up (28+/-7) days after last dose of study treatment (up to 24 days of treatment exposure)

Hematology abnormalities were graded using CTCAE version 5 where, grade 0=non-missing lab value outside the grading range for the corresponding lab parameter; grade 1=mild; grade 2=moderate; grade 3=severe; grade 4= life-threatening. Only those categories with non-zero values for any of the arms have been reported.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade White blood cell decreased: Grade 1	0 Participants	0 Participants	2 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Activated PTT prolonged: Grade 0	2 Participants	2 Participants	3 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Activated PTT prolonged: Grade 1	1 Participants	1 Participants	3 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Activated PTT prolonged: Grade 2	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Anemia: Grade 1	1 Participants	1 Participants	4 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Anemia: Grade 3	0 Participants	2 Participants	1 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Hemoglobin increased: Grade 0	3 Participants	4 Participants	6 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade INR increased: Grade 1	0 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Leukocytosis: Grade 0	3 Participants	4 Participants	6 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Neutrophil count decreased: Grade 1	2 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Neutrophil count decreased: Grade 2	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Platelet count decreased: Grade 1	1 Participants	2 Participants	2 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade White blood cell decreased: Grade 0	3 Participants	4 Participants	3 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade White blood cell decreased: Grade 2	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Anemia: Grade 0	1 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Anemia: Grade 2	1 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade INR increased: Grade 0	3 Participants	3 Participants	5 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Lymphocyte count decreased: Grade 0	1 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Lymphocyte count decreased: Grade 2	0 Participants	4 Participants	2 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Lymphocyte count decreased: Grade 3	2 Participants	0 Participants	4 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Lymphocyte count increased: Grade 0	3 Participants	4 Participants	6 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Neutrophil count decreased: Grade 0	1 Participants	4 Participants	5 Participants
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade Platelet count decreased: Grade 0	2 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment until 1 month follow-up (28+/-7) days after last dose of study treatment (up to 24 days of treatment exposure)

Clinical chemistry abnormalities were graded using CTCAE version 5 where, grade 0=non-missing lab value outside the grading range for the corresponding lab parameter; grade 1=mild; grade 2=moderate; grade 3=severe; grade 4= life-threatening. Only those categories with non-zero values for any of the arms have been reported.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Alkaline phosphatase increased: Grade 0	2 Participants	3 Participants	4 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Alkaline phosphatase increased: Grade 1	1 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Creatinine phosphokinase increased: Grade 1	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Cardiac Troponin I Increased: Grade 0	3 Participants	3 Participants	5 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypernatremia: Grade 0	3 Participants	4 Participants	6 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypoalbuminemia: Grade 0	2 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypoglycemia: Grade 0	2 Participants	3 Participants	3 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypoglycemia: Grade 1	1 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypoglycemia: Grade 3	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypomagnesemia: Grade 0	2 Participants	3 Participants	4 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypomagnesemia: Grade 1	1 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hyponatremia: Grade 0	1 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hyponatremia: Grade 1	2 Participants	4 Participants	4 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Alanine aminotransferase increased: Grade 0	3 Participants	3 Participants	4 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Alanine aminotransferase increased: Grade 1	0 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Aspartate aminotransferase increased: Grade 0	3 Participants	3 Participants	5 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Aspartate aminotransferase increased: Grade 1	0 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Blood bilirubin increased: Grade 0	3 Participants	3 Participants	4 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Blood bilirubin increased: Grade 1	0 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Creatinine phosphokinase increased: Grade 0	2 Participants	4 Participants	5 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Cardiac Troponin T Increased: Grade 0	—	1 Participants	0 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Cardiac Troponin T Increased: Grade 1	—	0 Participants	1 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Creatinine increased: Grade 0	2 Participants	4 Participants	4 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Creatinine increased: Grade 2	1 Participants	0 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypercalcemia: Grade 0	3 Participants	4 Participants	6 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hyperkalemia: Grade 0	3 Participants	4 Participants	5 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hyperkalemia: Grade 2	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypermagnesemia: Grade 0	3 Participants	4 Participants	6 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypoalbuminemia: Grade 1	1 Participants	3 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypoalbuminemia: Grade 2	0 Participants	0 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypocalcemia: Grade 0	3 Participants	4 Participants	5 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypocalcemia: Grade 1	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypokalemia: Grade 0	2 Participants	2 Participants	4 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hypokalemia: Grade 2	1 Participants	2 Participants	2 Participants
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade Hyponatremia: Grade 3	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

AEs were planned to be graded using CTCAE version 5 where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening; urgent intervention indicated; and grade 5= death related to AE.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first dose of study treatment until 35 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Hematology and clinical chemistry parameters were planned to be assessed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first dose of study treatment until CR or PR (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) and was determined using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment until CR or PR (up to maximum follow-up of 10.45 months)

Population: Response evaluable set included all participants who received at least one dose of study treatment and had baseline disease assessment \[or measurable disease at baseline, if applicable\] and at least one post-baseline disease assessment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

ORR was defined as the percentage of participants with a best overall response of CR or PR and was determined using RECIST version 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. 95% confidence interval (CI) was based on Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Objective Response Rate	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 60.2

SECONDARY outcome

Timeframe: From first documentation of CR or PR to date of first documentation of PD or death due to any cause (up to maximum follow-up of 10.45 months)

Population: Response evaluable set included all participants who received at least one dose of study treatment and had baseline disease assessment \[or measurable disease at baseline, if applicable\] and at least one post-baseline disease assessment. Only participants with CR or PR were analyzed. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

Duration of response was defined as the time from first documentation of CR or PR to date of first documentation of progressive disease (PD) or death due to any cause. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non- pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start date of treatment to the date of first documentation of PD or death due to any cause (up to maximum follow-up of 10.45 months)

Population: Full analysis set included all enrolled participants. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

Progression free survival was defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. 95% CI was based on Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Progression Free Survival	1.4 Months Interval 1.4 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	1.5 Months Interval 1.3 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	1.4 Months Interval 1.4 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From start date of treatment to the date of first documentation of PD (up to maximum follow-up of 10.45 months)

Population: Full analysis set included all enrolled participants. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

Time to progression was defined as the time from start date of treatment to the date of the first documentation of PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. 95% CI was based on Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Time to Progression	1.4 Months Interval 1.4 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	1.5 Months Interval 1.3 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	1.4 Months Interval 1.4 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)

Population: Blood viral load Kinetics Analysis Set included all enrolled participants treated who did not have protocol deviations influencing viral load kinetics assessment, and had sufficient information to estimate at least 1 of the parameters of interest. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood	NA Copies per milliliter Geometric Coefficient of Variation NA Cmax could not be calculated as the values were below limit of quantification.	NA Copies per milliliter Geometric Coefficient of Variation NA Cmax could not be calculated as the values were below limit of quantification.	NA Copies per milliliter Geometric Coefficient of Variation NA Cmax could not be calculated as the values were below limit of quantification.

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Time to Maximum Concentration (Tmax) of PF-07263689 in Blood	NA Hours Tmax could not be calculated as the values were below limit of quantification.	NA Hours Tmax could not be calculated as the values were below limit of quantification.	NA Hours Tmax could not be calculated as the values were below limit of quantification.

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood	NA Hours*copies per milliliter Geometric Coefficient of Variation NA AUC(0 to t) could not be calculated as the values were below limit of quantification.	NA Hours*copies per milliliter Geometric Coefficient of Variation NA AUC(0 to t) could not be calculated as the values were below limit of quantification.	NA Hours*copies per milliliter Geometric Coefficient of Variation NA AUC(0 to t) could not be calculated as the values were below limit of quantification.

SECONDARY outcome

Timeframe: pre-dose on Day 1, 8, 15 and 22

Population: Data was not collected as no participants were enrolled in Part 1b of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 30, 45 and 60 days post last dose of study treatment (up to 24 days of treatment exposure)

Population: Vector Shedding Analysis Set included all enrolled participants who were treated and had at least 1 analyte concentration above the lower limit of quantitation. Data is not reported for Part 1b as no participants were enrolled and data was not collected. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and contributed data to the table and 'Number Analyzed' signifies participants evaluable for the specified time points.

Viral titers in each matrix (saliva, urine and skin swabs \[30 days post last dose only\]) at 30, 45 and 60 days after last dose of study treatment is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose Saliva; 30 days post last dose	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	—
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose Saliva; 60 days post last dose	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	—
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose Skin swab; 30 days post last dose	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	—
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose Urine; 45 days post last dose	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose Urine; 60 days post last dose	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	—
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose Saliva; 45 days post last dose	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose Urine; 30 days post last dose	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	NA Copies per milliliter Standard Deviation NA Data could not be calculated as the values were below the limit of quantification.	—

SECONDARY outcome

Timeframe: From Baseline (pre-dose) on Day 1 up to Day 22

Population: Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Data is not reported for Part 1b as no participants were enrolled and data was not collected.

A participant was considered NAb positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced) or (2) positive titer at baseline and had a ratio of \>= 4 in titer (dilution) to baseline in \>= 1 post-treatment sample (treatment-boosted). Percentage of participants with positive neutralizing antibodies against PF-07263689 is presented in this outcome measure. Data was not collected for sasanlimab as no participants were enrolled in Part 1b of the study.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Percentage of Participants With Positive Neutralizing Antibodies Against PF-07263689 and Sasanlimab	66.7 Percentage of participants	50.0 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: From Baseline (pre-dose) on Day 1 up to Day 22

A participant was considered anti-drug antibody (ADA) positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced) or (2) positive titer at baseline and had a ratio of \>= 4 in titer (dilution) to baseline in \>= 1 post-treatment sample (treatment-boosted). Percentage of participants with positive anti-interleukin 2 antibodies against PF-07263689 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1A PF-07263689 210^8 PFU n=3 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 Participants Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1: Percentage of Participants With Positive Anti-interleukin 2 Antibodies	0.0 Percentage of participants	25.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Day 1, 8, 15 and 22

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30, 45 and 60 days after the last PF-07263689 dose

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment until CR, PR or SD (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Disease control rate was the percentage of participants with CR, PR or stable disease (SD), as defined by RECIST 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. SD: Does not qualify for CR, PR, or progression. All target lesions assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first documentation of CR or PR to date of first documentation of PD or death due to any cause (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start date of treatment to the date of first documentation of PD or death due to any cause (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start date of treatment to the date of first documentation of PD (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment to the date of death from any cause (up to 2 years)

Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.

Overall survival was defined as the duration from the start of study treatment to the date of death from any cause.

Outcome measures

Outcome data not reported

Adverse Events

Part 1A PF-07263689 2*10^8 PFU

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1A PF-07263689 6*10^8 PFU

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Part 1A PF-07263689 20*10^8PFU

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1B: PF-07263689 + Sasanlimab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: PF-07263689 + Sasanlimab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1A PF-07263689 210^8 PFU n=3 participants at risk Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 participants at risk Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 participants at risk Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1B: PF-07263689 + Sasanlimab Participants were planned to receive escalating doses of PF-07263689 in combination with sasanlimab.	Part 2: PF-07263689 + Sasanlimab Participants were planned to receive PF-07263689 in combination with sasanlimab at the preliminary combination recommended Phase 2 dose from Part 1B.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Nausea	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.

Other adverse events

Other adverse events
Measure	Part 1A PF-07263689 210^8 PFU n=3 participants at risk Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 610^8 PFU n=4 participants at risk Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1A PF-07263689 2010^8PFU n=6 participants at risk Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.	Part 1B: PF-07263689 + Sasanlimab Participants were planned to receive escalating doses of PF-07263689 in combination with sasanlimab.	Part 2: PF-07263689 + Sasanlimab Participants were planned to receive PF-07263689 in combination with sasanlimab at the preliminary combination recommended Phase 2 dose from Part 1B.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Cardiac disorders Tachycardia	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	83.3% 5/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	33.3% 2/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Ascites	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Constipation	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Nausea	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	33.3% 2/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Oral pain	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	33.3% 2/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
General disorders Asthenia	66.7% 2/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
General disorders Chills	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 3/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
General disorders Fatigue	66.7% 2/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
General disorders Induration	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
General disorders Mucosal inflammation	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
General disorders Oedema peripheral	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
General disorders Pain	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
General disorders Pyrexia	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	83.3% 5/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Immune system disorders Cytokine release syndrome	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Infections and infestations COVID-19	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Infections and infestations Oral herpes	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Infections and infestations Urinary tract infection	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Injury, poisoning and procedural complications Arthropod bite	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Investigations Alanine aminotransferase increased	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Investigations Blood bilirubin increased	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Investigations Blood creatinine increased	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Investigations Breath sounds abnormal	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	33.3% 2/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Metabolism and nutrition disorders Hypoglycaemia	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	33.3% 2/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	33.3% 2/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Nervous system disorders Headache	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	83.3% 5/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Nervous system disorders Slow speech	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Psychiatric disorders Anxiety	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Psychiatric disorders Disorientation	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Psychiatric disorders Insomnia	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 2/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Skin and subcutaneous tissue disorders Drug eruption	33.3% 1/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	16.7% 1/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	25.0% 1/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
Vascular disorders Hypertension	0.00% 0/3 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	0.00% 0/4 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	50.0% 3/6 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.	— 0/0 • All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months). Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.

Additional Information

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Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER