Trial Outcomes & Findings for A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors (NCT NCT03343054)

Last Updated: 2024-08-22

Results Overview

DLT was defined as any of the following adverse events occurred in 1st treatment cycle and attributable to talazoparib: hematologic- grade(G) 4 neutropenia greater than (\>)7days; Febrile neutropenia \>1 hour; G greater than or equal to (\>=)3 neutropenic infection, thrombocytopenia associated with G2 hemorrhage; G4 thrombocytopenia, anemia; G3 anemia required transfusion; daily dosing interrupted for \>=7 total days in first cycle for G3 neutropenia/thrombocytopenia. Non-hematologic: any G\>=3AE except non-clinically significant laboratory abnormalities, Non-hematologic AE deemed not clinically significant, nausea, vomiting, diarrhea responded to medical intervention within 72 hours, fatigue improved to G\>=2 within 7 days. Alanine/aspartate aminotransferase (ALT/AST)\>5\*upper limit of normal(ULN) and 2\*increases above baseline values; ALT/AST\>=3\*ULN concurrent with total bilirubin (TB)\>2\*ULN; TB\>5\*ULN; failure to deliver 75percent(%) of doses due to toxicities attributable to talazoparib.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Cycle 1 (28 days)

Results posted on

2024-08-22

Participant Flow

This study included 2 periods: dose escalation and dose expansion. The recommended dose for dose expansion period of talazoparib was determined in dose escalation period.

Dose escalation period: total 9 participants were screened, enrolled into the study and assigned to study treatment. Dose expansion period: total 22 participants were screened, out of which 3 participants were screen failure. 19 participants actually enrolled into the study and assigned to study treatment. Data reported based on the primary completion date of 11 January 2021.

Participant milestones

Participant milestones
Measure	Dose Escalation: Talazoparib 0.75 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 milligrams (mg) orally, once daily (QD) in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day minus (-) 7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with Germline breast cancer susceptibility gene mutation (gBRCAm) HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation Period (Up to 286 Days) STARTED	3	6	0
Dose Escalation Period (Up to 286 Days) COMPLETED	0	0	0
Dose Escalation Period (Up to 286 Days) NOT COMPLETED	3	6	0
Dose Expansion Period (Up to 502 Days) STARTED	0	0	19
Dose Expansion Period (Up to 502 Days) COMPLETED	0	0	0
Dose Expansion Period (Up to 502 Days) NOT COMPLETED	0	0	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation: Talazoparib 0.75 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 milligrams (mg) orally, once daily (QD) in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day minus (-) 7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with Germline breast cancer susceptibility gene mutation (gBRCAm) HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation Period (Up to 286 Days) Progressive Disease	2	6	0
Dose Escalation Period (Up to 286 Days) Global Deterioration of Health Status	1	0	0
Dose Expansion Period (Up to 502 Days) Progressive Disease	0	0	11
Dose Expansion Period (Up to 502 Days) Ongoing	0	0	8

Baseline Characteristics

A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg n=19 Participants Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).	Total n=28 Participants Total of all reporting groups
Age, Customized Less than (<)18 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized 18-44 Years	1 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants
Age, Customized 45-64 Years	1 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Age, Customized Greater than or equal to (>=)65 Years	1 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	19 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants	28 Participants n=4 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
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
Race (NIH/OMB) Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants	28 Participants n=4 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
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

PRIMARY outcome

Timeframe: Cycle 1 (28 days)

Population: The per-protocol analysis set included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during the first cycle. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation: Number of Participants With Dose-Limiting Toxicities (DLT)	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: From start of the treatment until disease progression or death (due to any cause) whichever occurred first (maximum duration: up to 502 days)

Population: FAS included all participants assigned to study treatment and who took at least 1 dose of study treatment.

Confirmed OR in participants was defined as the percentage of participants with complete response (CR) or partial response (PR) as best response determined by investigator as per RECIST v 1.1 and confirmed by a second image at least 4 weeks from the initial imaging showing response. As per RECIST v 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=19 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Percentage of Participants With Confirmed Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment	57.9 Percentage of participants Interval 36.8 to 77.0	—	—

SECONDARY outcome

Timeframe: From start of the treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (Dose escalation: maximum duration- up to 286 days; Dose expansion: maximum duration- up to 502 days)

Population: The safety analysis set (SAS) included all participants assigned to study treatment and who took at least 1 dose of study treatment.

Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were the events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy, whichever occurred first. TEAE graded by CTCAE v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg n=19 Participants Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Number of Participants With Treatment Emergent Adverse Events (TEAE) Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03	3 Participants	6 Participants	19 Participants

SECONDARY outcome

Population: The safety analysis set included all participants assigned to study treatment and who took at least 1 dose of study treatment.

A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Serious adverse event was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were the events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy, whichever occurred first. AE graded by CTCAE v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. Relatedness to study drug was assessed by the investigator.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg n=19 Participants Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Number of Participants With Treatment Related Adverse Events Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03	2 Participants	3 Participants	19 Participants

SECONDARY outcome

Population: The safety analysis set included all participants assigned to study treatment and who took at least 1 dose of study treatment.

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy, whichever occurred first. TEAE graded by CTCAE v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with grade 3 or higher AEs were reported.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg n=19 Participants Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03	1 Participants	2 Participants	11 Participants

SECONDARY outcome

Timeframe: Dose escalation: Baseline up to 286 days; Dose expansion: Baseline up to 502 days

Population: The safety analysis set included all participants assigned to study treatment and who took at least 1 dose of study treatment.

Parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. As per CTCAE v 4.03: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Only those categories in which at least one participant had data were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg n=19 Participants Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Alanine aminotransferase increased: Grade 1	1 Participants	2 Participants	8 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Alanine aminotransferase increased: Grade 2	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Alkaline phosphatase increased: Grade 1	1 Participants	2 Participants	4 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Alkaline phosphatase increased: Grade 2	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Aspartate aminotransferase increased: Grade 1	1 Participants	3 Participants	7 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Blood bilirubin increased: Grade 1	0 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Creatinine increased: Grade 1	2 Participants	6 Participants	17 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hyperglycemia: Grade 1	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hyperkalemia: Grade 1	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hypermagnesemia: Grade 1	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hypernatremia: Grade 1	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hypoalbuminemia: Grade 1	2 Participants	2 Participants	6 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hypoalbuminemia: Grade 2	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hypocalcemia: Grade 1	1 Participants	2 Participants	9 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hypoglycemia: Grade 1	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hypomagnesemia: Grade 1	0 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hyponatremia: Grade 1	1 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Chemistry Hypophosphatemia: Grade 2	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Dose escalation: Baseline up to 286 days; Dose expansion: Baseline up to 502 days

Population: The safety analysis set included all participants assigned to study treatment and who took at least 1 dose of study treatment.

Hematological parameters included: Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, White blood cell decreased. As per CTCAE v 4.03: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Only those categories in which at least one participant had data were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg n=19 Participants Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Anemia: Grade 1	3 Participants	2 Participants	8 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Anemia: Grade 2	0 Participants	3 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Anemia: Grade 3	0 Participants	1 Participants	9 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Lymphocyte count decreased: Grade 1	1 Participants	2 Participants	6 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Lymphocyte count decreased: Grade 2	2 Participants	3 Participants	4 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Lymphocyte count decreased: Grade 3	0 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Neutrophil count decreased: Grade 2	1 Participants	0 Participants	7 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Neutrophil count decreased: Grade 3	0 Participants	1 Participants	4 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Platelet count decreased: Grade 1	1 Participants	1 Participants	10 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology Platelet count decreased: Grade 2	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology White blood cell decreased: Grade 1	1 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology White blood cell decreased: Grade 2	1 Participants	1 Participants	9 Participants
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematology White blood cell decreased: Grade 3	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to 286 days

Population: The safety analysis set included all participants assigned to study treatment and who took at least 1 dose of study treatment. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period, as pre-specified in protocol.

Vital sign abnormalities: a) Sitting systolic blood pressure: \<90 millimeter of mercury (mmHg), decrease from baseline \>=30 mmHg, increase from baseline \>=30 mmHg; b) Sitting diastolic blood pressure: minimum \<50 mmHg, decrease from baseline \>=20 mmHg, increase from baseline \>=20 mmHg; c) Sitting pulse rate: minimum \<40 beats per minute (bpm), maximum \>120 bpm. Only those categories in which at least one participant had data were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation: Number of Participants With Abnormalities in Vital Signs Systolic blood pressure: <90 mmHg	1 Participants	0 Participants	—
Dose Escalation: Number of Participants With Abnormalities in Vital Signs Systolic blood pressure: decrease from baseline >=30 mmHg	0 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72 and 96 hours post dose on Day -7 of Cycle 1

Population: The Pharmacokinetic (PK) parameter analysis set included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic parameters of interest in the dose escalation period only. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period, as pre-specified in protocol.

Cmax was defined as the maximum observed plasma concentration of talazoparib.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Single Dose: Maximum Observed Plasma Concentration (Cmax) for Talazoparib	7.244 Nanogram per milliliter Geometric Coefficient of Variation 34	13.78 Nanogram per milliliter Geometric Coefficient of Variation 26	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72 and 96 hours post dose on Day -7 of Cycle 1

Population: The PK parameter analysis set included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic parameters of interest in the dose escalation period only. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period, as pre-specified in protocol.

Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) for Talazoparib	0.983 Hours Interval 0.75 to 1.92	0.967 Hours Interval 0.467 to 1.98	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72 and 96 hours post dose on Day -7 of Cycle 1

Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Single Dose: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Talazoparib	97.48 Nanogram hour per milliliter Geometric Coefficient of Variation 17	159.1 Nanogram hour per milliliter Geometric Coefficient of Variation 33	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose on Day -7 of Cycle 1

Area under the plasma concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Single Dose: Area Under the Curve From Time Zero to Time Tau (AUCtau) for Talazoparib	46.55 Nanogram hour per milliliter Geometric Coefficient of Variation 20	85.39 Nanogram hour per milliliter Geometric Coefficient of Variation 44	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72 and 96 hours post dose on Day -7 of Cycle 1

Population: The PK parameter analysis set included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic parameters of interest in the dose escalation period only. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period, as pre-specified in protocol.

Clearance is a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=4 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Single Dose: Apparent Oral Clearance of Talazoparib (CL/F)	6.968 Liter per hour Geometric Coefficient of Variation 12	5.010 Liter per hour Geometric Coefficient of Variation 9	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72 and 96 hours post dose on Day -7 of Cycle 1

Population: The PK parameter analysis set included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic parameters of interest in the dose escalation period only. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period, as pre-specified in protocol.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=4 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Single Dose: Apparent Volume of Distribution (Vz/F) for Talazoparib	551.8 Liter Geometric Coefficient of Variation 42	361.1 Liter Geometric Coefficient of Variation 20	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72 and 96 hours post dose on Day -7 of Cycle 1

Population: The PK parameter analysis set included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic parameters of interest in the dose escalation period only. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period, as pre-specified in protocol.

Terminal half-life (t1/2) is the time measured for the plasma concentration of a drug to decrease by half of its initial concentration.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=4 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Single Dose: Terminal Half-Life (t1/2) for Talazoparib	56.60 Hours Standard Deviation 17.860	50.73 Hours Standard Deviation 10.121	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72 and 96 hours post dose on Day -7 of Cycle 1

Population: The PK parameter analysis set included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic parameters of interest in the dose escalation period only. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period, as pre-specified in protocol.

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre dose) to extrapolated infinite time (0-inf).

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=4 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Single Dose: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Talazoparib	107.5 Nanogram hour per milliliter Geometric Coefficient of Variation 12	199.7 Nanogram hour per milliliter Geometric Coefficient of Variation 9	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose on Day 22 of Cycle 1

Css,max is maximum observed plasma concentration at steady state (post multiple dose) of Talazoparib.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Multiple Dose: Maximum Observed Plasma Concentration at Steady State (Css,Max) for Talazoparib	14.44 Nanogram per milliliter Geometric Coefficient of Variation 26	32.84 Nanogram per milliliter Geometric Coefficient of Variation 14	—

SECONDARY outcome

Timeframe: Pre dose on Day 22 of Cycle 1

Pre dose plasma concentration of talazoparib.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Multiple Dose: Predose Concentration (Cmin) for Talazoparib	2.175 Nanogram per milliliter Geometric Coefficient of Variation 8	3.645 Nanogram per milliliter Geometric Coefficient of Variation 49	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose on Day 22 of Cycle 1

Tss,max = Time to reach Cmax for talazoparib at steady state (post multiple dose).

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Multiple Dose: Time for Maximum Observed Plasma Concentration at Steady State (Tss,Max) for Talazoparib	1.02 Hours Interval 0.967 to 1.87	1.03 Hours Interval 0.733 to 1.92	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose on Day 22 of Cycle 1

Area under the plasma concentration curve from time 0 to end of dosing interval (AUCtau) at steady state (post multiple dose), where dosing interval was 24 hours.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Multiple Dose: Area Under the Curve From Time Zero to Time Tau at Steady State (AUCss,Tau) for Talazoparib	127.2 Nanogram hour per milliliter Geometric Coefficient of Variation 6	244.7 Nanogram hour per milliliter Geometric Coefficient of Variation 21	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dose on Day 22 of Cycle 1

Clearance is a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Multiple Dose: Apparent Oral Clearance of Talazoparib at Steady State (CL/Fss)	5.898 Liter per hour Geometric Coefficient of Variation 7	4.086 Liter per hour Geometric Coefficient of Variation 21	—

SECONDARY outcome

Timeframe: Pre dose, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 24 hours post dose on Day -7 and Day 22 of Cycle 1

Accumulation ratio for AUC was calculated as AUCtau for Day 22 divided by AUCtau for Day -7, where AUCtau was defined as area under the plasma concentration curve from time 0 to end of dosing interval, where dosing interval was 24 hours.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Multiple Dose: Accumulation Ratio (Rac) of AUCtau for Talazoparib	2.734 Ratio Geometric Coefficient of Variation 24	2.866 Ratio Geometric Coefficient of Variation 64	—

SECONDARY outcome

Timeframe: Pre dose, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72 and 96 hours post dose on Day -7 of Cycle 1; Pre dose, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 24 hours post dose on Day 22 of Cycle 1

Population: The PK parameter analysis set included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic parameters of interest in the dose escalation period only. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for dose expansion period, as pre-specified in protocol.

Rss was calculated by dividing AUCtau at steady state (post multiple dosing on Day 22) by single dose AUCinf (on Day -7). AUCtau was defined as area under the plasma concentration curve from time 0 to end of dosing interval, where dosing interval was 24 hours. AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=4 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation- Multiple Dose: Linearity Ratio (Rss) of AUC for Talazoparib	1.181 Ratio Geometric Coefficient of Variation 12	1.249 Ratio Geometric Coefficient of Variation 14	—

SECONDARY outcome

Timeframe: From start of the treatment until disease progression or death (due to any cause) whichever occurred first (maximum duration: up to 286 days)

Population: FAS included all participants assigned to study treatment and who took at least 1 dose of study treatment.

OR in participants was defined as the percentage of participants with CR or PR as best response determined by investigator as per RECIST v 1.1. As per RECIST v 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation: Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	0 Percentage of participants	0 Percentage of participants	—

SECONDARY outcome

Timeframe: From day of first dose until disease progression or death (due to any cause) whichever occur first (maximum duration: up to 286 days)

Population: FAS included all participants assigned to study treatment and who took at least 1 dose of study treatment.

PFS was defined as the time from the date of first dose of study drug to the earliest date of disease progression per RECIST v 1.1, or death due to any cause, whichever occurs first. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Escalation: Progression Free Survival (PFS)	3.0 Months Interval 2.1 to 3.0	3.4 Months Interval 1.2 to 9.6	—

SECONDARY outcome

Timeframe: From date of first documented response to date of first documented PD or death (due to any cause) whichever occurred first (maximum duration: up to 286 days)

Population: Due to no participants with response in dose escalation period, data collection and analysis for DOR was not performed. Hence, data is not reported.

DOR was defined as the time between the date of the first documented objective response (PR or CR) and the date of the first documented progression or death (due to any cause) whichever occurs first. As per RECIST v 1.1: CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of the treatment until disease progression or death (due to any cause) whichever occurred first (maximum duration: up to 502 days)

Population: FAS included all participants assigned to study treatment and who took at least 1 dose of study treatment.

Confirmed OR in participants was defined as the percentage of participants with CR or PR as best response determined by BICR as per RECIST v 1.1 and confirmed by a second image at least 4 weeks from the initial imaging showing response. As per RECIST v 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=19 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Blinded Independent Central Review (BICR)	52.6 Percentage of participants Interval 32.0 to 72.6	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 16, Baseline up to Week 24

Population: FAS included all participants assigned to study treatment and who took at least 1 dose of study treatment. Data for this outcome measure was not planned to be collected and analyzed for dose escalation period, as pre-specified in protocol.

Disease Control (DC) was defined as participants with a confirmed CR, confirmed PR and SD at 16 and 24 weeks as assessed by investigator as per RECIST v 1.1. As per RECIST v 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of diameters of target lesions) taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=19 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Percentage of Participants With Confirmed Disease Control as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment Up to Week 16	94.7 Percentage of participants Interval 77.4 to 99.7	—	—
Dose Expansion: Percentage of Participants With Confirmed Disease Control as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment Up to Week 24	94.7 Percentage of participants Interval 77.4 to 99.7	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 16, Baseline up to Week 24

Disease Control (DC) was defined as participants with a confirmed CR, confirmed PR and SD at 16 and 24 weeks as assessed by BICR as per RECIST v 1.1. As per RECIST v 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of diameters of target lesions) taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=19 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Percentage of Participants With Confirmed Disease Control as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Blinded Independent Central Review (BICR) Up to Week 16	89.5 Percentage of participants Interval 70.4 to 98.1	—	—
Dose Expansion: Percentage of Participants With Confirmed Disease Control as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Blinded Independent Central Review (BICR) Up to Week 24	89.5 Percentage of participants Interval 70.4 to 98.1	—	—

SECONDARY outcome

Timeframe: From first dose of study drug until first documentation of CR or PR (maximum duration: up to 502 days)

Population: Analysis was performed on subset of participants with OR. Data for this outcome measure was not planned to be collected and analyzed for dose escalation period, as pre-specified in protocol.

TTR was defined as the time (in months) from the date of first dose of study drug to the first documentation of objective response (CR or PR) as assessed by investigator according to RECIST v 1.1. As per RECIST v 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=11 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Time-to-Tumor Response (TTR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment	2.63 Months Interval 1.2 to 9.4	—	—

SECONDARY outcome

Timeframe: From first dose of study drug until first documentation of CR or PR (maximum duration: up to 502 days)

TTR was defined as the time (in months) from the date of first dose of study drug to the first documentation of objective response (CR or PR) as assessed by BICR according to RECIST v 1.1. As per RECIST v 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=10 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Time-to-Tumor Response (TTR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Blinded Independent Central Review (BICR)	2.07 Months Interval 1.2 to 4.2	—	—

SECONDARY outcome

Timeframe: From date of first documented response to date of first documented PD or death (due to any cause) whichever occurred first (maximum duration: up to 502 days)

Population: Analysis was performed on subset of participants with OR.

DOR was defined as the time between the date of first documented objective response (PR or CR) and the date of first documented progression or death (due to any cause) whichever occurs first. As per RECIST v 1.1: CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=11 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment	6.8 Months Interval 2.7 to Upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with event.	—	—

SECONDARY outcome

Timeframe: From date of first documented response to date of first documented PD or death (due to any cause) whichever occurred first (maximum duration: up to 502 days)

Population: Analysis was performed on subset of participants with OR.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=10 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Blinded Independent Central Review (BICR)	6.0 Months Interval 2.3 to Upper limit of 95% CI was not estimable due to low number of participants with event.	—	—

SECONDARY outcome

Timeframe: From day of first dose until disease progression or death (due to any cause) whichever occur first (maximum duration: up to 502 days)

Population: FAS included all participants assigned to study treatment and who took at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=19 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment	7.2 Months Interval 4.1 to Upper limit of 95% CI was not estimable due to low number of participants with event.	—	—

SECONDARY outcome

Timeframe: From day of first dose until disease progression or death (due to any cause) whichever occur first (maximum duration: up to 502 days)

Population: FAS included all participants assigned to study treatment and who took at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=19 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Blinded Independent Central Review (BICR)	7.2 Months Interval 3.9 to Upper limit of 95% CI was not estimable due to low number of participants with event.	—	—

SECONDARY outcome

Timeframe: At Month 12

OS was defined as the time from the first dose date to date of death due to any cause. Participant was considered as event (overall survival) free if participant was not died and was alive at Month 12. Probability of participants who were event free at Month 12 was estimated by Kaplan-Meier method and reported.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=19 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Overall Survival (OS): Probability of Participants Who Were Event-Free at Month 12	0.847 Probability of event free participants Interval 0.575 to 0.951	—	—

SECONDARY outcome

Timeframe: Pre dose at 0 hour on Day 1 of Cycle 2, 3, 4 and unplanned (any time during dose expansion period up to 502 days)

Population: The PK concentration analysis set included all enrolled participants who were treated and have at least 1 analyte concentration. Here "number analyzed" signifies number of participants evaluated for given time point. Data for this outcome measure was not planned to be collected and analyzed for dose escalation period, as pre-specified in protocol.

Pre dose plasma drug concentration.

Outcome measures

Outcome measures
Measure	Dose Escalation: Talazoparib 0.75 mg n=19 Participants Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Dose Expansion: Trough Concentrations (Ctrough) of Talazoparib Cycle 2 Day 1	3098 Picogram per milliliter Geometric Coefficient of Variation 40	—	—
Dose Expansion: Trough Concentrations (Ctrough) of Talazoparib Cycle 3 Day 1	3423 Picogram per milliliter Geometric Coefficient of Variation 41	—	—
Dose Expansion: Trough Concentrations (Ctrough) of Talazoparib Cycle 4 Day 1	2910 Picogram per milliliter Geometric Coefficient of Variation 52	—	—
Dose Expansion: Trough Concentrations (Ctrough) of Talazoparib Unplanned	3670 Picogram per milliliter Geometric Coefficient of Variation 38	—	—

Adverse Events

Dose Escalation: Talazoparib 0.75 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation: Talazoparib 1.0 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Expansion: Talazoparib 1.0 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation: Talazoparib 0.75 mg n=3 participants at risk Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.	Dose Escalation: Talazoparib 1.0 mg n=6 participants at risk Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.	Dose Expansion: Talazoparib 1.0 mg n=19 participants at risk Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	33.3% 1/3 • Dose escalation: maximum duration up to 286 days; Dose expansion: maximum duration up to 502 days Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Dose escalation: maximum duration up to 286 days; Dose expansion: maximum duration up to 502 days Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Dose escalation: maximum duration up to 286 days; Dose expansion: maximum duration up to 502 days Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3 • Dose escalation: maximum duration up to 286 days; Dose expansion: maximum duration up to 502 days Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Dose escalation: maximum duration up to 286 days; Dose expansion: maximum duration up to 502 days Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Dose escalation: maximum duration up to 286 days; Dose expansion: maximum duration up to 502 days Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.

Other adverse events

Additional Information

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