Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation

Part 1 - Maximum tolerated dose (MTD) of BTP-114 determined during the dose escalation phase of study based on number of patients experiencing a dose-limiting toxicity.

Time Frame: From the date of the first dose up to approximately 52 weeks.

Part 1 - Recommended Phase 2 Dose (RP2D) of BTP-114 based on the MTD, review of adverse event data and review of AUC, Tmax and t1/2 obtained from PK data during the dose escalation phase of the study.

Time Frame: From the date of the first dose up to approximately 52 weeks.

Part 1 - Number of patients experiencing treatment-related adverse events as assessed by CTCAE v4.3 during the study.

Time Frame: From the date of first dose up to approximately 52 weeks.

Part 2 - Proportion of patients with an objective response (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria.

Time Frame: From the date of the first dose to documented disease progression assessed up to approximately 52 weeks.

Part 2 - Proportion of patients whose disease is controlled (DCR) using RECIST, Version 1.1 or PCWG2 criteria.

Time Frame: From the date of the first dose to documented disease progression assessed up to approximately 52 weeks.

Part 2 - Duration of response (DOR) measured from the date of first CR or PR until the first date of progressive disease or death from any cause.

Time Frame: Assessed up to approximately 52 weeks.

Part 2 - Progression-free survival (PFS) measured as the time from the date of initiation of BTP-114 treatment to the documented disease progression (PD) or death from any cause.

Time Frame: Assessed up to approximately 52 weeks.