The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.
Eastern Cooperative Oncology Group (ECOG) Performance Status of <=1
Life expectancy is >= 3 months
Histologically or cytologically confirmed prostate adenocarcinoma
Disease progression during or following the direct prior line of therapy
Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
Structurally unstable bone lesions suggest an impending fracture
Untreated central nervous system (CNS) metastases or leptomeningeal disease
Uncontrolled pain
Sequential
GDC-1261
DrugParticipants will receive GDC-1261 as per the schedule described in the protocol.
Percentage of Participants With Adverse Events (AEs)
Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)
Plasma Concentration of GDC-1261
Plasma Concentration of GDC-1261 Either in Fasted or Fed State
Prostate-Specific Antigen-30% (PSA30) Response Rate
PSA50 Response Rate
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