A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GDC-1261

Treatment groups

260 Participants
are divided into 1 treatment group

Sponsors and collaborators