Actively Recruiting
Phase III Study of GDC-1261 for Safety and Effects in Men With Advanced or Metastatic Prostate Cancer
Led by Genentech, Inc. · Updated on 2026-08-10
260
Participants Needed
5
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, how the body processes the drug, and the early effects of GDC-1261 in adults with advanced or metastatic prostate cancer. This study aims to find the best dose and treatment plan for GDC-1261 to use in future research. It focuses on men who have prostate cancer that has progressed despite previous treatments. Participants will receive the study drug GDC-1261 according to a specific schedule outlined in the trial protocol. The study includes a dose-escalation phase where doses are increased carefully, followed by an expansion phase to further evaluate the treatment. It is a phase III trial designed to assess safety and initial activity of the drug. During the study, participants will be monitored for side effects, including dose-limiting toxicities, and drug levels in the blood will be measured up to about 24 months. Researchers will also assess prostate-specific antigen PSA responses and tumor responses to evaluate how the drug affects the cancer. Safety and effectiveness data will be collected throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
Research Team
R
Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.
F
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
