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Phase 1 Study of RO7656594 to Assess Safety, Dosage, and Activity in Men with Advanced or Metastatic Prostate Cancer
Led by Genentech, Inc. · Updated on 2026-08-10
210
Participants Needed
26
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and early activity of a drug called RO7656594 in men with advanced or metastatic prostate cancer. This phase 1 study aims to find the recommended doses and treatment schedules for RO7656594 for future research. Participants have prostate adenocarcinoma without small-cell or neuroendocrine features and have received prior hormone and chemotherapy treatments. Participants will receive RO7656594 orally at specified doses on certain days within 28-day cycles. The dose will be gradually increased in groups of participants until a specific threshold is reached, after which participants will receive doses at or below the maximum tolerated or administered dose. The study includes dose escalation and expansion stages to assess safety and activity. During the study, participants will be closely monitored for side effects and dose-limiting toxicities from the first day of treatment through up to 28 days after the final dose, potentially lasting about 24 months. Blood samples will be taken at multiple points to measure drug levels, and prostate-specific antigen PSA responses will be evaluated. This monitoring helps researchers understand how the drug behaves in the body and its potential effects on the cancer over time.
CONDITIONS
Brief Title
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Research Team
G
GO44537 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
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