Tests RO7656594 safety in advanced prostate cancer
Tests the drug RO7656594 for safety in adults with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Key facts
- Where
- Toronto and Vancouver, CanadaSee the 2 sites
- Phase
- Phase 1
Where in Canada
- Princess Margaret HospitalToronto, CanadaTaking people
- British Columbia Cancer AgencyVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech, Inc.
- Trial code
- NCT05800665EU 2023-504013-68-00
- Record updated
- 3 November 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.Read full original descriptionShow less
A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 in Patients With Advanced or Metastatic Prostate Cancer
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.
Inclusion: Eastern Cooperative Oncology Group (ECOG) performance status ≤1; Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features; Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide); Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified; For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2 mutation: prior therapy with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor, or are considered ineligible for treatment with a PARP inhibitor, if such therapy is approved and available.
Exclusion: Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, not to exceed 28 days) prior to the first study treatment; Treatment with any investigational agent within 28 days prior to the first study treatment; Treatment with any previous AR protein degrader; Untreated central nervous system (CNS) metastases or leptomeningeal disease; Note: Other protocol specified inclusion/exclusion criteria may apply.