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Evaluating a new treatment for advanced prostate cancer

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

Phase 1 Interventional Genentech, Inc. · NCT05800665

This study is testing a new treatment for advanced prostate cancer to see how safe it is and if it helps patients feel better.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment210 (estimated)
Ages18 Years and up
SexMale
SponsorGenentech, Inc. Industry-sponsored
Locations25 sites (Scottsdale, Arizona and 24 other locations)
Trial IDNCT05800665 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will involve administering the treatment to eligible patients and monitoring their responses to determine effective dosing regimens. The study will also gather data on how the drug is processed in the body and its potential effectiveness against the disease.

Who should consider this trial

Good fit: Ideal candidates include men with metastatic prostate adenocarcinoma who have previously undergone specific therapies and meet the study's inclusion criteria.

Not a fit: Patients with small-cell carcinoma or neuroendocrine features of prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced prostate cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
2. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
3. Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
4. 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.
5. 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.

Key Exclusion Criteria:

1. 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.
2. Treatment with any investigational agent within 28 days prior to the first study treatment.
3. Treatment with any previous AR protein degrader.
4. Untreated central nervous system (CNS) metastases or leptomeningeal disease.

Note: Other protocol specified inclusion/exclusion criteria may apply.

Where this trial is running

Scottsdale, Arizona and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Prostate CancerMetastatic Prostate CancerCastration-resistant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.