NCT05800665 A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
| NCT ID | NCT05800665 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Genentech, Inc. |
| Condition | Advanced Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 210 participants in total. It began in 2023-05-02 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
GO44537 https://forpatients.roche.com/
✉ global-roche-genentech-trials@gene.com📞 888-662-6728 (U.S. Only)
Clinical Trials
STUDY DIRECTOR
Genentech, Inc.
Frequently Asked Questions
Who can join the NCT05800665 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Advanced Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05800665 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05800665 currently recruiting?
Yes, NCT05800665 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT05800665 trial being conducted?
This trial is being conducted at Scottsdale, United States, New Haven, United States, Orlando, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT05800665 clinical trial?
NCT05800665 is sponsored by Genentech, Inc.. The principal investigator is Clinical Trials at Genentech, Inc.. The trial plans to enroll 210 participants.
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