OncoMatch/Clinical Trials/NCT05800665
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Is NCT05800665 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies RO7656594 for advanced prostate cancer.
Treatment: RO7656594 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Biomarker criteria
Allowed: BRCA1 pathogenic mutation
Allowed: BRCA2 pathogenic mutation
Disease stage
Metastatic disease required
Metastatic prostate adenocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: second-generation androgen receptor-targeted therapy (abiraterone, enzalutamide, apalutamide, darolutamide)
Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)
Must have received: taxane
Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen
Must have received: PARP inhibitor
For participants with a known pathogenic 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
Cannot have received: AR protein degrader
Treatment with any previous AR protein degrader
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- HonorHealth · Scottsdale, Arizona
- Yale Cancer Center · New Haven, Connecticut
- Sarah Cannon Research Institute @ Florida Cancer · Orlando, Florida
- University of Illinois Hospital & Health Sciences System · Chicago, Illinois
- SCRI Oncology Partners · Nashville, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05800665 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior AR protein degrader disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages