NCT05800665RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic 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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 24 Mar 2023
- Start date
- 2 May 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Genentech, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT05800665
- EU CT number
- 2023-504013-68-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 210
- From 2 May 2023 to the primary completion date, 30 Jun 2027
- 26 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Untreated central nervous system (CNS) metastases or leptomeningeal disease.
- Note: Other protocol specified inclusion/exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health (Monash Medical Centre) Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Macquarie University Hospital Coordinator of this site? Confirm its status | New South Wales | Australia | Recruiting |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| British Columbia Cancer Agency Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Cambridge Clinical Research Centre Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| The Christie Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Royal Marsden Hospital - Surrey Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital Yonsei University Health System - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| University of Illinois Hospital & Health Sciences System Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Sarah Cannon Research Institute @ Florida Cancer Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| HonorHealth Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.