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Clinical Trials in the USA / NCT05800665
Recruiting Phase 1

A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer

NCT05800665 · tracked via the Priya Life Science USA tracker
Sponsor
Genentech, Inc.
Phase
Phase 1
Started
2023-05-02
Last updated
2026-09-08

Condition(s) studied

Advanced Prostate CancerMetastatic Prostate Cancer

Investigational drug(s) / intervention(s)

RO7656594

RO7656594: RO7656594 will be administered orally at specified dose on specified days.

Study 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

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
HonorHealth Scottsdale Arizona Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Sarah Cannon Research Institute @ Florida Cancer Orlando Florida Recruiting
University of Illinois Hospital & Health Sciences System Chicago Illinois Recruiting
SCRI Oncology Partners Nashville Texas Recruiting
St Vincent's Hospital Sydney Darlinghurst New South Wales Recruiting
Macquarie University Hospital New South Wales New South Wales Recruiting
Monash Health Monash Medical Centre Clayton Victoria Recruiting
Austin Hospital Heidelberg Victoria Recruiting
British Columbia Cancer Agency Vancouver British Columbia Recruiting
Princess Margaret Hospital Toronto Ontario Recruiting
Gustave Roussy Villejuif Val-de-Marne Recruiting
Centre Léon Bérard Lyon France Recruiting
Institut Paoli Calmettes Marseille France Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Yonsei University Health System - PPDS Seoul South Korea Recruiting
Asan Medical Center - PPDS Seoul South Korea Recruiting
Samsung Medical Center - PPDS Seoul South Korea Recruiting
Clinica Universidad de Navarra Pamplona Navarre Recruiting
Hospital Universitario Vall d'Hebron - PPDS Barcelona Spain Recruiting
Clinica Universidad de Navarra-Madrid Madrid Spain Recruiting
Hospital Clinico San Carlos Madrid Spain Recruiting
Cambridge Clinical Research Centre Cambridge United Kingdom Recruiting
Leicester Royal Infirmary Leicester United Kingdom Recruiting
The Christie Manchester United Kingdom Recruiting
Royal Marsden Hospital - Surrey Sutton United Kingdom Recruiting

More Genentech, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05800665 on ClinicalTrials.gov ↗ ← All trials in the USA