Actively Recruiting
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Led by Genentech, Inc. · Updated on 2026-04-20
210
Participants Needed
25
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Diagnosis of metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features
- Prior therapy with a second-generation androgen receptor-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)
- Prior therapy with a taxane regimen or considered ineligible for taxane treatment or refused taxane treatment
- For participants with a known pathogenic BRCA1 or BRCA2 mutation: prior therapy with a PARP inhibitor, or considered ineligible for PARP inhibitor treatment if approved and available
You will not qualify if you...
- Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, up to 28 days) before starting study treatment
- Treatment with any investigational agent within 28 days before starting study treatment
- Treatment with any previous androgen receptor protein degrader
- Untreated central nervous system (CNS) metastases or leptomeningeal disease
- Other protocol specified inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Sarah Cannon Research Institute @ Florida Cancer
Orlando, Florida, United States, 32827
Actively Recruiting
4
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States, 60612
Actively Recruiting
5
SCRI Oncology Partners
Nashville, Texas, United States, 37203
Actively Recruiting
6
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
7
Macquarie University Hospital
New South Wales, New South Wales, Australia, 2162
Actively Recruiting
8
Monash Health Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
9
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
10
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
11
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
12
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
13
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
14
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
15
Severance Hospital Yonsei University Health System - PPDS
Seoul, South Korea, 03722
Actively Recruiting
16
Asan Medical Center - PPDS
Seoul, South Korea, 05505
Actively Recruiting
17
Samsung Medical Center - PPDS
Seoul, South Korea, 06351
Actively Recruiting
18
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
19
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 08035
Actively Recruiting
20
Clinica Universidad de Navarra-Madrid
Madrid, Spain, 28027
Actively Recruiting
21
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
22
Cambridge Clinical Research Centre
Cambridge, United Kingdom, CB2 0AU
Actively Recruiting
23
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
24
The Christie
Manchester, United Kingdom, M20 4BX
Actively Recruiting
25
Royal Marsden Hospital - Surrey
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
G
GO44537 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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