Actively Recruiting
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
Led by Genentech, Inc. · Updated on 2026-05-18
210
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying RO7656594, an investigational drug, in men with advanced or metastatic prostate cancer to assess its safety, how the body processes it, and its initial activity. The study aims to find appropriate doses and schedules for future research, focusing on patients who have previously received specific therapies including androgen receptor-targeted treatments and taxane regimens or are ineligible for such treatments. Participants will receive RO7656594 orally at set doses on specific days within each 28-day cycle. The dose will be gradually increased in groups of participants until reaching a study-defined limit. After this dose-escalation phase, participants will receive the drug at or below the maximum tolerated or administered dose. The study includes two phases: dose escalation and expansion. During the study, participants will be monitored for side effects from the first day of treatment through about 24 months after the last dose. Blood samples will be collected at multiple time points up to about 12 months to measure drug levels. Researchers will also evaluate prostate-specific antigen responses as indicators of activity. Eligibility assessments include performance status and prior treatments. The total duration of participation varies based on treatment and follow-up needs.
CONDITIONS
Brief 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 0 or 1
- Diagnosis of metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features
- Prior therapy with a second-generation androgen receptor-targeted therapy such as abiraterone, enzalutamide, apalutamide, or darolutamide
- Prior therapy with a taxane chemotherapy regimen, or ineligibility or refusal of taxane treatment
- For participants with known BRCA1 or BRCA2 mutations: prior therapy with a PARP inhibitor, or ineligibility 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 before starting study treatment (up to 28 days maximum)
- Treatment with any investigational agent within 28 days prior to starting study treatment
- Prior treatment with any androgen receptor protein degrader
- Untreated central nervous system metastases or leptomeningeal disease
- Other protocol-specified inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive RO7656594 administered orally at specified doses on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached, followed by treatment at or below the maximum tolerated or administered dose.
Repeated visits during 28-day treatment cycles
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/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here