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A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
NCT05800665 · Genentech, Inc.
In plain English
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Official title
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
About this study
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 criteria
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.
Study design
Enrollment target: 210 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-05-02
Estimated completion: 2027-06-30
Last updated: 2026-03-19
Interventions
Drug: RO7656594
Primary outcomes
- • Percentage of Participants with Adverse Events (From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days))
- • Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs) (Days 1-28 of Cycle 1)
Sponsor
Genentech, Inc. · industry
Contacts & investigators
ContactGO44537 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
InvestigatorClinical Trials · study_director, Genentech, Inc.
All locations (25)
HonorHealthRecruiting
Scottsdale, Arizona, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Sarah Cannon Research Institute @ Florida CancerRecruiting
Orlando, Florida, United States
University of Illinois Hospital & Health Sciences SystemRecruiting
Chicago, Illinois, United States
SCRI Oncology PartnersRecruiting
Nashville, Texas, United States
St Vincent's Hospital SydneyRecruiting
Darlinghurst, New South Wales, Australia
Macquarie University HospitalRecruiting
New South Wales, New South Wales, Australia
Monash Health Monash Medical CentreRecruiting
Clayton, Victoria, Australia
Austin HospitalRecruiting
Heidelberg, Victoria, Australia
British Columbia Cancer AgencyRecruiting
Vancouver, British Columbia, Canada
Princess Margaret HospitalRecruiting
Toronto, Ontario, Canada
Centre Léon BérardRecruiting
Lyon, France
Institut Paoli CalmettesRecruiting
Marseille, France
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital Yonsei University Health System - PPDSRecruiting
Seoul, South Korea
Asan Medical Center - PPDSRecruiting
Seoul, South Korea
Samsung Medical Center - PPDSRecruiting
Seoul, South Korea
Clinica Universidad de NavarraRecruiting
Pamplona, Navarre, Spain
Hospital Universitario Vall d'Hebron - PPDSRecruiting
Barcelona, Spain
Clinica Universidad de Navarra-MadridRecruiting
Madrid, Spain
Hospital Clinico San CarlosRecruiting
Madrid, Spain
Cambridge Clinical Research CentreRecruiting
Cambridge, United Kingdom
Leicester Royal InfirmaryRecruiting
Leicester, United Kingdom
The ChristieRecruiting
Manchester, United Kingdom
Royal Marsden Hospital - SurreyRecruiting
Sutton, United Kingdom