A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
NCT ID: NCT05800665
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
210 participants
INTERVENTIONAL
2023-05-02
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Stage 1: Dose Escalation
Participants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached.
RO7656594
RO7656594 will be administered orally at specified dose on specified days.
Stage 2: Expansion
Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).
RO7656594
RO7656594 will be administered orally at specified dose on specified days.
Interventions
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RO7656594
RO7656594 will be administered orally at specified dose on specified days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
MALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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HonorHealth
Scottsdale, Arizona, United States
Yale Cancer Center
New Haven, Connecticut, United States
Sarah Cannon Research Institute @ Florida Cancer
Orlando, Florida, United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States
SCRI Oncology Partners
Nashville, Texas, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Macquarie University Hospital
New South Wales, New South Wales, Australia
Monash Health Monash Medical Centre
Clayton, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, , South Korea
Asan Medical Center - PPDS
Seoul, , South Korea
Samsung Medical Center - PPDS
Seoul, , South Korea
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Clinica Universidad de Navarra-Madrid
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Cambridge Clinical Research Centre
Cambridge, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
The Christie
Manchester, , United Kingdom
Royal Marsden Hospital - Surrey
Sutton, , United Kingdom
Countries
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Central Contacts
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GO44537 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Other Identifiers
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GO44537
Identifier Type: -
Identifier Source: org_study_id
2023-504013-68-00
Identifier Type: CTIS
Identifier Source: secondary_id