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

Last updated: June 3, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Prostate Disorders

Urologic Cancer

Treatment

RO7656594

Clinical Study ID

NCT05800665
GO44537
2023-504013-68-00
  • Ages > 18
  • Male

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 Criteria

Inclusion

Key Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

  2. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrinefeatures.

  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 witha taxane regimen or have refused treatment with a taxane regimen, unless otherwisespecified.

  5. For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2mutation: 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

Key Exclusion Criteria:

  1. Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drugelimination half-lives (whichever is longer, not to exceed 28 days) prior to thefirst study treatment.

  2. Treatment with any investigational agent within 28 days prior to the first studytreatment.

  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

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: RO7656594
Phase: 1
Study Start date:
May 02, 2023
Estimated Completion Date:
July 30, 2026

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Macquarie University Hospital

    Sydney, New South Whales 2109
    Australia

    Site Not Available

  • Monash Health Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • St Vincents Hospital

    Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • St Vincents Hospital X

    Melbourne, Victoria 3065
    Australia

    Site Not Available

  • Macquarie University Hospital

    New South Wales, 2162
    Australia

    Active - Recruiting

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69008
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009
    France

    Active - Recruiting

  • Asan Medical Center - PPDS

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center - PPDS

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, Catalonia 08035
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Cambridge Clinical Research Centre

    Cambridge, CB2 0AU
    United Kingdom

    Active - Recruiting

  • Leicester Royal Infirmary

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • The Christie

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital - Surrey

    Surrey, SM2 5PT
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital - Surrey

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute - Lake Nona Cancer Center

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute @ Florida Cancer

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • University of Illinois Hospital & Health Sciences System

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee 37203-1503
    United States

    Active - Recruiting

  • Tennessee Oncology - Nashville

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology NASH - SCRI - PPDS

    Nashville, Tennessee 37203-1503
    United States

    Active - Recruiting

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