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NCT05800665PHASE1Recruiting

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

Genentech, Inc.

Start Date

5/2/2023

Completion Date

6/30/2027

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

RO7656594

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Conditions

Advanced Prostate CancerMetastatic Prostate Cancer

Locations

HonorHealth

Scottsdale, Arizona 85258

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Sarah Cannon Research Institute @ Florida Cancer

Orlando, Florida 32827

United States

University of Illinois Hospital & Health Sciences System

Chicago, Illinois 60612

United States

SCRI Oncology Partners

Nashville, Texas 37203

United States

St Vincent's Hospital Sydney

Darlinghurst, New South Wales 2010

Australia

Macquarie University Hospital

New South Wales, New South Wales 2162

Australia

Monash Health Monash Medical Centre

Clayton, Victoria 3168

Australia

Austin Hospital

Heidelberg, Victoria 3084

Australia

British Columbia Cancer Agency

Vancouver, British Columbia V5Z 4E6

Canada

Princess Margaret Hospital

Toronto, Ontario M5G 2M9

Canada

Gustave Roussy

Villejuif, Val-de-Marne 94805

France

Centre Léon Bérard

Lyon, 69008

France

Institut Paoli Calmettes

Marseille, 13009

France

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, 03722

South Korea

Asan Medical Center - PPDS

Seoul, 05505

South Korea

Samsung Medical Center - PPDS

Seoul, 06351

South Korea

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035

Spain

Clinica Universidad de Navarra-Madrid

Madrid, 28027

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Cambridge Clinical Research Centre

Cambridge, CB2 0AU

United Kingdom

Leicester Royal Infirmary

Leicester, LE1 5WW

United Kingdom

The Christie

Manchester, M20 4BX

United Kingdom

Royal Marsden Hospital - Surrey

Sutton, SM2 5PT

United Kingdom