Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT05800665

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

Led by Genentech, Inc. · Updated on 2026-04-20

210

Participants Needed

25

Research Sites

217 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
  • Diagnosis of metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features
  • Prior therapy with a second-generation androgen receptor-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)
  • Prior therapy with a taxane regimen or considered ineligible for taxane treatment or refused taxane treatment
  • For participants with a known pathogenic BRCA1 or BRCA2 mutation: prior therapy with a PARP inhibitor, or considered ineligible for PARP inhibitor treatment if approved and available
Not Eligible

You will not qualify if you...

  • Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, up to 28 days) before starting study treatment
  • Treatment with any investigational agent within 28 days before starting study treatment
  • Treatment with any previous androgen receptor protein degrader
  • Untreated central nervous system (CNS) metastases or leptomeningeal disease
  • Other protocol specified inclusion/exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

G

GO44537 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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