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

May 15, 2026 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital Sydney
      • New South Wales, New South Wales, Australia, 2162
        • Recruiting
        • Macquarie University Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health Monash Medical Centre
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • British Columbia Cancer Agency
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Hospital
  • France
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon Berard
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System - PPDS
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center - PPDS
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center - PPDS
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra-Madrid
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0AU
        • Recruiting
        • Cambridge Clinical Research Centre
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital - Surrey
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honorhealth
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Sarah Cannon Research Institute @ Florida Cancer
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Hospital & Health Sciences System
    • Texas
      • Nashville, Texas, United States, 37203
        • Recruiting
        • SCRI Oncology Partners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: RO7656594
RO7656594 will be administered orally at specified dose on specified days.
Other Names:
  • GDC-2992
Experimental: Stage 2: Expansion
Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Drug: RO7656594
RO7656594 will be administered orally at specified dose on specified days.
Other Names:
  • GDC-2992

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
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)
Time Frame: Days 1-28 of Cycle 1
Days 1-28 of Cycle 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594
Time Frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
Time Frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Plasma Concentration of RO7656594
Time Frame: Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma.
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO44537
  • 2023-504013-68-00 (Ctis: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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