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New hope for advanced prostate cancer: experimental drug enters human trials

NCT ID NCT05800665

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This early-stage trial is testing an experimental oral drug called RO7656594 in people with advanced or metastatic prostate cancer that has progressed after standard treatments. The study aims to find safe doses and check for any signs that the drug can shrink tumors or lower PSA levels. About 210 participants will receive the drug at different doses to see how well it is tolerated and how the body processes it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RO7656594 (also called GDC-2992), an oral drug
What this could lead to
If successful, this could point toward a new treatment option for advanced prostate cancer that has stopped responding to other therapies.
What could go wrong
This is an early Phase 1 trial with only 210 participants, focused on safety and dosing. It is too soon to know if the drug will work or have manageable side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced prostate cancer Metastatic prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center - PPDS

    RECRUITING

    Seoul, 05505, South Korea

  • Austin Hospital

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • British Columbia Cancer Agency

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Cambridge Clinical Research Centre

    RECRUITING

    Cambridge, CB2 0AU, United Kingdom

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69008, France

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Clinica Universidad de Navarra-Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Gustave Roussy

    RECRUITING

    Villejuif, Val-de-Marne, 94805, France

  • HonorHealth

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    RECRUITING

    Barcelona, 08035, Spain

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • Macquarie University Hospital

    RECRUITING

    New South Wales, New South Wales, 2162, Australia

  • Monash Health Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Royal Marsden Hospital - Surrey

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Texas, 37203, United States

  • Samsung Medical Center - PPDS

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute @ Florida Cancer

    RECRUITING

    Orlando, Florida, 32827, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System - PPDS

    RECRUITING

    Seoul, 03722, South Korea

  • St Vincent's Hospital Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • The Christie

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • University of Illinois Hospital & Health Sciences System

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.