NCT05800665

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_1

Timeline
14mo left

Started May 2023

Longer than P75 for phase_1

Geographic Reach
7 countries

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2023Jun 2027

First Submitted

Initial submission to the registry

March 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

March 24, 2023

Last Update Submit

April 17, 2026

Conditions

Advanced Prostate CancerMetastatic Prostate Cancer

Keywords

Castration-resistant

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants with Adverse Events

    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)

    Days 1-28 of Cycle 1

Secondary Outcomes (3)

  • Plasma Concentration of RO7656594

    Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)

  • Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594

    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

    From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)

Study Arms (2)

Stage 1: Dose Escalation

EXPERIMENTAL

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

Stage 2: Expansion

EXPERIMENTAL

Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Drug: RO7656594

Interventions

RO7656594DRUG

RO7656594 will be administered orally at specified dose on specified days.

Also known as: GDC-2992
Stage 1: Dose EscalationStage 2: Expansion

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
  • Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
  • 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.
  • 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.

You may not qualify if:

  • 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.
  • Treatment with any investigational agent within 28 days prior to the first study treatment.
  • Treatment with any previous AR protein degrader.
  • Untreated central nervous system (CNS) metastases or leptomeningeal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Sarah Cannon Research Institute @ Florida Cancer

Orlando, Florida, 32827, United States

RECRUITING

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612, United States

RECRUITING

SCRI Oncology Partners

Nashville, Texas, 37203, United States

RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Macquarie University Hospital

New South Wales, New South Wales, 2162, Australia

RECRUITING

Monash Health Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

RECRUITING

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System - PPDS

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center - PPDS

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center - PPDS

Seoul, 06351, South Korea

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

RECRUITING

Clinica Universidad de Navarra-Madrid

Madrid, 28027, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Cambridge Clinical Research Centre

Cambridge, CB2 0AU, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

RECRUITING

The Christie

Manchester, M20 4BX, United Kingdom

RECRUITING

Royal Marsden Hospital - Surrey

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Central Study Contacts

GO44537 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 5, 2023

Study Start

May 2, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Locations

KR(4)GB(4)US(5)AU(4)FR(2)CA(2)ES(4)