Recruiting
Phase 1

RO7656594

Sponsor:

Genentech, Inc.

Code:

NCT05800665

Conditions

Advanced Prostate Cancer

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RO7656594

Study Details

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.

Conditions

Advanced Prostate Cancer

Metastatic Prostate Cancer

Study ID

NCT05800665

Start date

May 2, 2023

Status verified date

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Stage 2: Expansion

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

Interventions

RO7656594

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

Primary outcome measure

  • 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) ]
  • Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs) [ Time Frame: Days 1-28 of Cycle 1 ]

Central Contacts and Locations

Central contacts

GO44537 https://forpatients.roche.com/ No attachments to email below.

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

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Sarah Cannon Research Institute @ Florida Cancer

Recruiting

Orlando, Florida, United States, 32827

University of Illinois Hospital & Health Sciences System

Recruiting

Chicago, Illinois, United States, 60612

SCRI Oncology Partners

Recruiting

Nashville, Texas, United States, 37203

British Columbia Cancer Agency

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

Genentech, Inc.

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Castration-resistant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-09-08.