Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

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

NCT ID: NCT05800665Sponsor: Genentech, Inc.Last updated: 2026-06-15

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.

Arms & interventions

  • DrugRO7656594

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

Outcome measures

Primary

  • 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

Secondary

  • Plasma Concentration of RO7656594

    Time frame: 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

    Time frame: 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)

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (5)

HonorHealth

Scottsdale, Arizona, 85258

Recruiting

Yale Cancer Center

New Haven, Connecticut, 06510

Recruiting

Sarah Cannon Research Institute @ Florida Cancer

Orlando, Florida, 32827

Recruiting

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612

Recruiting

SCRI Oncology Partners

Nashville, Texas, 37203

Recruiting