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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Advanced Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Scottsdale

HonorHealth, Scottsdale, Arizona, United States, 85258

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06520

Orlando

Sarah Cannon Research Institute @ Florida Cancer, Orlando, Florida, United States, 32827

Chicago

University of Illinois Hospital & Health Sciences System, Chicago, Illinois, United States, 60612

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ≥1 second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
  • 4. Prior therapy with ≥1 taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen.
  • 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

2026-07-30