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
Genentech, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy 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 mutat…
Interventions
- DrugRO7656594
RO7656594 will be administered orally at specified dose on specified days.
Locations (25)
- HonorHealthScottsdale, Arizona
- Yale Cancer CenterNew Haven, Connecticut
- Sarah Cannon Research Institute @ Florida CancerOrlando, Florida
- University of Illinois Hospital & Health Sciences SystemChicago, Illinois
- SCRI Oncology PartnersNashville, Texas
- St Vincent's Hospital SydneyDarlinghurst, New South Wales