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

Launched by GENENTECH, INC. · Mar 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called RO7656594 to see how safe it is and how well it works for men with advanced or metastatic prostate cancer, which means the cancer has spread beyond the prostate gland. The trial aims to find out the best doses of this drug and gather information that could help in future studies. Currently, the trial is looking for male participants aged between 65 and 74 who have already received certain treatments for their cancer.

To be eligible for this trial, participants should have a specific type of prostate cancer and must have tried at least one other treatment aimed at blocking male hormones that can fuel cancer growth. Participants should not have received other cancer treatments within a certain time frame before starting the trial. Those who join will receive RO7656594 and will be monitored for any side effects and how their body processes the drug. This study is an important step in finding new treatment options for prostate cancer patients.

Gender

MALE

Eligibility criteria

• 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.