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RecruitingLast updated: 16 December 2025

GO44537: This study is evaluating how safe, tolerable and effective a new cancer drug (called RO7656594) is in people with advanced or metastatic prostate cancer, as well as identifying the recommended doses and regimens for RO7656594.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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

GO44537

Clinical summary

Summary

This study has two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion), and is recruiting people with metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.

In Stage 1 (Dose Escalation), participants will receive RO7656594 which will be administered orally 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 of safety and tolerability is reached. 

In Stage 2 (Dose Expansion), participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD) that was determined in Stage 1.

Conditions

This trial is treating people with advanced or metastatic prostate cancer

Eligibility

Inclusion

  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.

Exclusion

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Genentech

Scientific Title

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

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