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RecruitingLast updated: 6 October 2023

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

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.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I

Trial Acronym

GO44537

More information

Trial Identifiers

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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

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

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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