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

  • Cancer
  • Prostate Cancer
  • Advanced Prostate Cancer
  • Metastatic Prostate Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • South Korea
  • United States
Trial Identifier:

NCT05800665 2023-504013-68-00 GO44537

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT05800665,GO44537,2023-504013-68-00 Trial Identifier
      RO7656594 Treatments
      Advanced Prostate Cancer, Metastatic Prostate Cancer Condition
      Official 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 Criteria

      Male Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
      • Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
      • Prior therapy with ≥1 second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
      • Prior therapy with ≥1 taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen.
      • 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.
      Exclusion Criteria
      • 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.
      • Treatment with any investigational agent within 28 days prior to the first study treatment.
      • Treatment with any previous AR protein degrader.
      • Untreated central nervous system (CNS) metastases or leptomeningeal disease.

      Note: Other protocol specified inclusion/exclusion criteria may apply.

      For the latest version of this information please go to www.forpatients.roche.com

       

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