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Phase I

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

  • Study HIC#:2000035126
  • Last Updated:03/14/2024

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.

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    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 ≥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.

    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.

    Principal Investigator


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