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

Clinicaltrials.gov ID: NCT05800665
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 160

Conditions

Advanced Prostate Cancer, Metastatic Prostate Cancer

Drugs

RO7656594

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.

Locations

5 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Study Director

  • Clinical Trials

Status

  • RECRUITING

Central Contacts

Study Director

  • Clinical Trials

Status

  • RECRUITING

Central Contacts

Study Director

  • Clinical Trials

Status

  • RECRUITING

Central Contacts

Study Director

  • Clinical Trials

Status

  • RECRUITING

Central Contacts

Study Director

  • Clinical Trials

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.
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.

Study Plan

Stage 1: Dose Escalation

EXPERIMENTAL

Participants will receive RO7656594 administered 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 is reached.

  • DRUG:

    RO7656594

    Description:

    RO7656594 will be administered orally at specified dose on specified days.

Stage 2: Expansion

EXPERIMENTAL

Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).

  • DRUG:

    RO7656594

    Description:

    RO7656594 will be administered orally at specified dose on specified days.

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Adverse Events

Time Frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)

Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)

Time Frame: Days 1-28 of Cycle 1

Secondary Outcome Measures

Plasma Concentration of RO7656594

Time Frame: Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)

Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594

Time Frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)

Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594

Time Frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)

Timeline

  • Last Updated
    November 4, 2024
  • Start Date
    April 5, 2023
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    July 30, 2026

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