A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Conditions
Advanced Prostate Cancer, Metastatic Prostate CancerDrugs
RO7656594Summary
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
- GO44537 https://forpatients.roche.com/
- 888-662-6728 (U.S. Only)
- [email protected]
Study Director
- Clinical Trials
Status
- RECRUITING
Central Contacts
- GO44537 https://forpatients.roche.com/
- 888-662-6728 (U.S. Only)
- [email protected]
Study Director
- Clinical Trials
Status
- RECRUITING
Central Contacts
- GO44537 https://forpatients.roche.com/
- 888-662-6728 (U.S. Only)
- [email protected]
Study Director
- Clinical Trials
Status
- RECRUITING
Central Contacts
- GO44537 https://forpatients.roche.com/
- 888-662-6728 (U.S. Only)
- [email protected]
Study Director
- Clinical Trials
Status
- RECRUITING
Central Contacts
- GO44537 https://forpatients.roche.com/
- 888-662-6728 (U.S. Only)
- [email protected]
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:
RO7656594Description:
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:
RO7656594Description:
RO7656594 will be administered orally at specified dose on specified days.
Outcome Measures
Primary Outcome Measures
Percentage of Participants with Adverse Events
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Secondary Outcome Measures
Plasma Concentration of RO7656594
Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
Timeline
Last Updated
November 4, 2024Start Date
April 5, 2023Today
February 5, 2025Completion Date ( Estimated )
July 30, 2026
Sponsors of this trial
Lead Sponsor
Genentech, Inc.