Metastatic Prostate Cancer Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | July 30, 2026 |
Est. primary completion date | July 30, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | St Vincent's Hospital Sydney | Darlinghurst | New South Wales |
Australia | Austin Hospital | Heidelberg | Victoria |
Korea, Republic of | Asan Medical Center - PPDS | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
United States | Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | Florida Cancer Specialists & Research Institute - Lake Nona Cancer Center | Orlando | Florida |
United States | HonorHealth | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States, Australia, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with Adverse Events | From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days) | ||
Primary | Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs) | Days 1-28 of Cycle 1 | ||
Secondary | Plasma Concentration of RO7656594 | The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma. | Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days) | |
Secondary | Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594 | From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days) | ||
Secondary | Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594 | From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days) |
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