Advanced Prostate Cancer, Metastatic Prostate Cancer
Conditions
Keywords
Castration-resistant
Brief 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.
Interventions
DRUGRO7656594
RO7656594 will be administered orally at specified dose on specified days.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). 4. Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified. 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs) | Days 1-28 of Cycle 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of RO7656594 | Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days) | The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma. |
| 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) | — |
| 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) | — |
Countries
Australia, Canada, France, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTGO44537 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed