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Tests treatment safety and results for Advanced Prostate Cancer
Official title A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT05800665
What this study is testing
What is RO7656594?
RO7656594 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced prostate cancer.
Also referred to as GDC-2992.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
- Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
- Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen...
- For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2 mutation: prior therapy with a poly (adenosine diphosphate...
You likely can't join if
- 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)...
- Treatment with any investigational agent within 28 days prior to the first study treatment.
- Treatment with any previous AR protein degrader.
- Untreated central nervous system (CNS) metastases or leptomeningeal disease. Note: Other protocol specified inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- New Haven, Connecticut, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Nashville, Texas, United States
- Darlinghurst, New South Wales, Australia
- New South Wales, New South Wales, Australia
- Clayton, Victoria, Australia
- Heidelberg, Victoria, Australia
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Villejuif, Val-de-Marne, France
- Lyon, France
- Marseille, France
- Seoul, South Korea
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
- Cambridge, United Kingdom
- Leicester, United Kingdom
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; New Haven, Connecticut, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Nashville, Texas, United States; Darlinghurst, New South Wales, Australia and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.