A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Recruiting · NCT05800665 · Interventional (participants receive a specific treatment) · Lead sponsor: Genentech, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
RO7656594
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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, unless otherwise specified.
- 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
- 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.
- 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.
Where it is running
26 locations listed across 5 US states.
- HonorHealth - Scottsdale, Arizona, United States
- Yale Cancer Center - New Haven, Connecticut, United States
- Sarah Cannon Research Institute @ Florida Cancer - Orlando, Florida, United States
- University of Illinois Hospital & Health Sciences System - Chicago, Illinois, United States
- SCRI Oncology Partners - Nashville, Texas, United States
- Hospital Universitario Vall d'Hebron - PPDS - Barcelona, Spain
- Cambridge Clinical Research Centre - Cambridge, United Kingdom
- Leicester Royal Infirmary - Leicester, United Kingdom
- Centre Léon Bérard - Lyon, France
- Clinica Universidad de Navarra-Madrid - Madrid, Spain
- Hospital Clinico San Carlos - Madrid, Spain
- The Christie - Manchester, United Kingdom
- Institut Paoli Calmettes - Marseille, France
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital Yonsei University Health System - PPDS - Seoul, South Korea
- Asan Medical Center - PPDS - Seoul, South Korea
- Samsung Medical Center - PPDS - Seoul, South Korea
- Royal Marsden Hospital - Surrey - Sutton, United Kingdom
- British Columbia Cancer Agency - Vancouver, British Columbia, Canada
- Clinica Universidad de Navarra - Pamplona, Navarre, Spain
- St Vincent's Hospital Sydney - Darlinghurst, New South Wales, Australia
- Macquarie University Hospital - New South Wales, New South Wales, Australia
- Princess Margaret Hospital - Toronto, Ontario, Canada
- Gustave Roussy - Villejuif, Val-de-Marne, France
- Monash Health Monash Medical Centre - Clayton, Victoria, Australia
- Austin Hospital - Heidelberg, Victoria, Australia