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Recruiting Phase 1 NCT05800665

A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer

Phase 1 – testing safety in a small group of people
Conditions: Advanced Prostate Cancer Metastatic Prostate Cancer

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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 participate
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/exclusion criteria may apply.
Interventions
RO7656594
DRUG
Locations 25
Australia (4)
Monash Health Monash Medical Centre
Clayton , Victoria
St Vincent's Hospital Sydney
Darlinghurst , New South Wales
Austin Hospital
Heidelberg , Victoria
Macquarie University Hospital
New South Wales , New South Wales
Canada (2)
Princess Margaret Hospital
Toronto , Ontario
British Columbia Cancer Agency
Vancouver , British Columbia
France (2)
Centre Léon Bérard
Lyon
Institut Paoli Calmettes
Marseille
South Korea (4)
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System - PPDS
Seoul
Asan Medical Center - PPDS
Seoul
Samsung Medical Center - PPDS
Seoul
Spain (4)
Hospital Universitario Vall d'Hebron - PPDS
Barcelona
Clinica Universidad de Navarra-Madrid
Madrid
Hospital Clinico San Carlos
Madrid
Clinica Universidad de Navarra
Pamplona , Navarre
United Kingdom (4)
Cambridge Clinical Research Centre
Cambridge
Leicester Royal Infirmary
Leicester
The Christie
Manchester
Royal Marsden Hospital - Surrey
Sutton
United States (5)
University of Illinois Hospital & Health Sciences System
Chicago , Illinois
SCRI Oncology Partners
Nashville , Texas
Yale Cancer Center
New Haven , Connecticut
Sarah Cannon Research Institute @ Florida Cancer
Orlando , Florida
HonorHealth
Scottsdale , Arizona
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
02.05.2023
Completion date
30.06.2027
Registry ID
NCT05800665
Source
clinicaltrials.gov
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