Recruiting NCT05800665
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RO7656594.
- Who it may be relevant to
- Registry conditions: Advanced Prostate Cancer, Metastatic Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, France, South Korea +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Interventions
- Drug RO7656594
RO7656594 will be administered orally at specified dose on specified days.
Primary outcome measures
- Percentage of Participants with Adverse Events [Time frame: 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) [Time frame: Days 1-28 of Cycle 1]
Secondary outcome measures (3)
- Plasma Concentration of RO7656594 [Time frame: Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)]
- Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594 [Time frame: 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 [Time frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- HonorHealth — Scottsdale
- Yale Cancer Center — New Haven
- Sarah Cannon Research Institute @ Florida Cancer — Orlando
- University of Illinois Hospital & Health Sciences System — Chicago
- SCRI Oncology Partners — Nashville
Australia · 4 centers
- St Vincent's Hospital Sydney — Darlinghurst
- Macquarie University Hospital — New South Wales
- Monash Health Monash Medical Centre — Clayton
- Austin Hospital — Heidelberg
South Korea · 4 centers
- 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 centers
- Clinica Universidad de Navarra — Pamplona
- Hospital Universitario Vall d'Hebron - PPDS — Barcelona
- Clinica Universidad de Navarra-Madrid — Madrid
- Hospital Clinico San Carlos — Madrid
United Kingdom · 4 centers
- Cambridge Clinical Research Centre — Cambridge
- Leicester Royal Infirmary — Leicester
- The Christie — Manchester
- Royal Marsden Hospital - Surrey — Sutton
France · 3 centers
- Gustave Roussy — Villejuif
- Centre Léon Bérard — Lyon
- Institut Paoli Calmettes — Marseille
Canada · 2 centers
- British Columbia Cancer Agency — Vancouver
- Princess Margaret Hospital — Toronto
Identifiers
NCT: NCT05800665 · GO44537 · 2023-504013-68-00