RecruitingPhase 1NCT05800665

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

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

Sponsor

Genentech, Inc.

Enrollment

210 participants

Start Date

May 2, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Prostate Cancer Metastatic Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called RO7656594 for men with advanced metastatic prostate cancer that has stopped responding to hormonal treatments. It is an early-phase safety and activity study. **You may be eligible if:** - You have metastatic prostate cancer (the cancer has spread beyond the prostate) - You have already been treated with at least one newer hormonal therapy (such as enzalutamide or abiraterone) - You have already been treated with a taxane chemotherapy drug, or are not able to or not willing to receive it - If you carry a BRCA1 or BRCA2 gene mutation, you have already tried a PARP inhibitor drug (or are ineligible for it) - You are in reasonably good physical health (ECOG score 0 or 1) **You may NOT be eligible if:** - You have not tried standard hormonal therapies first - You have cancer that has spread to the brain or spinal fluid (untreated) - You received another cancer treatment within the past 2–4 weeks - You have previously been treated with an androgen receptor degrader drug - You have small-cell or neuroendocrine prostate cancer features Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7656594

RO7656594 will be administered orally at specified dose on specified days.

Locations(25)

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

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Macquarie University Hospital

New South Wales, New South Wales, Australia

Monash Health Monash Medical Centre

Clayton, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Centre Léon Bérard

Lyon, France

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

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Clinica Universidad de Navarra-Madrid

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Cambridge Clinical Research Centre

Cambridge, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

The Christie

Manchester, United Kingdom

Royal Marsden Hospital - Surrey

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05800665

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