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NCT05800665 | RECRUITING | Advanced Prostate Cancer

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

Genentech, Inc.

Brief 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.

Condition or disease

Advanced Prostate Cancer

Metastatic Prostate Cancer

Intervention/treatment

RO7656594

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-05-02
Estimated Primary Completion Date : 2026-07-30
Estimated Study Completion Date : 2026-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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.
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer

Location Details

NCT05800665

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06520

RECRUITING

United States, Florida

Sarah Cannon Research Institute @ Florida Cancer

Orlando, Florida, United States, 32827

RECRUITING

United States, Illinois

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States, 60612

RECRUITING

United States, Tennessee

Tennessee Oncology - Nashville

Nashville, Tennessee, United States, 37203

RECRUITING

Australia, New South Wales

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

RECRUITING

Australia, Victoria

Monash Health Monash Medical Centre

Clayton, Victoria, Australia, 3168

RECRUITING

Australia, Victoria

Austin Hospital

Heidelberg, Victoria, Australia, 3084

RECRUITING

Australia,

Macquarie University Hospital

New South Wales, Australia, 2162

RECRUITING

Canada, British Columbia

British Columbia Cancer Agency

Vancouver, British Columbia, Canada, V5Z 4E6

RECRUITING

Canada, Ontario

Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

France,

Center Léon Bérard

Lyon, France, 69008

RECRUITING

France,

Institut Paoli CALMETTES

Marseille, France, 13009

RECRUITING

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

RECRUITING

Korea, Republic of,

Severance Hospital Yonsei University Health System - PPDS

Seoul, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

Asan Medical Center - PPDS

Seoul, Korea, Republic of, 05505

RECRUITING

Korea, Republic of,

Samsung Medical Center - PPDS

Seoul, Korea, Republic of, 06351

RECRUITING

Spain, Navarra

Clinic University of Navarra

Pamplona, Navarra, Spain, 31008

RECRUITING

Spain,

Vall d'Hebron University Hospital - PPDS

Barcelona, Spain, 08035

RECRUITING

Spain,

Clinic University of Navarra-Madrid

Madrid, Spain, 28027

RECRUITING

Spain,

San Carlos Clinic Hospital

Madrid, Spain, 28040

RECRUITING

United Kingdom,

Cambridge Clinical Research Centre

Cambridge, United Kingdom, CB2 0au

RECRUITING

United Kingdom,

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

RECRUITING

United Kingdom,

The Christie

Manchester, United Kingdom, M20 4BX

RECRUITING

United Kingdom,

Royal Marsden Hospital - Surrey

Suton, United Kingdom, SM2 5pt