Prostate Cancer Clinical Trial

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

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
Prior therapy with ≥1 second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
Prior therapy with ≥1 taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen.
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.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT05800665

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 8 Locations for this study

See Locations Near You

HonorHealth
Scottsdale Arizona, 85258, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Florida Cancer Specialists & Research Institute - Lake Nona Cancer Center
Orlando Florida, 32827, United States
Tennessee Oncology NASH - SCRI - PPDS
Nashville Tennessee, 37203, United States
St Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
Austin Hospital
Heidelberg Victoria, 3084, Australia
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center - PPDS
Seoul , 05505, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT05800665

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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