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

Metastatic Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800665
• Other study ID #: GO44537
• Secondary ID: 2023-504013-68-0
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: April 2024
• Source: Genentech, Inc.
• Contact: GO44537 https://forpatients.roche.com/
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 =1 second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).

4. Prior therapy with =1 taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen.

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.

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• RO7656594
RO7656594 will be administered orally at specified dose on specified days.

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Austin Hospital	Heidelberg	Victoria
Korea, Republic of	Asan Medical Center - PPDS	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
United States	Sarah Cannon Research Institute / Tennessee Oncology	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	Florida Cancer Specialists & Research Institute - Lake Nona Cancer Center	Orlando	Florida
United States	HonorHealth	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events		From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Primary	Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)		Days 1-28 of Cycle 1
Secondary	Plasma Concentration of RO7656594	The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma.	Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Secondary	Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594		From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Secondary	Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594		From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)