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

Genentech, Inc.49 sites in 7 countries210 target enrollmentMay 2, 2023

ConditionsAdvanced Prostate Cancer Metastatic Prostate Cancer

InterventionsRO7656594

Overview

Phase: Phase 1
Intervention: RO7656594
Conditions: Advanced Prostate Cancer
Sponsor: Genentech, Inc.
Enrollment: 210
Locations: 49
Primary Endpoint: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Status: Recruiting
Last Updated: 12 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2, 2023

End Date

June 30, 2027

Last Updated

12 days ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status ≤
•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.

Arms & Interventions

Stage 2: Expansion

Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Intervention: RO7656594

Stage 1: Dose Escalation

Participants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached.

Intervention: RO7656594

Outcomes

Primary Outcomes

Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)

Time Frame: Days 1-28 of Cycle 1

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)

Secondary Outcomes

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))
Plasma Concentration of RO7656594(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(From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days))