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

Genentech

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Prostate Cancer; Advanced Prostate Cancer

Treatments: Drug: RO7656594

Study type: Interventional

Funder types: Industry

Identifiers

NCT05800665

GO44537

2023-504013-68-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 ≥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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Stage 1: Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: RO7656594

Stage 2: Expansion

Experimental group

Description:

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

Treatment:

Drug: RO7656594