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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests RO7656594 in people with prostate cancer that is advanced or has spread to other parts of the body. It checks safety, side effects, how the body processes the drug, and early signs that it works. It also aims to choose doses and treatment schedules for future studies.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can do all usual activities or can do light work but not hard physical activity.
  • You have prostate adenocarcinoma, a cancer that starts in gland cells, that has spread. It must not have small-cell or neuroendocrine features, which are special types of cancer cells.
  • You have had a newer treatment that blocks male hormone signals, such as abiraterone, enzalutamide, apalutamide, or darolutamide.
  • You have had taxane chemotherapy, cannot receive it, or have refused it, unless the study rules say otherwise.
  • If you have a known harmful BRCA1 or BRCA2 gene change, you must have had a PARP inhibitor or be unable to receive one, if it is approved and available. PARP inhibitors are drugs that block cancer cells from repairing their DNA.

Who can't join

  • You recently had an approved cancer treatment that works throughout the body. Before study treatment, you must wait 14 days or the time needed for the drug level to fall by half 5 times, whichever is longer, up to 28 days.
  • You had an experimental drug within 28 days before the first study treatment.
  • You have ever had an AR protein degrader, a drug that breaks down a protein that receives male hormone signals.
  • You have untreated cancer that has spread to the brain or spinal cord, or cancer in the tissue and fluid around them.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (5)

AZ

CT

FL

IL

TX