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Looking for participantsPhase1

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

Sponsor: Genentech, Inc.

NCT ID: NCT05800665

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
RO7656594 (drug)
How long the study runs
Study runs about 49 months (dates as stated)
About the drug or intervention
RO7656594 — drug: RO7656594 will be administered orally at specified dose on specified days.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
210
Started
2023-05-02
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced prostate cancer
  • • Phase1 - 210 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with advanced prostate cancer
  • • Male only

Where?

  • • Cambridge - Cambridge Clinical Research Centre
  • • Leicester - Leicester Royal Infirmary
  • • Manchester - The Christie
  • • Sutton - Royal Marsden Hospital - Surrey

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Advanced Prostate CancerMetastatic Prostate Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

BRCA1BRCA2

Treatment history

Treatments you must have had:

  • ✓ a second-generation
  • ✓ a taxane regimen
  • ✓ a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibit

What the study is looking for

  • ✓activity scale (ECOG) performance status ≤1.
  • ✓that has spread prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
  • ✓Prior therapy with a second-generation androgen receptor (AR)-treatment that targets specific changes in the cancer (e.g., abiraterone, enzalutamide,...
  • ✓Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused...

Who cannot take part

  • ✗Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever...
  • ✗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.
See the full 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.

Where Is This Study? (4 UK sites)

Cambridge Clinical Research Centre

Cambridge CB2 0AU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

The Christie

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Royal Marsden Hospital - Surrey

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Barnett

rsc-tr.ResearchAndDevelopment@nhs.net01483 688600

How to Get in Touch

GO44537 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10