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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (4 UK sites)
Cambridge Clinical Research Centre
Cambridge CB2 0AU, United Kingdom
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351The Christie
Manchester M20 4BX, United Kingdom
Royal Marsden Hospital - Surrey
Sutton SM2 5PT, United Kingdom
How to Get in Touch
GO44537 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
