Advanced Prostate CancerPhase 1NCT05800665
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
A Phase 1 study testing RO7656594 in people with Advanced Prostate Cancer and Metastatic Prostate Cancer, run by Genentech, Inc. at 26 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer, Metastatic Prostate Cancer
- What is being tested?
- RO7656594
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 26 sitesin 7 countries
- Study dates
- 2 May 2023to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
GO44537 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
26 sites in 7 countries
United States5 sites, 5 recruiting
- Recruiting
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
- Recruiting
SCRI Oncology Partners
Nashville, Texas, 37203
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
- Recruiting
Sarah Cannon Research Institute @ Florida Cancer
Orlando, Florida, 32827
- Recruiting
HonorHealth
Scottsdale, Arizona, 85258
Australia4 sites, 4 recruiting
- Recruiting
Monash Health Monash Medical Centre
Clayton, Victoria, 3168
- Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
- Recruiting
Austin Hospital
Heidelberg, Victoria, 3084
- Recruiting
Macquarie University Hospital
New South Wales, New South Wales, 2162
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital Yonsei University Health System - PPDS
Seoul, 03722
- Recruiting
Asan Medical Center - PPDS
Seoul, 05505
- Recruiting
Samsung Medical Center - PPDS
Seoul, 06351
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
- Recruiting
Clinica Universidad de Navarra-Madrid
Madrid, 28027
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
United Kingdom4 sites, 4 recruiting
- Recruiting
Cambridge Clinical Research Centre
Cambridge, CB2 0AU
- Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
- Recruiting
The Christie
Manchester, M20 4BX
- Recruiting
Royal Marsden Hospital - Surrey
Sutton, SM2 5PT
France3 sites, 3 recruiting
- Recruiting
Centre Léon Bérard
Lyon, 69008
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
- Recruiting
Gustave Roussy
Villejuif, Val-de-Marne, 94805
Canada2 sites, 2 recruiting
- Recruiting
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
- Recruiting
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: 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
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.
- Being tested
- RO7656594
- Keywords
- Castration-resistant
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7656594Drug
Also called GDC-2992
RO7656594 will be administered orally at specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Dose Escalation | Experimental | 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. Receives: Drug: RO7656594 |
| Stage 2: Expansion | Experimental | Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD). Receives: Drug: RO7656594 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Measured: Days 1-28 of Cycle 1
Secondary outcomes (3)
Plasma Concentration of RO7656594
The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma.
Measured: 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
Measured: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
Measured: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start2 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800665
- Sponsor's protocol ID
- GO44537
- Other IDs
- 2023-504013-68-00, 2023
- Status last verified
- Nov 2026
- First submitted
- 24 Mar 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05800665
- Acronym / sponsor ID
- GO44537
- Keywords
- Castration-resistant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Dose Escalation | Experimental | Drug: RO7656594Participants 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. |
| Stage 2: Expansion | Experimental | Drug: RO7656594Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7656594Also: GDC-2992RO7656594 will be administered orally at specified dose on specified days. | Drug | Stage 1: Dose Escalation, Stage 2: Expansion |
Primary outcome
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)
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Time frame: Days 1-28 of Cycle 1
3 secondary outcomes
Plasma Concentration of RO7656594
Time frame: 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
Time frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
Time frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GO44537 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Genentech, Inc.
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7656594 in people with Advanced Prostate Cancer and Metastatic Prostate Cancer, run by Genentech, Inc. at 26 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Australia, South Korea, Spain, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GO44537 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.