Advanced Prostate CancerPhase 1/2NCT07567846
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
A Phase 1/2 study testing GDC-1261 in people with Advanced Prostate Cancer and Metastatic Prostate Cancer, run by Genentech, Inc. at 5 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 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?
- GDC-1261
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 29 Apr 2026to 30 Dec 2027
- Phase
- Phase 1/2
- 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 of <=1
- Life expectancy is >= 3 months
- Histologically or cytologically confirmed prostate adenocarcinoma
- Disease progression during or following the direct prior line of therapy
- Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy
- Metastatic disease
- Adequate end organ function
Who cannot join
- Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
- Structurally unstable bone lesions suggest an impending fracture
- Untreated central nervous system (CNS) metastases or leptomeningeal disease
- Uncontrolled pain
- History of malignancy within 5 years
- Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection
- Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GO46445 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
5 sites in 3 countries
United States2 sites, 2 recruiting
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258-4566
Australia2 sites, 2 recruiting
- Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
- Recruiting
Austin Hospital
Heidelberg, Victoria, 3084
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden in Sutton, Surrey - Downs Rd
Sutton, Surrey, SM2 5PT
About this study
Official title: A Phase I/II Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic Prostate Cancer
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.
- Being tested
- GDC-1261
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-1261Drug
Participants will receive GDC-1261 as per the schedule described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation + Expansion | Experimental | Participants will receive GDC-1261 as per the schedule described in the protocol. Receives: Drug: GDC-1261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
Measured: Up to approximately 24 months
Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)
Measured: From Day 1-28 of Cycle 1 (1 Cycle = 28 days)
Secondary outcomes (7)
Plasma Concentration of GDC-1261
Measured: Up to approximately 24 months
Plasma Concentration of GDC-1261 Either in Fasted or Fed State
Measured: Up to approximately 24 months
Prostate-Specific Antigen-30% (PSA30) Response Rate
Measured: Up to approximately 24 months
PSA50 Response Rate
Measured: Up to approximately 24 months
PSA90 Response Rate
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
Measured: Up to approximately 24 months
Recommended Dose of GDC-1261
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start29 Apr 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 260 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
- NCT07567846
- Sponsor's protocol ID
- GO46445
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT07567846
- Acronym / sponsor ID
- GO46445
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 May 2026 (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, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation + Expansion | Experimental | Drug: GDC-1261Participants will receive GDC-1261 as per the schedule described in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of <=1
- Life expectancy is >= 3 months
- Histologically or cytologically confirmed prostate adenocarcinoma
- Disease progression during or following the direct prior line of therapy
- Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy
Key exclusion criteria (7 listed)
- Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
- Structurally unstable bone lesions suggest an impending fracture
- Untreated central nervous system (CNS) metastases or leptomeningeal disease
- Uncontrolled pain
- History of malignancy within 5 years
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 |
|---|---|---|
| GDC-1261Participants will receive GDC-1261 as per the schedule described in the protocol. | Drug | Dose Escalation + Expansion |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 24 months
Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)
Time frame: From Day 1-28 of Cycle 1 (1 Cycle = 28 days)
7 secondary outcomes
Plasma Concentration of GDC-1261
Time frame: Up to approximately 24 months
Plasma Concentration of GDC-1261 Either in Fasted or Fed State
Time frame: Up to approximately 24 months
Prostate-Specific Antigen-30% (PSA30) Response Rate
Time frame: Up to approximately 24 months
PSA50 Response Rate
Time frame: Up to approximately 24 months
PSA90 Response Rate
Time frame: Up to approximately 24 months
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Recommended Dose of GDC-1261
Time frame: Up to approximately 24 months
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 6 Oct 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.
Reference Study ID Number: GO46445 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.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GDC-1261 in people with Advanced Prostate Cancer and Metastatic Prostate Cancer, run by Genentech, Inc. at 5 sites in 3 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 7 inclusion and 7 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, 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 (AEs) (time frame: Up to approximately 24 months). 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 6 Oct 2026.