NCT07567846RecruitingPhase 1/2
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- Apr 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Genentech, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT07567846
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 260
- From Apr 2026 to the primary completion date, Nov 2027
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
- Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection
Other illness
- Untreated central nervous system (CNS) metastases or leptomeningeal disease
- History of malignancy within 5 years
Lab values
- 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
Other
- Structurally unstable bone lesions suggest an impending fracture
- Uncontrolled pain
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| The Royal Marsden in Sutton, Surrey - Downs Rd Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Honor Health Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.