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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.
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Vincent's Hospital Sydney
Coordinator of this site? Confirm its status
DarlinghurstAustraliaRecruiting
Austin Hospital
Coordinator of this site? Confirm its status
HeidelbergAustraliaRecruiting
The Royal Marsden in Sutton, Surrey - Downs Rd
Coordinator of this site? Confirm its status
SuttonUnited KingdomRecruiting
Sarah Cannon Research Institute
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Honor Health Research Institute
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.