NCT07567846PHASE1, PHASE2Recruiting
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
Genentech, Inc.
Start Date
4/29/2026
Completion Date
12/30/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Interventions
DRUG
GDC-1261
Conditions
Advanced Prostate CancerMetastatic Prostate Cancer
Locations
Honor Health Research Institute
Scottsdale, Arizona 85258-4566
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
Australia
Austin Hospital
Heidelberg, Victoria 3084
Australia