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Clinical Trials in the UK / NCT07567846
Recruiting Phase 1/2

A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer

NCT07567846 · tracked via the Priya Life Science UK tracker
Sponsor
Genentech, Inc.
Phase
Phase 1/2
Started
2026-04-29
Last updated
2026-09-04

Condition(s) studied

Advanced Prostate CancerMetastatic Prostate Cancer

Investigational drug(s) / intervention(s)

GDC-1261

GDC-1261: Participants will receive GDC-1261 as per the schedule described in the protocol.

Study 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

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Honor Health Research Institute Scottsdale Arizona Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
St Vincent's Hospital Sydney Darlinghurst New South Wales Recruiting
Austin Hospital Heidelberg Victoria Recruiting
The Royal Marsden in Sutton, Surrey - Downs Rd Sutton Surrey Recruiting

More Genentech, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07567846 on ClinicalTrials.gov ↗ ← All trials in the UK