NCT07567846
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentGenentech, Inc.
~260 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:GDC-1261
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Adverse Events (AEs)
Measured over Up to approximately 24 months
+1 more outcome measured
Conditions
Where it's being run
4 sites across 4 statesArizona1
Tennessee1
New South Wales1
Victoria1
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Genentech, Inc.
Who to contact
Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Percentage of Participants With Adverse Events (AEs)Up to approximately 24 months
- Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)From Day 1-28 of Cycle 1 (1 Cycle = 28 days)