Testing GDC-1261 in people with advanced or metastatic prostate cancer
Tests GDC-1261 for safety and early effects in advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
Key facts
- Where
- Nashville, New Haven, and Scottsdale, United StatesSee the 3 sites
- Phase
- Phase 1/2
Where in United States
- Sarah Cannon Research InstituteNashville, United StatesTaking people
- Yale Cancer CenterNew Haven, United StatesTaking people
- Honor Health Research InstituteScottsdale, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech, Inc.
- Trial code
- NCT07567846
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
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; Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection; Untreated central nervous system (CNS) metastases or leptomeningeal disease; History of malignancy within 5 years; 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; Structurally unstable bone lesions suggest an impending fracture; Uncontrolled pain.