RecruitingRecruiting
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
NCT07567846 · Genentech, Inc.
In plain English
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Official title
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
About this study
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
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
Study design
Enrollment target: 260 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-29
Estimated completion: 2027-12-30
Last updated: 2026-07-09
Interventions
Drug: GDC-1261
Primary outcomes
- • 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))
Sponsor
Genentech, Inc. · industry
Contacts & investigators
ContactReference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below. · contact · global-roche-genentech-trials@gene.com · 888-662-6728
ContactFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Genentech, Inc.
All locations (4)
Honor Health Research InstituteRecruiting
Scottsdale, Arizona, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
St Vincent's Hospital SydneyRecruiting
Darlinghurst, New South Wales, Australia
Austin HospitalRecruiting
Heidelberg, Victoria, Australia