Study Evaluating GDC1261 in Patients with advanced or Metastatic Prostate Cancer
Research type
Research Study
Full 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
IRAS ID
1013841
Contact name
Head of Clinical Trial Regulatory Management
Contact email
Sponsor organisation
Genentech, Inc.
Research summary
Advanced metastatic prostate cancer is cancer that has spread from the original site in the prostate to the surrounding area or more distant parts of the body. Symptoms can include fatigue, bone pain, difficulty urinating, weight loss.
GDC-1261 is an experimental drug being studied for prostate cancer. It is not currently approved and it has not been tested in people before. GDC-1261 works by targeting the specific signals that help prostate cancer cells grow and may shrink or delay the progression of the prostate cancer.
The study will involve patients who have not responded to previous standard of care treatment, such as radiotherapy or chemotherapy. It will include up to around 260 people worldwide aged 18 and above. Participants will be on the study for anywhere from 1 day to 24 months or longer, depending on how they respond to and tolerate the treatment.
The aim of the study is to test GDC-1261 at different doses and find out of it is safe and how the body processes the drug.
The study involves 3 parts:
- Screening – to find out if patients are eligible to take part
- Treatment
- Follow up – to monitor participants after treatment
In the treatment part of the study, participants will receive GDC-1261 as tablets, taken either once or twice daily depending on the dose level they are assigned to. The study doctor will instruct participants and ensure they know when and how many tablets they need to take. During the study, the participants will attend clinic visits where they will undergo various procedures, such as blood samples, physical examination and tumour assessments.REC name
South Central - Berkshire Research Ethics Committee
REC reference
26/SC/0165
Date of REC Opinion
2 Jul 2026
REC opinion
Further Information Favourable Opinion