Phase 2 Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Research type
Research Study
Full title
GRECO-2: A Randomized, Phase 2 Study of Stereotactic Body Radiation Therapy (SBRT) in combination with GC4711 in the Treatment of Unresectable or Borderline Resectable, Nonmetastatic Pancreatic Cancer
IRAS ID
1003850
Contact name
Kara Terry
Contact email
Sponsor organisation
Galera Therapeutics, Inc
Eudract number
2021-002827-39
Research summary
This is a study for patients diagnosed with localised pancreatic cancer, who will receive SBRT as standard treatment for their cancer. The study is planned to include up to 160 participants. Participants will be randomised to receive either GC4711 + SBRT or placebo + SBRT.
The main purpose of the study is to investigate the effect of GC4711 on overall survival (measuring the time participants survive after treatment) in combination with called stereotactic body radiation therapy (SBRT). This study will also investigate how long the study drug remains in the body after administration as well as side effects and changes in your disease and your daily life during and after completion of treatment.
Laboratory studies show that GC4711 may improve the effectiveness of the radiation therapy treatment, meaning that tumours are better controlled with the radiation plus GC4711 than with radiation alone. The results of this study will help determine the safety and effectiveness of GC4711. GC4711 has previously been tested in healthy participants as an intravenous (IV) infusion (into the vein). This will be one of the first 2 studies of GC4711 in people with cancer, studying the safety and effectiveness of GC4711 in combination with radiation.
This study is being conducted in the United States, UK and Canada at approximately 30 centers and is sponsored by Galera Therapeutics, Inc.
The Screening portion of the study will take approximately 21 days, and Treatment will take approximately 1 week. The Follow-up visit period will be approximately 36 months following the Treatment period. However, participants will be followed for up to 5 years via telephone visits.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0193
Date of REC Opinion
13 Oct 2021
REC opinion
Further Information Favourable Opinion