Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
About the study
GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
- Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
- Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT
- Remain non-metastatic as confirmed by a CT scan at screening.
- Female or male subjects ≥ 18 years of age
- ECOG performance status of 0-2
- Adequate end-organ function
EXCLUSION CRITERIA
Exclusion Criteria:
- Subjects with documented metastatic disease
- First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen
- Prior abdominal RT with substantial overlap in radiation fields
- Subjects not recovered/controlled from treatment-related toxicities
- Uncontrolled malignancy other than PC
- Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
- Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
SBRT,Borderline Resectable Pancreatic Cancer,Unresectable Pancreatic Cancer
Age (in years)
18+
Phase
Phase 2
Participants needed
160
Est. Completion Date
Oct 31, 2027
Treatment type
Interventional
Sponsor
Galera Therapeutics, Inc.
ClinicalTrials.gov identifier
NCT04698915
Study number
GTI-4711-201
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