Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galera Therapeutics, Inc.

Criteria

Inclusion Criteria:

1. Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.

2. Newly diagnosed non-metastatic PC judged by tumor board to be feasible for (m)FOLFIRINOX and SBRT

3. Remains non-metastatic (i.e., M0 disease) after 3 months of chemotherapy

4. Female or male subjects ≥ 18 years of age

5. ECOG performance status of 0-2

6. Adequate end-organ function

Exclusion Criteria:

1. Subjects with documented metastatic disease

2. First-line chemotherapy other than (m)FOLFIRINOX and/or chemotherapy given for a total period of longer than 4 months prior to start of SBRT

3. Prior abdominal RT with substantial overlap in radiation fields

4. Subjects not recovered/controlled from treatment-related toxicities

5. Uncontrolled malignancy other than PC

6. Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing

7. Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy