drugset / Trial / NCT06896188
9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
Phase 1
Recruiting
12 enrolled
Anwaar Saeed
Actuate Therapeutics Inc. · collabIncyte Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a study of the combination of 9 ING-41 (elraglusib) and retifanlimab plus mFOLFIRINOX in patients with pancreatic cancer without prior systemic therapy for advanced disease. The safety lead-in cohort will consist of 6 patients, followed by dose de-escalation if necessary, based on safety assessments. After evaluating the safety and tolerability at the initial dose level, the study will proceed to an expansion cohort at the determined safe dose level, with the total maximum enrollment not exceeding 12 patients for the entire study.
Timeline
- Start
- 2025-09-22
- Primary completion
- 2027-09-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elraglusib | Small molecule | 9.3 mg/kg | Intravenous |
| Subject | Retifanlimab | Monoclonal antibody | 500 mg | Intravenous |
| Background | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |