NCT07199764

Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer

IGNITE: A Phase 2 Study of Maintenance Combinatorial Myeloid Immunotherapy in Patients With Unresectable Pancreatic Ductal Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II, open-label, single-arm study of CD40/Dectin-1 immunotherapy as maintenance treatment in patients with unresectable pancreatic ductal adenocarcinoma (PDA) who have not progressed following 4-6 months of first line (1L) chemotherapy.

Detailed description

Phase II, open-label, single-arm study of CD40/Dectin-1 immunotherapy as maintenance treatment in patients with unresectable pancreatic ductal adenocarcinoma (PDA) who have not progressed following 4-6 months of first line (1L) chemotherapy. The protocol incorporates an initial safety run-in phase evaluating dose-limiting (DLTs) over the first 21 days (Cycle 1), followed by a full Phase II efficacy evaluation. The safety run-in will enroll an initial cohort of 3 patients at the recommended Phase 2 dose (RP2D) for both odetiglucan and mitazalimab; if no DLTs occur, the study progresses to full enrollment. If DLTs occur, the cohort will expand to 6 patients with protocol-defined criteria for dose modification or de-escalation. The study includes three treatment cohorts and an observational cohort. Treatment Cohorts: * Cohort A: 26 patients with metastatic PDA achieving partial response (PR) on 1L chemotherapy * Cohort B: 12 patients with metastatic PDA achieving stable disease (SD) on 1L chemotherapy * Cohort C: 12 patients with locally advanced PDA achieving disease stability (PR or SD) on 1L chemotherapy Observational Cohort: An observational cohort of approximately 50-60 patients will be included, divided into three subgroups corresponding to the eligibility criteria of Cohorts A, B, and C: * Observational Subgroup A: 26-30 patients * Observational Subgroup B: 12-15 patients * Observational Subgroup C: 12-15 patients The observational cohort will include patients who meet eligibility criteria but do not receive the study intervention, either due to declining participation in the treatment arm or through retrospective chart review. Total enrollment will be 50 patients in the treatment arm and approximately 50-60 patients in the observational cohort.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Odetiglucan	Odetiglucan 4 mg/kg IV every 3 weeks
DRUG	Mitazalimab	Mitazalimab 0.9 mg/kg IV every 3 weeks

Timeline

• Start date: 2025-11-25
• Primary completion: 2027-10-01
• Completion: 2028-12-01
• First posted: 2025-09-30
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study