NCT05494697

Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC

A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy and Safety of Ampligen in Combination With Standard of Care Versus SOC Alone Following First-Line Therapy in Subjects With Locally Advanced Pancreatic Adenocarcinoma

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: AIM ImmunoTech Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma

Detailed description

This is a Phase 2, randomized, open-label controlled study to evaluate the efficacy and safety of Ampligen treatment combined with standard of care (SOC) versus SOC alone following First-line therapy in subjects with locally advanced pancreatic adenocarcinoma.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Rintatolimod	Rintatolimod (poly I : poly C12U)

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-12-01
• Completion: 2030-01-01
• First posted: 2022-08-10
• Last updated: 2025-10-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study