Elicio Therapeutics, Inc. announced on December 3, 2024, the completion of enrollment in its Phase 2 AMPLIFY-7P study (NCT05726864). This randomized trial is evaluating ELI-002 7P, a 7-peptide formulation, in 135 patients with mutant KRAS (mKRAS)-driven pancreatic ductal adenocarcinoma (PDAC) who are at high risk of relapse following surgery.
The speed of study enrollment exceeded initial expectations, reflecting substantial interest from both investigators and patients in an off-the-shelf monotherapy treatment option. Patients were randomized 2:1 to receive subcutaneous injections of ELI-002 7P versus standard of care observation.
The primary endpoint of the Phase 2 trial is disease-free survival (DFS), with a formal interim analysis, reviewed by the Independent Data Monitoring Committee, on track for the first half of 2025. This milestone brings the company closer to a critical data readout that could validate its AMP platform.
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