IDMC Recommends Continuation of ELI-002 7P Trial in PDAC

The developers remain blinded to the efficacy outcomes of the agent in this patient population.

An independent data monitoring committee (IDMC) has recommended the continuation of the phase 1/2 AMPLIFY-7P trial (NCT05726864) evaluating ELI-002 7P in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma (PDAC) following a pre-specified interim review of the trial’s unblinded safety and efficacy outcomes, according to a news release from the drug’s developer, Elicio Therapeutics.¹

The IDMC has confirmed the favorable safety profile of ELI-002 7P in the KRAS-mutant PDAC population to date. Additionally, the developers remain blinded to the efficacy outcomes of the agent in this patient population.

“We are encouraged by the IDMC’s recommendation to support the continuation of the AMPLIFY-7P trial as planned, as we believe it indicates that ELI-002 7P has shown preliminary signals of efficacy. We look forward to the final disease-free survival (DFS) analysis anticipated to occur in the fourth quarter of 2025 and continue to believe that ELI-002 7P has the potential, based on the compelling data generated to date, to offer a new solution to patients [with] PDAC in the adjuvant setting,” Robert Connelly, chief executive officer of Elicio, said in the news release on the IDMC recommendation.¹

The phase 2 AMPLIFY-7P trial randomly assigned patients with KRAS-mutant PDAC (n = 144) 2:1 across 24 US sites to receive either ELI-002 7P monotherapy or observation, the standard of care (SOC). Treatment with ELI-002 7P was conducted in the adjuvant setting following local therapy, surgery, and chemotherapy with or without radiation.

Patients treated with the investigational agent in the experimental phase 1A portion of the trial received 10.0 mg of ELI-002 Amph-CpG-7909 admixed with 1.4 mg or 4.9 mg of ELI-002 Amph-Peptides 7P via weekly subcutaneous injection for 4 weeks followed by biweekly dosing over the next 4 weeks during the immunization period.² After 2 months of no dosing, additional subcutaneous injections were given weekly for 4 weeks during the booster period.

During the phase 1B and phase 2 portions of the study, a dose selected during the phase 1A portion of the study was used in the same schedule. The phase 1B portion of the trial included patients with colorectal cancer.

The primary end point of the phase 1 portion of the trial was safety. The primary end point of the phase 2 portion of the trial was DFS. Secondary end points included overall survival, biomarker reduction clearance rate, the 1-year DFS rate, as well as safety.

ELI-002, a 2-peptide formulation, was engineered as a structurally novel investigational AMP cancer vaccine that targets KRAS-mutant cancers. The 2 primary components include AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG oligodeoxynucleotide adjuvant, known as ELI-004, which is available off-the-shelf as a subcutaneously administered agent.

“Importantly, we previously reached alignment with the FDA on the key elements of the planned pivotal phase 3 study design, and, upon final DFS analysis, plan to request an end-of-phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 phase 3 study,” Connelly concluded.¹

Patients with KRAS/NRAS-mutant solid tumors, CT negativity for recurrent disease, and an ECOG performance status of 0 or 1 were eligible for trial enrollment. For the phase 1 portion of the trial, patients must have had circulating tumor DNA positivity and/or elevated serum tumor biomarkers despite prior standard therapy.

Those with mutations where a specific therapy is approved, known brain metastases, and prior use of immunosuppressive drugs were ineligible for trial enrollment.

References

1. Elicio Therapeutics announces positive recommendation by IDMC to continue ELI-002 7P randomized phase 2 study in pancreatic cancer without modifications to final analysis. News release. Elicio Therapeutics. August 5, 2025. Accessed August 5, 2025. https://tinyurl.com/2epe7mns
2. A study of ELI-002 7P in subjects with KRAS/​NRAS mutated solid tumors (AMPLIFY-7P). ClinicalTrials.gov. Updated May 20, 2025. Accessed August 5, 2025. https://tinyurl.com/4zace83s