Christopher Haqq, MD, PhD
About the Phase 2 AMPLIFY-7p Study
Trial Name: First in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
ClinicalTrials.gov Identifier: NCT05726864
Sponsor: Elicio Therapeutics
Recruitment Contact: Clinical Trial Inquiries, 617-714-9884, firstname.lastname@example.org
Completion Date: November 2026
The first patient with KRAS-mutated pancreatic ductal adenocarcinoma (PDAC) has been dosed with ELI-002 7P in the phase 2 AMPLIFY-7P study (NCT05726864), according to Elicio Therapeutics, Inc.1
This investigational therapeutic cancer vaccine ELI-002 7P was developed with the proprietary lymph node-targeting amphiphile technology from Elicio Therapeutics which aims to treat cancers that are driven by the common KRAS mutations, including G12D, G12R, G12V, G12A, G12C, G12S, and G13D. These mutations are present in 25% of all solid tumor cancers as well as 88% of patients with PDAC.
AMPLIFY-7P builds on positive findings from the 2-peptide formulation of ELI-002 which was recently published in Nature Medicine. Here, ELI-002 significantly decreased tumor biomarkers, produced strong T-cell responses leading to a reduced risk of relapse and death among patients, and was overall deemed safe.
“Approximately 90% of pancreatic cancers are positive for KRAS mutations and in most cases, patients with circulating tumor DNA post-surgery relapse. There are no treatment options during this “wait and see” observation window before relapse,” explained Christopher Haqq, MD, PhD, Elicio’s executive vice president, head of research and development, and chief medical officer, in an interview with Targeted OncologyTM. “By initiating this study, we seek to determine if ELI-002 7P could be a treatment option for this patient population. We are conducting the study with our 7-peptide formulation designed to address a broad spectrum of KRAS mutations and potentially defeat resistance mechanisms.”
About the AMPLIFY-7P Study
In the phase 1/2 AMPLIFY-7- trial, investigators are assessing the safety and efficacy of ELI-002 7P immunotherapy as adjuvant treatment in patients with solid tumors with KRAS/NRAS mutations.2 The first patient was dosed at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research, New York.1
“ELI-002 7P is being evaluated in the AMPLIFY-7P phase 2 trial as an adjuvant monotherapy in patients with mKRAS PDAC following surgery and chemotherapy with or without radiation,” said Haqq.
The study is made up of 3 phases. In phase 1A, Amph-Peptides 7P will be evaluated in combination with the recommended phase 2 dose of Amph-CpG-7909, which is 10 mg.2 Amph-CpG-7909 will be evaluated with the 2 Amph-Peptides 7P dose levels of 1.4 mg and 4.9 mg and will include 6 patients per dose level. Once the 12 patients are enrolled, the independent data monitoring committee will decide if the dose can be determined for the phase 1B and phase 2 portions of the study, or if an additional 6 patients must be enrolled.
Phase 1B of the trial includes 1 dose-expansion cohort of up to 17 patients with colorectal cancer (CRC). ELI-002 7P will be given at a dose selected during the phase 1A portion of the trial and administered via subcutaneous (SC) injection weekly for 4 consecutive weeks. This will be followed by bi-weekly injections over 4 weeks during the immunization period. Additional SC injections will be given to patients during the booster period for 4 consecutive weeks.
Further, the phase 2 portion of the trial will enroll an additional 135 patients with PDAC who will be randomly assigned in a 2:1 fashion to receive ELI-002 7P or undergo observation. Those given ELI-002 7P will receive ELI-002 7P via SC injections during the immunization and booster periods.
“Patients under observation with confirmed radiographic disease progression will be able to cross over to treatment with ELI-002 7P,” added Haqq.
Patients are eligible for enrollment in the study if they have a KRAS- or NRAS-mutated, an ECOG performance status of 0 or 1, and a screening CT that is negative for recurrent disease. In phase 1 of the trial, patients must also be positive for circulating tumor DNA and/or elevated serum tumor biomarkers. Patients who have a presence of tumor mutations where specific therapy is approved, known brain metastases, or those who use immunosuppressive drugs will be excluded from the study.
“The primary goal of the study is to see if ELI-002 7P prolongs disease-free survival vs observation, which is the current standard. Secondary goals include evaluating tumor biomarker reduction and clearance compared to baseline, median overall survival, assess safety, objective response rate per iRECIST in the cross-over cohort. We’ll also explore the immunogenicity, the number and function of the T cells induced by ELI-002 7P, compared with baseline,” added Haqq.
In addition to ELI-002 7P, ELI-002 2P is currently being studied in the phase 1 AMPLIFY-201 trial (NCT04853017) in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy.1 ELI-002 2P is made up of AMP-modified mutant KRAS peptide antigens.
1. Elicio Therapeutics announces first patient dosed in randomized phase 2 pancreatic cancer study. News release. Elicio Therapeutics, Inc. January 11, 2024. Accessed January 11, 2024. http://tinyurl.com/3zyfkhs3
2. A study of ELI-002 in subjects with KRAS mutated pancreatic ductal adenocarcinoma (PDAC) and other solid tumors (AMPLIFY-201). ClinicalTrials.gov. Updated December 20, 2023. Accessed January 11, 2024. https://clinicaltrials.gov/study/NCT04853017