4 trials tracked · 2 active · last refreshed 2026-08-10
ELI-002 is Elicio Therapeutics' lymph-node-targeted vaccine against mutant KRAS/NRAS — the mutation driving the large majority of pancreatic cancers and a meaningful share of colorectal and other GI cancers — designed to concentrate the immune response in lymph nodes rather than at the injection site. Its two active trials are testing a broadened 7-peptide version (ELI-002 7P, covering more KRAS/NRAS mutation variants than the original 2-peptide formulation), both alone and combined with tislelizumab, an anti-PD-1 checkpoint inhibitor.
An earlier expanded-access protocol is now listed no-longer-available, and the completed original 2-peptide Phase I established the approach's safety in pancreatic cancer specifically — the broadened 7P version now being tested is what's actually recruiting.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | NCT07671339 | A Study of ELI-002 7P, With or Without Tislelizumab, in People With Pancreatic Cancer | Phase I | Recruiting | 2026-06-22 |
The researchers are doing this study to find out whether ELI-002 7P in combination with mFOLFIRINOX, with or without tislelizumab, is a safe treatment approach in people who have pancreatic ductal adenocarcinoma (PDAC) with a KRAS mutation. In addition, the researchers are doing this study to find out whether the study treatment is effective against PDAC. Enrollment 20 (estimated) Sites 7 across 1 country Countries United States Sponsor Memorial Sloan Kettering Cancer Center Primary outcome: the proportion of patients with a Grade 3 or higher drug-related adverse event (AE) | |||||
| ▸ | NCT05726864 | A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors | Phase I, Phase II | Active, not recruiting | 2023-04-14 |
This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides 7P\]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909. Enrollment 158 (actual) Sites 28 across 1 country Countries United States Sponsor Elicio Therapeutics Primary outcome: Phase 1: Evaluate the safety of ELI-002 7P | |||||
| ▸ | NCT04853017 | A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors | Phase I | Completed | 2021-10-04 |
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides\]) as adjuvant treatment of minimal residual disease (MRD) in subjects with KRAS/neuroblastoma ras viral oncogene homolog (NRAS) mutated PDAC or other solid tumors. Enrollment 25 (actual) Sites 10 across 1 country Countries United States Sponsor Elicio Therapeutics Primary outcome: The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002 | |||||
| ▸ | NCT07083479 | Expanded Access Protocol of ELI-002-102 in Subjects With KRAS/NRAS Mutated Pancreatic Ductal Adenocarcinoma | N/A | No_Longer_Available | — |
This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides 7P\]) as adjuvant treatment in patients with KRAS/NRAS-mutated pancreatic ductal adenocarcinoma who are at high risk for relapse (ie, presence of isolated tumor cells in a patient whose primary tumor has been removed and is currently without clinical signs of disease). This protocol builds on the experience being obtained with ELI-002 7P (with Amph-Peptides G12D, G12R, G12V, G12A, G12C, G12S, G13D), which is being studied in protocol ELI-002-201. Enrollment — Sites 0 across 0 countries Countries — Sponsor Elicio Therapeutics | |||||
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