Expanded Access Protocol of ELI-002-102 in Subjects With KRAS/NRAS Mutated Pancreatic Ductal Adenocarcinoma
NCT07083479 · Status: AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2026-05-19
Summary
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.
Conditions
- Pancreatic Ductal Adenocarcinoma
- KRAS G12D
- KRAS G12V
- KRAS G12S
- KRAS G12A
- KRAS G12C
- KRAS G12R
- KRAS G13D
- NRAS G12D
- NRAS G12V
- NRAS G12S
- NRAS G12A
- NRAS G12C
- NRAS G12R
- NRAS G13D
Interventions
- DRUG
-
ELI-002 7P
ELI-002 Amph-CpG-7909 (10.0 mg) admixed with ELI-002 Amph-Peptides 7P (4.9 mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections weekly for 4 weeks during the Booster Period (the two periods are separated by 2 months of no dosing).
Sponsors & Collaborators
-
Elicio Therapeutics
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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