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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04853017.
This is a Phase 1 dose escalation study in which ELI-002 2P (Amph modified KRAS peptides,
Amph-G12D and Amph-G12R admixed with admixed Amph-CpG-7909) will be evaluated, with plans
to transition to the ELI-002 7P drug product containing all 7 Amph-Peptides (G12D, G12R,
G12V, G12A, G12C, G12S, G13D) in future clinical trials.
The study is an open-label, dose-escalation, 3+3 design in which approximately 18
subjects will be treated in 3 planned dose level cohorts. Increasing doses of
Amph-CpG-7909 will be evaluated sequentially. Additional cohorts may be added to explore
intermediate or higher dose levels based on cumulative safety review and preliminary
review of pharmacodynamic responses. Safety and pharmacodynamic data will be evaluated
and a recommended Phase 2 dose (RP2D) will be determined in consideration of a maximum
tolerated dose (MTD) if observed.
Lead OrganizationElicio Therapeutics
