This is a Phase 1/2 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 tumor.
First in Human Phase 1/2 Trial of ELI-002 Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors
The study consists of 3 phases: Phase 1A, Phase 1B, and Phase 2. In Phase 1A, Amph modified KRAS peptides, Amph-G12D and Amph-G12R (ELI-002 2P) will be evaluated with admixed Amph-CpG-7909, with plans to transition to an Amph-Peptide 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) for Phase 1B dose expansion and Phase 2 studies. The Phase 1A portion of the study is an open-label, dose-escalation, 3+3 design in which up to 18 subjects will be treated in 3 planned dose level cohorts. In this phase, increasing doses of Amph-CpG-7909 will be evaluated sequentially. 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. In Phase 1B, three dose expansion cohorts (up to 17 subjects in each cohort for a total of up to 51 subjects) will be added to evaluate for preliminary evidence of antitumor activity in KRAS and NRAS mutated solid tumors (including colorectal cancer, non-small cell lung cancer, mucinous ovarian cancer, as well as bile duct and gallbladder cancer) and changes from baseline in tumor biomarkers. In Phase 2, an additional 90 pancreatic cancer subjects will be randomized 2:1 (ELI-002 versus observation) to further evaluate antitumor activity. Subjects randomized to ELI-002 will receive subcutaneous (SC) injections of ELI-002 during Immunization and Booster Periods. Subjects randomized to observation will have the same safety and efficacy evaluations and will follow the same assessment schedule as subjects randomized to ELI-002 but will not receive ELI-002 treatment. Subjects randomized to observation will be able to cross-over to ELI-002 treatment in the event of confirmed disease progression.