A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumor
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumor
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.
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.
Inclusion Criteria:

 -  KRAS/NRAS mutated (G12D or G12R) solid tumor

 -  Positive for circulating tumor DNA despite prior standard therapy including surgery
 and chemotherapy/radiation therapy where applicable

 -  Screening CT is negative for recurrent disease

 -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

 Exclusion Criteria:

 -  Presence of tumor mutations where specific therapy is approved

 -  Known brain metastases

 -  Use of immunosuppressive drugs