for people ages 18 years and up (full criteria)
study started
completion around



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.

Official Title

First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors


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 pharmcodynamic 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.


Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D, NRAS G12R, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Cholangiocarcinoma, Bile Duct Cancer, Gallbladder Carcinoma, Minimal residual disease (MRD), Kirsten rat sarcoma (KRAS), Neuroblastoma ras viral oncogene homolog (NRAS), Pancreatic ductal adenocarcinoma (PDAC), Colorectal cancer (CRC), Colon cancer, Rectal cancer, Non-small-cell lung cancer (NSCLC), Mucinous Ovarian cancer, Cholangiocarcinoma (CCA), Immunotherapy, Vaccine therapy, Adjuvant therapy, circulating tumor DNA (ctDNA), Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Adenocarcinoma, Ovarian Neoplasms, Residual Neoplasm, Bile Duct Neoplasms, ELI-002 2P


You can join if…

Open to people ages 18 years and up

  • KRAS/NRAS mutated (G12D or G12R) solid tumor
  • Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker 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

You CAN'T join if...

  • Presence of tumor mutations where specific therapy is approved, and the patient is able to receive the approved therapy
  • Known brain metastases
  • Use of immunosuppressive drugs


  • University of California Los Angeles
    Los Angeles California 90095 United States
  • City of Hope
    Duarte California 91010 United States


in progress, not accepting new patients
Start Date
Completion Date
Elicio Therapeutics
Phase 1 research study
Study Type
About 25 people participating
Last Updated