A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors

Last updated: August 19, 2025
Sponsor: Elicio Therapeutics
Overall Status: Completed

Phase

1

Condition

Ovarian Cancer

Colorectal Cancer

Ovarian Cysts

Treatment

ELI-002 2P

Clinical Study ID

NCT04853017
ELI-002-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarkerdespite prior standard therapy including surgery and chemotherapy/radiation therapywhere applicable

  • Screening CT is negative for recurrent disease

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

Exclusion

Exclusion Criteria:

  • Presence of tumor mutations where specific therapy is approved, and the patient isable to receive the approved therapy

  • Known brain metastases

  • Use of immunosuppressive drugs

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: ELI-002 2P
Phase: 1
Study Start date:
October 04, 2021
Estimated Completion Date:
September 24, 2024

Study Description

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.

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Henry Ford Cancer Institute

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Northwell Health

    Lake Success 5123853, New York 5128638 11042
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Tennessee Oncology - Centennial Clinic

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology - Centennial Clinic

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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