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

  • STATUS
    Recruiting
  • End date
    Mar 22, 2025
  • participants needed
    159
  • sponsor
    Elicio Therapeutics
Updated on 22 August 2021
KRAS
NRAS
cancer chemotherapy

Summary

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.

Description

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.

Details
Condition Non-Small Cell Lung Cancer, Bile duct carcinoma, Adenocarcinoma, Ovarian disorder, Minimal Residual Disease, Colorectal Cancer, Cholangiocarcinoma, Rectal disorder, Biliary neoplasm, Ovarian Cancer, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Ovarian Function, Pancreatic Ductal Adenocarcinoma, Gallbladder Carcinoma, Recurrent Ovarian Cancer, Urothelial Tract Cancer, Malignant Adenoma, Biliary Tract Cancer, KRAS G12D, colorectal neoplasm, cancer of the bile duct, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, colorectal cancers, nsclc, ovarian tumors, cancer, colorectal, colorectal tumor, tumors, colorectal, KRAS G12R, NRAS G12D, NRAS G12R
Treatment Observation, ELI-002 (Dose Escalation), ELI-002 (at the RP2D)
Clinical Study IdentifierNCT04853017
SponsorElicio Therapeutics
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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