A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (AMPLIFY-201)

  • STATUS
    Recruiting
  • End date
    Sep 27, 2024
  • participants needed
    18
  • sponsor
    Elicio Therapeutics
Updated on 27 July 2022
KRAS
NRAS
cancer chemotherapy

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.

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.

This 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. 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.

Details
Condition 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
Treatment Observation, ELI-002 (Dose Escalation), ELI-002 (at the RP2D), ELI-002 2P
Clinical Study IdentifierNCT04853017
SponsorElicio Therapeutics
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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