A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors

Conditions: Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, KRAS G12D, KRAS G12R, KRAS G12V, KRAS G12A, KRAS G12C, KRAS G12S, KRAS G13D, NRAS G12D, NRAS G12R, NRAS G12V, NRAS G12C, NRAS G12S

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE1, PHASE2

Enrollment: 158

Sponsor: Elicio Therapeutics

Summary

This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides 7P\]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.

Eligibility Criteria

Inclusion Criteria: * KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor * Phase 1 only: positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05726864). StuddyBuddy aggregates publicly available trial information.