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NCT05726864
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
Conditions: Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung 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
Phase: PHASE1, PHASE2
Enrollment: 156
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 tumorPhase 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 applicableScreening CT is negative for recurrent diseaseEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Exclusion Criteria:Presence of tumor mutations where specific therapy is approvedKnown brain metastasesUse of immunosuppressive drugs
Source: ClinicalTrials.gov (NCT05726864). StuddyBuddy aggregates publicly available trial information.
