A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
NCT05726864 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 158
Last updated 2026-05-19
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.
Conditions
- NRAS G12S
- KRAS G12C
- KRAS G12S
- KRAS G13D
- NRAS G12D
- NRAS G12R
- NRAS G12V
- NRAS G12C
- Pancreatic Ductal Adenocarcinoma
- Colorectal Cancer
- KRAS G12D
- KRAS G12R
- KRAS G12V
- KRAS G12A
Interventions
- DRUG
-
ELI-002 7P
ELI-002 Amph-CpG-7909 admixed with ELI-002 Amph-Peptides 7P administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections weekly for 4 weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
Sponsors & Collaborators
-
Elicio Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-14
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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