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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase 1: Evaluate the safety of ELI-002 7P
Timeframe: 28 days after the first dose of ELI-002 7P
Phase 2: Compare ELI-002 7P versus standard of care (SOC; observation) in DFS (disease free survival)
Timeframe: After the last radiographic assessment at Visit 26 (Week 150)