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.
Official Title
First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors
Details
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.
Keywords
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, Minimal residual disease (MRD), Kirsten rat sarcoma (KRAS), Neuroblastoma ras viral oncogene homolog (NRAS), Pancreatic ductal adenocarcinoma (PDAC), Colorectal cancer (CRC), Colon cancer, Rectal cancer, Non-small-cell lung cancer (NSCLC), Mucinous Ovarian cancer, Cholangiocarcinoma (CCA), Immunotherapy, Vaccine therapy, Adjuvant therapy, circulating tumor DNA (ctDNA), Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Adenocarcinoma, Ovarian Neoplasms, Neoplasm, Residual, Bile Duct Neoplasms, ELI-002 2P