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ELI-002 7P · 1 trial · 14 indications
Safety will be assessed by the incidence of adverse events (AEs) and clinically significant changes in laboratory tests and vital signs
DFS is assessed by the investigator through computed tomography (CT) imaging or magnetic resonance imaging (MRI) with contrast and using iRECIST criteria
| Arm | Type | Description |
|---|---|---|
| Phase 1A: ELI-002 7P (Low Peptide dose) | EXPERIMENTAL | ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (1.4mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
| Phase 1A: ELI-002 7P (High Peptide dose) | EXPERIMENTAL | ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (4.9mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
| Phase 1B: ELI-002 7P | EXPERIMENTAL | The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
| Phase 2 randomized: ELI-002 7P | EXPERIMENTAL | The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
| Name | Type | Description |
|---|---|---|
| ELI-002 7P | DRUG | 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) |
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...
ELI-002 7P is an investigational small molecule therapeutic being developed by Elicio Therapeutics, Inc. for KRAS and NRAS mutated solid tumors. It is currently in Phase 1 clinical development, with pancreatic ductal adenocarcinoma as a primary indication. The program is biomarker-selected, meaning patients are enrolled based on specific KRAS or NRAS mutations.
ELI-002 7P is being studied in pancreatic ductal adenocarcinoma, a type of pancreatic cancer. The Phase 1 trial also enrolls patients with colorectal cancer and other KRAS or NRAS mutated solid tumors. It is an investigational therapy and has not been approved for any indication.
ELI-002 7P targets mutant KRAS, or mKRAS, a gene that is frequently mutated in pancreatic and other solid tumors. The trial also includes patients with NRAS mutations. By directing activity toward these mutated genes, the therapy is designed for tumors that carry specific KRAS or NRAS alterations.
ELI-002 7P is being developed by Elicio Therapeutics, Inc., which trades under the ticker ELTX. The company is running the clinical program for this asset in KRAS and NRAS mutated solid tumors, including pancreatic ductal adenocarcinoma.
ELI-002 7P is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The single registered trial is currently active but not recruiting, and no trials for this asset have been completed.
ELI-002 7P is being studied in one clinical trial, NCT05726864, titled A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors. The Phase 1 trial has an enrollment of 158 participants, is controlled and randomized, and is being conducted in the United States.