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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 being studied for the treatment of Pancreatic Ductal Adenocarcinoma. It is also being evaluated in other KRAS/NRAS mutated solid tumors, including Colorectal Cancer. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
ELI-002 7P targets mKRAS, which is a mutated form of the KRAS gene. This target is relevant in cancers with specific KRAS mutations, such as G12D, G12R, G12V, G12A, G12C, G12S, and G13D, as well as NRAS mutations. By targeting mKRAS, the drug aims to address tumors driven by these genetic alterations.
ELI-002 7P is being developed by Elicio Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ELTX. Elicio Therapeutics is conducting clinical research on this investigational drug for oncology indications.
ELI-002 7P is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is currently being studied in an active clinical trial to evaluate its safety and efficacy in patients with KRAS/NRAS mutated solid tumors.
ELI-002 7P is being studied in clinical trial NCT05726864, titled 'A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors.' This Phase 1 trial is active but not recruiting, with an enrollment of 158 participants. The trial is being conducted in the United States and includes patients aged 18 years and older.