drugset / Trial / NCT04853017
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-10-04
- Primary completion
- 2023-01-26
- Completion
- 2024-09-24
Publications
- Wainberg ZA, Weekes CD, Furqan M, Kasi PM, Devoe CE, Leal AD, Chung V, Perry JR, Kheoh T, McNeil LK, Welkowsky E, DeMuth PC, Haqq CM, Pant S, O'Reilly EM. Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: phase 1 AMPLIFY-201 trial final results. Nat Med. 2025 Nov;31(11):3648-3653. doi: 10.1038/s41591-025-03876-4. Epub 2025 Aug 11.
- Pant S, Wainberg ZA, Weekes CD, Furqan M, Kasi PM, Devoe CE, Leal AD, Chung V, Basturk O, VanWyk H, Tavares AM, Seenappa LM, Perry JR, Kheoh T, McNeil LK, Welkowsky E, DeMuth PC, Haqq CM, O'Reilly EM. Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial. Nat Med. 2024 Feb;30(2):531-542. doi: 10.1038/s41591-023-02760-3. Epub 2024 Jan 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ELI-002 2P | Vaccine | 0.1 mg | Subcutaneous |
| Subject | ELI-002 2P | Vaccine | 0.5 mg | Subcutaneous |
| Subject | ELI-002 2P | Vaccine | 2.5 mg | Subcutaneous |
| Subject | ELI-002 2P | Vaccine | 5 mg | Subcutaneous |
| Subject | ELI-002 2P | Vaccine | 10 mg | Subcutaneous |