drugset / Trial / NCT05726864
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
RandomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2023-04-14
- Primary completion
- 2026-04-20
- Completion
- 2026-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amph-CpG-7909 | Oligonucleotide (other) | 10 mg | Subcutaneous |
| Subject | Amph-Peptides 7P | Peptide | 1.4 mg | Subcutaneous |
| Subject | Amph-Peptides 7P | Peptide | 4.9 mg | Subcutaneous |