Clinical trial · Interventional
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
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
NCT04853017CI-TRIAL-00094569AMPLIFY-201completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gallbladder Carcinoma | Gallbladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| KRAS G12D | — | UNRESOLVED | — |
| KRAS G12R | — | UNRESOLVED | — |
| Minimal Residual Disease | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ELI-002 2P | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- ELI-002 2P Cohort 1
- description
- ELI-002 2P Amph-CpG-7909 (0.1 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via subcutaneous (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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
- interventionNames
- Drug: ELI-002 2P
- type
- EXPERIMENTAL
- label
- ELI-002 2P Cohort 2
- description
- ELI-002 2P Amph-CpG-7909 (0.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
- interventionNames
- Drug: ELI-002 2P
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * KRAS/NRAS mutated (G12D or G12R) solid tumor * Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable * Screening CT is negative for recurrent disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Presence of tumor mutations where specific therapy is approved, and the patient is able to receive the approved therapy * Known brain metastases * Use of immunosuppressive drugs
References
Publications (2)
- DERIVEDWainberg 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. PMID 40790272
- DERIVEDPant 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. PMID 38195752