NCT05726864Active, not recruitingPhase 1/2
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
First in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 158 (actual)
- First submitted
- 3 Feb 2023
- Start date
- 14 Apr 2023
- Primary completion date
- 20 Apr 2026
- Lead sponsor
- Elicio Therapeutics
- Diseases
- Neuroblastoma, Pancreatic cancer, Colorectal cancer, Sarcoma
- NCT number
- NCT05726864
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 158
- From 14 Apr 2023 to the primary completion date, 20 Apr 2026
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of tumor mutations where specific therapy is approved
- Use of immunosuppressive drugs
Other
- Known brain metastases
Who the study is looking for
- 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 applicable
- Screening CT is negative for recurrent disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lehigh Valley Health Network Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Colorado Hospital-Anschutz Cancer Pavillion Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| University of Florida Health Cancer Center Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Mayo Clinic Comprehensive Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Ochsner Health Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| New York - Presbyterian - Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Comprehensive Cancer Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Mayo Clinic Comprehensive Cancer Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
Related publications
- Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial.Nat Med · 2026 · PMID 42919966
This page is information, not medical advice. Discuss any trial with your doctor.