A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Completed · Phase 1
Conditions studied: Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D, NRAS G12R, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Cholangiocarcinoma, Bile Duct Cancer, Gallbladder Carcinoma
In brief
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.
Key facts
- Study ID
- NCT04853017
- Run by
- Elicio Therapeutics
- People needed
- 25
- Starts
- 2021-10-04
- Expected to finish
- 2024-09-24
- Last updated by the study team
- 2025-09-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- City of Hope — Duarte, California, United States
- University of California Los Angeles — Los Angeles, California, United States
- University of Colorado — Aurora, Colorado, United States
- University of Iowa — Iowa City, Iowa, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Northwell Health — Lake Success, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Tennessee Oncology - Centennial Clinic — Nashville, Tennessee, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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