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A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
Sponsor: Elicio Therapeutics
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2023-04-14
Completion Date
2026-11
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
ELI-002 7P
ELI-002 Amph-CpG-7909 admixed with ELI-002 Amph-Peptides 7P 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 weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
Locations (28)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of Colorado Hospital-Anschutz Cancer Pavillion
Aurora, Colorado, United States
University of Miami
Coral Gables, Florida, United States
University of Florida Health Cancer Center
Gainesville, Florida, United States
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
Ochsner Health
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, United States
Northwell Health
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Presbyterian Weill Cornell Medical Center
New York, New York, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States