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ACTIVE NOT RECRUITING
NCT05726864
PHASE1/PHASE2

A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors

Sponsor: Elicio Therapeutics

View on ClinicalTrials.gov

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

Interventions

DRUG

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