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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, KRAS G12D, KRAS G12R, KRAS G12V, KRAS G12A, KRAS G12C, KRAS G12S, KRAS G13D, NRAS G12D, NRAS G12R, NRAS G12V, NRAS G12C, NRAS G12S

In brief

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.

Key facts

Study ID

NCT05726864

Run by

Elicio Therapeutics

People needed

158

Starts

2023-04-14

Expected to finish

2026-11-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Presence of tumor mutations where specific therapy is approved
• Known brain metastases
• Use of immunosuppressive drugs

Where it is running

• 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

Full record on ClinicalTrials.gov

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