A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
NCT ID: NCT05726864
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
158 participants
INTERVENTIONAL
2023-04-14
2026-11-30
Brief Summary
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Detailed Description
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In Phase 1B, one dose expansion cohort of up to 17 colorectal cancer \[CRC\] subjects may be added to evaluate for preliminary evidence of biomarker response, including circulating tumor deoxyribonucleic acid (ctDNA) and/or serum tumor biomarker (such as CA19-9 and CEA) reduction and clearance in KRAS and NRAS.
In Phase 2, an additional 135 PDAC subjects will be randomized 2:1 (ELI-002 7P versus observation) to further evaluate antitumor activity. Subjects randomized to ELI-002 7P will receive subcutaneous (SC) injections of ELI-002 7P during Immunization and Booster Periods. Subjects randomized to observation will have the same safety and efficacy evaluations and will follow the same assessment schedule as subjects randomized to ELI-002 7P but will not receive study treatment. Subjects randomized to observation will be able to elect to cross-over to ELI-002 7P treatment in the event of confirmed disease progression.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1A: ELI-002 7P (Low Peptide dose)
ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (1.4mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
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)
Phase 1A: ELI-002 7P (High Peptide dose)
ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (4.9mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
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)
Phase 1B: ELI-002 7P
The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
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)
Phase 2 randomized: ELI-002 7P
The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Known brain metastases
* Use of immunosuppressive drugs
18 Years
ALL
No
Sponsors
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Elicio Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ELI-002-201
Identifier Type: -
Identifier Source: org_study_id
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