A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
AMPLIFY-7P
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
1 other identifier
interventional
158
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2023
Typical duration for phase_1
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedStudy Start
First participant enrolled
April 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
March 17, 2026
March 1, 2026
3.6 years
February 3, 2023
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1: Evaluate the safety of ELI-002 7P
Safety will be assessed by the incidence of adverse events (AEs) and clinically significant changes in laboratory tests and vital signs
28 days after the first dose of ELI-002 7P
Phase 2: Compare ELI-002 7P versus standard of care (SOC; observation) in DFS (disease free survival)
DFS is assessed by the investigator through computed tomography (CT) imaging or magnetic resonance imaging (MRI) with contrast and using iRECIST criteria
After the last radiographic assessment at Visit 26 (Week 150)
Secondary Outcomes (4)
Phase 2: Overall Survival (OS)
After Visit 13 (Week 20)
Phase 1 and Phase 2: Determine the biomarker reduction or clearance rate
6 months
Phase 2: Determine the 1-year DFS
1 year
Phase 2: Evaluate the safety of ELI-002 7P
30 days after the last ELI-002 7P dose
Study Arms (4)
Phase 1A: ELI-002 7P (Low Peptide dose)
EXPERIMENTALELI-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)
Phase 1A: ELI-002 7P (High Peptide dose)
EXPERIMENTALELI-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)
Phase 1B: ELI-002 7P
EXPERIMENTALThe 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)
Phase 2 randomized: ELI-002 7P
EXPERIMENTALThe 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)
Interventions
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, 85054, United States
City of Hope
Duarte, California, 91010, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California, Irvine
Orange, California, 92868, United States
University of Colorado Hospital-Anschutz Cancer Pavillion
Aurora, Colorado, 80045, United States
University of Miami
Coral Gables, Florida, 33124, United States
University of Florida Health Cancer Center
Gainesville, Florida, 32610, United States
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Florida, 32224, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Ochsner Health
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02210, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, 55905, United States
Northwell Health
Lake Success, New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
New York Presbyterian Weill Cornell Medical Center
New York, New York, 10065, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18003, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2023
First Posted
February 14, 2023
Study Start
April 14, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
March 17, 2026
Record last verified: 2026-03