A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors

Phase 1

Active, not recruiting

• Conditions: KRAS G12R; Cholangiocarcinoma; Minimal Residual Disease; NRAS G12D; Ovarian Cancer; Non-small Cell Lung Cancer; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Bile Duct Cancer; KRAS G12D
• Interventions: Drug: ELI-002 2P

• Registration Number: NCT04853017
• Lead Sponsor: Elicio Therapeutics

Brief Summary

This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides\]) as adjuvant treatment of minimal residual disease (MRD) in subjects with KRAS/neuroblastoma ras viral oncogene homolog (NRAS) mutated PDAC or other solid tumors.

Detailed Description

This is a Phase 1 dose escalation study in which ELI-002 2P (Amph modified KRAS peptides, Amph-G12D and Amph-G12R admixed with admixed Amph-CpG-7909) will be evaluated, with plans to transition to the ELI-002 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) in future clinical trials.

The study is an open-label, dose-escalation, 3+3 design in which approximately 18 subjects will be treated in 3 planned dose level cohorts. Increasing doses of Amph-CpG-7909 will be evaluated sequentially. Additional cohorts may be added to explore intermediate or higher dose levels based on cumulative safety review and preliminary review of pharmacodynamic responses. Safety and pharmacodynamic data will be evaluated and a recommended Phase 2 dose (RP2D) will be determined in consideration of a maximum tolerated dose (MTD) if observed.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Study Start: 2021-10-04
• Primary Completion: 2023-01-26
• Results First Submitted: 2024-10-08
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Results First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• KRAS/NRAS mutated (G12D or G12R) solid tumor
• Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker 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

• Presence of tumor mutations where specific therapy is approved, and the patient is able to receive the approved therapy
• Known brain metastases
• Use of immunosuppressive drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ELI-002 2P Cohort 5	ELI-002 2P	ELI-002 2P Amph-CpG-7909 (10.0 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
ELI-002 2P Cohort 1	ELI-002 2P	ELI-002 2P Amph-CpG-7909 (0.1 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via subcutaneous (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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
ELI-002 2P Cohort 2	ELI-002 2P	ELI-002 2P Amph-CpG-7909 (0.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
ELI-002 2P Cohort 3	ELI-002 2P	ELI-002 2P Amph-CpG-7909 (2.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
ELI-002 2P Cohort 4	ELI-002 2P	ELI-002 2P Amph-CpG-7909 (5.0 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)

Primary Outcome Measures

Name	Time	Method
The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002	Adverse events were collected through 28 days after the last dose	The safety of ELI-002 was monitored through adverse events, including those considered related to treatment by the investigator

Secondary Outcome Measures

Name	Time	Method
The Proportion of Participants With Biomarker Reduction	6 months	A biomarker reduction was any decrease from baseline in circulating tumor DNA (ctDNA) and/or serum tumor antigen levels (carbohydrate antigen 19-9 \[CA19-9\] or carcinoembryonic antigen \[CEA\]).
The Proportion of Participants With Biomarker Clearance	6 months	Biomarker clearance was defined as no detectable ctDNA, CA19-9, or CEA at post-treatment time points.
The Proportion of Participants With Biomarker Reduction by Biomarker Type	6 months	A biomarker reduction was any decrease from baseline in ctDNA and/or serum tumor antigen levels (CA19-9 or CEA).
The Proportion of Participants With Biomarker Clearance by Biomarker Type	6 months	Biomarker clearance was defined as no detectable ctDNA, CA19-9, or CEA at post-treatment time points

Trial Locations

Locations (10)

City of Hope; 🇺🇸 Duarte, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Tennessee Oncology - Centennial Clinic; 🇺🇸 Nashville, Tennessee, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States