A Study Of ELI-002 7P In Subjects With KRAS/NRAS Mutated Solid Tumors

Study Overview

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

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.

The study consists of 3 phases: Phase 1A, Phase 1B, and Phase 2. In Phase 1A, seven Amph modified KRAS and NRAS peptides, G12D, G12R, G12V, G12A, G12C, G12S, G13D (Amph-Peptides 7P) will be evaluated in combination with recommended Phase 2 dose of Amph-CpG-7909 (10.0mg). This Amph-CpG-7909 dose will be evaluated with two Amph-Peptides 7P dose levels (1.4mg and 4.9mg) in 6 subjects per dose level. Following enrollment of these 12 subjects, the independent data monitoring committee (IDMC) will decide if another 6 subjects should be enrolled or if the dose can be determined for Phase 1B and Phase 2 portions of the study to be opened. If another 6 subjects are enrolled to Phase 1A, the IDMC will meet again to decide upon the dose for Phase 1B and Phase 2 prior to opening these portions of the study. 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.

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

DRUG: ELI-002 7P

ELI-002-201

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-02-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-18
First Submitted that Met QC Criteria 2023-02-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-19
First Posted (ACTUAL) 2023-02-14	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 consec	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
EXPERIMENTAL: 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 consec	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
EXPERIMENTAL: 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 conse	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
EXPERIMENTAL: 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 conse	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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Phase 2: Overall Survival (OS)	To compare OS between cohorts, ELI-002 7P vs Observation	After Visit 13 (Week 20)
Phase 1 and Phase 2: Determine the biomarker reduction or clearance rate	The ctDNA reduction or clearance is defined as reduction or clearance of ctDNA from baseline, or if ctDNA was not detectable at baseline, serum tumor biomarker (such as CA19-9 and CEA) reduction and clearance compared to baseline	6 months
Phase 2: Determine the 1-year DFS	Compare between cohorts, ELI-002 7P vs Observation, the 1-year DFS	1 year
Phase 2: Evaluate the safety of ELI-002 7P	Safety will be assessed by the incidence of AEs and clinically significant laboratory tests and vital signs	30 days after the last ELI-002 7P dose

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record