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NCT04853017 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2025-09-05

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002

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outcome · POSTED

The Proportion of Participants With Biomarker Reduction

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outcome · POSTED

The Proportion of Participants With Biomarker Clearance

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outcome · POSTED

The Proportion of Participants With Biomarker Reduction by Biomarker Type

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outcome · POSTED

The Proportion of Participants With Biomarker Clearance by Biomarker Type

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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)
    intervention Names
    1. Drug: ELI-002 2P
    label
    ELI-002 2P Cohort 1
    type
    EXPERIMENTAL
  2. description
    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)
    intervention Names
    1. Drug: ELI-002 2P
    label
    ELI-002 2P Cohort 2
    type
    EXPERIMENTAL
  3. description
    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)
    intervention Names
    1. Drug: ELI-002 2P
    label
    ELI-002 2P Cohort 3
    type
    EXPERIMENTAL
  4. description
    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)
    intervention Names
    1. Drug: ELI-002 2P
    label
    ELI-002 2P Cohort 4
    type
    EXPERIMENTAL
  5. description
    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)
    intervention Names
    1. Drug: ELI-002 2P
    label
    ELI-002 2P Cohort 5
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. ELI-002 2P Cohort 1
    2. ELI-002 2P Cohort 2
    3. ELI-002 2P Cohort 3
    4. ELI-002 2P Cohort 4
    5. ELI-002 2P Cohort 5
    description
    Amph-CpG-7909 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)
    name
    ELI-002 2P
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
25
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The safety of ELI-002 was monitored through adverse events, including those considered related to treatment by the investigator
    measure
    The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002
    time Frame
    Adverse events were collected through 28 days after the last dose
secondary Outcomes
  1. description
    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 \[CEA\]).
    measure
    The Proportion of Participants With Biomarker Reduction
    time Frame
    6 months
  2. description
    Biomarker clearance was defined as no detectable ctDNA, CA19-9, or CEA at post-treatment time points.
    measure
    The Proportion of Participants With Biomarker Clearance
    time Frame
    6 months
  3. description
    A biomarker reduction was any decrease from baseline in ctDNA and/or serum tumor antigen levels (CA19-9 or CEA).
    measure
    The Proportion of Participants With Biomarker Reduction by Biomarker Type
    time Frame
    6 months
  4. description
    Biomarker clearance was defined as no detectable ctDNA, CA19-9, or CEA at post-treatment time points
    measure
    The Proportion of Participants With Biomarker Clearance by Biomarker Type
    time Frame
    6 months
Full study description
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.
Source references
references
  1. citation
    Wainberg ZA, Weekes CD, Furqan M, Kasi PM, Devoe CE, Leal AD, Chung V, Perry JR, Kheoh T, McNeil LK, Welkowsky E, DeMuth PC, Haqq CM, Pant S, O'Reilly EM. Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: phase 1 AMPLIFY-201 trial final results. Nat Med. 2025 Nov;31(11):3648-3653. doi: 10.1038/s41591-025-03876-4. Epub 2025 Aug 11.
    pmid
    40790272
    type
    DERIVED
  2. citation
    Pant S, Wainberg ZA, Weekes CD, Furqan M, Kasi PM, Devoe CE, Leal AD, Chung V, Basturk O, VanWyk H, Tavares AM, Seenappa LM, Perry JR, Kheoh T, McNeil LK, Welkowsky E, DeMuth PC, Haqq CM, O'Reilly EM. Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial. Nat Med. 2024 Feb;30(2):531-542. doi: 10.1038/s41591-023-02760-3. Epub 2024 Jan 9.
    pmid
    38195752
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice