NCT04853017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2021

Typical duration for phase_1

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2024

Completed
4 months until next milestone

Results Posted

Study results publicly available

January 17, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

April 16, 2021

Results QC Date

October 8, 2024

Last Update Submit

August 19, 2025

Conditions

Minimal Residual DiseaseKRAS G12DKRAS G12RNRAS G12DNRAS G12RPancreatic Ductal AdenocarcinomaColorectal CancerNon-small Cell Lung CancerOvarian CancerCholangiocarcinomaBile Duct CancerGallbladder Carcinoma

Keywords

Minimal residual disease (MRD)Kirsten rat sarcoma (KRAS)Neuroblastoma ras viral oncogene homolog (NRAS)Pancreatic ductal adenocarcinoma (PDAC)Colorectal cancer (CRC)Colon cancerRectal cancerNon-small-cell lung cancer (NSCLC)Mucinous Ovarian cancerCholangiocarcinoma (CCA)Bile duct cancerGallbladder carcinomaImmunotherapyVaccine therapyAdjuvant therapycirculating tumor DNA (ctDNA)

Outcome Measures

Primary Outcomes (1)

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

    The safety of ELI-002 was monitored through adverse events, including those considered related to treatment by the investigator

    Adverse events were collected through 28 days after the last dose

Secondary Outcomes (4)

  • The Proportion of Participants With Biomarker Reduction

    6 months

  • The Proportion of Participants With Biomarker Clearance

    6 months

  • The Proportion of Participants With Biomarker Reduction by Biomarker Type

    6 months

  • The Proportion of Participants With Biomarker Clearance by Biomarker Type

    6 months

Study Arms (5)

ELI-002 2P Cohort 1

EXPERIMENTAL

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)

Drug: ELI-002 2P

ELI-002 2P Cohort 2

EXPERIMENTAL

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)

Drug: ELI-002 2P

ELI-002 2P Cohort 3

EXPERIMENTAL

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)

Drug: ELI-002 2P

ELI-002 2P Cohort 4

EXPERIMENTAL

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)

Drug: ELI-002 2P

ELI-002 2P Cohort 5

EXPERIMENTAL

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)

Drug: ELI-002 2P

Interventions

ELI-002 2PDRUG

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)

ELI-002 2P Cohort 1ELI-002 2P Cohort 2ELI-002 2P Cohort 3ELI-002 2P Cohort 4ELI-002 2P Cohort 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

City of Hope

Duarte, California, 91010, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Tennessee Oncology - Centennial Clinic

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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: 40790272DERIVED

  • 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: 38195752DERIVED

MeSH Terms

Conditions

Neoplasm, ResidualColorectal NeoplasmsCarcinoma, Non-Small-Cell LungOvarian NeoplasmsCholangiocarcinomaBile Duct NeoplasmsGallbladder NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder Diseases

Results Point of Contact

Title
Study Director
Organization
Elicio Therapeutics, Inc.
info@elicio.com
(857) 209-0050

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

October 4, 2021

Primary Completion

January 26, 2023

Study Completion

September 24, 2024

Last Updated

September 5, 2025

Results First Posted

January 17, 2025

Record last verified: 2025-08

Locations

US(10)