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Pancreatic Ductal AdenocarcinomaPhase 1/2AMPLIFY-7PNCT05726864

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

A Phase 1/2 study testing ELI-002 7P in people with Pancreatic Ductal Adenocarcinoma and Colorectal Cancer, run by Elicio Therapeutics at 28 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ELI-002 7P
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
28 sitesUnited States
Study dates
14 Apr 2023to Nov 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites
  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18003

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Colorado Hospital-Anschutz Cancer Pavillion

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02210

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Miami

    Coral Gables, Florida, 33124

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • City of Hope

    Duarte, California, 91010

  • University of Florida Health Cancer Center

    Gainesville, Florida, 32610

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • Mayo Clinic Comprehensive Cancer Center

    Jacksonville, Florida, 32224

  • Northwell Health

    Lake Success, New York, 11042

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Ochsner Health

    New Orleans, Louisiana, 70121

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022

  • New York Presbyterian Weill Cornell Medical Center

    New York, New York, 10065

  • University of California, Irvine

    Orange, California, 92868

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Comprehensive Cancer Center

    Phoenix, Arizona, 85054

  • Mayo Clinic Comprehensive Cancer Center

    Rochester, Minnesota, 55905

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
ELI-002 7P
Keywords
Kirsten rat sarcoma (KRAS), Neuroblastoma ras viral oncogene homolog (NRAS), Pancreatic ductal adenocarcinoma (PDAC), Colorectal cancer (CRC), Colon cancer, Rectal cancer, Immunotherapy, Vaccine therapy, Adjuvant therapy, serum tumor biomarker, Carbohydrate antigen 19-9 (CA19-9), Carcinoembryonic antigen (CEA), circulating tumor DNA (ctDNA)
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELI-002 7PDrug

    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)

Study groups in NCT05726864
Study groupRoleWhat they receive
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)
Receives: Drug: ELI-002 7P
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)
Receives: Drug: ELI-002 7P
Phase 1B: ELI-002 7PExperimentalThe 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)
Receives: Drug: ELI-002 7P
Phase 2 randomized: ELI-002 7PExperimentalThe 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)
Receives: Drug: ELI-002 7P

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 28 days after the first dose of ELI-002 7P

  2. 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

    Measured: After the last radiographic assessment at Visit 26 (Week 150)

Secondary outcomes (4)
  1. Phase 2: Overall Survival (OS)

    To compare OS between cohorts, ELI-002 7P vs Observation

    Measured: After Visit 13 (Week 20)

  2. 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

    Measured: 6 months

  3. Phase 2: Determine the 1-year DFS

    Compare between cohorts, ELI-002 7P vs Observation, the 1-year DFS

    Measured: 1 year

  4. 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

    Measured: 30 days after the last ELI-002 7P dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start14 Apr 2023
  3. Primary completion20 Apr 2026
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726864
Sponsor's protocol ID
ELI-002-201
Acronym
AMPLIFY-7P
Status last verified
Jul 2026
First submitted
3 Feb 2023
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • George B, Singh H, Devoe CE, Chung V, Hosein PJ, Hendifar A, Kim DW, Valerin JB, Bekaii-Saab T, Cardin DB, Hidalgo M, Kasi PM, Leal AD, Pelster M, Fei N, Weekes CD, O'Hara MH, George TJ, Kazmi SM, Mizrahi JD, Nair S, Maiers M, Kheoh T, Amato G, Xavier J, Snyder JP, Milaszewski MH, Cabana-Puig X, Perry JR, McNeil LK, Welkowsky E, DeMuth PC, Haqq CM, Pant S, Wainberg ZA, O'Reilly EM. Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial. Nat Med. 2026 Oct 23. doi: 10.1038/s41591-026-04734-7. Online ahead of print.

    PubMed 42919966

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ELI-002 7P in people with Pancreatic Ductal Adenocarcinoma and Colorectal Cancer, run by Elicio Therapeutics at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Evaluate the safety of ELI-002 7P (time frame: 28 days after the first dose of ELI-002 7P). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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