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A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (AMPLIFY-201)

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ClinicalTrials.gov Identifier: NCT04853017
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : February 10, 2023
Sponsor:
Information provided by (Responsible Party):
Elicio Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Minimal Residual Disease KRAS G12D KRAS G12R NRAS G12D NRAS G12R Pancreatic Ductal Adenocarcinoma Colorectal Cancer Non-small Cell Lung Cancer Ovarian Cancer Cholangiocarcinoma Bile Duct Cancer Gallbladder Carcinoma Drug: ELI-002 2P Phase 1

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 pharmcodynamic 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors
Actual Study Start Date : October 4, 2021
Actual Primary Completion Date : January 26, 2023
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ELI-002 2P Cohort 1
ELI-002 2P Amph-CpG-7909 (0.1 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
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)
Experimental: ELI-002 2P Cohort 2
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
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)
Experimental: ELI-002 2P Cohort 3
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
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)
Experimental: ELI-002 2P Cohort 4
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
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)
Experimental: ELI-002 2P Cohort 5
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
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)


Outcome Measures
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Primary Outcome Measures :
  1. Determine the MTD of ELI-002 and the RP2D [ Time Frame: 28 days after first dose ]
    The MTD is defined as the highest dose level for which <33% of subjects had a dose-limiting toxicity.

  2. Evaluate the safety of ELI-002 [ Time Frame: 30 days after last dose ]
    Safety will be assessed by the incidence of adverse events (AEs) and clinically significant laboratory tests and vital signs.


Secondary Outcome Measures :
  1. Determine the biomarker reduction and clearance rate [ Time Frame: 6 months ]
    The ctDNA reduction and clearance rate is defined as the reduction or clearance of ctDNA , or if ctDNA was not detectable at baseline, serum tumor biomarker reduction or clearance compared to baseline.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853017


Contacts
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Contact: Clinical Trial Inquiries 617-714-9884 clinicaltrialinquiries@elicio.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Vincent Chung, MD    626-218-8900    vchung@coh.org   
Contact: City of Hope Clinical Trials Line    626-218-1133      
Principal Investigator: Vincent Chung, MD         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Lisa Yonemoto    310-633-8400 ext 16045    lyonemoto@mednet.ucla.edu   
Principal Investigator: Zev Wainberg, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: McKenna Russen    720-848-8785    mckenna.russen@cuanschutz.edu   
Principal Investigator: Alexis Leal, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Alyssa Pratt       alyssa-pratt@uiowa.edu   
Principal Investigator: Muhammed Furqan, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Colin D Weekes, MD    617-724-4000    cdweekes@mgh.harvard.edu   
Principal Investigator: Colin D Weekes, MD         
United States, Michigan
Henry Ford Cancer Institute Withdrawn
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Northwell Health Recruiting
Lake Success, New York, United States, 11042
Contact: Craig Devoe, MD    516-734-8896      
Contact       CCTOPhase1@northwell.edu   
Principal Investigator: Craig Devoe, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Research Manager    646-888-4327    yaqubiea@mskcc.org   
Contact: Eileen M O'Reilly, MD    646-888-4182      
Principal Investigator: Eileen M O'Reilly, MD         
United States, Tennessee
Tennessee Oncology - Centennial Clinic Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Mercy David    832-421-7290    MFDavid@mdanderson.org   
Contact: Li Xu    713-745-2416    lixu@mdanderson.org   
Principal Investigator: Shubham Pant, MD         
Sponsors and Collaborators
Elicio Therapeutics
More Information
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Responsible Party: Elicio Therapeutics
ClinicalTrials.gov Identifier: NCT04853017    
Other Study ID Numbers: ELI-002-001
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: February 10, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elicio Therapeutics:
Minimal residual disease (MRD)
Kirsten rat sarcoma (KRAS)
Neuroblastoma ras viral oncogene homolog (NRAS)
Pancreatic ductal adenocarcinoma (PDAC)
Colorectal cancer (CRC)
Colon cancer
Rectal cancer
Non-small-cell lung cancer (NSCLC)
 Mucinous Ovarian cancer
Cholangiocarcinoma (CCA)
Bile duct cancer
Gallbladder carcinoma
Immunotherapy
Vaccine therapy
Adjuvant therapy
circulating tumor DNA (ctDNA)
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Adenocarcinoma
Ovarian Neoplasms
Cholangiocarcinoma
Neoplasm, Residual
Bile Duct Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases