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

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ClinicalTrials.gov Identifier: NCT04853017
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Elicio Therapeutics

Brief Summary:
This is a Phase 1/2 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 tumor.

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 (Dose Escalation) Drug: ELI-002 (at the RP2D) Other: Observation Phase 1 Phase 2

Detailed Description:

The study consists of 3 phases: Phase 1A, Phase 1B, and Phase 2. In Phase 1A, Amph modified KRAS peptides, Amph-G12D and Amph-G12R (ELI-002 2P) will be evaluated with admixed Amph-CpG-7909, with plans to transition to an Amph-Peptide 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) for Phase 1B dose expansion and Phase 2 studies.

The Phase 1A portion of the study is an open-label, dose-escalation, 3+3 design in which up to 18 subjects will be treated in 3 planned dose level cohorts. In this phase, increasing doses of Amph-CpG-7909 will be evaluated sequentially. 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.

In Phase 1B, three dose expansion cohorts (up to 17 subjects in each cohort for a total of up to 51 subjects) will be added to evaluate for preliminary evidence of antitumor activity in KRAS and NRAS mutated solid tumors (including colorectal cancer, non-small cell lung cancer, mucinous ovarian cancer, as well as bile duct and gallbladder cancer) and changes from baseline in tumor biomarkers.

In Phase 2, an additional 90 pancreatic cancer subjects will be randomized 2:1 (ELI-002 versus observation) to further evaluate antitumor activity. Subjects randomized to ELI-002 will receive subcutaneous (SC) injections of ELI-002 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 but will not receive ELI-002 treatment. Subjects randomized to observation will be able to cross-over to ELI-002 treatment in the event of confirmed disease progression.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First in Human Phase 1/2 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 : March 19, 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025


Arm Intervention/treatment
Experimental: ELI-002 (Phase 1A)
Dose escalation
Drug: ELI-002 (Dose Escalation)
Amph-CpG-7909 admixed with Amph modified KRAS peptides 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 (Phase 1B)
Dose expansion at RP2D
Drug: ELI-002 (at the RP2D)
Amph-CpG-7909 admixed with Amph modified KRAS peptides 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) at the dose determined to be the recommended dose in Phase 1A

Experimental: ELI-002 or Observation (Phase 2, randomized)
Subjects randomized to ELI-002 will receive ELI-002 at the RP2D. Subjects randomized to Observation will not receive ELI-002 intervention, however they will have the possibility to receive treatment following confirmed disease progression.
Drug: ELI-002 (at the RP2D)
Amph-CpG-7909 admixed with Amph modified KRAS peptides 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) at the dose determined to be the recommended dose in Phase 1A

Other: Observation
Observation only (no ELI-002 treatment)




Primary Outcome Measures :
  1. Phase 1A: 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. Phase 1: 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.

  3. Phase 2: Determine whether ELI-002 improves relapse-free survival (RFS) compared with Observation [ Time Frame: After the last radiographic assessment at Visit 24 (Day 791) ]
    RFS is assessed by the investigator through computed tomography (CT) imaging with contrast and using iRECIST criteria.


Secondary Outcome Measures :
  1. Phase 1: Determine the ctDNA clearance rate [ Time Frame: 6 months ]
    The ctDNA clearance rate is defined as the proportion of subjects whose ctDNA status changes from positive at baseline to negative at 6 months.

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

  3. Phase 2: Determine the ctDNA clearance [ Time Frame: 6 months ]
    Compare between treatments, ELI-002 vs Observation, the proportion of subjects whose ctDNA status changes from positive at baseline to negative at 6 months.

  4. Phase 2: Determine the 1-year RFS [ Time Frame: 1 year ]
    Compare between treatments, ELI-002 vs Observation, the 1-year RFS.

  5. Phase 2: Determine the overall survival (OS) [ Time Frame: 24 months ]
    Compare between treatments, ELI-002 vs Observation, assuming proportional hazards, the OS (defined as the time from randomization to death).

  6. Phase 2: Determine the objective response rate (ORR) in subjects who crossover from Observation to ELI-002 after confirmed relapse [ Time Frame: After Visit 15 (Day 217) ]
    ORR is defined as the proportion of subjects achieving a complete response or a partial response per iRESIST.



Information from the National Library of Medicine

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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 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
  • Known brain metastases
  • Use of immunosuppressive drugs

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, Michigan
Henry Ford Cancer Institute Recruiting
Detroit, Michigan, United States, 48202
Contact: CTO P1 Trials       CTOP1Trials@hfhs.org   
Principal Investigator: Ding M Wang, MD         
United States, Missouri
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
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 Recruiting
Nashville, Tennessee, United States, 37203
Contact    844-482-4812    DDUReferrals@sarahcannon.com   
Principal Investigator: Melissa Johnson, MD         
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
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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: April 30, 2021
Last Verified: April 2021

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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
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