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

• ClinicalTrials.gov Identifier: NCT04853017
• Recruitment Status: Active, not recruiting
• First Posted: April 21, 2021
• Last Update Posted: April 15, 2024
• Sponsor: Elicio Therapeutics
• Information provided by (Responsible Party): Elicio Therapeutics

Tracking Information

• First Submitted Date: April 16, 2021
• First Posted Date: April 21, 2021
• Last Update Posted Date: April 15, 2024
• Actual Study Start Date: October 4, 2021
• Actual Primary Completion Date: January 26, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 6, 2021)

• 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.
• 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.

Original Primary Outcome Measures (submitted: April 16, 2021)

• 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.
• 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.
• 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.

Current Secondary Outcome Measures (submitted: December 27, 2022)

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.

Original Secondary Outcome Measures (submitted: April 16, 2021)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
• 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
• 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 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• 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

Intervention

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)

Study Arms

• 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)
  Intervention: Drug: ELI-002 2P
• 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)
  Intervention: Drug: ELI-002 2P
• 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)
  Intervention: Drug: ELI-002 2P
• 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)
  Intervention: Drug: ELI-002 2P
• 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)
  Intervention: Drug: ELI-002 2P

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 25, 2023): 25
• Original Estimated Enrollment (submitted: April 16, 2021): 159
• Estimated Study Completion Date: March 2026
• Actual Primary Completion Date: January 26, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04853017
• Other Study ID Numbers: ELI-002-001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Elicio Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Elicio Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Elicio Therapeutics
• Verification Date: April 2024