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

Colorectal Cancer Clinical Trial

— AMPLIFY-201  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04853017
• Other study ID #: ELI-002-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 4, 2021
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Elicio Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: March 2026
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Bile Duct Cancer
• Bile Duct Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Cholangiocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Gallbladder Carcinoma
• KRAS G12D
• Minimal Residual Disease
• Neoplasm, Residual
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Pancreatic Ductal Adenocarcinoma

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)

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	City of Hope	Duarte	California
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Northwell Health	Lake Success	New York
United States	University of California Los Angeles	Los Angeles	California
United States	Tennessee Oncology - Centennial Clinic	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Elicio Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the MTD of ELI-002 and the RP2D	The MTD is defined as the highest dose level for which <33% of subjects had a dose-limiting toxicity.	28 days after first dose
Primary	Evaluate the safety of ELI-002	Safety will be assessed by the incidence of adverse events (AEs) and clinically significant laboratory tests and vital signs.	30 days after last dose
Secondary	Determine the biomarker reduction and clearance rate	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.	6 months