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

Colorectal Cancer Clinical Trial

— AMPLIFY-7P  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726864
• Other study ID #: ELI-002-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 14, 2023
• Est. completion date: November 2026

Study information

• Verified date: June 2024
• Source: Elicio Therapeutics
• Contact: Clinical Trial Inquiries
• Phone: 617-714-9884
• Email: clinicaltrialinquiries[@]elicio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Presence of tumor mutations where specific therapy is approved

• Known brain metastases

• Use of immunosuppressive drugs

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• KRAS G12D
• KRAS G13D
• Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• ELI-002 7P
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)

Locations

Country	Name	City	State
United States	University of Colorado Hospital-Anschutz Cancer Pavillion	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Miami	Coral Gables	Florida
United States	University of Texas Southwestern	Dallas	Texas
United States	City of Hope	Duarte	California
United States	University of Florida Health Cancer Center	Gainesville	Florida
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Mayo Clinic Comprehensive Cancer Center	Jacksonville	Florida
United States	Northwell Health	Lake Success	New York
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York Presbyterian Weill Cornell Medical Center	New York	New York
United States	University of California, Irvine	Orange	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Comprehensive Cancer Center	Phoenix	Arizona
United States	Mayo Clinic Comprehensive Cancer Center	Rochester	Minnesota
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Elicio Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days after the first dose of ELI-002 7P
Primary	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	After the last radiographic assessment at Visit 26 (Week 150)
Secondary	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	6 months
Secondary	Phase 2: Determine the 1-year DFS	Compare between cohorts, ELI-002 7P vs Observation, the 1-year DFS	1 year
Secondary	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	30 days after the last ELI-002 7P dose
Secondary	Phase 2: Determine the objective response rate (ORR) in subjects who crossover from Observation to ELI-002 7P treatment after confirmed progressive disease according to iRECIST	ORR is defined as the proportion of subjects achieving a complete response or partial response per iRECIST	After Visit 13 (Week 20)