Clinical trial

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

Name

ELI-002-201

Description

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.

Trial arms

Trial start

2023-04-14

Estimated PCD

2026-11-01

Trial end

2026-11-01

Status

Recruiting

Phase

Early phase I

Treatment

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)

Arms:

Phase 1A: ELI-002 7P (High Peptide dose), Phase 1A: ELI-002 7P (Low Peptide dose), Phase 1B: ELI-002 7P, Phase 2 randomized: ELI-002 7P

Size

156

Primary endpoint

Phase 1: Evaluate the safety of ELI-002 7P

28 days after the first dose of ELI-002 7P

Phase 2: Compare ELI-002 7P versus standard of care (SOC; observation) in DFS (disease free survival)

After the last radiographic assessment at Visit 26 (Week 150)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 156, 'type': 'ESTIMATED'}}

Updated at

2024-05-03

1 organization

1 product

1 abstract

12 indications

Organization

Elicio Therapeutics

Product

ELI-002

Indication

Pancreatic Ductal Adenocarcinoma

Indication

Indication

Indication

Indication

Indication

Indication

Indication

Indication

Indication

Indication

Indication

Abstract

AMPLIFY-7P, a first-in-human safety and efficacy trial of adjuvant mKRAS-specific lymph node targeted amphiphile ELI-002 7P vaccine in patients with minimal residual disease–positive pancreatic and colorectal cancer.

Org: Northwell Heath, University of Florida Health Cancer Center, Weill Cornell Medicine, Englander Institute of Precision Medicine, NewYork-Presbyterian Hospital,