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Protocol # 21-121

Status

Recruiting

Description

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.

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

Interventions

  • ELI-002 2P

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Determine the MTD of ELI-002 and the RP2D
  • Evaluate the safety of ELI-002

Secondary Outcome:

  • Determine the circulating tumor DNA (ctDNA) reduction and clearance rate

Enrollment

18

Study Start Date

October 4, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Elicio Therapeutics

Source

Elicio Therapeutics

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

Clinicaltrials.gov Identifier

NCT04853017

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.