AMPLIFY-EAP-002-102

Full Clinical Trial Name

Expanded Access Protocol for ELI-002 7P Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS viral oncogene homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC)

Clinical Trial

  • Cancer
  • Pancreatic Cancer

Phase

Phase
2

Patient Type

Adult
Doctor(s) running this study
Suresh G. Nair, MD
Location(s):
Call 610-402-9543
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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.

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

Doctor(s) running this study