Clinical Trial: Cancer, Pancreatic Cancer

MSK 22-352 Pancreatic Cancer

Full Name

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

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

Specialties

  • Hematology/Medical Oncology

Area of focus i

  • Melanoma
  • Kidney cancer (renal cancer)
  • Sarcoma

Affiliated with

LVPG Cliniciani

Accepting New Patients