Clinical Trial 22007

• Overview

  Study 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

  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.

  Objective:

  Phase 1 Primary Objective: To assess the safety and tolerability of ELI-002 7P as adjuvant therapy for subjects with KRAS/NRAS mutated solid tumors who have minimal residual disease (MRD) identified using either ctDNA or a serum tumor biomarker Phase 1 Secondary Objective: To assess circulating tumor deoxyribonucleic acid (ctDNA) reduction and clearance, defined as reduction or clearance in ctDNA compared to baseline, or if ctDNA was not detectable at baseline, serum tumor biomarker (such as carbohydrate antigen [CA]19-9, carcinoembryonic antigen [CEA], and CA-125) reduction and clearance compared to baseline.

• Treatments

  Therapies:

  Chemotherapy (NOS); Radiotherapy; Vaccine

  Medications:

  ELI-002 7P (); FOLFIRINOX (); Radiotherapy ()

• Inclusion 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
  • 18 years of age or older

• Exclusion Criteria

  Exclusion Criteria:
  • Presence of tumor mutations where specific therapy is approved
  • Known brain metastases
  • Use of immunosuppressive drugs

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