QUILT-3.019: Phase 2 Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal Cancer
Condition: Metastatic Pancreatic Cancer; Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the phase 2 component of this study is to determine if giving the immune
      molecule NPC-1C to individuals who have cancer of the pancreas or gastrointestinal tract
      (colon or rectum) which has not responded to standard treatments can shrink or halt the
      growth of cancer, and to obtain additional data to study its effect on the immune system.
      Safety data will also be accumulated and evaluated during this study. NPC-1C is a monoclonal
      antibody that recognizes a specific tumor target on certain cancers. In laboratory studies,
      the antibody killed tumor cells in some colon and pancreatic cancers that express the NPC-1C
      antigen by a process called "antibody-dependent cell cytotoxicity" or ADCC.
    

Detailed description: 
      The limitations of many current therapeutic products for pancreatic cancer are widely
      recognized. Despite the development of several new treatment regimens for pancreatic cancer,
      little if any benefit has been appreciated, leaving this disease as one of the most
      significant unmet medical needs in cancer.

      NPC-1C is a chimeric immunoglobulin molecule comprised from the variable region of the heavy
      chain and light chain of murine NPC-1, genetically engineered in-frame with the constant
      regions of a human IgG1 isotype. NPC-1, the predecessor of NPC-1C, was derived from a Tumor
      Associated Antigen (TAA) based vaccine that was previously tested in a Phase 1-2 clinical
      trial performed in the United States in the 1980's that explored the use of TAA therapy in
      patients with adenocarcinoma of the colon. These early studies demonstrated safety as well as
      preliminary evidence of activity in these patients treated with the vaccine.

      NPC-1C antibody-staining studies demonstrate specific immunoreactivity with cancer tissues
      from colon and pancreas patients, whereas only weak binding, if at all, is observed in normal
      pancreas or colon tissues with no cross-reactivity observed in other normal human tissues.
      The Phase 2 portion of this trial is an open label, multi-center study estimated to treat
      approximately 30 patients with pancreatic cancer who have failed first line therapy, and 43
      patients with metastatic colorectal cancer who are refractory to standard treatment.
    

Intervention name(s): NPC-1C/NEO-102
Intervention type(s): Drug
Intervention description(s): Subjects will receive NPC-1C at a dose of 3.0 mg/kg. NPC-1C will be given intravenously (by vein) over approximately 1-6 hours, once every 2 weeks for 4 doses per course. Courses will be repeated in the absence of disease progression or unacceptable toxicity.
Other intervention name(s): Ensituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NPC-1C; Monoclonal antibody; Pancreatic Cancer; Adenocarcinoma of the pancreas; Ductal carcinoma of the pancreas; Duct cell carcinomas, pancreas; Carcinomas, pancreas duct cell; Pancreas duct cell carcinoma; Pancreatic duct cell carcinoma; Adenocarcinoma of the colon; Adenocarcinoma of the rectum; Colorectal cancer; Colorectal tumor; Colorectal neoplasm