A Phase 1/2A Therapeutic, Open Label, Multi-Center Clinical Trial of NPC-1C, a Chimeric Monoclonal Antibody, in Adults With Recurrent, Locally Advanced Unresectable or Metastatic Pancreatic and Colorectal Cancer After Standard Therapy
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 2A portion of this trial is an open label, multi-center study estimated
to treat approximately 10-24 pancreatic cancer patients who have failed first line therapy,
and metastatic colon cancer patients who are refractory to standard treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy will be assessed by analysis of CT scans pre and post therapy, clinical laboratory tests, and physical examinations.
Philip M Arlen, M.D.
Precision Biologics, Inc
United States: Food and Drug Administration
|Duke University Medical Center||Durham, North Carolina 27710|
|Ut Southwestern Medical Center||Dallas, Texas 75390|
|Johns Hopkins Kimmel Comprehensive Cancer Center||Baltimore, Maryland 21231|