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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

Phase 1/Phase 2
18 Years
85 Years
Open (Enrolling)
Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer

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Trial Information

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.

Inclusion Criteria


- Age: >/= 18 and
- Diagnosis:

- Histologically confirmed recurrent, locally advanced unresectable or metastatic
adenocarcinoma of the pancreas who have progressed after front line
chemotherapy, OR

- Histologically confirmed metastatic colorectal adenocarcinoma who have
progressed after at least 2 standard chemotherapy regimens.

- Tumor sections must stain >/= 20% positive for NPC-1C antibody/antigen target

- Measurable disease (by RECIST)

- Karnofsky performance status of >/= 50%

- Laboratory Function (within 21 days of receiving first dose of study drug):

- Hemoglobin > 8.5 g/dL, or on stable doses (hematocrit stable within 1 gram and
dose stable for one month) of erythropoietin or similar medication.

- Absolute neutrophil count (ANC) >/= 1,500/mm3

- Platelets >/= 50,000/mm3

- Total bilirubin
- ALT and AST 5 times the ULN

- Creatinine
- Voluntary written informed consent before performance of any study-related procedure
that is not part of normal medical care.

- Expected to be able to remain on a study protocol for at least 8 weeks.

- Is post-menopausal, surgically sterilized, or willing to use acceptable methods of
birth control for the duration of the study. Male subject agrees to use an
acceptable barrier method for contraception during the study.


- Has history of disseminated or uncontrolled brain metastases or central nervous
system disease.

- Ascites with abdominal distention.

- Mechanical, non-reversible reason for not being able to eat, or have a likelihood of
developing malignant bowel obstruction during the course of the induction phase of
treatment; subjects with uncomplicated J-tubes will not be excluded.

- Any major surgery within four weeks of enrollment.

- Uncontrolled concomitant illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac

- Has another serious medical illness, including a second malignancy, or psychiatric
illness that could, in the Investigator's opinion, potentially interfere with the
completion of treatment according to this protocol.

- Pregnant or breast-feeding.

- Any chemotherapeutic agents or corticosteroids within 2 weeks of study entry or
biologic treatment within 4 weeks of study entry.

- Use of any high risk medications that prolong the QT/QTc interval.

- History of allergic reaction to Erbitux greater than grade 1.

- Uncontrolled diabetes.

- Prior history of a documented hemolytic event.

- Receiving warfarin.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy will be assessed by analysis of CT scans pre and post therapy, clinical laboratory tests, and physical examinations.

Outcome Time Frame:

10 weeks

Safety Issue:


Principal Investigator

Philip M Arlen, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Precision Biologics, Inc


United States: Food and Drug Administration

Study ID:

Neogenix 0901



Start Date:

January 2012

Completion Date:

April 2015

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Metastatic Colorectal Cancer
  • 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
  • Colorectal Neoplasms
  • Pancreatic Neoplasms



Duke University Medical Center Durham, North Carolina  27710
Ut Southwestern Medical Center Dallas, Texas  75390
Johns Hopkins Kimmel Comprehensive Cancer Center Baltimore, Maryland  21231