Overview

This trial is active, not recruiting.

Conditions metastatic pancreatic cancer, metastatic colorectal cancer
Treatment npc-1c/neo-102
Phase phase 1/phase 2
Sponsor Precision Biologics, Inc
Start date January 2012
End date January 2018
Trial size 116 participants
Trial identifier NCT01040000, Neogenix 0901

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
npc-1c/neo-102 Ensituximab
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.

Primary Outcomes

Measure
Efficacy will be assessed by analysis of CT scans pre and post therapy, clinical laboratory tests, and physical examinations.
time frame: 10 weeks
Efficacy OS
time frame: 5 months

Secondary Outcomes

Measure
Safety will be assessed by analysis of adverse experiences, clinical laboratory tests, and physical examinations.
time frame: 10 weeks
Pharmacokinetics and select immune responses to the antibody will be assessed.
time frame: 10 weeks

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

INCLUSION CRITERIA: - Age: >/= 18 - 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

Additional Information

Official title A Phase 1/2 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Precision Biologics, Inc.