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QUILT-3.019: Phase 2 Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal Cancer

Primary Purpose

Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NPC-1C/NEO-102
Sponsored by
Precision Biologics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring 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

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 </= 2.0 mg/dL
    • ALT and AST </= 2.5 times the ULN, or, if the patient has liver metastases, </= 5 times the ULN
    • Creatinine </= ULN
  • 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.

EXCLUSION CRITERIA:

  • 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 arrhythmia.
  • 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.

Sites / Locations

  • Moffitt Cancer Center
  • Johns Hopkins Kimmel Comprehensive Cancer Center
  • Washington University in St. Louis
  • Cancer Institute of New Jersey
  • Duke University Medical Center
  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NPC-1C/NEO-102

Arm Description

Outcomes

Primary Outcome Measures

Efficacy will be assessed by analysis of CT scans pre and post therapy, clinical laboratory tests, and physical examinations.
Efficacy OS
Using the recommended phase 2 dose (RP2D) evaluate the overall survival (OS) associated with administration of NPC-1C (NEO-102) in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer that express NPC-1C target on tumor.

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2009
Last Updated
August 3, 2017
Sponsor
Precision Biologics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01040000
Brief Title
QUILT-3.019: Phase 2 Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Precision Biologics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPC-1C/NEO-102
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NPC-1C/NEO-102
Other Intervention Name(s)
Ensituximab
Intervention Description
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 Outcome Measure Information:
Title
Efficacy will be assessed by analysis of CT scans pre and post therapy, clinical laboratory tests, and physical examinations.
Time Frame
10 weeks
Title
Efficacy OS
Description
Using the recommended phase 2 dose (RP2D) evaluate the overall survival (OS) associated with administration of NPC-1C (NEO-102) in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer that express NPC-1C target on tumor.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Safety will be assessed by analysis of adverse experiences, clinical laboratory tests, and physical examinations.
Time Frame
10 weeks
Title
Pharmacokinetics and select immune responses to the antibody will be assessed.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 </= 2.0 mg/dL ALT and AST </= 2.5 times the ULN, or, if the patient has liver metastases, </= 5 times the ULN Creatinine </= ULN 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. EXCLUSION CRITERIA: 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 arrhythmia. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip M Arlen, M.D.
Organizational Affiliation
Precision Biologics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Johns Hopkins Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9179
Country
United States

12. IPD Sharing Statement

Learn more about this trial

QUILT-3.019: Phase 2 Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal Cancer

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