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NCT01040000 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Precision Biologics.

Completed
Registry status
Phase 1
Development phase
94
Enrollment target

NCT01040000 is a Phase 1 study that has completed, run by Precision Biologics. The registered enrollment target is 94 participants.

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The verdict

NCT01040000, a Phase 1 study, has completed, sponsored by Precision Biologics.

COMPLETED
Registry status
Phase 1
Development phase
94 participants
Enrollment target

Study 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.

Interventions

  • DRUG NPC-1C/NEO-102

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2012-01
Est. Completion 2017-03
Phase Phase 1

Sponsor

Precision Biologics

3 total trials

What the Registry Record Tells You About NCT01040000

The ClinicalTrials.gov registry entry for NCT01040000 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Precision Biologics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which NPC-1C/NEO-102 is the first listed.

NCT01040000 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01040000 about?

NCT01040000 is a clinical study titled "QUILT-3.019: Phase 2 Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal Cancer". 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 add...

What is the current status of trial NCT01040000?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2012-01. Estimated completion is 2017-03.

What interventions are being tested in trial NCT01040000?

The interventions under investigation include: NPC-1C/NEO-102 (DRUG).

Who is sponsoring clinical trial NCT01040000?

This trial is sponsored by Precision Biologics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.