A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)

Phase 1

Completed

• Conditions: Breast Cancer; Colorectal Cancer; Pancreatic Cancer; Bladder Cancer; Ovarian Cancer

• Registration Number: NCT00709462
• Lead Sponsor: Celldex Therapeutics

Brief Summary

This research study is for individuals who have advanced breast, colon, pancreatic, ovarian or bladder cancer. Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer. The study includes administration of additional treatments, in combination, thought to enhance the immune response effect. (CDX 1307-01)

Detailed Description

Protocol CDX1307-01: CDX-1307 is an investigational drug that is being tested to see if it can stimulate the immune system (the cells and substances that protect the body from infection and foreign matter) of people with certain kinds of cancer. It is believed that the body's immune system can attack tumor cells and kill them. It is thought that immune cells recognize special proteins on the surface of tumors as a signal to fight the cancer. One of these proteins is called human chorionic gonadotropin-beta (hCG-β) and is found on several types of cancers including breast, colorectal, pancreatic, bladder and ovarian. The study drug will be given as an injection under the skin (an intradermal or intracutaneous injection). In addition, the study includes combination with TLR agonists, which are thought to stimulate the immune response against tumor cells.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-03
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-23
• Last Update Posted: 2010-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To establish the safety and tolerability profile of CDX-1307 in patients with incurable breast, colorectal, pancreatic, ovarian or bladder cancer, alone and in combination with adjuvants.	up to 2 years or until progression

Secondary Outcome Measures

Name	Time	Method
To evaluate dose-limiting toxicities, immune response, and clinical activity (tumor response and time to progression)	up to 2 years or until progression

Trial Locations

Locations (3)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Carolina BioOncology Institute Cancer; 🇺🇸 Huntersville, North Carolina, United States