Trials / Completed
CompletedNCT00709462
A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)
A Phase I, Open-Label, Dose-Escalation, Multidose Study of CDX-1307, a Mannose Receptor-Targeted hCG-β Vaccine, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX-1307-01)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Celldex Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CDX1307 |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2010-05-01
- Completion
- 2010-06-01
- First posted
- 2008-07-03
- Last updated
- 2010-07-26
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00709462. Inclusion in this directory is not an endorsement.