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Sponsors and Collaborators: |
BioInvent International AB Thrombogenics NV |
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Information provided by: | BioInvent International AB |
ClinicalTrials.gov Identifier: | NCT00702494 |
TB-403 is a monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding, growth of tumor vessels are inhibited and tumor growth prevented.
In this study we are investigating the tolerability and safety of TB-403 in patients with solid tumors who receives multiple intravenous doses of TB-403.
Condition | Intervention | Phase |
---|---|---|
Solid Tumors |
Biological: TB-403 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open, Phase I, Dose Escalation Study of the Monoclonal Antibody TB-403 Directed Against PlGF, Given as Multiple IV-Doses to Patients With Solid Tumors. |
Estimated Enrollment: | 21 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Multiple IV doses of TB-403, an antibody directed against PlGF
|
Biological: TB-403
Multiple IV
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lena Winstedt, MSc, PhD | +46 46 286 3832 | lena.winstedt@bioinvent.com |
Contact: Per-Anders Johansson, MSc | +46-46-286 85 50 | per-anders.johansson@bioinvent.com |
Denmark | |
Onkologisk Klinik 5072 Finsencentret Rigshospitalet | Recruiting |
Copenhagen, Denmark, DK-2100 | |
Contact: Ulrik Lassen, MD, PhD +45 35458923 | |
Principal Investigator: Ulrik Lassen, MD, PhD | |
Onkologisk Afdeling 54B1 Herlev Hospital | Recruiting |
Herlev, Denmark, DK-2730 | |
Contact: Dorte Nielsen, MD, PhD +454488000 ext 43154 | |
Principal Investigator: Dorte Nielsen, MD, PhD |
Study Chair: | Ulrik Lassen, MD, PhD | Rigshospitalet, Copenhagen, Denmark |
Study Director: | Steven Glazer, MD | BioInvent International AB |
Principal Investigator: | Dorthe Nielsen, MD, PhD | Herlev Hospital, Herlev, Denmark |
Responsible Party: | Bioinvent International AB ( Steven Glazer, Senior Vice President, Development ) |
Study ID Numbers: | 07-TB-403-02, EUDRACT No: 2008-001345-25 |
Study First Received: | June 19, 2008 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00702494 |
Health Authority: | Denmark: Danish Medicines Agency |
placental growth factor monoclonal antibody Phase I solid tumors Patients with solid tumors |
Antibodies, Monoclonal Antibodies Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |