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Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702494
First Posted: June 20, 2008
Last Update Posted: December 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thrombogenics NV
Information provided by:
BioInvent International AB
  Purpose

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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Further study details as provided by BioInvent International AB:

Primary Outcome Measures:
  • Safety and tolerability of an anti-PlGF antibody [ Time Frame: 85 days ]

Secondary Outcome Measures:
  • Determine multiple dose IV pharmacokinetics [ Time Frame: 85 days ]

Estimated Enrollment: 21
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Multiple IV doses of TB-403, an antibody directed against PlGF
Biological: TB-403
Multiple IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed malignity
  • Measurable disease
  • Performance status 1 or less (ECOG)

Exclusion Criteria:

  • Acute illness or infection
  • Concurrent second malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702494


Locations
Denmark
Onkologisk Klinik 5072 Finsencentret Rigshospitalet
Copenhagen, Denmark, DK-2100
Onkologisk Afdeling 54B1 Herlev Hospital
Herlev, Denmark, DK-2730
Sponsors and Collaborators
BioInvent International AB
Thrombogenics NV
Investigators
Study Chair: Ulrik Lassen, MD, PhD Rigshospitalet, Denmark
Study Director: Lena Winstedt, PhD BioInvent International AB
Principal Investigator: Dorthe Nielsen, MD, PhD Herlev Hospital, Herlev, Denmark
  More Information

Responsible Party: Steven Glazer, Senior Vice President, Development, Bioinvent International AB
ClinicalTrials.gov Identifier: NCT00702494     History of Changes
Other Study ID Numbers: 07-TB-403-02
EUDRACT No: 2008-001345-25
First Submitted: June 19, 2008
First Posted: June 20, 2008
Last Update Posted: December 4, 2009
Last Verified: December 2009

Keywords provided by BioInvent International AB:
placental growth factor
monoclonal antibody
Phase I
solid tumors
Patients with solid tumors

Additional relevant MeSH terms:
Neoplasms
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs


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