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

This study is currently recruiting participants.

Verified by BioInvent International AB, September 2008

Sponsors and Collaborators:	BioInvent International AB Thrombogenics NV
Information provided by:	BioInvent International AB
ClinicalTrials.gov Identifier:	NCT00702494

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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.

Further study details as provided by BioInvent International AB:

Primary Outcome Measures:

Safety and tolerability of an anti-PlGF antibody [ Time Frame: 85 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine multiple dose IV pharmacokinetics [ Time Frame: 85 days ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702494

Contacts

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

Locations

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

Sponsors and Collaborators

BioInvent International AB

Thrombogenics NV

Investigators

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

More Information

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

Keywords provided by BioInvent International AB:

placental growth factor
monoclonal antibody
Phase I
solid tumors
Patients with solid tumors

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009