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

This study has been completed.

First Received on June 19, 2008. Last Updated on December 3, 2009 History of Changes

Sponsor:	BioInvent International AB
Collaborator:	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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
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

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

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, Copenhagen, Denmark
Study Director:	Lena Winstedt, PhD	BioInvent International AB
Principal Investigator:	Dorthe Nielsen, MD, PhD	Herlev Hospital, Herlev, Denmark

More Information

No publications provided

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
Study First Received:	June 19, 2008
Last Updated:	December 3, 2009
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

Additional relevant MeSH terms:

Neoplasms
Antibodies
Immunoglobulins
Antibodies, Monoclonal

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012