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

This study has been completed.
Sponsor:
Collaborator:
Thrombogenics NV
Information provided by:
BioInvent International AB
ClinicalTrials.gov Identifier:
NCT00702494
First received: June 19, 2008
Last updated: December 3, 2009
Last verified: December 2009
  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: 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:


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, 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 April 17, 2014