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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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antibodies, Monoclonal
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014