Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours
March 1, 2022 updated by: BioInvent International AB
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.
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, DK-2100
- Onkologisk Klinik 5072 Finsencentret Rigshospitalet
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Herlev, Denmark, DK-2730
- Onkologisk Afdeling 54B1 Herlev Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed malignity
- Measurable disease
- Performance status 1 or less (ECOG)
Exclusion Criteria:
- Acute illness or infection
- Concurrent second malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Multiple IV doses of TB-403, an antibody directed against PlGF
|
Multiple IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety and tolerability of an anti-PlGF antibody
Time Frame: 85 days
|
85 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine multiple dose IV pharmacokinetics
Time Frame: 85 days
|
85 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
June 19, 2008
First Submitted That Met QC Criteria
June 19, 2008
First Posted (Estimate)
June 20, 2008
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 1, 2022
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-TB-403-02
- EUDRACT No: 2008-001345-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.