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

NCT ID: NCT00702494

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Multiple IV doses of TB-403, an antibody directed against PlGF

Group Type EXPERIMENTAL

TB-403

Intervention Type BIOLOGICAL

Multiple IV

Interventions

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TB-403

Multiple IV

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Confirmed malignity
* Measurable disease
* Performance status 1 or less (ECOG)

Exclusion Criteria

* Acute illness or infection
* Concurrent second malignancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxurion

INDUSTRY

Sponsor Role collaborator

BioInvent International AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrik Lassen, MD, PhD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Lena Winstedt, PhD

Role: STUDY_DIRECTOR

BioInvent International AB

Dorthe Nielsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital, Herlev, Denmark

Locations

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Onkologisk Klinik 5072 Finsencentret Rigshospitalet

Copenhagen, , Denmark

Site Status

Onkologisk Afdeling 54B1 Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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EUDRACT No: 2008-001345-25

Identifier Type: -

Identifier Source: secondary_id

07-TB-403-02

Identifier Type: -

Identifier Source: org_study_id

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