Phase I Study on Monoclonal Antibody TB-403 Directed Agai... | NCT00702494

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

NCT00702494

Sponsor

BioInvent International AB

Status

Completed

Last Update Posted

Mar 16, 2022Actual

Enrollment

21Estimated

Phase

Phase 1

Conditions

Solid Tumors

Interventions

TB-403

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRACT No: 2008-001345-25

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jun 19, 2008

First Submission Date that Met QC Criteria

Jun 19, 2008

First Posted Date

Jun 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2022

Last Update Posted Date

Mar 16, 2022Actual

Name	Class
Oxurion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Multiple IV doses of TB-403, an antibody directed against PlGF	Biological: TB-403

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TB-403	Biological	Multiple IV	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of an anti-PlGF antibody		85 days

Secondary Outcomes

Measure	Description	Time Frame
Determine multiple dose IV pharmacokinetics		85 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Acute illness or infection
Concurrent second malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrik Lassen, MD, PhD	Rigshospitalet, Denmark	Study Chair
Lena Winstedt, PhD	BioInvent International AB	Study Director
Dorthe Nielsen, MD, PhD	Herlev Hospital, Herlev, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Onkologisk Klinik 5072 Finsencentret Rigshospitalet		Copenhagen		DK-2100	Denmark
Onkologisk Afdeling 54B1 Herlev Hospital

Intervention Browse Module

MeSH Terms

ID	Term
C569915	TB-403

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided