NCT00702494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 16, 2022

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

June 19, 2008

Last Update Submit

March 1, 2022

Conditions

Solid Tumors

Keywords

placental growth factormonoclonal antibodyPhase Isolid tumorsPatients with solid tumors

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of an anti-PlGF antibody

    85 days

Secondary Outcomes (1)

  • Determine multiple dose IV pharmacokinetics

    85 days

Study Arms (1)

1

EXPERIMENTAL

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

Biological: TB-403

Interventions

TB-403BIOLOGICAL

Multiple IV

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute illness or infection
  • Concurrent second malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Onkologisk Klinik 5072 Finsencentret Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Onkologisk Afdeling 54B1 Herlev Hospital

Herlev, DK-2730, Denmark

Location

MeSH Terms

Interventions

TB-403

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 16, 2022

Record last verified: 2009-12

Locations

DK(2)