Solid TumorsPhase 1NCT00702494
Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours
A Phase 1 study testing TB-403 in people with Solid Tumors, run by BioInvent International AB at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- TB-403
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2008to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed malignity
- Measurable disease
- Performance status 1 or less (ECOG)
Who cannot join
- Acute illness or infection
- Concurrent second malignancy
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Onkologisk Klinik 5072 Finsencentret Rigshospitalet
Copenhagen, DK-2100
Onkologisk Afdeling 54B1 Herlev Hospital
Herlev, DK-2730
About this study
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.
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.
- Conditions
- Solid Tumors
- Being tested
- TB-403
- Keywords
- placental growth factor, monoclonal antibody, Phase I, solid tumors, Patients with solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB-403Biological
Multiple IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Multiple IV doses of TB-403, an antibody directed against PlGF Receives: Biological: TB-403 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of an anti-PlGF antibody
Measured: 85 days
Secondary outcomes (1)
Determine multiple dose IV pharmacokinetics
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioInvent International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oxurion
- Responsible party
- Sponsor
- Investigators
- Ulrik Lassen, MD, PhD, Study chair, Copenhagen University Hospital, RigshospitaletLena Winstedt, PhD, Study director, BioInvent International ABDorthe Nielsen, MD, PhD, Principal investigator, Herlev Hospital, Herlev, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702494
- Sponsor's protocol ID
- 07-TB-403-02
- Other IDs
- EUDRACT No: 2008-001345-25
- Status last verified
- Dec 2009
- First submitted
- 19 Jun 2008
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00702494
- Acronym / sponsor ID
- 07-TB-403-02
- Conditions
- Solid Tumors
- Keywords
- placental growth factor, monoclonal antibody, Phase I, solid tumors, Patients with solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- BioInvent International ABIndustry (pharma, biotech, devices)
- Collaborators
- Oxurion
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: TB-403Multiple IV doses of TB-403, an antibody directed against PlGF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed malignity
- Measurable disease
- Performance status 1 or less (ECOG)
Key exclusion criteria (2 listed)
- Acute illness or infection
- Concurrent second malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB-403Multiple IV | Biological | 1 |
Primary outcome
Safety and tolerability of an anti-PlGF antibody
Time frame: 85 days
1 secondary outcome
Determine multiple dose IV pharmacokinetics
Time frame: 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
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Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
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Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Lassen, MD, PhD study chair
Copenhagen University Hospital, Rigshospitalet
Lena Winstedt, PhD study director
BioInvent International AB
Dorthe Nielsen, MD, PhD principal investigator
Herlev Hospital, Herlev, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TB-403 in people with Solid Tumors, run by BioInvent International AB at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of an anti-PlGF antibody (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.