NCT00702494CompletedPhase 1
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.
BioInvent International AB2 sites in 1 country21 target enrollmentStarted: June 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- BioInvent International AB
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Safety and tolerability of an anti-PlGF antibody
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed malignity
- •Measurable disease
- •Performance status 1 or less (ECOG)
Exclusion Criteria
- •Acute illness or infection
- •Concurrent second malignancy
Arms & Interventions
1
Experimental
Multiple IV doses of TB-403, an antibody directed against PlGF
Intervention: TB-403 (Biological)
Outcomes
Primary Outcomes
Safety and tolerability of an anti-PlGF antibody
Time Frame: 85 days
Secondary Outcomes
- Determine multiple dose IV pharmacokinetics(85 days)
Investigators
Study Sites (2)
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