The purpose of this study is to assess the safety and tolerability profile of TB-403 (humanized monoclonal antibody against placental growth factor (PlGF)) in pediatric subjects with relapsed or refractory Medulloblastoma.
The maximum tolerated dose of TB-403 will be determined in pediatric subjects with relapsed or refractory Medulloblastoma (MB) and as well Neuroblastoma (NB), Ewing Sarcoma (ES) and Alveolar Rhabdomyosarcoma (ARMS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
bi-weekly intravenous doses of TB-403 20mg/kg
bi-weekly intravenous doses of TB-403 50mg/kg
bi-weekly intravenous doses of TB-403 100mg/kg
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Hartford, Connecticut, United States
Unnamed facility
Boston, Massachusetts, United States
The primary safety endpoint will be the determination of the maximum tolerated dose (MTD) / study maximum dose (SMD) based on the occurrence of dose-limiting toxicities (DLTs) during the 28-day DLT assessment period.
Time frame: Day28
TB-403 total exposure (AUC∞) after single ascending dose
Time frame: Day 1, day 4, day 8, day 15, day 29, day 60, day 90, day 165 and day 195.
TB-403 Dose/CL after single ascending dose
Time frame: Day 1, day 4, day 8, day 15, day 29, day 60, day 90, day 165 and day 195.
TB-403 Volume of the central compartment (Vc) after single ascending dose
Time frame: Day 1, day 4, day 8, day 15, day 29, day 60, day 90, day 165 and day 195.
TB-403 Volume of distribution at steady-state (Vss) after single ascending dose
Time frame: Day 1, day 4, day 8, day 15, day 29, day 60, day 90, day 165 and day 195.
TB-403 terminal half-life (t½,z) after single ascending dose
Time frame: Day 1, day 4, day 8, day 15, day 29, day 60, day 90, day 165 and day 195.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
bi-weekly intravenous doses of TB-403 175mg/kg
Unnamed facility
Grand Rapids, Michigan, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Hackensack, New Jersey, United States
Unnamed facility
Charleston, South Carolina, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
Dallas, Texas, United States