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A Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma

NCT02748135 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-01-13

No results posted yet for this study

Summary

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.

Conditions

  • Relapsed or Refractory Medulloblastoma (MB), Neuroblastoma (NB), Ewing Sarcoma (ES) and Alveolar Rhabdomyosarcoma (ARMS)

Interventions

DRUG

TB-403 20mg/kg

bi-weekly intravenous doses of TB-403 20mg/kg

DRUG

TB-403 50mg/kg

bi-weekly intravenous doses of TB-403 50mg/kg

DRUG

TB-403 100mg/kg

bi-weekly intravenous doses of TB-403 100mg/kg

DRUG

TB-403 175mg/kg

bi-weekly intravenous doses of TB-403 175mg/kg

Sponsors & Collaborators

  • Beat Childhood Cancer

    collaborator UNKNOWN

  • Oncurious NV

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2020-10-06
Completion
2020-10-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02748135 on ClinicalTrials.gov