A Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma (NCT02748135) | Clinical Trial Compass
CompletedPhase 1
A Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma
United States18 participantsStarted 2016-05
Plain-language 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.
Who can participate
Age range6 Months – 18 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent (Subject or legal representative)
✓. Be \> 6 months and \< 18 years of age. For each dose cohort, the first 3 subjects must be at least 2 years of age
✓. Have a histologically-confirmed diagnosis of MB, NB, ES, or ARMS
✓. Have documented relapse or refractoriness after standard-of-care therapy
✓. Have undergone magnetic resonance imaging (MRI) for MB (brain \[all cohorts\] and spinal cord \[cohort 4 only\], a computerized tomography (CT) / metaiodobenzylguanidine (MIBG) scan for NB, and CT / magnetic resonance imaging (MRI) for ES or ARMS within 1 month prior to first dose of study treatment
✓. Have a Lansky score ≥ 40 for subjects up to 16 years of age or a Karnofsky score ≥ 40 for subjects 16 years of age to \< 18 years
✓. Have adequate organ function, defined as:
✓. Have no symptoms of cranial hypertension or convulsions within 14 days before Cycle 1 Day 1 (anti-epileptic drugs and corticoids are allowed to control any preexisting symptoms)
Exclusion criteria
✕. Have any clinically significant disease considered by the investigator to interfere with study participation
✕. Have not fully recovered from the acute toxic effects of prior anticancer therapy (e.g., chemotherapy, immunotherapy, radiation therapy) or are currently receiving cytotoxic chemotherapy, immunotherapy or radiation therapy. Subjects must be within the following timelines relative to first dose of study treatment:
What they're measuring
1
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.