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A Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma, Neuroblastoma, Ewing Sarcoma or Alveolar Rhabdomyosarcoma

NCT02748135•Oncurious NV

View on ClinicalTrials.gov

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.

Detailed Description

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).

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provide written informed consent (Subject or legal representative)
•2. Be \> 6 months and \< 18 years of age. For each dose cohort, the first 3 subjects must be at least 2 years of age
•3. Have a histologically-confirmed diagnosis of MB, NB, ES, or ARMS
•4. Have documented relapse or refractoriness after standard-of-care therapy
•5. 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
•6. 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
•7. Have adequate organ function, defined as:
•* Peripheral absolute neutrophil count ≥ 1.5 × 10\^9/L
•* Platelet count ≥ 100 × 10\^9/L (transfusion to reach this level is permitted)
•* Hemoglobin ≥ 8mg/dL (transfusion to reach this level is permitted)
+10 more criteria

Exclusion Criteria

•1. Have any clinically significant disease considered by the investigator to interfere with study participation
•2. 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:
•* Myelosuppressive chemotherapy: Must not have received within 2 weeks (6 weeks if prior nitrosourea)
•* Hematopoietic growth factors: At least 5 days since the completion of therapy with a growth factor
•* Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Sponsor
•* Immunotherapy: At least 6 weeks since the completion of any type of immunotherapy, e.g., tumor vaccines
•* Monoclonal antibodies: At least 7 days or 3 half-lives, whichever is longer, must have elapsed since prior treatment with a monoclonal antibody
•* Radiotherapy: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site
•* Stem Cell Transplant or Rescue: No evidence of active graft vs. host disease and ≥ 2 months must have elapsed since transplant
•3. Have participated in another therapeutic clinical trial with an investigational drug within 1 month before first dose of study treatment
+7 more criteria

Locations (10)

Little Rock, Arkansas, United States

Oakland, California, United States

Hartford, Connecticut, United States

Boston, Massachusetts, United States

Grand Rapids, Michigan, United States

St Louis, Missouri, United States

Hackensack, New Jersey, United States

Charleston, South Carolina, United States

Austin, Texas, United States

Dallas, Texas, United States

Key Dates

Start Date

May 1, 2016

Primary Completion Date

October 6, 2020

Completion Date

October 6, 2020

Last Updated

January 13, 2021

Enrollment

ACTUAL participants

Conditions

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

Interventions

TB-403 20mg/kg

DRUG

TB-403 50mg/kg

DRUG

TB-403 100mg/kg

DRUG

TB-403 175mg/kg

DRUG