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COMPLETEDPHASE1

Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors

A Phase 1, Open-label, Dose Escalation Study of MGA271 in Pediatric Patients With B7-H3-Expressing Relapsed or Refractory Solid Tumors

NCT02982941•MacroGenics

View on ClinicalTrials.gov

Summary

Detailed Description

This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or refractory malignant solid tumors. The study consists of a Dose Escalation Phase to determine the MTD (or MAD) of enoblituzumab followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of enoblituzumab. In the cohort expansion phase, 5 cohorts of 10 patients each will be enrolled to further evaluate the safety and potential efficacy of enoblituzumab administered at the MTD/MAD in patients with:1) neuroblastoma - measurable disease, 2) neuroblastoma - non-measurable disease, 3) rhabdomyosarcoma, 4) osteosarcoma, and 5) Ewing's sarcoma, Wilms' tumor, desmoplastic small round cell tumors, or malignant solid tumors of any other histology that test positive for B7-H3. All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC). Disease assessment in patients with neuroblastoma will use neuroblastoma overall response criteria.

Eligibility

Age

1 - 35 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age at treatment 1 to 35 years.
•Relapsed or refractory malignant solid tumors of any histology for which no standard curative therapy is available (escalation phase).
•Histologically proven: neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/ primitive neuroectodermal tumor, Wilms tumor, desmoplastic small round cell tumor or malignant solid tumors of any other histology that test positive for B7-H3 .
•Must have malignant solid tumors that demonstrate B7-H3 expression at 2+ or greater levels on the membranous surface of at least 10% of tumor cells or ≥ 25% of tumor vasculature by IHC.
•With the exception of patients with non-measurable neuroblastoma patients must have measurable disease as per RECIST 1.1
•Karnofsky (patients ≥ 16 years)/Lansky (patients \< 16 years) index ≥ 70.
•Acceptable laboratory parameters and adequate organ reserve.

Exclusion Criteria

•Patients are to be excluded from the study if they have any of the following:
•Patients with a history of symptomatic central nervous system (CNS) unless they have been treated and are asymptomatic.
•Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment within the past 2 years, and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
•History of prior allogeneic bone marrow/stem-cell or solid organ transplantation.
•Patients receiving autologous stem cell transplantation must wait 8 weeks before initiation of study drug administration.
•Treatment with systemic chemotherapy or investigational therapy within 4 weeks of first study drug administration; other agents (e.g., biologics) within 2 weeks; radiation within 2 weeks; patients receiving 131I-MIBG therapy must wait 6 weeks prior to the initiation of study drug administration; corticosteroids (≥ 0.2 mg/kg/day prednisone or equivalent) or other immune suppressive drugs within the 2 weeks prior to the initiation of study drug administration.
•History of clinically significant cardiovascular disease
•Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
•Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
•Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction.
+4 more criteria

Locations (6)

Lucile Packard Children's Hospital, Stanford

Palo Alto, California, United States

National Cancer Institute, Center for Cancer Research

Bethesda, Maryland, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's

Seattle, Washington, United States

University of Wisconsin, American Family Children's Hospital

Madison, Wisconsin, United States

Key Dates

Start Date

December 1, 2016

Primary Completion Date

May 22, 2019

Completion Date

May 22, 2019

Last Updated

February 8, 2022

Enrollment

ACTUAL participants

Conditions

NeuroblastomaRhabdomyosarcomaOsteosarcomaEwing SarcomaWilms TumorDesmoplastic Small Round Cell Tumor

Interventions

Enoblituzumab

DRUG

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

NCT07479732

OsteosarcomaOsteosarcoma Metastatic

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RECRUITINGPHASE2

A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

NCT04936529

Neuroblastoma

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RECRUITINGPHASE1

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors

Inclusion Criteria

Exclusion Criteria

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors