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

Completed · Phase 1

Conditions studied: Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Ewing Sarcoma, Wilms Tumor, Desmoplastic Small Round Cell Tumor

In brief

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.

Key facts

Study ID

NCT02982941

Run by

MacroGenics

People needed

25

Starts

2016-12-01

Expected to finish

2019-05-22

Last updated by the study team

2022-02-08

Who can join

Age: 1 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• Second primary invasive malignancy that has not been in remission for greater than 2 years.
• History of severe trauma or major surgery within 4 weeks prior to the initiation of study drug administration.
• Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for enoblituzumab
• Patients in Canada may not have a history or evidence of latent or active tuberculosis infection.

Where it is running

• 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

Full record on ClinicalTrials.gov

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