Last updated on September 2017

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


Brief description of study

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.

Detailed Study 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 and desmoplastic small round cell tumors. 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.

Clinical Study Identifier: NCT02982941

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Crystal Mackall, MD

Lucile Packard Children's Hospital, Stanford
Palo Alto, CA United States
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Rosandra Kaplan, MD

National Cancer Institute, Center for Cancer Research
Bethesda, MD United States
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John M Maris, MD

Children's Hospital of Philadelphia
Philadelphia, PA United States
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Meenakshi Hegde, MD

Texas Children's Hospital
Houston, TX United States
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Julie Park, MD

Seattle Children's
Seattle, WA United States
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Kenneth DeSantes, MD

University of Wisconsin, American Family Children's Hospital
Madison, WI United States
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