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Enoblituzumab

Phase 1

Neuroblastoma | Small molecule | Oncology |MacroGenics, Inc.|Last Updated: Feb 8, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Enoblituzumab · 1 trial · 6 indications

Phase 1 1
NCT02982941Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid TumorsNeuroblastoma
COMPLETED25 Analytics
PHASE1COMPLETED
Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors
Neuroblastoma
NCT0298294125
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Study Endpoints

Primary Endpoints

Safety and tolerability of enoblituzumab.
Time of first dose through end of treatment (up to 2 years)

Adverse events, SAEs, incidence of treatment-emergent AE

Secondary Endpoints

Peak plasma concentration
Time of first dose through end of treatment (up to 96 weeks)
Number of participants that develop anti-drug antibodies
Time of first dose through end of treatment (up to 96 weeks)
Antitumor activity of enoblituzumab
Time of first dose through end of treatment (up to 96 weeks)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation & Cohort ExpansionEXPERIMENTALenoblituzumab administered IV weekly

Interventions

NameTypeDescription
EnoblituzumabDRUGenoblituzumab administered IV weekly for up to 96 weeks
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Eligibility Criteria

Age Range1 Year to 35 Years
SexALL
Healthy VolunteersNo
Study Sites6

General 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 n...

Countries:United States
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Frequently asked questions about Enoblituzumab

What is Enoblituzumab used for?

Enoblituzumab is an investigational oncology drug being studied for the treatment of neuroblastoma and melanoma. It is also being evaluated in clinical trials for other B7-H3-expressing solid tumors, including non-small cell lung cancer, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, Wilms tumor, and desmoplastic small round cell tumor.

How does Enoblituzumab work?

Enoblituzumab targets B7-H3, a protein expressed on the surface of many solid tumors. By binding to B7-H3, the drug is designed to direct the immune system to attack and destroy cancer cells that express this protein.

Who makes Enoblituzumab?

Enoblituzumab is developed by MacroGenics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MGNX.

What phase is Enoblituzumab in?

Enoblituzumab is in Phase 1 clinical development. It is an investigational drug that has not been approved by the FDA and is still being studied in clinical trials.

What clinical trials is Enoblituzumab in?

Enoblituzumab has been studied in two completed Phase 1 clinical trials. NCT02381314 evaluated the drug in combination with ipilimumab in patients with refractory melanoma and non-small cell lung cancer. NCT02982941 evaluated Enoblituzumab as a single agent in children with B7-H3-expressing solid tumors, including neuroblastoma.

Is Enoblituzumab the same as MGA271?

Yes, Enoblituzumab is also known as MGA271. The clinical trial NCT02381314 refers to the drug as Enoblituzumab (MGA271), confirming that these names refer to the same investigational agent.