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Also known as Enoblituzumab
enoblituzumab plus ipilimumab · 2 trials · 8 indications
Adverse events, SAEs, incidence of treatment-emergent AE
Adverse events, serious adverse events
| Arm | Type | Description |
|---|---|---|
| Dose Escalation & Cohort Expansion | EXPERIMENTAL | enoblituzumab administered IV weekly |
| enoblituzumab plus ipilimumab | EXPERIMENTAL | Enoblituzumab: Fc-optimized, humanized monoclonal antibody. Ipilimumab: Yervoy; recombinant, fully humanized IgG-1 CTLA-4 blocking antibody approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of unresectable or metastatic melanoma. |
| Name | Type | Description |
|---|---|---|
| Enoblituzumab | DRUG | enoblituzumab administered IV weekly for up to 96 weeks |
| enoblituzumab plus ipilimumab | BIOLOGICAL | enoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses. |
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...
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Enoblituzumab plus ipilimumab is an investigational combination of two monoclonal antibodies studied in adults with refractory cancer, including melanoma and non small cell lung cancer. Enoblituzumab is also known as MGA271. The combination was evaluated in a Phase 1 safety study and is not an approved treatment.
Enoblituzumab targets CD276, also known as B7-H3, a molecule expressed on tumor cells and in the tumor microenvironment. By binding CD276, the antibody is designed to engage immune effector mechanisms against B7-H3-expressing tumors. Ipilimumab, the combination partner, is a separate antibody directed at a different immune checkpoint.
Enoblituzumab is developed by MacroGenics, Inc., which trades on Nasdaq under the ticker MGNX. The company sponsored the clinical studies of enoblituzumab, including the Phase 1 trial combining it with ipilimumab in refractory cancer.
Enoblituzumab plus ipilimumab is in Phase 1 development. The combination has been tested in a completed Phase 1 safety study in adults with refractory melanoma and non small cell lung cancer. It is investigational and has not been approved by the FDA for any indication.
The combination was studied in NCT02381314, a completed Phase 1 safety study of enoblituzumab with ipilimumab in refractory cancer, including melanoma and non small cell lung cancer, with 24 participants. Enoblituzumab was also studied as a single agent in NCT02982941, a completed Phase 1 trial in children with B7-H3-expressing solid tumors, including neuroblastoma, with 25 participants.