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Also known as Enoblituzumab Schedule 1, Enoblituzumab Schedule 2, Enoblituzumab
MGA271 · 2 trials · 9 indications
Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.
Adverse events, serious adverse events, ECG monitoring, adrenal function monitoring, monitoring for development of anti-drug antibodies
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Enoblituzumab 3 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Cohort 2 | EXPERIMENTAL | Enoblituzumab 10 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Cohort 3 | EXPERIMENTAL | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Cohort 4 | EXPERIMENTAL | Enoblituzumab 15 mg/kg IV plus retifanlimab 375 mg IV every 3 weeks |
| Melanoma Cohort | EXPERIMENTAL | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Urothelial Cancer Cohort | EXPERIMENTAL | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Non-small Cell Cancer (NSCLC) Cohort | EXPERIMENTAL | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Squamous Cell Cancer of Head and Neck (SCCHN) Cohort | EXPERIMENTAL | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| MGA271 | EXPERIMENTAL | Fc-optimized, humanized monoclonal antibody |
| Name | Type | Description |
|---|---|---|
| Enoblituzumab Schedule 1 | BIOLOGICAL | enoblituzumab is administered by IV infusion once per week for up to 51 doses. |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses. |
| Enoblituzumab Schedule 2 | BIOLOGICAL | Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses |
| retifanlimab | BIOLOGICAL | Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses |
| MGA271 | BIOLOGICAL | Up to 9 dose escalation cohorts will be enrolled to determine the maximum tolerated dose of MGA271. Patients with evidence of clinical benefit will be allowed to continue therapy at the same dose once per week for 3 weeks out of every 4-week cycle until documented progression. Patients treated in the Expansion Segment at the maximum administered dose will receive weekly, uninterrupted infusions of MGA271 in 8 week cycles for up to 12 cycles. |
Inclusion Criteria: * To enroll on cohorts 1-4, participants must have a histologically-proven, previously treated, unresectable, locally advanced or metastatic mesothelioma, urothelial cancer, thyroid cancer, pancreatic cancer, ovarian cancer, colon cancer, prostate cancer, soft tissue sarcoma, tr...
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MGA271 is an investigational monoclonal antibody being studied in prostate cancer and other advanced solid tumors. It was evaluated in a Phase 1 safety study in adults with refractory cancer, including prostate cancer, melanoma, renal cell carcinoma, triple-negative breast cancer, head and neck cancer, bladder cancer, and non-small cell lung cancer.
MGA271 targets B7-H3, an immune regulator. B7-H3 is a member of the B7 family of immune checkpoint molecules, and MGA271 is designed as a monoclonal antibody directed against this target. Targeting B7-H3 places MGA271 in the immune regulator class of oncology therapeutics.
MGA271 is being developed by MacroGenics, Inc., which trades under the ticker MGNX. MacroGenics is the sponsor of the clinical program evaluating MGA271 in refractory cancer, including prostate cancer and other solid tumor types.
MGA271 is in Phase 1 clinical development. It is investigational and has been studied in a single Phase 1 trial, which is now completed. No active trials of MGA271 are currently listed, and the completed study enrolled 179 participants.
MGA271 has been studied in one clinical trial, NCT01391143, titled Safety Study of MGA271 in Refractory Cancer. This Phase 1 trial was completed and enrolled 179 participants across sites in the United States. It was an uncontrolled study without randomization or double-blinding.