Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MGA271
Enoblituzumab Schedule 1 · 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...
Top 20 of 52 competitors
Enoblituzumab Schedule 1 is an investigational monoclonal antibody being studied in melanoma, a form of skin cancer. It has also been evaluated in head and neck cancer, non small cell lung cancer, and urothelial carcinoma. It is not an approved therapy and remains in clinical development.
Enoblituzumab Schedule 1 targets CD276, also known as B7-H3, a molecule expressed on tumor cells and involved in immune regulation. The antibody is classified as a cross-linking agent. By binding CD276, it is designed to engage the immune system against CD276-expressing tumor cells.
Enoblituzumab Schedule 1 is being developed by MacroGenics, Inc., a clinical-stage biopharmaceutical company that trades under the ticker MGNX. MacroGenics is the sponsor of the clinical program evaluating this monoclonal antibody in oncology indications.
Enoblituzumab Schedule 1 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 program has been completed, and no trials of this asset are currently listed as active.
Enoblituzumab Schedule 1 has been studied in one completed Phase 1 trial, NCT02475213, titled a safety study of enoblituzumab (MGA271) in combination with pembrolizumab or MGA012 in refractory cancer. The trial enrolled 146 participants across sites in the United States in melanoma, head and neck cancer, non small cell lung cancer, and urothelial carcinoma.
Yes. Enoblituzumab Schedule 1 is also known as MGA271, the designation used in its clinical trial listing. Both names refer to the same anti-CD276 monoclonal antibody developed by MacroGenics, so search results and publications using either name describe the same investigational agent.