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Enoblituzumab Schedule 1

Phase 1

Melanoma | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Aug 11, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment146

FDA Designations

No designations recorded

Clinical trial landscape

Enoblituzumab Schedule 1 · 1 trial · 4 indications

Phase 1 1
NCT02475213Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory CancerMelanoma
COMPLETED146 Analytics
PHASE1COMPLETED
Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab
Study Day 1-42, for Cohorts 1-4.

Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.

Secondary Endpoints

Mean Maximum Concentration of Enoblituzumab
Baseline, 1, 4, 24, and 72 hours after the first dose.
Mean Trough Concentration of Enoblituzumab
At baseline, and Day 7.
Mean Area Under the Concentration Time Curve (AUC) From Time 0 to Day 7 of Enoblituzumab
At baseline, 1, 4, 24, 72 hours, and Day 7.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALEnoblituzumab 3 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Cohort 2EXPERIMENTALEnoblituzumab 10 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Cohort 3EXPERIMENTALEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Cohort 4EXPERIMENTALEnoblituzumab 15 mg/kg IV plus retifanlimab 375 mg IV every 3 weeks
Melanoma CohortEXPERIMENTALEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Urothelial Cancer CohortEXPERIMENTALEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Non-small Cell Cancer (NSCLC) CohortEXPERIMENTALEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Squamous Cell Cancer of Head and Neck (SCCHN) CohortEXPERIMENTALEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks

Interventions

NameTypeDescription
Enoblituzumab Schedule 1BIOLOGICALenoblituzumab is administered by IV infusion once per week for up to 51 doses.
PembrolizumabBIOLOGICALPembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Enoblituzumab Schedule 2BIOLOGICALEnoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses
retifanlimabBIOLOGICALRetifanlimab is administered by IV infusion every 3 weeks for up to 17 doses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

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...

Countries:United States
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Frequently asked questions about Enoblituzumab Schedule 1

What is Enoblituzumab used for in melanoma?

Enoblituzumab is an investigational monoclonal antibody being studied for the treatment of melanoma. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety and potential efficacy in patients with refractory cancer, including melanoma.

What does Enoblituzumab target?

Enoblituzumab is a monoclonal antibody designed to target a specific antigen on cancer cells. As a monoclonal antibody, it works by binding to its target to potentially induce an immune response against the tumor. The exact molecular target has not been specified in the available information.

Who makes Enoblituzumab?

Enoblituzumab is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MGNX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types, including melanoma.

What phase is Enoblituzumab in?

Enoblituzumab is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical evaluation for the treatment of melanoma and other cancers.

What clinical trials is Enoblituzumab in?

Enoblituzumab has been studied in a Phase 1 clinical trial with the identifier NCT02475213. This trial, titled 'Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer,' enrolled 146 participants and has been completed. The study was conducted in the United States and included patients with melanoma, head and neck cancer, non-small cell lung cancer, and urothelial carcinoma.

Is Enoblituzumab the same as MGA271?

Yes, Enoblituzumab is also known as MGA271. The clinical trial NCT02475213 refers to the drug as Enoblituzumab (MGA271), confirming that these names refer to the same investigational monoclonal antibody being developed by MacroGenics.