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Enoblituzumab Schedule 1

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02475213Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory CancerPHASE1 COMPLETED 146Jul 1, 2015Aug 18, 2021Aug 11, 202520 United States
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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 — 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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Competitive Landscape -Melanoma 127 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Intismeran autogene, Pembrolizumab, pembrolizumab, Pembrolizumab Berahyaluronidase alfa
Bristol-Myers Squibb CompanyBMY7PHASE3Nivolumab, Nivolumab + Relatlimab, rHuPH20, Relatlimab, relatlimab+nivolumab
Regeneron Pharmaceuticals, Inc.REGN8PHASE3Fianlimab, Cemiplimab, Pembrolizumab, fianlimab, cemiplimab
Pfizer Inc.PFE4PHASE3Encorafenib, Binimetinib, Pembrolizumab, PF-08046049, PF-07799933
IDEAYA Biosciences, Inc.IDYA4PHASE3Darovasertib, IDE196, Crizotinib, Pembrolizumab, Ipilimumab
Iovance Biotherapeutics IncIOVA6PHASE3Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period, Lifileucel, LN-145/LN-144, Cyclophosphamide
Replimune Group, Inc.REPL5PHASE3Vusolimogene Oderparepvec, Nivolumab, Pembrolizumab, Single-agent chemotherapy, RP1
Amgen Inc.AMGN1PHASE3ABP 206, Nivolumab
Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 ShIMCR3PHASE3Tebentafusp, Brenetafusp, Nivolumab
Immatics N.V.IMTX2PHASE3IMA203, nivolumab plus relatlimab, lifileucel, pembrolizumab, ipilimumab
Aura Biosciences IncAURA4PHASE3Bel-sar
Novartis AG Sponsored ADRNVS6PHASE2LXH254, LTT462, Trametinib, Ribociclib, DYP688
IO Biotech, Inc.IOBT2PHASE3IO102-IO103, Pembrolizumab, Pembrolizumab KEYTRUDA
Erasca, Inc.ERAS1PHASE3Naporafenib, Dacarbazine, Temozolomide, Trametinib
AstraZeneca PLCAZN3PHASE2Ceralasertib, Durvalumab, AZD6750, rilvegostomig, Trastuzumab deruxtecan
Eikon Therapeutics, Inc.EIKN2PHASE2EIK1001, Pembrolizumab, Association atezolizumab + BDB001 + RT
Moderna, Inc.MRNA1PHASE2mRNA-4157, Pembrolizumab
Genmab A/S Sponsored ADRGMAB2PHASE2Acasunlimab, Pembrolizumab, GEN1042, Cisplatin, Carboplatin
Agenus Inc.AGEN1PHASE2Botensilimab, Balstilimab
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
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