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tebotelimab

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Dec 21, 2023

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 Enrollment277
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03219268A Study of MGD013 in Patients With Unresectable or Metastatic NeoplasmsPHASE1 COMPLETED 277 — — Aug 18, 2017Feb 8, 2023Dec 21, 202340 United States, Australia +6
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Study Endpoints
Primary Endpoints
Number of participants with Treatment-Emergent Adverse Events (TEAE) as assessed by CTCAE v4.03 (tebotelimab monotherapy)
up to 24 months

Safety Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.

Number of participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (tebotelimab plus margetuximab)
up to 24 months

Safety

Secondary Endpoints
Area Under the Plasma Concentration versus Time Curve (AUC) of tebotelimab
From Day 1 to Day 15 after the first and second doses
Maximum Plasma Concentration (Cmax) of tebotelimab and tebotelimab plus margetuximab
At the end of infusion on Study Days 1, 15, 29 and 43 in Cycles 1 and 2 and on Study Day 1 for all subsequent cycles until treatment discontinuation, up to 2 years
Time to reach maximum (peak) plasma concentration (Tmax) of tebotelimab and tebotelimab plus margetuximab
At the end of infusion on Study Days 1, 15, 29 and 43 in Cycles 1 and 2 and on Study Day 1 for all subsequent cycles until treatment discontinuation, up to 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Tebotelimab: 1 mgEXPERIMENTAL -
Tebotelimab 3 mgEXPERIMENTAL -
Tebotelimab: 10 mgEXPERIMENTAL -
Tebotelimab: 30 mgEXPERIMENTAL -
Tebotelimab: 120 mgEXPERIMENTAL -
Tebotelimab: 400 mgEXPERIMENTAL -
Tebotelimab: 600 mgEXPERIMENTAL -
Tebotelimab: 800 mgEXPERIMENTAL -
Tebotelimab: 1200 mgEXPERIMENTAL -
Combination cohort 1EXPERIMENTALTebotelimab and margetuximab
Combination Cohort 2EXPERIMENTALTebotelimab and margetuximab
Monotherapy Cohort ExpansionEXPERIMENTALMonotherapy expansion at 600 mg
Interventions
NameTypeDescription
tebotelimab 1 mgBIOLOGICAL1 mg IV every other week
tebotelimab 3 mgBIOLOGICAL3 mg IV every other week
tebotelimab 10 mgBIOLOGICAL10 mg IV every other week
tebotelimab 30 mgBIOLOGICAL30 mg IV every other week
tebotelimab 120 mgBIOLOGICAL120 mg IV every other week
tebotelimab 300 mgBIOLOGICAL300 mg IV every other wee
tebotelimab 400 mgBIOLOGICAL400 mg IV every other wee
tebotelimab 600 mgBIOLOGICAL600 mg IV every other week
tebotelimab 800 mgBIOLOGICAL800 mg IV every other week
tebotelimab 1200 mgBIOLOGICAL1200 mg IV every other week
margetuximabBIOLOGICAL15 mg/kg IV every 3 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Histologically proven, locally advanced unresectable or metastatic solid tumors (or hematologic malignancies, Cohort Expansion only) for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined. * Eastern Cooperative Oncology ...

Countries:United StatesAustraliaBulgariaHong KongPolandSpainThailandUkraine
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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