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MGC026 Dose Escalation

Phase 1

Advanced Solid Tumor | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Feb 5, 2026

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06242470A Study of MGC026 in Participants With Advanced Solid TumorsPHASE1 RECRUITING 250 — — Mar 6, 2024Oct 1, 2028Feb 5, 202612 United States, Australia +1
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.
Throughout the study, up to 135 weeks
Secondary Endpoints
Overall response rate in advanced solid tumors
Throughout the study, up to 135 weeks
Duration of response (DoR) in advanced solid tumors
Throughout the study, up to 135 weeks
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
Throughout the study, up to 135 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALMGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks.
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 5EXPERIMENTAL -
Cohort 6EXPERIMENTAL -
Expansion cohort 1EXPERIMENTAL -
Expansion cohort 2EXPERIMENTAL -
Expansion cohort 3EXPERIMENTAL -
Expansion cohort 4EXPERIMENTAL -
Expansion Cohort 5EXPERIMENTAL -
Expansion Cohort 6EXPERIMENTAL -
Interventions
NameTypeDescription
MGC026 Dose EscalationBIOLOGICALEscalating doses of MGC026
MGC026 Dose for ExpansionBIOLOGICALMGC026 recommended dose for expansion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Adults ≥ 18 years old, able to provide informed consent * Adequate performance and laboratory parameters * Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an arc...

Countries:United StatesAustraliaUnited Kingdom
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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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06242470primaryCompletionDate: changed
LOWMay 24, 2026NCT06242470studyFirstPostDate: changed