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MGC028

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Apr 27, 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 Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06723236A Study of MGC028 in Participants With Advanced Solid TumorsPHASE1 RECRUITING 124 — — Feb 13, 2025Apr 1, 2027Apr 27, 20267 United States
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Study Endpoints
Primary Endpoints
Number and Types of Adverse Events (AEs) in Participants Receiving MGC028
Throughout the study treatment and safety follow up period, up to 25 months

Types of AEs include Serious Adverse Events (SAEs), and AEs Leading to Treatment Delay or Discontinuation or Dose Reduction, dose limiting toxicities, and AEs of Special Interest. Observation of side effects determines the highest safe dose for further study

Secondary Endpoints
Mean maximum concentration of MGC028 antibody
Through Cycle 6 of the study, approximately 18 weeks
Mean Area Under the Concentration Time Curve of MGC028 antibody
Through Cycle 6 of the study, approximately 18 weeks
Number of Participants Who Develop Anti-Drug Antibodies to MGC028
Throughout the study treatment period, up to 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALDose level 1 of MGC028, IV
Cohort 2EXPERIMENTALDose level 2 of MGC028, IV
Cohort 3EXPERIMENTALDose level 3 of MGC028, IV
Cohort 4EXPERIMENTALDose level 4 of MGC028, IV
Cohort 5EXPERIMENTALDose level 5 of MGC028, IV
Cohort 6EXPERIMENTALDose level 6 of MGC028, IV
Expansion Cohort 1EXPERIMENTALMTD or MAD of MGC028, IV
Expansion Cohort 2EXPERIMENTALMTD or MAD of MGC028, IV
Expansion Cohort 3EXPERIMENTALMTD or MAD of MGC028, IV
Interventions
NameTypeDescription
MGC028BIOLOGICALMGC028 is an antibody-drug conjugate targeted against ADAM9.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), or pancreatic carcinoma...

Countries:United States
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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, 2026NCT06723236primaryCompletionDate: changed
LOWMay 24, 2026NCT06723236studyFirstPostDate: changed