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MGC030

Phase 1

Urothelial Cancer | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Sep 16, 2026

Target and mechanism

Molecular targetTOP1i
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment314

FDA Designations

No designations recorded

Clinical trial landscape

MGC030 · 1 trial · 6 indications

Phase 1 1
NCT07822399A Study of MGC030 in Participants With Advanced Solid TumorsUrothelial Cancer
NOT YET_RECRUITING314 Analytics
PHASE1NOT YET_RECRUITING
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer
NCT07822399314
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Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to dose interruption, AEs leading to dose reduction or treatment discontinuation, does limiting toxicities and AEs of special interest.
Throughout the study, estimated duration 2 years.

Secondary Endpoints

Mean concentrations MGC030 antibody-drug conjugate, total antibody and unconjugated payload.
Throughout the study treatment period, up to 2 years
Number of Participants Who Develop Anti-Drug Antibodies to MGC030
Throughout the study treatment period, up to 2 years
Objective response rate
Throughout the study treatment period, up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose escalation Cohort 1EXPERIMENTALMGC030 Dose Level 1
Dose escalation Cohort 2EXPERIMENTALMGC030 Dose Level 2
Dose escalation Cohort 3EXPERIMENTALMGC030 Dose Level 3
Dose escalation Cohort 4EXPERIMENTALMGC030 Dose Level 4
Dose escalation Cohort 5EXPERIMENTALMGC030 Dose Level 5
Dose escalation Cohort 6EXPERIMENTALMGC030 Dose Level 6
Dose Optimization Cohort 1EXPERIMENTALDose Optimization Dose Level 1
Dose Optimization Cohort 2EXPERIMENTALDose Optimization Dose Level 2
Expansion Cohort 1EXPERIMENTALRecommended dose for expansion
Expansion Cohort 2EXPERIMENTALRecommended dose for expansion
Expansion Cohort 3EXPERIMENTALRecommended dose for expansion
Expansion Cohort 4EXPERIMENTALRecommended dose for expansion
Expansion Cohort 5EXPERIMENTALRecommended dose for expansion

Interventions

NameTypeDescription
MGC030BIOLOGICALAntibody-drug conjugate
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participants in dose escalation cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: urothelial cancer, colorectal cancer (CRC), gastric or gastroesophageal junction (GEJ) cancer, esophageal can...

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Recent Changes (Last 90 Days)

LOWSep 16, 2026NCT07822399NEW_TRIAL: changed
LOWSep 16, 2026NCT07822399NEW_TRIAL: changed