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MGC030

Phase 1

Urothelial Cancer | Antibody-Drug Conjugates (ADCs) | Oncology |MacroGenics, Inc.|Trials Updated: Oct 30, 2026

MGC030 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2026

MGC030 target and mechanism

Molecular targetTOP1i
Target classProtein
ModalityAntibody-Drug Conjugates (ADCs)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment314

FDA Designations

No designations recorded

MGC030 clinical trials

MGC030 · 1 trial · 6 indications

Phase 1 1
NCT07822399A Study of MGC030 in Participants With Advanced Solid TumorsUrothelial Cancer
RECRUITING314 Analytics
PHASE1RECRUITING
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
Study Sites1

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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWOct 30, 2026NCT07822399Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 30, 2026NCT07822399Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 16, 2026NCT07822399NEW_TRIAL: changed
LOWSep 16, 2026NCT07822399NEW_TRIAL: changed

Frequently asked questions about MGC030

What is MGC030 used for?

MGC030 is an investigational monoclonal antibody being studied for urothelial cancer and other advanced solid tumors, including gastroesophageal, colorectal, esophageal, gastric, and pancreatic cancers. It is in Phase 1 clinical development and is not yet available as a marketed treatment.

What does MGC030 target?

MGC030 targets TOP1i, a protein target. It is a monoclonal antibody designed against this target and is being developed by MacroGenics as a biomarker-selected oncology candidate for advanced solid tumors, including urothelial cancer.

Who is developing MGC030?

MGC030 is being developed by MacroGenics, Inc., a biopharmaceutical company whose common stock trades under the ticker MGNX. MacroGenics is the sponsor of the Phase 1 study evaluating MGC030 in participants with advanced solid tumors.

What phase is MGC030 in?

MGC030 is in Phase 1 clinical development. It is an investigational agent and has not completed the clinical testing required for regulatory approval. The single registered trial is currently recruiting participants and has an planned enrollment of 314.

What clinical trial is MGC030 in?

MGC030 is being evaluated in the Phase 1 trial NCT07822399, titled A Study of MGC030 in Participants With Advanced Solid Tumors. The trial is recruiting in the United States, enrolls adults 18 years and older of all sexes, and includes urothelial, gastroesophageal, colorectal, esophageal, gastric, and pancreatic cancers.

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