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NCT07822399

A Study of MGC030 in Participants With Advanced Solid Tumors

StatusRecruiting

PhasePhase 1

SponsorMacroGenics

Primary completionSep 2028 (estimated)

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Record History

All 2 versions: 2 with changes below.

Notable Oct 27, 2026 Recruitment opened
- Start date changed from estimate of Sep 2026 to Oct 7, 2026
- Study sites: 0 to 1
Sep 10, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

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.

Timeframe: Throughout the study, estimated duration 2 years.

Secondary (4)

Mean concentrations MGC030 antibody-drug conjugate, total antibody and unconjugated payload.

Number of Participants Who Develop Anti-Drug Antibodies to MGC030

Objective response rate

Duration of Response

Arms and interventions

Dose escalation Cohort 1Experimental

MGC030 Dose Level 1

Dose escalation Cohort 2Experimental

MGC030 Dose Level 2

Dose escalation Cohort 3Experimental

MGC030 Dose Level 3

Dose escalation Cohort 4Experimental

MGC030 Dose Level 4

Dose escalation Cohort 5Experimental

MGC030 Dose Level 5

Dose escalation Cohort 6Experimental

MGC030 Dose Level 6

Dose Optimization Cohort 1Experimental

Dose Optimization Dose Level 1

Dose Optimization Cohort 2Experimental

Dose Optimization Dose Level 2

Expansion Cohort 1Experimental

Recommended dose for expansion

Expansion Cohort 2Experimental

Recommended dose for expansion

Expansion Cohort 3Experimental

Recommended dose for expansion

Expansion Cohort 4Experimental

Recommended dose for expansion

Expansion Cohort 5Experimental

Recommended dose for expansion

Biologicals: MGC030

Sites

1 site in 1 country

START New York-Long IslandLake Success, New York, United States

About this trial

The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types. The main question the study aims to answer is: * What types of side effects will participants experience when receiving MGC030? * Can MGC030 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will * Undergo screening procedures to determine eligibility * Receive study treatments initially every 3 weeks. * Have blood samples taken for routine and research tests * Have other examinations to check heart and lung function, and general health status * Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary. * Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.

Trial details

Enrollment: 314 participants (estimated)
Started: Oct 7, 2026
Study completion: Mar 2029 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, non-randomized, open label, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Colorectal Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Urothelial Cancer, GastroEsophageal Cancer, Colorectal Cancer, Esophageal Cancer +2 more
Official title: A Phase 1, First-in-Human, Open Label, Dose Escalation, Dose Optimization, and Cohort Expansion Study of MGC030 in Participants With Advanced Solid Tumors
First posted: Sep 16, 2026
Registry updated: Oct 30, 2026
Last verified: Oct 2026

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