RecruitingPhase 1NCT06723236

A Study of MGC028 in Participants With Advanced Solid Tumors

A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors


Sponsor

MacroGenics

Enrollment

124 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9. The main question the study aims to answer is: * What types of side effects will participants experience when receiving MGC028? * Can MGC028 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer drug called MGC028 in patients with certain advanced solid tumors that have not responded to previous treatments. The drug targets a protein called ADAM9 found on cancer cells. **You may be eligible if...** - Have an advanced, inoperable, or metastatic (spread) solid tumor that is one of: non-small cell lung cancer (adenocarcinoma type), bile duct cancer (cholangiocarcinoma), colorectal cancer, or pancreatic cancer - Have tried at least one prior standard treatment - Have measurable cancer on scans - Have adequate organ function - Age 18 or older **You may NOT be eligible if...** - Have active brain metastases (cancer spread to the brain) - Have had recent major surgery or radiation - Have serious heart, liver, or lung conditions - Are receiving other cancer treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMGC028

MGC028 is an antibody-drug conjugate targeted against ADAM9.


Locations(7)

UCSF - Helen Diller Family Cancer Center

San Francisco, California, United States

Mass General Brigham

Boston, Massachusetts, United States

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, United States

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

South Texas Accelerated Research Therapeutics (START) San Antonio

San Antonio, Texas, United States

South Texas Accelerated Research Therapeutics (START) Mountain Region

West Valley City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06723236


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