RecruitingPhase 1NCT06242470

A Study of MGC026 in Participants With Advanced Solid Tumors

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors


Sponsor

MacroGenics

Enrollment

250 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called MGC026, an antibody-drug conjugate — essentially a targeted missile that delivers chemotherapy directly to cancer cells — in people with advanced solid tumors that have spread or cannot be surgically removed. It is an early-phase trial to find the right dose and understand how safe the drug is. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic solid tumor, including cancers of the head and neck, lung, bladder, breast, colon, stomach, liver, ovary, cervix, prostate, skin (melanoma), or other types listed in the trial - Your cancer is measurable on imaging scans - You have not previously been treated with any drug targeting B7-H3 or any antibody-drug conjugate with a topoisomerase payload - You are not pregnant or breastfeeding and agree to use effective birth control **You may NOT be eligible if...** - You have a separate active cancer requiring treatment in the last 2 years - You have untreated or progressing brain metastases - You have had a stem cell or organ transplant - You recently had surgery, systemic cancer treatment, or immunotherapy - You have significant heart or lung problems 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALMGC026 Dose Escalation

Escalating doses of MGC026

BIOLOGICALMGC026 Dose for Expansion

MGC026 recommended dose for expansion


Locations(12)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

START Midwest

Grand Rapids, Michigan, United States

START-New York Long Island

Lake Success, New York, United States

Providence Cancer Institute

Portland, Oregon, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

START Mountain Region

West Valley City, Utah, United States

ICON Cancer Centre Wesley

Auchenflower, Queensland, Australia

ICON Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia

Austin Health- Olivia Newton John Cancer Center

Heidelberg, Victoria, Australia

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06242470


Related Trials