RecruitingEarly Phase 1NCT07268053

A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases


Sponsor

Nader Sanai

Enrollment

15 participants

Start Date

Feb 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This will be an open-label Phase 0/1 study that will enroll approximately 15 participants, 9 participants with recurrent WHO Grade 4 glioma (rGBM) and 6 participants with brain metastases, who will receive the investigational drug risvutatug rezetecan (GSK5764227), a B7-H3-targeted antibody-drug conjugate (ADC) with the GSK5757810 payload. The trial will consist of a Phase 0 component (subdivided into Arms A and B) and an Expansion Phase 1 component. Participants with tumors demonstrating a positive pharmacokinetic (PK) response in the Phase 0 component will be eligible to enroll in the Expansion Phase to receive therapeutic dosing of risvutatug rezetecan.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new antibody-drug conjugate (ADC) called GSK5764227 that targets a protein called B7-H3, which is found on many brain tumor cells. It is being tested in people with recurrent grade 4 glioma (an aggressive brain tumor) or brain metastases (cancer that has spread to the brain from elsewhere in the body). **You may be eligible if...** - You are 18 or older - You have been diagnosed with glioblastoma (grade 4 brain tumor) that has returned after standard treatment including surgery and chemoradiation, OR you have brain metastases requiring surgical removal - You have tumor tissue available for analysis - Your cancer is measurable on brain imaging - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to the lining around the brain and spinal cord (leptomeningeal disease) or is compressing the spinal cord - You cannot have an MRI scan with contrast - You have active serious infections, HIV, or active hepatitis B or C - You have had a recent heart attack, stroke, or severe heart failure - You have a history of serious lung disease or inflammation of the lungs - You have active autoimmune disease requiring systemic treatment in the past 2 years - You are pregnant or breastfeeding 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

DRUGRisvutatug rezetecan

Risvutatug rezetecan will be administered intravenously.


Locations(1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

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NCT07268053


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