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

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.

NCT Number	NCT07268053
Lead Sponsor	Nader Sanai Collaborators: GlaxoSmithKline
Conditions	Glioblastoma (GBM), Brain Metastasases
Enrollment	15 participants
Start Date	2026-02-11
Primary Completion	2027-07 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2026-03-06