Early Phase 01 Study of Intravenous Risvutatug Rezetecan, a B7-H3-Targeted Antibody-Drug Conjugate, in Adults with Recurrent Grade 4 Glioma or Brain Metastases

What this Trial Is About

Researchers are evaluating risvutatug rezetecan, a B7-H3-targeted antibody-drug conjugate ADC, in an open-label Phase 01 clinical trial involving about 15 participants. The study includes patients with recurrent WHO Grade 4 glioma rGBM and brain metastases. The trial aims to assess pharmacokinetics PK, pharmacodynamics PD, and safety of this investigational drug to better understand its effects in these brain tumor conditions. In Phase 0, participants with rGBM enter Arm A to establish the optimal time interval OTI for surgery after drug infusion, based on PK data. Arm A has two cohorts Cohort 1 determines OTI, and Cohort 2 receives the drug infusion at that OTI. Patients with brain metastases enroll in Arm B and receive the infusion at the same OTI. Only participants with positive PK response in Phase 0 proceed to Phase 1 expansion. In Phase 1, these participants receive risvutatug rezetecan intravenously every three weeks after surgery recovery, continuing until disease progression or other stopping criteria. Participants undergo multiple assessments including blood, serum, cerebrospinal fluid, and tumor tissue collection during surgery to evaluate drug concentration and biological response. Safety is monitored through routine visits, with follow-ups at 30, 60, and 90 days post-treatment, and survival monitored up to 12 months. MRI scans are performed every 2-3 months to track disease status. Overall participation lasts about 15 months post last infusion, encompassing screening, treatment, follow-up, and survival monitoring periods.

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