drugset / Trial / NCT04656535

AB154 Combined With AB122 for Recurrent Glioblastoma

NCT04656535

RandomizedSequentialTriple-blindTreatment

Summary

This is a phase 0/I exploratory study. Patients at first or second recurrence of glioblastoma will be enrolled. The study will be divided into two cohorts: Cohort A (safety cohort) and Cohort B (surgical patient cohort). Cohort A: Eligible patients will be sequentially enrolled to receive intravenous domvanalimab combined with zimberelimab (N=6). Domvanalimab will be given at a dose of 10 mg/kg and zimberelimab will be given at a dose of 240 mg (flat). The dosing was determined in a separate study in solid tumors; this cohort will confirm the safety of the dosing schedule in patients with brain tumors. Cohort B: Expansion surgical cohort. The purpose of cohort B is to provide an additional safety evaluation of domvanalimab + zimberelimab as well as tissue and blood for exploratory ancillary studies investigating the effects of domvanalimab + zimberelimab in the tumor and tumor microenvironment. A total of 46 patients will be enrolled in this cohort.

Timeline

Start
2021-04-21
Primary completion
2026-03-17
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Domvanalimab Monoclonal antibody 10 mg/kg Intravenous
Subject Zimberelimab Monoclonal antibody 240 mg Intravenous

Indications