AB154 Combined With AB122 for Recurrent Glioblastoma

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

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 AB154 combined with AB122 (N=6). AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat). Cohort B: Expansion surgical cohort. The purpose of cohort B is to provide an additional safety evaluation of AB154 + AB122 as well as tissue and blood for exploratory ancillary studies investigating the effects of AB154 + AB122 in the tumor and tumor microenvironment. A total of 40 patients will be enrolled in this cohort. Following completion of cohort A, patients who are candidates for surgical resection for management of tumor progression (i.e. need for diagnostic confirmation or tumor debulking) will be enrolled prior to surgical resection, and initiate study treatment approximately two weeks prior to the resection. Patients will be randomized to one of the four treatment arms and initiate treatment prior to surgery, according to treatment assignment. The pre-surgical dose (neoadjuvant treatment) will be double-blinded. A total of 10 patients will be allocated to each one of the following groups in a blinded fashion, approximately two weeks before surgery: - B1 (N=10): AB154 single agent (10 mg/kg) + placebo - B2 (N=10): AB122 single agent (240 mg) + placebo - B3 (N=10): AB154 (10 mg/kg) +AB122 (240 mg) - B4 (N=10): Two placebo infusions Following surgery, all patients (N=40) will initiate treatment with the combination of AB154 and AB122. ;

Study Design

Related Conditions & MeSH terms

Glioblastoma

Clinical Trial Details

NCT number	NCT04656535
Study type	Interventional
Source	Yale University
Contact	Tara McPartland
Phone	203-737-7173
Email	tara.mcpartland@yale.edu
Status	Recruiting
Phase	Early Phase 1
Start date	April 21, 2021
Completion date	December 31, 2025

View Details

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