AB154 Combined With AB122 for Recurrent Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glioblastoma
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: After the initial safety cohort confirms the safety of the dosing schedule an expansion surgical cohort will be enrolled and this cohort will be randomized to one of four treatment arms for the first cycle prior to surgery,Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Masking will only occur in the surgical cohort B (4 arms) during the first cycle prior to surgery. The masking will be removed after surgery and all patients will receive open label treatment with both AB122 and AB154.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 intravenou...
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.
Tracking Information
- NCT #
- NCT04656535
- Collaborators
- Arcus Biosciences, Inc.
- Investigators
- Principal Investigator: Antonio Omuro, MD Professor of Neurology
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