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

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05664243` - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma	Phase 1/Phase 2
Completed	`NCT02768389` - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma	Early Phase 1
Recruiting	`NCT05635734` - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma	Phase 1/Phase 2
Completed	`NCT03679754` - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102	Phase 1
Completed	`NCT01250470` - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma	Phase 1
Terminated	`NCT03927222` - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma	Phase 2
Recruiting	`NCT03897491` - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma	Phase 2
Active, not recruiting	`NCT03587038` - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma	Phase 1
Completed	`NCT01922076` - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas	Phase 1
Recruiting	`NCT04391062` - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma	Phase 2
Active, not recruiting	`NCT03661723` - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma	Phase 2
Active, not recruiting	`NCT02655601` - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001	Phase 2
Completed	`NCT02206230` - Trial of Hypofractionated Radiation Therapy for Glioblastoma	Phase 2
Completed	`NCT03493932` - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade	Phase 1
Terminated	`NCT02709889` - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06058988` - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer	Phase 2
Completed	`NCT03018288` - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)	Phase 2
Not yet recruiting	`NCT04552977` - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma	Phase 2
Withdrawn	`NCT03980249` - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells	Early Phase 1
Terminated	`NCT02905643` - Discerning Pseudoprogression vs True Tumor Growth in GBMs