Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

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).

Candidates for surgical resection will be enrolled and initiate study treatment approximately two weeks prior to the resection. The pre-surgical dose (neoadjuvant treatment) will be double-blinded.

B1 (N=10): AB154 single agent (10 mg/kg) + placebo

Following surgery, all patients will initiate treatment with the combination of AB154 and AB122. AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).

Candidates for surgical resection will be enrolled and initiate study treatment approximately two weeks prior to the resection. The pre-surgical dose (neoadjuvant treatment) will be double-blinded.

B2 (N=10): AB122 single agent (240 mg) + placebo

Following surgery, all patients will initiate treatment with the combination of AB154 and AB122. AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).

Candidates for surgical resection will be enrolled and initiate study treatment approximately two weeks prior to the resection. The pre-surgical dose (neoadjuvant treatment) will be double-blinded.

B3 (N=10): AB154 (10 mg/kg) +AB122 (240 mg)

Following surgery, all patients will initiate treatment with the combination of AB154 and AB122. AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).

Candidates for surgical resection will be enrolled and initiate study treatment approximately two weeks prior to the resection. The pre-surgical dose (neoadjuvant treatment) will be double-blinded.

B4 (N=10): Two placebo infusions

Following surgery, all patients will initiate treatment with the combination of AB154 and AB122. AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).

AB122 is a fully human immunoglobulin G4 (hIgG4) monoclonal antibody (mAb) that targets PD-1 immune checkpoint.

AB122

AB154 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets TIGIT immune checkpoint.

AB154

Saline placebo comparator for pre-surgery treatment in cohort B4

Placebo

Tara McPartland

Stephanie Lewis

Nicholas Butowski, MD

Adam Blanchard

Nicholas Blondin, MD

Alyssa Russ

Amanda Spearman

Patrick Wen, MD

Joachim Baehring, MD

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.

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.

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 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.

AB154 Combined With AB122 for Recurrent Glioblastoma

A Multi-Center Phase 0/I Trial of Anti-TIGIT Antibody AB154 in Combination With Anti-PD-1 Antibody AB122 for Recurrent Glioblastoma.

Adverse events will be listed individually by patient and treatment group. The number of patients experiencing each adverse event will be summarized by organ and grade. The number and percentage of patients with adverse events in the different categories will be summarized by treatment group.

Pharmacodynamic effects of each pre-surgery treatment will be evaluated with single-cell RNA sequencing of tumor and blood to determine effects of each intervention on the immune response.

Resected tumors in cohorts B1 to 4 will be analyzed utilizing immunofluorescence for the ratio between Tregs and CD8 T cells, calculated by counting cells that are positive for a FoxP3 or a CD8 staining.

Spots Global Cancer Trial Database for ab154

Every month we try and update this database with for ab154 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ab154

Every month we try and update this database with for ab154 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ab154 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.