NCT04406272

VB-111 in Surgically Accessible Recurrent/Progressive GBM

A Randomized, Controlled Phase II Surgical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters for the Viral Cancer Therapy Ofranergene Obadenovec (VB-111) in Patients With Surgically Accessible Recurrent/Progressive Glioblastoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a new viral cancer therapy, ofranergene obadenovec (VB-111), for recurrent or progressive glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment.

Detailed description

This is a randomized, controlled, blinded, phase II, surgical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether it works in treating a specific disease. "Investigational" means that the drug is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved this intervention for recurrent or progressive glioblastoma. In this research study, ofranergene obadenovec (VB-111) is the investigational drug being studied. VB-111 has been studied in lab experiments and in other types of cancer, and information from these studies suggest that it may be beneficial for recurrent or progressive glioblastoma. VB-111 works by targeting and damaging the blood vessels that grow and nourish cancerous tumors leading to tumor starvation. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. After enrollment, participants will be randomized into one of three study groups. Randomization means that participants are put into a group by chance. Neither the participant nor the research doctor will choose what group a participant will be in. * In group A participants receive VB-111 before and after surgery. * In group B participants receive VB-111 after surgery. * In group C participants won't receive VB-111 but would receive standard of care. Treatment will be provided blindly, meaning participants do not know (are blinded as to) what treatment they are receiving to ensure that the results are not affected by a placebo effect (the power of suggestion). Participants will be given a study medication and it will contain either VB-111 or placebo (IV solution with no medicine). VBL Therapeutics is supporting this research study by providing funding for the research study and the study drug. Participants will be in this research study for as long as they do not have serious side effects and their disease does not get worse. It is expected that about 45 people will take part in this research study.

Conditions

• Glioblastoma
• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	VB11	Intravenously administered type of gene therapy that works by blocking the process of blood-vessel creation. Disrupting a cancer from growing blood vessels, might slow the growth of the cancer or shrink it.
PROCEDURE	Surgery	Treatment of disease or injury by cutting, abrading, suturing, or otherwise physically changing body tissues and organs.
OTHER	Placebo	Intravenous solution that has no therapeutic effect, used as a control in testing investigational drug.
DRUG	Bevacizumab	A type of antibody, Bevacizumab is intravenously administered and works by binding to and disrupting the vascular endothelial growth factor (VEGF). VEGF is a signal protein produced by cells that stimulates the formation of blood vessels. By disrupting VEGF, Bevacizumab helps to prevent the growth and maintenance of tumor blood vessels.

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2020-05-28
• Last updated: 2025-06-10
• Results posted: 2025-06-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study