Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608812
Status:
TERMINATED
Last Update Posted:
2023-08-18
First Post:
2020-10-21
Brief Title:
Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection
Sponsor:
OncoSynergy Inc
Organization:
OncoSynergy Inc
Study Overview
Official Title:
A Pilot Study of Intratumorally and Intraparenchymally Administered OS2966 Using Convection-enhanced Delivery in Patients With RecurrentProgressive High-grade Glioma Undergoing a Clinically-indicated Surgical Resection
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment and financial constraints
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this Phase 1 study is to determine if a new investigational drug OS2966 when delivered directly to the brain of adult participants with recurrentprogressive high-grade glioma HGG is safe and well tolerated
OS2966 is a therapeutic antibody blocking a cell surface receptor governing fundamental biological processes that allow cancer cells to grow spread and become resistant to cancer treatment Despite availability of new promising cancer treatments successful treatment of HGG has been limited by the presence of the brains protective blood brain barrier BBB The BBB is made up of tightly knit cells that block entry of several substances including cancer treatments To overcome this obstacle a technique called convection-enhanced-delivery CED will be utilized to deliver OS2966 directly to the site of disease Convection-enhanced delivery involves placement of one or more catheters into the brain tumor and tumor-infiltrated brain in order to slowly pump a therapy into the tissue
To be eligible for this study participants must require surgical resection of their recurrent HGG
OS2966 is a therapeutic antibody blocking a cell surface receptor governing fundamental biological processes that allow cancer cells to grow spread and become resistant to cancer treatment Despite availability of new promising cancer treatments successful treatment of HGG has been limited by the presence of the brains protective blood brain barrier BBB The BBB is made up of tightly knit cells that block entry of several substances including cancer treatments To overcome this obstacle a technique called convection-enhanced-delivery CED will be utilized to deliver OS2966 directly to the site of disease Convection-enhanced delivery involves placement of one or more catheters into the brain tumor and tumor-infiltrated brain in order to slowly pump a therapy into the tissue
To be eligible for this study participants must require surgical resection of their recurrent HGG
Detailed Description:
This study is an open-label ascending-dose 2-part study designed to determine the safety and tolerability of OS2966 as well as the optimal infusion parameters when administering OS2966 directly to the tumor and the surrounding tumor-infiltrated brain by CED in participants with recurrentprogressive HGG undergoing a surgical resection
OS2966 is an anti-CD29 Beta1 Integrin monoclonal antibody mAb that has demonstrated preclinical efficacy in resistantrecurrent glioblastoma animal models This study will recruit participants with recurrentprogressive high-grade glioma HGG WHO Grade III or IV glioma The development of effective treatments for HGG has been limited by an infiltrative growth pattern the blood brain barrier BBB and the rapid development of therapeutic resistance
Convection-enhanced delivery is a specific technique that allows direct delivery of therapeutics to the brain and to brain tumors Convection-enhanced delivery bypasses the BBB and allows for infusion of therapeutics that would otherwise be excluded from the central nervous system Importantly CEDs targeted delivery obviates systemic toxicity
Participants enrolled in this study will undergo 2 staged parts of treatment In Study Part 1 participants will receive a single intratumoral infusion of OS2966 directly to the contrast-enhancing bulk tumor by CED over 4 hours or until maximal tumor coverage is obtained In Study Part 2 participants will undergo surgical resection of the previously infused tumor Immediately following surgical resection catheters will be placed directly into the surrounding tumor-infiltrated brain and OS2966 will be infused over a 4 hour period and then the catheters removed To confirm the quality of OS2966 delivery a gadolinium contrast agent will be added to OS2966 before each infusion in order to monitor the infusion via magnetic resonance imaging
All participants will be closely monitored clinically and through the use of imaging assessments to determine how effective OS2966 is at preventing further disease progression Tumor tissue will be collected in both study parts to evaluate how well OS2966 binds to its intended target and to confirm mechanism of action All enrolled patients will also receive standard supportive care therapy
OS2966 is an anti-CD29 Beta1 Integrin monoclonal antibody mAb that has demonstrated preclinical efficacy in resistantrecurrent glioblastoma animal models This study will recruit participants with recurrentprogressive high-grade glioma HGG WHO Grade III or IV glioma The development of effective treatments for HGG has been limited by an infiltrative growth pattern the blood brain barrier BBB and the rapid development of therapeutic resistance
Convection-enhanced delivery is a specific technique that allows direct delivery of therapeutics to the brain and to brain tumors Convection-enhanced delivery bypasses the BBB and allows for infusion of therapeutics that would otherwise be excluded from the central nervous system Importantly CEDs targeted delivery obviates systemic toxicity
Participants enrolled in this study will undergo 2 staged parts of treatment In Study Part 1 participants will receive a single intratumoral infusion of OS2966 directly to the contrast-enhancing bulk tumor by CED over 4 hours or until maximal tumor coverage is obtained In Study Part 2 participants will undergo surgical resection of the previously infused tumor Immediately following surgical resection catheters will be placed directly into the surrounding tumor-infiltrated brain and OS2966 will be infused over a 4 hour period and then the catheters removed To confirm the quality of OS2966 delivery a gadolinium contrast agent will be added to OS2966 before each infusion in order to monitor the infusion via magnetic resonance imaging
All participants will be closely monitored clinically and through the use of imaging assessments to determine how effective OS2966 is at preventing further disease progression Tumor tissue will be collected in both study parts to evaluate how well OS2966 binds to its intended target and to confirm mechanism of action All enrolled patients will also receive standard supportive care therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None