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Single D2C7-IT intratumoral infusion (4613.2 ng/mL in 36 mL) over 72 hours followed by single 2141-V11 infusion (5 dose levels) over 7 hours

D2C7-IT

2141-V11

Annick Desjardins, MD. FRCPC

Stevie Threatt

Daniel Landi, MD

Annick Desjardins, MD,FRCPC

This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.

Within this study, a maximum of 30 patients with recurrent WHO grade III and IV malignant glioma will receive D2C7-IT and 2141-V11 to determine the impact of the combination of D2C7-IT and 2141-V11 on safety. D2C7-IT and 2141-V11 will be delivered sequentially directly into the tumor by Convection Enhanced Delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. Based on phase 1 studies of D2C7-IT alone and D2C7-IT in combination with atezolizumab in adult patients with recurrent glioblastoma (GBM), the amount of D2C7-IT to be delivered will be 4613.2 ng/mL (36 mL). 2141-V11 will be dose escalated during the study to determine the maximum tolerated dose (MTD) when used in combination with D2C7-IT.

Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma

A Phase 1 Trial of D2C7-IT in Combination With an Fc-engineered Anti-CD40 Monoclonal Antibody (2141-V11) Administered Intratumorally Via Convection-Enhanced Delivery for Adult Patients With Recurrent Malignant Glioma

DLTs are defined as any of the following events that are at least possibly, probably, or definitely attributable to study treatment (2141-V11 or the combination of D2C7-IT and 2141-V11) during dose escalation. As the optimal dose of D2C7-IT in monotherapy has been well established, only toxicity starting or increasing in grade at any time after the start of 2141-V11 will be considered for DLT definition.

Rockefeller University

Darell Bigner

E. L. and Lucille F. Jones Cancer Distinguished Research Professor, in the School of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma	NCT04547777	Glioma, Maligna...	D2C7-IT 2141-V11	18 Years -	Duke University
Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma	NCT04547777	Glioma, Maligna...	D2C7-IT 2141-V11	18 Years -	Duke University

Spots Global Cancer Trial Database for pro00104852

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Spots Global Cancer Trial Database for pro00104852

Every month we try and update this database with for pro00104852 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 pro00104852 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.