Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma
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- STATUS
- Recruiting
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- End date
- Dec 31, 2025
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- participants needed
- 30
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- sponsor
- Darell Bigner
Summary
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.
Description
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.
Details
| Condition | Gliomas, Glioma |
|---|---|
| Treatment | D2C7-IT, 2141-V11 |
| Clinical Study Identifier | NCT04547777 |
| Sponsor | Darell Bigner |
| Last Modified on | 4 October 2022 |
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