ASP8374 + Cemiplimab in Recurrent Glioma

Summary

Participation Requirements

Description

This is a multicenter, randomized, open-label, phase Ib trial of ASP8374 plus cemiplimab among recurrent malignant glioma participants. Initially, eligible participants will enroll to Cohort 1 which will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ASP8374 when co...

This is a multicenter, randomized, open-label, phase Ib trial of ASP8374 plus cemiplimab among recurrent malignant glioma participants. Initially, eligible participants will enroll to Cohort 1 which will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ASP8374 when combined with cemiplimab among recurrent malignant glioma participants using a 3+3 design. Upon determination of the MTD/RP2D of ASP8374 plus cemiplimab in Cohort 1, a dose expansion will be performed in which eligible participants who are candidates for surgical resection will enroll to Cohort 2 and will be randomized into one of four treatment groups (2A-2D). Group 2A: IV ASP8374 within 14± 5 days prior to surgery. Group 2B: IV Cemiplimab within 14± 5 days prior to surgery. Group 2C: IV ASP8374 plus cemiplimab within 14± 5 days prior to surgery at the MTD/RP2D established in Cohort 1. Group 2D: No immune checkpoint therapy prior to surgery. The U.S. Food and Drug Administration (FDA) has not approved ASP8374 as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved cemiplimab for recurrent malignant glioma but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has not approved 89Zr-Df- IAB22M2C as a treatment for any disease. The research study procedures include: screening for eligibility, then study treatment including evaluations and follow up visits. Participants will receive study treatment for up to two years and will be followed for their tumor's response, whether or not their disease gets worse, and for side effects. It is expected that about 65 people will take part in this research study. At least 6 in cohort 1 and 55 in cohort 2. Pharmaceutical company Astellas is supporting this research study by providing study funding and study drug, ASP8374, Regeneron is supporting this research by providing study drug cemiplimab, and ImaginAb is supporting this research by providing study drug 89Zr-Df-IAB22M2C.

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