NCT04826393

ASP8374 + Cemiplimab in Recurrent Glioma

Phase Ib Trial of ASP8374 and Cemiplimab in Recurrent Malignant Glioma Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is looking at the safety and efficacy of the drug combination of ASP8374 with cemiplimab in people with recurrent malignant glioma. The study will be conducted in two parts, the first portion of the study will be to establish the highest dose of ASP8374 that can be given safely with cemiplimab and will be used as the recommended dose of ASP8374 in combination with cemiplimab for the second portion of the study. The second portion of the study will be to compare the effect of having ASP8374 in combination with cemiplimab prior to surgery. The names of the study drugs involved in this study are: * ASP8374 * Cemiplimab

Detailed 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 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 two treatment groups (2A-2B). Group 2A: IV ASP8374 plus cemiplimab within 14± 5 days prior to surgery at the MTD/RP2D established in Cohort 1. Group 2B: 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 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 24 people will take part in this research study. At least 6 in cohort 1 and 18 in cohort 2. Pharmaceutical company Astellas is supporting this research study by providing study funding and study drug, ASP8374 and Regeneron is supporting this research by providing study drug cemiplimab.

Conditions

• Glioblastoma
• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	ASP8374	every 3 weeks by intravenous infusion
DRUG	cemiplimab	intravenous infusion

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-10-31
• Completion: 2024-01-01
• First posted: 2021-04-01
• Last updated: 2025-10-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study