Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04826393 | ASP8374 + Cemiplimab in Recurrent Glioma | PHASE1 | COMPLETED | 14 | — | — | Mar 9, 2022 | Jan 1, 2024 | Oct 22, 2025 | 4 | United States |
primary endpoint for Cohort 1 will be determination of the MTD/RP2D of ASP8374 when administered with cemiplimab among recurrent malignant glioma participants.
CD8+ TIL density from tumors obtained from participants randomized to the neoadjuvant study arm (2A) will be compared to tumor CD8+ TIL density obtained from control participants enrolled on Arm 2B who do not receive neoadjuvant therapy.
| Arm | Type | Description |
|---|---|---|
| ASP8374 and Cemiplimab-Cohort 1 | EXPERIMENTAL | A 3+3 dose escalation design will be used to determine maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ASP8374 when combined with cemiplimab. Participants will receive ASP8374 and Cemiplimab every 3 weeks for up to 2 years. ASP8374 will be available until October 31, 2022. Subjects may continue treatment with cemiplimab alone after that date. |
| ASP8374 and Cemiplimab-Cohort 2 | EXPERIMENTAL | 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. Post-operatively, all Cohort 2 participants will receive ASP8374 plus cemiplimab every 3 weeks administered at the MTD/RP2D established by Cohort 1 |
| Name | Type | Description |
|---|---|---|
| ASP8374 | DRUG | every 3 weeks by intravenous infusion |
| cemiplimab | DRUG | intravenous infusion |
Inclusion Criteria: * Have histologically confirmed WHO grade IV GBM or its variants. Participants will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of GBM is made. Participants with WHO grade III recurrent malignant glioma will be allowed to en...