Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ASP8374 · 1 trial · 2 indications
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...
ASP8374 is an investigational small molecule being studied for the treatment of glioblastoma, specifically recurrent glioblastoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.
ASP8374 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN.
ASP8374 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it is not yet approved for any use.
ASP8374 has been studied in a completed Phase 1 trial with the identifier NCT04826393. The trial evaluated ASP8374 in combination with cemiplimab in patients with recurrent glioblastoma and enrolled 14 participants in the United States.
No, ASP8374 is not the same as cemiplimab. In the clinical trial NCT04826393, ASP8374 was studied in combination with cemiplimab, indicating they are distinct investigational agents.