drugset / Trial / NCT06241456
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.
Timeline
- Start
- 2024-01-05
- Primary completion
- 2029-05-01
- Completion
- 2044-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | — | Intravenous |
| Subject | FT825 | Cell therapy | — | Intravenous |
| Background | Bendamustine | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Docetaxel | Small molecule | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |