drugset / Trial / NCT07320963
Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma.
Phase 1/2
Not yet recruiting
52 enrolled
Sun Yat-sen University
Fujian Cancer Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collab
NaSingle-groupOpen-labelTreatment
Summary
To explore and evaluate the dose-limiting toxicity (DLT) profile of the fixed-dose combination of toripalimab, anlotinib, and chidamide in patients with recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), and to determine the maximum tolerated dose (MTD) of chidamide, thereby informing subsequent clinical dosing regimens. To assess the objective response rate (ORR) of the combination regimen in this patient population.
Timeline
- Start
- 2026-03-31
- Primary completion
- 2027-03-28
- Completion
- 2028-03-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Catequentinib | Small molecule | — | Oral |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Tucidinostat | Small molecule | 15 mg | Oral |
| Subject | Tucidinostat | Small molecule | 20 mg | Oral |
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |