drugset / Trial / NCT06719479
A Clinical Trial to Evaluate Effect of IAE0972 Combined with Chemotherapy for R/M HNSCC or NPC(Note: It is Currently Phase II.).
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Phase II: To evaluate the safety and tolerability of IAE0972 combined with chemotherapy selected by doctors for R/M HNSCC/NPC after failure or progress of ≤2-line system therapy, and to determine the MTD of combined therapy. Phase III: According to the RECIST 1.1, the effectiveness of IAE0972 combined with chemotherapy regimen chosen by doctors compared with placebo plus chemotherapy regimen chosen by doctors was evaluated through OS in patients with R/M NPC who failed or progressed after treatment with ≤2-line system.
Timeline
- Start
- 2025-01-01
- Primary completion
- 2028-01-01
- Completion
- 2028-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IAE0972 | Unknown | 7.5 mg/kg | Intravenous |
| Subject | IAE0972 | Unknown | 10 mg/kg | Intravenous |
| Subject | IAE0972 | Unknown | 15 mg/kg | Intravenous |
| Subject | IAE0972 | Unknown | 20 mg/kg | Intravenous |
| Background | Capecitabine | Small molecule | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |