drugset / Trial / NCT07354984
A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Phase 2
Not yet recruiting
30 enrolled
Sun Yat-sen University
Biotech Pharmaceutical Co., Ltd. · collabLepu Biopharma Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-arm Phase II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1 inhibitor and platinum-based therapies, for second-line and later-line treatment.
Timeline
- Start
- 2026-01-01
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Nimotuzumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Pucotenlimab | Monoclonal antibody | 200 mg | Intravenous |