drugset / Trial / NCT04297995
Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors
RandomizedSequentialDouble-blindTreatment
Summary
Part1: A mutilpe-center, open-label, Phase II clinical trial to evaluate the efficacy and the safety of HLX10 in combination with HLX07 in patients with advanced advanced head and neck tumors. Part2: A randomized, double-blind, multi-center, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 in combination with HLX07 and chemotherapy versus HLX10 in combination with placebo and chemotherapy in the first-line treatment of R/M HNSCC.
Timeline
- Start
- 2020-07-29
- Primary completion
- 2024-05-30
- Completion
- 2025-06-30
Publications
- Results Y. Guo, W. Wang, G. Cao, et al. A phase 2 study of serplulimab plus HLX07 in patients with advanced head and neck tumours. Abstract Book. ICHNO-ECHNO 2022: 590
- Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PIMURUTAMAB | Monoclonal antibody | 600 mg | — |
| Subject | PIMURUTAMAB | Monoclonal antibody | 800 mg | — |
| Subject | PIMURUTAMAB | Monoclonal antibody | 1000 mg | — |
| Subject | Serplulimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 300 mg | Intravenous |
| Background | Carboplatin | Small molecule | 100 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Background | fluorouracil | Small molecule | 1000 mg/m2 | — |