drugset / Trial / NCT03577704
The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors.
Non-randomizedSequentialOpen-labelTreatment
Summary
HLX07 is a new anti-EGFR monoclonal antibody (mAb) with improved glycosylation pattern.In pre-clinical efficacy studies, HLX-07 is either equivalent or more potent than cetuximab in multiple cancer models without increased toxicities.This study is an open-labeled, dose-escalation study designed to explore the maximum tolerated dose (MTD) and safety of HLX07 in combination with different chemotherapy regimens.
Timeline
- Start
- 2018-08-08
- Primary completion
- 2022-09-30
- Completion
- 2022-12-30
Publications
- Background M.M. Hou, C.L. Ho, H.Y. Lin, W. Jiang, S. Liu, Y. Hong, A. Luk, S.F. Lin, T.C. Hsieh, E. Liu. A novel anti-EGFR antibody HLX07 for potential treatment of squamous cell carcinoma of the head and neck. Annals of Oncology. Volume 30 | Supplement 9 | November 2019.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5-fluouracil | Unknown | 2400 mg/m2 | — |
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | PIMURUTAMAB | Monoclonal antibody | 400 mg | Intravenous |
| Subject | PIMURUTAMAB | Monoclonal antibody | 600 mg | Intravenous |
| Subject | PIMURUTAMAB | Monoclonal antibody | 800 mg | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | — |