drugset / Trial / NCT04053205
A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer
Phase 1/2
Completed
76 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Fujian Cancer Hospital · collabShanghai East Hospital · collabShanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collabSir Run Run Shaw Hospital · collabSixth Affiliated Hospital, Sun Yat-sen University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe First Hospital of Jilin University · collabThe Second Affiliated Hospital of Harbin Medical University · collabTongji Hospital · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabZhejiang University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study. Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
Timeline
- Start
- 2019-11-05
- Primary completion
- 2020-06-01
- Completion
- 2020-09-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gentuximab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | Gentuximab | Monoclonal antibody | 12 mg/kg | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |