drugset / Trial / NCT05246982
HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
Timeline
- Start
- 2022-03-23
- Primary completion
- 2023-12-20
- Completion
- 2024-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PIMURUTAMAB | Monoclonal antibody | 1500 mg | — |
| Subject | Serplulimab | Monoclonal antibody | 300 mg | — |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | — |