drugset / Trial / NCT05671822
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients. The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.
Timeline
- Start
- 2023-03-14
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adebrelimab | Monoclonal antibody | — | Intravenous |
| Subject | Capecitabine | Small molecule | — | Oral |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | Retlirafusp alfa | Protein / enzyme biologic | — | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |