About this trial
This study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer or resectable gastric cancer.
Eligibility criteria
Qualifiers
Age≥18 years old.
Histologically or cytologically confirmed diagnosis of gastric cancer.
The first-line population enrolls participants with HER2-positive unresectable locally advanced or metastatic gastric cancer who had not received systemic treatment, and Perioperative population enrolls participants with HER2-positive resectable gastric cancer who had not received treatment.
HER2-positive (defined as IHC3+ or IHC 2+/FISH +).
Disqualifiers
Has received anti-tumor treatment such as systemic chemotherapy or other trial interventions within 28 days, or immunotherapy (e.g. interleukin, interferon, thymospipeptide, etc.), hormone therapy or targeted therapy within 14 days or 5 half-life (whichever is shorter) before the first dose or randomization.
Has previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors.
Participants with brain metastasis or spinal cord compression at screening (except for completed local treatment and discontinued glucocorticoids for at least 4 weeks before the first dose or randomization , and stable central nervous system imaging and brain metastasis symptoms for at least 4 weeks).
Participants with PD-L1 CPS ≥1, who are receiving long-term immunotherapy (e.g., cyclosporine) or require daily systemic steroid therapy (e.g., >20 mg prednisone or equivalent), except those who treated with local glucocorticoids using nasal spray, inhalation, or other pathways.
Trial design
Treatments tested in this trial
- JSKN003
- KN026
- Capecitabine
- Enlonstobart
- Oxaliplatin
- Trastuzumab
- Pembolizumab