JSKN003 Combined Treatment of HER2-positive Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai JMT-Bio Inc.

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

Treatment groups

153 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators