This is a multi-cohort, multi-center Phase II clinical study exploring the efficacy of treatment with either Adebrelimab plus SHR-A1811/SHR-A1904 and chemotherapy, or Adebrelimab plus SHR-8068 in patients with gastric or gastroesophageal junction (GEJ) cancer. The study also evaluates the safety and tolerability of these combination regimens.
Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-tumor therapy for gastric/gastroesophageal junction cancer.
Age: ≥18 and ≤70 years, both male and female.
Ability to provide fresh tumor tissue (preferred) or archival formalin-fixed paraffin-embedded (FFPE) tumor blocks/unstained slides obtained within 6 months before enrollment.
Availability of biomarker testing results before enrollment.
Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.
20% body weight loss within 2 months before enrollment.
Prior treatments: Anti-tumor therapy for gastric/gastroesophageal junction cancer; Participation in other drug trials with last dose ≤4 weeks or ≤5 half-lives (whichever longer) before enrollment; Major surgery within 28 days before enrollment; Live attenuated vaccination within 28 days before enrollment or planned during/within 60 days after treatment.
Known hypersensitivity to any study drug component (Adebrelimab, SHR-A1811, SHR-A1904, SHR-8068, fluorouracil, capecitabine, tegafur/gimeracil/oteracil) or humanized monoclonal antibodies.
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Lead sponsor