SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

Korábbi kezelés

• Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment;

Más betegség

• Active leptomeningeal disease or uncontrolled brain metastasis
• Patients with active hepatitis B or hepatitis C;
• Patients have significant gastric bleeding
• Have clinically significant systemic diseases that may adversely affect the safety of the study;

Egyéb

• Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
• The presence of clinically uncontrollable third interspace fluid
• Patients who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the patients are not appropriate to patients in the study.

• Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
• No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
• Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;
• Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
• Estimated survival ≥ 3 months as judged by the investigator;
• Adequate organ and bone marrow function (no blood components and cytokines are allowed within 2 weeks prior to the first dose) ;
• Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing;