ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.

A two-part, dose-escalation and expansion study of ASKB589 was initiated to determine the MTD, PK, PD, and efficacy in combination with chemotherapy and PD-1 inhibitors.

Inclusion criteria

• Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy.
• Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment.
• Tumor tissue samples are CLDN18.2 positive detected by central laboratory
• ECOG performance status 0-1.
• The results of the laboratory tests must meet all criteria
• Life expectancy of at least 3 months.

Exclusion criteria

• Known active central nervous system metastasis or suspected cancerous meningitis;
• There are moderate to large amounts of abdominal and pleural fluid.
• The presence of clinically uncontrollable third interspace fluid；
• Patients with any other malignant tumors within the past 5 years.
• Applicable to anti-HER-2 drug therapy；
• Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past；
• Patients have received antitumor therapy during the first 4 weeks before study drug use;
• Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;