Overview
This was an open-label, phase 1/2 study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in combination with CAPOX and Sintilimab in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.
Description
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 Sintilimab.
Eligibility
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;