HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Exclusion Criteria34

• Treatment with any of the following:
• Previous or current treatment with B7-H3 targeted therapy.
• Previous or current treatment with topoisomerase I inhibitors.
• Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093
• Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093
• Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093
• Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
• Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
• Histology shows squamous cell carcinoma, undifferentiated carcinoma, or mixed tumors , such as adenosquamous carcinoma or other mixed tumors.
• Any unresolved toxicities from prior therapy greater than Grade 1 according to CTCAE 5.0 or baseline status.
• Presence of pleural effusion/ascites requiring clinical intervention.
• Newly diagnosed brain metastases without treatment, or brain metastases that have not achieved stability despite treatment; presence of leptomeningeal metastasis or brainstem metastasis; presence of spinal cord compression.
• History of other primary malignancies
• Evidence of cardiovascular risk.
• Severe, uncontrolled or active cardiovascular diseases.
• Severe or poorly controlled hypertension.
• Severe or poorly controlled diabetes.
• Poorly controlled cancer-related pain.
• The presence of active infectious diseases has been known: hepatitis B, hepatitis C and HIV.
• Major surgery within 4 weeks prior to the first scheduled dose of HS-20093.
• Active infection requiring therapeutic intravenous antibiotics within 2 weeks prior to the first dose.
• Clinically significant bleeding symptoms or marked hemorrhagic tendency within 1 month prior to the first dose of HS-20093.
• Serious arterial or venous thromboembolic events occurring within 3 months prior to the first dose of HS-20093.
• Active tuberculosis.
• History of known interstitial pneumonia or immune-mediated pneumonitis.
• History of active or prior autoimmune disease requiring systemic treatment.
• Severe malnutrition.
• Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.
• Requires long-term glucocorticoid therapy.
• Having undergone any major surgery within 4 weeks prior to the first dose.
• Vaccination within 4 weeks prior to the first dose of HS-20093.
• History of severe allergy.
• Previous history of serious neurological or mental disorders. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
• Currently enrolled in or participating in any other clinical study involving investigational interventions or other types of interventional medical research.