HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors

Korábbi kezelés

• Treatment with any of the following:
  • Previous or current treatment with B7-H3 targeted therapy 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 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093
• Subjects with previous or concurrent malignancies
• Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
• Severe infections occured within 4 weeks before the first dose
• Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093

Más betegség

• Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula
• Evidence of current severe or uncontrolled systemic diseases
• The presence of active infectious diseases has been known before first dose such as hepatitis B, hepatitis C, ect
• History of neuropathy or mental disorders
• History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093
• Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Egyéb

• Any of the following would exclude the subject from participation in the study:
• Inadequate bone marrow reserve or organ dysfunction.
• Evidence of cardiovascular risk
• Pregnant or lactating female
• Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator

• Men or women aged more than or equal to (≥) 18 years.
• Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.
• At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions).
• Agree to provide fresh or archival tumor tissue and blood samples.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
• Estimated life expectancy >12 weeks.
• Agree to use medically accepted methods of contraception.
• Men or women should be using adequate contraceptive measures throughout the study.
• Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
• Signed and dated Informed Consent Form.