HS-10502 Combination Treatment in Patients With Advanced Solid Tumors

Exclusion Criteria25

• Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
• Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
• Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.
• Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.
• Presence of pleural/abdominal effusion requiring clinical intervention.
• Known history of other primary malignancy.
• Evidence of brain metastasis and/or cancerous meningitis
• Inadequate bone marrow reserve or hepatic/renal functions.
• Cardiological examination abnormality.
• Severe, uncontrolled or active cardiovascular disorders.
• Serious or poorly controlled diabetes.
• Serious or poorly controlled hypertension.
• Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.
• Serious infections within 4 weeks prior to the first dose.
• Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.
• Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.
• Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.
• Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
• History of severe neurological or psychiatric disorder.
• Pregnant or breast-feeding women or women who intend to become pregnant during the study.
• Attenuated live vaccination within 4 weeks prior to the first dose.
• Subjects with autoimmune disease that is active or is likely to recur.
• Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms/signs of intestinal obstruction within 6 months prior to the first dose of study drug.
• Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.
• Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.