A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors

Exclusion Criteria

• •1. History of any second malignancy within 3 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
• •2. Previously experienced ≥ Grade 3 immune-related Adverse Events during immunotherapy.
• •3. Pleural effusion or pericardial effusion, or ascites requiring clinical intervention as determined by the investigator;
• •4. Subjects with clinical symptoms of brain metastases, spinal cord compression, meningitis carcinomatosa, or other evidence indicating that brain or spinal cord metastatic lesions are not yet controlled; Note: Subjects with asymptomatic or stable brain metastases, spinal cord compression, or meningitis carcinomatosa as determined by theinvestigator may be eligible for enrollment;
• •5. Subjects with a history or current condition of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of pulmonary function, as determined by the sub investigator, that may interfere with the detection and management of suspected drug-related pulmonary toxicity;
• •6. The subject has poorly controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure or left ventricular ejection fraction (LVEF) \<50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the past 6 months (excluding lacunar infarction, minor cerebral ischaemia, or transient ischaemic attack); (4) uncontrolled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females, with QTc interval calculated using the Fridericia formula); (5) poorly controlled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg despite active treatment);
• •7. History of immunodeficiency diseases, including testing positive for human immunodeficiency virus (HIV), or having other acquired or congenital immunodeficiency diseases, or a history of organ transplant;
• •8. Has active pulmonary tuberculosis;
• •9. Subjests with active HBV, HCV infection or co-infection;
• •10. There is a known active or suspected autoimmune disease. Enrollment is allowed for subjects in a stable condition who do not require systemic immunosuppressive therapy.
• •11. Subjects requiring systemic corticosteroids (\>10 mg/day prednisone therapeutic dosage) or other immunosuppressive drug therapy within 14 days prior to the first administration of the Investigational Product or during the study. However, the following situations allow for enrollment: in the absence of active autoimmune disorders, the use of topical external application or inhaled steroids and adrenal hormone replacement therapy at a dosage ≤10 mg/day prednisone therapeutic dosage is permitted; prophylactic medication is allowed.
• •12. Any active infection requiring systemic anti-infective therapy within 14 days prior to the first administration of the Investigational Product;
• •13. Within 28 days prior to the first administration of the Investigational Product, the subject has undergone major surgery. In this study, major surgery is defined as a procedure requiring at least 3 weeks of postoperative recovery before being eligible to receive treatment in this study. Tumor paracentesis or lymph node incisional biopsy is permitted for enrollment.
• •14. Strong inhibitors or strong inducers of CYP2D6 or CYP3A were used within 2 weeks prior to the first administration of the drug.
• •15. Received live viral vaccine treatment within 28 days prior to the first administration of the Investigational Product; however, inactivated viral vaccines for seasonal flu and novel coronavirus are permitted;
• •16. Participating in another clinical trial or planning to start this study with less than 14 days since the end-of-therapy of the previous clinical trial; less than 5 half-lives since the last course of anti-tumor therapy;
• •17. Known to have a severe allergy to any monoclonal antibody;
• •18. Subjects who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.