A Phase Ib/ II Clinical Study to Evaluate the Safety ,Torlerbility , and Efficacy of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Anti-PD-1 Humanized Monocl ) in Patients With Advanced/Metastatic Solid Tumors
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced/metastatic solid tumors
• Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the Informed Consent Form (ICF); be willing and able to comply with and complete all trial procedures;
• Age at the time of signing the ICF is ≥ 18 years and ≤ 75 years;
• Phase Ib enrollment of patients with histologically or cytologically confirmed advanced /metastatic solid tumor who have experienced treatment failure or for whom no standard treatment is available;Phase II enrollment includes advanced /metastatic NSCLC subjects confirmed by histology or cytology, requiring the presence of EGFR mutation and failure or intolerance to EGFR-TKI and platinum-based chemotherapy.
• Within 4 weeks prior to the first dose, at least one measurable lesion assessed by the investigator according to RECIST 1.1;
• Subjects must provide qualified tumor tissue samples for the determination of PD-L1 expression levels.
• The ECOG PS score within 7 days prior to the first use of the Investigational Product is 0 or 1;
• Expected survival ≥ 12 weeks;
• Major organ functions are normal, meeting the following criteria (within 14 days prior to the first administration in this study, no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatment was received):
• Female subjects of childbearing potential must meet the following criteria:
• a)The blood pregnancy test must be negative within 7 days prior to the first administration of the medication; b)Agree to use at least one highly effective method of contraception during the trial period and for at least 6 months after the last administration of the drug;c)Breastfeeding is contraindicated.
⁃ Male subjects must meet the following criteria: agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose.