[Translation] An open, multicenter Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of XYD-9668-198 antibody conjugate in patients with advanced solid tumors
I期剂量递增阶段主要目的:评价XYD-9668-198抗体偶联剂的安全性和耐受性;确定XYD-9668-198抗体偶联剂的最大耐受剂量(MTD)和II期试验推荐剂量(RP2D)。次要目的:考察XYD-9668-198抗体偶联剂及其代谢产物的药代动力学特征;评价XYD-9668-198抗体偶联剂的初步抗肿瘤活性;评估XYD-9668-198抗体偶联剂的免疫原性。II期剂量扩展阶段主要目的:评价XYD-9668-198抗体偶联剂的安全性和耐受性;评价XYD-9668-198抗体偶联剂的初步抗肿瘤活性。次要目的:考察XYD-9668-198抗体偶联剂及其代谢产物的药代动力学特征;评估XYD-9668-198抗体偶联剂的免疫原性。
[Translation] The main objectives of the Phase I dose escalation phase are: to evaluate the safety and tolerability of the XYD-9668-198 antibody conjugate; to determine the maximum tolerated dose (MTD) and the recommended dose (RP2D) of the XYD-9668-198 antibody conjugate for Phase II trials. Secondary objectives: to investigate the pharmacokinetic characteristics of the XYD-9668-198 antibody conjugate and its metabolites; to evaluate the preliminary anti-tumor activity of the XYD-9668-198 antibody conjugate; and to assess the immunogenicity of the XYD-9668-198 antibody conjugate. The main objectives of the Phase II dose expansion phase are: to evaluate the safety and tolerability of the XYD-9668-198 antibody conjugate; to evaluate the preliminary anti-tumor activity of the XYD-9668-198 antibody conjugate. Secondary objectives: to investigate the pharmacokinetic characteristics of the XYD-9668-198 antibody conjugate and its metabolites; and to assess the immunogenicity of the XYD-9668-198 antibody conjugate.