[Translation] An open, multi-center, multi-cohort Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary efficacy of FTL001 in subjects with advanced recurrent, metastatic and refractory solid tumors
主要目的是评价FTL001在晚期复发转移和难治性实体瘤受试者中的安全性和耐受性。次要目的包括评价 FTL001的初步抗肿瘤活性、药代动力学(PK)特征和免疫原性等。探索目的包括探索FTL001的药效学特征、相关生物标志物与抗肿瘤疗效的关系等。
[Translation] The primary objective is to evaluate the safety and tolerability of FTL001 in subjects with advanced recurrent metastatic and refractory solid tumors. Secondary objectives include evaluating the preliminary anti-tumor activity, pharmacokinetic (PK) characteristics and immunogenicity of FTL001. Exploratory objectives include exploring the pharmacodynamic characteristics of FTL001, the relationship between relevant biomarkers and anti-tumor efficacy, etc.