[Translation] A Phase I clinical study to evaluate the safety, pharmacokinetics and pharmacodynamics (PK/PD) and preliminary efficacy of ABO2011 monotherapy in patients with advanced solid tumors that have progressed or metastasized after systemic standard treatment
试验主要目的是评价ABO2011的安全性和耐受性,并探索最大耐受剂量(MTD)以及确定ABO2011的Ⅱ期临床试验推荐剂量(RP2D);次要目的是评价ABO2011的初步有效性、PK和PD特征以及免疫原性,同时分析分子标记物与有效性和安全性的关系以及评价外周血中炎性细胞因子、肿瘤组织内部免疫微环境的变化和肿瘤免疫相关基因表达的变化
[Translation] The primary purpose of the trial is to evaluate the safety and tolerability of ABO2011, explore the maximum tolerated dose (MTD) and determine the recommended dose (RP2D) for Phase II clinical trials of ABO2011; the secondary purpose is to evaluate the preliminary efficacy, PK and PD characteristics and immunogenicity of ABO2011, analyze the relationship between molecular markers and efficacy and safety, and evaluate the changes in inflammatory cytokines in peripheral blood, changes in the immune microenvironment in tumor tissue, and changes in the expression of tumor immune-related genes.