一项在系统性标准治疗后进展或转移的晚期实体瘤患者中评估ABO2011单药安全性、药代动力学和药效学(PK/PD)及初步有效性的I期临床研究
[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.
一项在晚期实体瘤患者中评估ABO2011单药及与特瑞普利单抗联合的安全性、药代动力学和药效学(PK/PD)及初步有效性的I/II期临床研究
[Translation] A Phase I/II clinical study evaluating the safety, pharmacokinetics and pharmacodynamics (PK/PD) and preliminary efficacy of ABO2011 alone and in combination with toripalimab in patients with advanced solid tumors
I期 1. 评价ABO2011单药及与特瑞普利单抗联合的安全性和耐受性 2. 确定ABO2011单药及与特瑞普利单抗联合的推荐剂量和/或最大耐受剂量(MTD)
II期 1. 评估ABO2011单药及与特瑞普利单抗联合的初步抗肿瘤作用
[Translation] Phase I 1. Evaluate the safety and tolerability of ABO2011 alone and in combination with toripalimab 2. Determine the recommended dose and/or maximum tolerated dose (MTD) of ABO2011 alone and in combination with toripalimab
Phase II 1. Evaluate the preliminary anti-tumor effect of ABO2011 alone and in combination with toripalimab
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100 Translational Medicine associated with Abogen Biotechnology (Shanghai) Co., Ltd.