[Translation] An open-label, multicenter phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of JH021 injection in patients with advanced solid tumors.
主要目的:
Ⅰa期:剂量递增研究 评价JH021在晚期实体瘤患者中的安全性和耐受性; 确定JH021的最大耐受剂量(MTD)(如有),以及确定临床推荐剂量。
Ⅰb期:剂量扩展研究 评价JH021单药治疗EGFR突变且三代EGFR-TKIs耐药且含铂化疗方案治疗后进展(或无标准治疗)的局晚期或转移性NSCLC的有效性。
次要目的:
Ⅰa期:剂量递增研究 评价JH021在晚期实体瘤受试者中的药代动力学特征。 评价JH021在晚期实体瘤受试者中的免疫原性。 评价JH021在晚期实体瘤受试者中的初步有效性。
Ⅰb期:剂量扩展研究 评价JH021在EGFR突变且三代EGFR-TKIs耐药且含铂化疗方案治疗后进展(或无标准治疗)的局晚期或转移性NSCLC患者中的安全性、药代动力学特征、免疫原性。
探索性目的: 探索EGFR突变类型或MET扩增或表达与JH021抗肿瘤疗效之间的关系。
[Translation] Primary Objectives:
Phase Ia: Dose Elevation Study To evaluate the safety and tolerability of JH021 in patients with advanced solid tumors; to determine the maximum tolerated dose (MTD) of JH021 (if applicable), and to determine the clinically recommended dose.
Phase Ib: Dose Expansion Study To evaluate the efficacy of JH021 monotherapy in patients with EGFR-mutant, third-generation EGFR-TKI-resistant, and platinum-based chemotherapy-advanced (or untreated) locally advanced or metastatic NSCLC.
Secondary Objectives:
Phase Ia: Dose Elevation Study To evaluate the pharmacokinetic characteristics of JH021 in subjects with advanced solid tumors. To evaluate the immunogenicity of JH021 in subjects with advanced solid tumors. To evaluate the preliminary efficacy of JH021 in subjects with advanced solid tumors.
Phase Ib: Dose Expansion Study. To evaluate the safety, pharmacokinetic profile, and immunogenicity of JH021 in patients with EGFR-mutant, third-generation EGFR-TKI-resistant, and platinum-based chemotherapy-treated (or without standard treatment) locally advanced or metastatic NSCLC.
Exploratory Objective: To investigate the relationship between EGFR mutation type or MET amplification or expression and the antitumor efficacy of JH021.