[Translation] An open-label, multicenter Phase I clinical study to evaluate the safety/tolerability, pharmacokinetics and efficacy of JMT203 in patients with tumor cachexia
Ia期
主要目的:评估JMT203在肿瘤恶病质患者中的安全性/耐受性;确定JMT203的最大耐受剂量(MTD)(如有)和/或推荐的扩展期剂量(RDE)
次要目的:评估JMT203在肿瘤恶病质患者中的药代动力学(PK)和药效动力学(PD)特征;评估JMT203在肿瘤恶病质患者中的免疫原性;评估 JMT203 治疗肿瘤恶病质的初步疗效;
探索性目的:探索血清 GDF15 表达水平及系统性炎症状态与恶病质疗效的相关性
Ib期
主要目的:评估JMT203治疗肿瘤恶病质的初步疗效;确定JMT203的Ⅱ期推荐剂量(RP2D)
次要目的:评估JMT203治疗肿瘤恶病质的骨骼肌指数改善情况;评估JMT203在肿瘤恶病质患者中的食欲改善程度;评估JMT203在肿瘤恶病质患者中的安全性;评估JMT203在肿瘤恶病质患者中的PK和PD特征;评估JMT203在肿瘤恶病质患者中的免疫原性;评估 JMT203 治疗肿瘤恶病质患者中的生存获益
探索性目的:评估 JMT203 在肿瘤恶病质患者中的生活质量改善程度、身体功能改善程度;探索血清 GDF15 表达水平及系统性炎症状态与恶病质疗效的相关性
[Translation] Phase Ia
Primary objectives: To evaluate the safety/tolerability of JMT203 in patients with tumor cachexia; To determine the maximum tolerated dose (MTD) (if any) and/or recommended dose for extension (RDE) of JMT203
Secondary objectives: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of JMT203 in patients with tumor cachexia; To evaluate the immunogenicity of JMT203 in patients with tumor cachexia; To evaluate the preliminary efficacy of JMT203 in the treatment of tumor cachexia;
Exploratory objectives: To explore the expression of serum GDF15 Correlation between expression level and systemic inflammatory status and cachexia efficacy
Phase Ib
Main purpose: To evaluate the preliminary efficacy of JMT203 in the treatment of tumor cachexia; To determine the recommended Phase II dose (RP2D) of JMT203
Secondary purpose: To evaluate the improvement of skeletal muscle index in the treatment of tumor cachexia by JMT203; To evaluate the degree of appetite improvement of JMT203 in patients with tumor cachexia; To evaluate the safety of JMT203 in patients with tumor cachexia; To evaluate the PK and PD characteristics of JMT203 in patients with tumor cachexia; To evaluate the immunogenicity of JMT203 in patients with tumor cachexia; To evaluate the survival benefit of JMT203 in patients with tumor cachexia
Exploratory purpose: To evaluate the degree of improvement in quality of life and physical function of JMT203 in patients with tumor cachexia; To explore the correlation between serum GDF15 expression level and systemic inflammatory status and cachexia efficacy