[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
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
[Translation] Phase Ia
Primary objective: 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 objective: 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
Phase Ib
Primary objective: To evaluate the preliminary efficacy of JMT203 in the treatment of tumor cachexia; To determine the recommended phase II dose (RP2D) of JMT203
Secondary objectives: To evaluate the improvement of skeletal muscle index in the treatment of tumor cachexia by JMT203; To evaluate the improvement of appetite by 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