[Translation] A Phase I clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of DXP-106 as monotherapy or in combination with standard chemotherapy in patients with advanced solid tumors.
Part 1单药剂量递增阶段
主要目的:
评价DXP-106在晚期实体瘤患者中的安全性和耐受性;
探索DXP-106在晚期实体瘤患者中的剂量限制性毒性(DLT),并确定最大耐受剂量(MTD)和/或Ⅱ期推荐剂量(RP2D)。
Part 2联合用药剂量递增阶段
主要目的:
评价DXP-106在晚期实体瘤患者中联合标准化疗给药后的安全性和耐受性;
探索DXP-106与标准化疗联用的推荐剂量和/或优势瘤种。
[Translation] Part 1: Monotherapy Dosage Escalation Phase
Main Objectives:
To evaluate the safety and tolerability of DXP-106 in patients with advanced solid tumors;
To explore dose-limiting toxicities (DLTs) of DXP-106 in patients with advanced solid tumors and determine the maximum tolerated dose (MTD) and/or the recommended dose for Phase II (RP2D).
Part 2: Combination Therapy Dosage Escalation Phase
Main Objectives:
To evaluate the safety and tolerability of DXP-106 in combination with standard chemotherapy in patients with advanced solid tumors;
To explore the recommended dose and/or preferred tumor types for combination therapy of DXP-106 with standard chemotherapy.