[Translation] A single-arm, open-label, single/multiple-dose escalation and expansion cohort Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of ABP1011T tablets in patients with advanced malignant solid tumors
一期:
主要目的:评估 ABP1011T片在晚期恶性实体瘤患者中的安全性和耐受性;确定剂量限制毒性(DLT)、最大耐受剂量(MTD)和II期临床试验推荐剂量(RP2D)以及给药方案。
次要目的:
1) 研究ABP1011T片单次和多次给药在晚期恶性实体瘤患者中的药代动力学(PK)特征。
2) 初步评估ABP1011T片治疗晚期恶性实体瘤的有效性。
二期:
主要目的:初步评估ABP1011T片在目标晚期恶性实体瘤患者中的有效性。
次要目的:
1) 初步评估ABP1011T片在目标晚期实体瘤患者中的有效性。
2) 评估ABP1011T片在目标晚期恶性实体瘤患者中的安全性和耐受性。
[Translation] Phase I:
Primary purpose: To evaluate the safety and tolerability of ABP1011T tablets in patients with advanced malignant solid tumors; to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RP2D) for Phase II clinical trials and dosing regimen.
Secondary purpose:
1) To study the pharmacokinetic (PK) characteristics of single and multiple doses of ABP1011T tablets in patients with advanced malignant solid tumors.
2) To preliminarily evaluate the effectiveness of ABP1011T tablets in the treatment of advanced malignant solid tumors.
Phase II:
Primary purpose: To preliminarily evaluate the effectiveness of ABP1011T tablets in target patients with advanced malignant solid tumors.
Secondary purpose:
1) To preliminarily evaluate the effectiveness of ABP1011T tablets in target patients with advanced malignant solid tumors.
2) To evaluate the safety and tolerability of ABP1011T tablets in target patients with advanced malignant solid tumors.