[Translation] A Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics, and initial efficacy of AOB01-0036 capsules in patients with advanced solid tumors, including an open-label, first-in-human dose escalation, and dose expansion study.
(1)剂量递增阶段(Ia):
主要目的:评估 AOB01-0036 胶囊单药在晚期实体瘤患者的安全性和耐受性,确定 AOB01-0036 胶囊的扩展期推荐剂量(RDE)和/或最大耐受剂量(MTD)(如有)。
次要目的:评估 AOB01-0036 胶囊单药在晚期实体瘤患者中的药代动力学(PK)特征和药效动力学(PD)特征; 初步评估 AOB01-0036 胶囊单药在晚期实体瘤患者中的抗肿瘤活性;评估AOB01-0036 胶囊在晚期实体瘤患者中的食物影响。
(2)剂量扩展阶段(Ib)
主要目的:评估 AOB01-0036 胶囊单药在晚期特定瘤种实体瘤患者中的有效性及为 II 期推荐剂量(RP2D)。
次要目的:评估 AOB01-0036 胶囊单药在晚期特定瘤种实体瘤患者的安全性和耐受性;以其他疗效终点评估 AOB01-0036 胶囊单药在晚期特定瘤种实体瘤患者中的有效性;评估AOB01-0036 胶囊在晚期特定瘤种实体瘤患者中的 PK/PD 特征。
[Translation] (1) Dose Escalation Phase (Ia):
Primary Objective: To evaluate the safety and tolerability of AOB01-0036 capsules as monotherapy in patients with advanced solid tumors, and to determine the recommended dose (RDE) and/or maximum tolerated dose (MTD) (if any) for the extended phase of AOB01-0036 capsules.
Secondary Objectives: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of AOB01-0036 capsules as monotherapy in patients with advanced solid tumors; to preliminarily assess the antitumor activity of AOB01-0036 capsules as monotherapy in patients with advanced solid tumors; and to evaluate the food effects of AOB01-0036 capsules in patients with advanced solid tumors.
(2) Dose Expansion Phase (Ib):
Primary Objective: To evaluate the efficacy of AOB01-0036 capsules as monotherapy in patients with advanced solid tumors of a specific type and to determine the recommended dose (RP2D) for Phase II. Secondary objectives: To evaluate the safety and tolerability of AOB01-0036 capsule monotherapy in patients with advanced-stage solid tumors of specific types; to evaluate the efficacy of AOB01-0036 capsule monotherapy in patients with advanced-stage solid tumors of specific types using other efficacy endpoints; and to evaluate the PK/PD characteristics of AOB01-0036 capsule in patients with advanced-stage solid tumors of specific types.