[Translation] Single-dose and multi-dose of CK21 fat emulsion injection in patients with advanced malignant solid tumors
Dosing Safety, Pharmacokinetics and Pharmacodynamics Phase Ia Clinical Study
主要研究目的
确定CK21在晚期恶性实体肿瘤患者的安全性、耐受性,以及II期临床试验推荐剂量(RP2D)。
次要研究目的
(1)确定CK21在晚期恶性实体肿瘤患者的药代动力学及药效动力学特征。
(2)评估CK21在晚期恶性实体肿瘤患者的初步疗效。
探索性研究目的
(1)探索潜在预测疗效的生物标志物的水平及其与疗效的关系。
(2)探索分析PK与药效动力学的关系。
[Translation] Main research purpose
To determine the safety, tolerability, and recommended dose (RP2D) of CK21 in patients with advanced malignant solid tumors.
Secondary research purpose
(1) To determine the pharmacokinetic and pharmacodynamic characteristics of CK21 in patients with advanced malignant solid tumors.
(2) To evaluate the preliminary efficacy of CK21 in patients with advanced malignant solid tumors.
exploratory research purpose
(1) Explore the levels of biomarkers that potentially predict efficacy and their relationship with efficacy.
(2) Explore and analyze the relationship between PK and pharmacodynamics.