[Translation] A single-center, open-label, dose-escalation phase I clinical study to evaluate the safety and tolerability of iodine [131I] exetutinib injection in the treatment of advanced malignant solid tumors
主要目的
确定表达CEA的晚期恶性实体瘤患者对药物的最大耐受剂量。
次要目的
考察药物单次给药及连续给药在人体内的药代动力学特点。
观察患者体内抗药性抗体产生情况。
确定药物在体内肿瘤及各器官组织中的代谢规律;肿瘤及各器官组织中的内照射吸收剂量及与用药量的关系;初步观察药物的抗肿瘤疗效与吸收剂量及与用药量的关系。
[Translation] Main purpose
To determine the maximum tolerated dose of the drug in patients with advanced malignant solid tumors expressing CEA.
Secondary purpose
To investigate the pharmacokinetic characteristics of the drug in humans after single and continuous administration.
To observe the production of anti-drug antibodies in patients.
To determine the metabolic rules of the drug in tumors and various organs and tissues in the body; the internal radiation absorbed dose in tumors and various organs and tissues and its relationship with the dosage; to preliminarily observe the relationship between the anti-tumor efficacy of the drug and the absorbed dose and the dosage.