[Translation] A multicenter, open-label, dose-escalation/expansion Phase I/II study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CTS3497 capsules in patients with MTAP-deficient advanced solid tumors and lymphomas
I期:主要目的:评估CTS3497在实体瘤和淋巴瘤患者中的安全性和耐受性,确定最大耐受剂量和/或II期推荐剂量。次要目的:1.评估CTS3497在实体瘤和淋巴瘤患者中的药代动力学(PK)特征,初步抗肿瘤活性,对实体瘤和淋巴瘤患者生活质量的影响。探索性目的:1. 探索MTAP缺失程度与CTS3497在MTAP缺失实体瘤和淋巴瘤患者中的疗效之间的关系,对胶质瘤患者神经功能的影响及在实体瘤和淋巴瘤患者中的药效学(PD)特征。4. 探索CTS3497在实体瘤和淋巴瘤患者中的代谢产物。II期:主要目的:评估选定剂量的CTS3497在MTAP缺失实体瘤和淋巴瘤患者中的初步抗肿瘤活性。次要目的:评估选定剂量的CTS3497在MTAP缺失实体瘤和淋巴瘤患者中的安全性,抗肿瘤活性,PK特征,PD特征,对MTAP缺失实体瘤和淋巴瘤患者生活质量的影响。探索性目的:探索MTAP缺失程度与CTS3497在MTAP缺失实体瘤和淋巴瘤患者中的疗效之间的关系及CTS3497胶囊对胶质瘤患者神经功能的影响。
[Translation] Phase I: Primary objective: To evaluate the safety and tolerability of CTS3497 in patients with solid tumors and lymphomas, and to determine the maximum tolerated dose and/or Phase II recommended dose. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics, preliminary anti-tumor activity, and effects on the quality of life of patients with solid tumors and lymphomas of CTS3497 in patients with solid tumors and lymphomas. Exploratory objectives: 1. To explore the relationship between the degree of MTAP deficiency and the efficacy of CTS3497 in patients with MTAP-deficient solid tumors and lymphomas, the effects on the neurological function of patients with gliomas, and the pharmacodynamic (PD) characteristics in patients with solid tumors and lymphomas. 4. To explore the metabolites of CTS3497 in patients with solid tumors and lymphomas. Phase II: Primary objective: To evaluate the preliminary anti-tumor activity of selected doses of CTS3497 in patients with MTAP-deficient solid tumors and lymphomas. Secondary objectives: To evaluate the safety, antitumor activity, PK characteristics, PD characteristics, and the effects on the quality of life of patients with MTAP-deficient solid tumors and lymphomas at selected doses of CTS3497. Exploratory objectives: To explore the relationship between the degree of MTAP deficiency and the efficacy of CTS3497 in patients with MTAP-deficient solid tumors and lymphomas, and the effects of CTS3497 capsules on the neurological function of patients with gliomas.