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MAX-10181联合仑伐替尼在晚期恶性实体瘤患者中的安全性和有效性的Ⅱ期临床研究
[Translation] A Phase II clinical study of the safety and efficacy of MAX-10181 in combination with lenvatinib in patients with advanced malignant solid tumors.
1)第1阶段:评估MAX-10181联合仑伐替尼在晚期实体瘤患者中的耐受性及安全性,确定II期推荐剂量(RP2D)和/或最大耐受剂量(MTD)。
2)第2阶段:评估MAX-10181联合仑伐替尼在晚期实体瘤患者中的初步疗效。
[Translation] 1) Phase 1: Evaluate the tolerability and safety of MAX-10181 in combination with lenvatinib in patients with advanced solid tumors, and determine the Phase II recommended dose (RP2D) and/or maximum tolerated dose (MTD).
2) Phase 2: Evaluate the preliminary efficacy of MAX-10181 in combination with lenvatinib in patients with advanced solid tumors.
MAX-10181联合TMZ治疗高级别脑胶质瘤患者的安全性和有效性的Ⅱ期临床研究
[Translation] Phase II clinical study on the safety and efficacy of MAX-10181 combined with TMZ in the treatment of patients with high-grade brain glioma
1)评估MAX-10181联合替莫唑胺(TMZ)在复发/进展高级别脑胶质瘤(HGG)患者中的安全性和耐受性、药代动力学、联合用药推荐剂量(RP2D)。 2)评估MAX-10181联合TMZ治疗初治脑胶质瘤患者的初步疗效。
[Translation] 1) To evaluate the safety and tolerability, pharmacokinetics, and recommended combined dose (RP2D) of MAX-10181 combined with temozolomide (TMZ) in patients with recurrent/progressive high-grade glioma (HGG). 2) To evaluate the preliminary efficacy of MAX-10181 combined with TMZ in patients with newly diagnosed glioma.
MAX-10181联合卡培他滨片治疗晚期/转移性实体瘤患者的安全性和有效性的临床研究
[Translation] Clinical study on the safety and efficacy of MAX-10181 combined with capecitabine tablets in the treatment of patients with advanced/metastatic solid tumors
主要目的:1)第一阶段:评估MAX-10181联合卡培他滨在晚期/转移性实体瘤患者中的耐受性及安全性,确定MAX-10181联合卡培他滨在不同实体瘤中的推荐剂量(RP2D)。2)第二阶段:评估MAX-10181联合卡培他滨在晚期/转移性实体瘤患者中的初步疗效。次要目的:1)评价MAX-10181联合卡培他滨治疗晚期/转移性实体瘤患者的药代动力学(PK)特征。2)回顾性分析相关生物标志物与MAX-10181联合卡培他滨抗肿瘤效应之间的关系。
[Translation] Primary objectives: 1) Phase I: Evaluate the tolerability and safety of MAX-10181 combined with capecitabine in patients with advanced/metastatic solid tumors, and determine the recommended dose (RP2D) of MAX-10181 combined with capecitabine in different solid tumors. 2) Phase II: Evaluate the preliminary efficacy of MAX-10181 combined with capecitabine in patients with advanced/metastatic solid tumors. Secondary objectives: 1) Evaluate the pharmacokinetic (PK) characteristics of MAX-10181 combined with capecitabine in the treatment of patients with advanced/metastatic solid tumors. 2) Retrospectively analyze the relationship between relevant biomarkers and the anti-tumor effect of MAX-10181 combined with capecitabine.
100 Clinical Results associated with Guangzhou Zaiji Medical Technology Co., Ltd.
0 Patents (Medical) associated with Guangzhou Zaiji Medical Technology Co., Ltd.
100 Deals associated with Guangzhou Zaiji Medical Technology Co., Ltd.
100 Translational Medicine associated with Guangzhou Zaiji Medical Technology Co., Ltd.