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Mechanismc-Met inhibitors |
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Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评估AL2846胶囊在既往TKI治疗失败的碘难治分化型甲状腺癌中有效性和安全性的Ib期临床试验
[Translation] A phase Ib clinical trial to evaluate the efficacy and safety of AL2846 capsules in iodine-refractory differentiated thyroid cancer that has failed previous TKI treatment
主要目的
评价AL2846胶囊在既往TKI治疗失败的碘难治分化型甲状腺癌患者中的初步疗效。
次要目的
评价AL2846胶囊在既往TKI治疗失败的碘难治分化型甲状腺癌患者中的安全性
[Translation] Primary objective
To evaluate the preliminary efficacy of AL2846 capsules in patients with iodine-refractory differentiated thyroid cancer who have failed previous TKI treatment.
Secondary objective
To evaluate the safety of AL2846 capsules in patients with iodine-refractory differentiated thyroid cancer who have failed previous TKI treatment.
一项AL8326 片联合特瑞普利单抗治疗晚期复发或转移性实体瘤I/IIa期临床试验
[Translation] A Phase I/IIa clinical trial of AL8326 tablets combined with toripalimab in the treatment of advanced recurrent or metastatic solid tumors
主要目的:评估 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤的安全性及耐受性,观 察 DLT 的发生,确定 MTD 及 RP2D。
次要目的:初步获得 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤受试者的药代动力 学参数(仅第一部分)。 初步评价 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤的有效性
[Translation] Primary objective: To evaluate the safety and tolerability of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors, observe the occurrence of DLT, and determine the MTD and RP2D.
Secondary objective: To preliminarily obtain the pharmacokinetic parameters of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors (only the first part). Preliminary evaluation of the effectiveness of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors
评估AL2846胶囊在中国I型神经纤维瘤病相关(神经纤维瘤和外周恶性神经鞘膜瘤)受试者中安全性和有效性的Ib期临床试验
[Translation] A Phase Ib clinical trial evaluating the safety and efficacy of AL2846 capsules in Chinese subjects with neurofibromatosis type I-related diseases (neurofibromas and peripheral malignant nerve sheath tumors)
【第一阶段(剂量导入)】
评价AL2846胶囊在中国Ⅰ型神经纤维瘤病(NF1)相关(神经纤维瘤和外周恶性神经鞘膜瘤)患者中的安全性及Ⅱ期临床推荐剂量。
【第二阶段(队列扩展)】
初步评估AL2846胶囊在中国Ⅰ型神经纤维瘤病(NF1)相关(神经纤维瘤和外周恶性神经鞘膜瘤)患者中的有效性与安全性,以及探索相关治疗标志物。
[Translation] 【Phase I (dose introduction)】
Evaluate the safety of AL2846 capsules in Chinese patients with neurofibromatosis type 1 (NF1)-related (neurofibromas and peripheral malignant nerve sheath tumors) and the recommended dose for Phase II clinical trials.
【Phase II (cohort expansion)】
Preliminary evaluation of the efficacy and safety of AL2846 capsules in Chinese patients with neurofibromatosis type 1 (NF1)-related (neurofibromas and peripheral malignant nerve sheath tumors), and exploration of relevant therapeutic markers.
100 Clinical Results associated with Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.
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