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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
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MechanismPRMT5 inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
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评价GTA182在MTAPnull/lost的晚期实体瘤受试者中的安全性、耐受性的剂量递增和剂量扩展的I期临床研究
[Translation] A Phase I clinical study evaluating the safety and tolerability of GTA182 in subjects with MTAPnull/lost advanced solid tumors through dose escalation and expansion
Ia期(剂量递增阶段)(1)主要目的:评估GTA182在MTAPnull/lost晚期实体瘤受试者中的安全性和耐受性,以确定扩展期推荐剂量(RDEs)或最大耐受剂量(MTD)(如存在)。(2)次要目的:评估GTA182在MTAPnull/lost晚期实体瘤受试者中的药代动力学特征;评估GTA182在MTAPnull/lost晚期实体瘤受试者中的初步有效性。(3)探索性目的:探索与GTA182疗效相关的生物标志物。Ib期(剂量扩展阶段)(1)主要目的:评估在RDEs剂量下GTA182在MTAPnull/lost晚期实体瘤受试者中的安全性和耐受性,以确认II期推荐剂量(RP2D)。(2)次要目的:评估在RDEs剂量下GTA182在MTAPnull/lost晚期实体瘤受试者中的药代动力学特征;评估在RDEs剂量下GTA182在MTAPnull/lost晚期实体瘤受试者中的初步有效性,为后续临床试验推荐剂量和适应症选择提供依据。(3)探索性目的:探索与GTA182疗效相关的生物标志物。
[Translation] Phase Ia (dose escalation phase) (1) Primary objective: To evaluate the safety and tolerability of GTA182 in subjects with MTAPnull/lost advanced solid tumors to determine the recommended dose (RDEs) or maximum tolerated dose (MTD) for the extension phase (if any). (2) Secondary objectives: To evaluate the pharmacokinetic characteristics of GTA182 in subjects with MTAPnull/lost advanced solid tumors; To evaluate the preliminary efficacy of GTA182 in subjects with MTAPnull/lost advanced solid tumors. (3) Exploratory objective: To explore biomarkers associated with the efficacy of GTA182. Phase Ib (dose expansion phase) (1) Primary objective: To evaluate the safety and tolerability of GTA182 in subjects with MTAPnull/lost advanced solid tumors at the RDEs dose to confirm the recommended dose for Phase II (RP2D). (2) Secondary objectives: To evaluate the pharmacokinetic characteristics of GTA182 at RDEs doses in subjects with MTAPnull/lost advanced solid tumors; To evaluate the preliminary efficacy of GTA182 at RDEs doses in subjects with MTAPnull/lost advanced solid tumors, and to provide a basis for the recommended dose and indication selection for subsequent clinical trials. (3) Exploratory objectives: To explore biomarkers associated with the efficacy of GTA182.
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