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MechanismBcr-Abl T315I inhibitors [+1] |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date24 Nov 2021 |
HQP1351治疗酪氨酸激酶抑制剂耐药的慢性髓性白血病患者的剂量递增的Ⅰ期临床试验
[Translation] Phase I clinical trial of HQP1351 in the treatment of patients with chronic myeloid leukemia resistant to tyrosine kinase inhibitors
主要目的:确定HQP1351治疗TKI耐药的慢性髓性白血病患者的最大耐受剂量,或Ⅱ期临床推荐剂量(RP2D)。 次要目的:评估HQP1351治疗TKI耐药的慢性髓性白血病患者的安全性。评估HQP1351治疗TKI耐药的慢性髓性白血病患者的疗效。评估HQP1351体内的药代动力学特征。 探索性目的:探讨HQP1351潜在的生物标志物与疗效的相关性。
[Translation] Primary objective: To determine the maximum tolerated dose of HQP1351 for the treatment of TKI-resistant chronic myeloid leukemia patients, or the recommended dose for phase II clinical trials (RP2D). Secondary objective: To evaluate the safety of HQP1351 in the treatment of TKI-resistant chronic myeloid leukemia patients. To evaluate the efficacy of HQP1351 in the treatment of TKI-resistant chronic myeloid leukemia patients. To evaluate the pharmacokinetic characteristics of HQP1351 in vivo. Exploratory objective: To explore the correlation between potential biomarkers of HQP1351 and efficacy.
Phase I Dose Escalation Study of HQP1351 on Tyrosine Kinase Inhibitor (TKI) Resistant Patients with Chronic Myelogenous Leukemia
HQP8361治疗晚期实体瘤患者剂量递增的Ⅰ期临床试验
[Translation] Phase I clinical trial of HQP8361 in patients with advanced solid tumors
主要目的:
评价HQP8361的安全性、耐受性,包括剂量限制性毒性(DLT),最大耐受剂量(MTD),和Ⅱ期临床推荐剂量(RP2D)。 次要目的:
评估HQP8361体内的药代动力学特征。
探索HQP8361的药效动力学特征(PK-PD)。
初步评估HQP8361在晚期实体肿瘤患者中的疗效。
基于药效动力学特征和疗效资料确定II期试验给药方案以及敏感瘤种。
[Translation] Primary purpose:
Evaluate the safety and tolerability of HQP8361, including dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical trial (RP2D). Secondary purpose:
Evaluate the pharmacokinetic characteristics of HQP8361 in vivo.
Explore the pharmacodynamic characteristics (PK-PD) of HQP8361.
Preliminary evaluation of the efficacy of HQP8361 in patients with advanced solid tumors.
Determine the dosing regimen and sensitive tumor types for Phase II trial based on pharmacodynamic characteristics and efficacy data.
100 Clinical Results associated with Guangzhou Shunjian Biomedical Technology Co. Ltd.
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