[Translation] A Phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of HNC664 capsules as a single agent in patients with advanced solid tumors and to expand its combination with first-line standard treatment
主要目的 剂量递增试验:评估HNC664胶囊单药在晚期实体瘤患者中的安全性和耐受性,观察剂量限制性毒性(DLT),确定HNC664最大耐受剂量(MTD)和扩展试验推荐剂量,为后续临床试验给药剂量和给药方案提供依据。 扩展试验:评价HNC664胶囊联合吉西他滨和白蛋白紫杉醇在局部晚期或转移性胰腺癌患者中的安全性及初步疗效。
次要目的:评价HNC664胶囊单药或与吉西他滨和白蛋白紫杉醇联用在晚期实体瘤患者中的药代动力学(PK)和药效动力学(PD)特征;
探索性目的(仅扩展试验):探索胰腺癌患者血液中的生物标志物与疗效之间的关系。
[Translation] Main purpose Dose escalation trial: Evaluate the safety and tolerability of HNC664 capsules alone in patients with advanced solid tumors, observe dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) of HNC664 and the recommended dose for the extended trial, and provide a basis for the subsequent clinical trial dosage and dosing regimen. Extended trial: Evaluate the safety and preliminary efficacy of HNC664 capsules combined with gemcitabine and albumin-paclitaxel in patients with locally advanced or metastatic pancreatic cancer.
Secondary purpose: Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HNC664 capsules alone or in combination with gemcitabine and albumin-paclitaxel in patients with advanced solid tumors;
Exploratory purpose (extended trial only): Explore the relationship between biomarkers in the blood of pancreatic cancer patients and efficacy.