An Open-label, Single-arm, Investigator-initiated Phase I Clinical Study Evaluating BPI-1178 Capsules in Combination With Osimertinib Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.

开始日期2024-05-22

申办/合作机构-

CTR20192521

/ Recruiting临床1/2期

评估BPI-1178胶囊在晚期实体瘤患者中的耐受性、安全性及药代动力学和初步疗效的I期临床研究及联合内分泌治疗在HR+/HER2-的晚期/复发乳腺癌患者中疗效与安全性的IIa期临床研究

I期研究主要评估BPI-1178单次及多次口服给药在晚期实体瘤患者中的耐受性和安全性及其药代动力学特征；并初步考察其对晚期实体瘤的疗效、初步进行血浆代谢产物的鉴定。IIa期研究主要评估BPI-1178联合内分泌治疗在HR+/HER2-的晚期乳腺癌患者中的疗效和安全性。如数据允许，初步考察BPI-1178及其代谢产物（如适用）的暴露-效应关系。

开始日期2020-06-15

申办/合作机构

倍而达药业（苏州）有限公司

NCT04282031

/ Recruiting临床1/2期

A Phase 1/2a Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of BPI-1178 Alone in Advanced Solid Tumor and of BPI-1178 in Combination With Endocrine Therapy in Advanced HR+/HER2- Breast Cancer

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4（CDK4）and CDK6 kinase activity. This Phase I study is a first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of oral BPI-1178 in patients with advanced solid tumors. The Phase IIa trial is designed to investigate the anti-tumor activity and safety of BPI-1178 in combination with endocrine therapy in patients with HR+/HER2-advanced breast cancer and to determine the dosing regimen for combination with endocrine therapy in a later confirmatory study.

开始日期2020-06-15

申办/合作机构

倍而达药业（苏州）有限公司

100 项与 BPI-1178 相关的临床结果

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100 项与 BPI-1178 相关的转化医学

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100 项与 BPI-1178 相关的专利（医药）

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100 项与 BPI-1178 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期乳腺癌	临床2期	中国	倍而达药业（苏州）有限公司	2020-06-15
晚期恶性实体瘤	临床2期	中国	倍而达药业（苏州）有限公司	2020-06-15
HR阳性/HER2阴性乳腺癌	临床2期	中国	倍而达药业（苏州）有限公司	2020-06-15
晚期非小细胞肺癌	临床1期	中国	-	2024-05-22