Sacibertinib(Sacibertinib) - 药物靶点：HER2_在研适应症：乳腺癌，ER阳性乳腺癌，HER2阳性乳腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

HER2

作用机制

HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、Tyrosine kinase inhibitors

治疗领域

肿瘤皮肤和肌肉骨骼疾病

在研适应症

乳腺癌ER阳性乳腺癌HER2阳性乳腺癌+ [3]

非在研适应症-

原研机构

天津合美医药科技有限公司

在研机构

天津和美生物技术有限公司峡江和美药业有限公司天津和美奥康医药科技有限公司

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评特殊审批 (中国)

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结构

分子式C32H31ClN6O4

InChIKeyZGYIXVSQHOKQRZ-COIATFDQSA-N

CAS号1351941-69-9

关联

9

项与 Sacibertinib 相关的临床试验

NCT05122494 / Recruiting临床3期

A Randomized, Multicenter, Parallel,Phase III Open-label Study of the Efficacy and Safety of Hemay022 + AI in Patients With ER+/HER2+ Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

This is a Phase III, randomized, multicenter, 2-arm, open-label clinical trial designed to compare the safety and efficacy of Hemay022+Aromatase inhibitor(AI) with that of capecitabine + lapatinib in participants with ER+/HER2+ locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up.

开始日期2022-01-19

申办/合作机构

天津和美奥康医药科技有限公司

CTR20212304 / Recruiting临床3期

评价 Hemay022 联合芳香化酶抑制剂用于经含曲妥珠单抗方案治疗的绝经后 HER2+/ER+晚期乳腺癌患者疗效和安全性的随机、开放、对照、多中心Ⅲ期临床研究

主要研究目的：基于 IRC 评估的无进展生存期 PFS，评估 Hemay022 联合 AI治疗 ER 阳性和 HER2 阳性晚期乳腺癌患者的有效性。关键次要目的：基于受试者的 OS 评估 Hemay022 联合 AI治疗 ER阳性和 HER2 阳性晚期乳腺癌患者的有效性。其他次要目的：基于研究者评估的 PFS、ORR、DCR、DOR 等指标进一步评估 Hemay022联合 AI治疗 ER 阳性和 HER2 阳性晚期乳腺癌患者的有效性。

开始日期2022-01-14

申办/合作机构

峡江和美药业有限公司

[+1]

CTR20201527 / Completed临床1期

Hemay022片在健康受试者中单次给药食物影响I期临床试验研究方案

主要目的：通过健康受试者在空腹和餐后条件下单次服用Hemay022片，评价食物对Hemay022片药代动力学特征的影响，为制定临床给药方案提供参考依据。次要目的：观察Hemay022片在空腹和餐后条件下单次口服Hemay022片的安全性；对Hemay022片人体中代谢产物进行扫描鉴定。

开始日期2020-12-09

申办/合作机构

峡江和美药业有限公司

[+1]

100 项与 Sacibertinib 相关的临床结果

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100 项与 Sacibertinib 相关的转化医学

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100 项与 Sacibertinib 相关的专利（医药）

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1

项与 Sacibertinib 相关的文献（医药）

2024-01-01·Chinese Journal of Cancer Research

A phase I study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer

Article

作者: Jones, Richard ; Zhang, Hesheng ; Zhen, Yueying ; Zhang, Pin ; Wang, Lin ; Xu, Binghe ; Wang, Zhihong

ObjectiveHemay022 is a novel small-molecule and an irreversible tyrosine kinase inhibitor with the target of epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER2), which demonstrated anti-tumor activity in preclinical studies. This first-in-human study evaluated the safety, pharmacokinetics, tolerability and preliminary anti-tumor activity of Hemay022 in HER2-positive advanced breast cancer patients.MethodsHeavily pretreated patients with HER2-positive advanced breast cancer were assigned to eight dose cohorts in a 3+3 dose-escalation pattern at doses of 50-600 mg QD and 300 mg BID. Eligible patients were given a single dose of Hemay022 on d 1 in week 0, followed by once daily continuous doses for four weeks in 28-day cycles. Pharmacokinetic samples were obtained on d 1 and d 28. Clinical responses were assessed every eight weeks.ResultsTwenty-eight patients with advanced breast cancer were treated with Hemay022. The most frequently reported drug-related adverse events were diarrhoea (85.7%), vomiting (28.6%), nausea (25.0%) and decreased appetite (17.9%). No grade 4 drug-related adverse events were reported. At 50-600 mg doses, steady state areas under the concentration-time curve and peak concentrations increased with doses. One patient achieved complete response (CR), and three achieved partial response (PR). The objective response rate (ORR) and disease control rate (DCR) were 14.3% and 46.4% in 28 patients, respectively. The median progression-free survival (PFS) was 3.98 months.ConclusionsHemay022 at the dose of 500 mg once daily was well tolerated. The pharmacokinetic properties and encouraging anti-tumor activities of Hemay022 in advanced breast cancer patients warranted further evaluation of Hemay022 for treating breast cancer patients in the current phase III trial (No. NCT05122494).

100 项与 Sacibertinib 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
乳腺癌	临床3期	中国	天津和美奥康医药科技有限公司	2022-01-19
ER阳性乳腺癌	临床3期	中国	峡江和美药业有限公司	2022-01-14
ER阳性乳腺癌	临床3期	中国	天津和美生物技术有限公司	2022-01-14
HER2阳性乳腺癌	临床3期	中国	天津和美生物技术有限公司	2022-01-14
HER2阳性乳腺癌	临床3期	中国	峡江和美药业有限公司	2022-01-14
晚期乳腺癌	临床3期	中国	天津和美生物技术有限公司	2022-01-08
ER阳性/HER2阳性乳腺癌	临床3期	中国	天津和美生物技术有限公司	2022-01-08
晚期 HER2 阳性乳腺癌	临床1期	中国	天津和美生物技术有限公司	2015-10-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05122494 (phase I study of Hemay022, Pubmed \| Chin J Cancer Res)	临床1期	晚期 HER2 阳性乳腺癌 HER2-positive	28	Hemay022 50 mg QD	壓築獵廠窪構憲築壓夢(積壓窪鏇鏇鏇顧鬱鑰築) = 糧鏇製窪鏇積襯鹹顧艱願遞蓋襯範鏇蓋鹹廠憲 (廠積襯築齋願獵範衊簾 ) 更多	积极	2024-01-01
				Hemay022 300 mg BID	鹹糧壓廠鏇餘夢築壓遞(糧繭鹹製餘鬱餘鬱鑰願) = 網遞簾積築艱淵憲窪積積顧鏇願齋選遞鹽簾鹹 (窪選繭願築積遞積願顧 ) 更多