Delving into the Latest Updates on Sacibertinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HEMAY 022, Hemay-022

Target

HER2 x Tyrosine kinase

Mechanism

HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), Tyrosine kinase inhibitors

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Breast CancerEstrogen receptor positive breast cancerHER2 Positive Breast Cancer+ [3]

Inactive Indication-

Originator Organization

Tianjin Hemay Pharmaceutical Technology Co., Ltd.

Active Organization

Tianjin Hemei Biological Technology Co.,Ltd.Xiajiang Hemei Pharmaceutical Co., Ltd.Tianjin Hemei Aokang Pharmaceutical Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationSpecial Review Project (CN)

Structure

Molecular FormulaC32H31ClN6O4

InChIKeyZGYIXVSQHOKQRZ-COIATFDQSA-N

CAS Registry1351941-69-9

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.

Start Date19 Jan 2022

Sponsor / Collaborator

Tianjin Hemei Aokang Pharmaceutical Technology Co., Ltd.

CTR20212304 / RecruitingPhase 3

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

[Translation] A randomized, open-label, controlled, multicenter phase III clinical study to evaluate the efficacy and safety of Hemay022 combined with aromatase inhibitors in postmenopausal patients with HER2+/ER+ advanced breast cancer treated with a trastuzumab-containing regimen

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。

[Translation]

The main purpose of the study is to evaluate the effectiveness of Hemay022 combined with AI in the treatment of patients with ER-positive and HER2-positive advanced breast cancer based on the progression-free survival (PFS) assessed by IRC. The key secondary purpose is to evaluate the effectiveness of Hemay022 combined with AI in the treatment of patients with ER-positive and HER2-positive advanced breast cancer based on the OS of the subjects. Other secondary purposes are to further evaluate the effectiveness of Hemay022 combined with AI in the treatment of patients with ER-positive and HER2-positive advanced breast cancer based on the PFS, ORR, DCR, DOR and other indicators assessed by the investigators.

Start Date14 Jan 2022

Sponsor / Collaborator

Xiajiang Hemei Pharmaceutical Co., Ltd.

[+1]

CTR20201527 / CompletedPhase 1

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

[Translation] Phase I clinical trial study plan on the effect of food on single administration of Hemay022 tablets in healthy subjects

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。

[Translation]

Primary purpose: To evaluate the effect of food on the pharmacokinetic characteristics of Hemay022 tablets by taking a single dose of Hemay022 tablets on an empty stomach and after a meal in healthy subjects, and to provide a reference for the formulation of clinical dosing regimens. Secondary purpose: To observe the safety of a single oral dose of Hemay022 tablets on an empty stomach and after a meal; to scan and identify the metabolites of Hemay022 tablets in the human body.

Start Date09 Dec 2020

Sponsor / Collaborator

Xiajiang Hemei Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Sacibertinib

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100 Translational Medicine associated with Sacibertinib

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100 Patents (Medical) associated with Sacibertinib

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1

Literatures (Medical) associated with Sacibertinib

01 Jan 2024·Chinese journal of cancer research = Chung-kuo yen cheng yen chiu

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

Article

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

Objective:

Hemay022 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.

Methods:

Heavily 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.

Results:

Twenty-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.

Conclusions:

Hemay022 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 Deals associated with Sacibertinib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	CN	Tianjin Hemei Aokang Pharmaceutical Technology Co., Ltd.	19 Jan 2022
Estrogen receptor positive breast cancer	Phase 3	CN	Tianjin Hemei Biological Technology Co.,Ltd.	14 Jan 2022
Estrogen receptor positive breast cancer	Phase 3	CN	Xiajiang Hemei Pharmaceutical Co., Ltd.	14 Jan 2022
HER2 Positive Breast Cancer	Phase 3	CN	Xiajiang Hemei Pharmaceutical Co., Ltd.	14 Jan 2022
HER2 Positive Breast Cancer	Phase 3	CN	Tianjin Hemei Biological Technology Co.,Ltd.	14 Jan 2022
Advanced breast cancer	Phase 3	CN	Tianjin Hemei Biological Technology Co.,Ltd.	08 Jan 2022
ER-positive/HER2-positive Breast Cancer	Phase 3	CN	Tianjin Hemei Biological Technology Co.,Ltd.	08 Jan 2022
Advanced HER2-Positive Breast Carcinoma	Phase 1	CN	Tianjin Hemei Biological Technology Co.,Ltd.	14 Oct 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05122494 (phase I study of Hemay022, Pubmed \| Chin J Cancer Res)	Phase 1	Advanced HER2-Positive Breast Carcinoma HER2-positive	28	Hemay022 50 mg QD	rhhyoishsi(iwacfgcwns) = pdpeuwddek efuhnjwvxg (dbfybbrmfu ) View more	Positive	01 Jan 2024
	Phase 1	Advanced HER2-Positive Breast Carcinoma HER2-positive	28	Hemay022 300 mg BID	nzoqytckvx(nyqqquvizc) = cxgrhdmbmf lgigdthuon (fevsbhlgrs ) View more	Positive	01 Jan 2024
phase 1b 3+3 dose escalation and expansion study (SABCS2023)	Phase 1	Metastatic human epidermal growth factor 2 positive carcinoma of breast estrogen receptor-positive \| HER2+	55	Sacibertinib plus endocrine therapy	kmkfnfpszk(uxqwuoxazk) = 9.1% ykxqojctxm (ntopuhjmhq ) View more	Positive	05 Dec 2023
NCT03308201 (SABCS2023)	Phase 1	Metastatic human epidermal growth factor 2 positive carcinoma of breast estrogen receptor-positive \| HER2-positive	55	Sacibertinib (Hemay022) plus endocrine therapy	klcwjtxyzg(ubwzojlhap) = naqilcofkh jbbpnoqjlt (xoxbpvshze, 5.5 - 11.0)	Positive	05 Dec 2023