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DRUG:

sacibertinib (Hemay022)

i
Other names: Hemay022
Company:
Tianjin Hemay Pharma
Drug class:
EGFR inhibitor
Related drugs:
8ms
New P3 trial • Combination therapy • Metastases
|
Herceptin (trastuzumab) • lapatinib • capecitabine • sacibertinib (Hemay022)
8ms
A phase I study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer. (PubMed, Chin J Cancer Res)
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).
P1 data • Journal • Metastases
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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sacibertinib (Hemay022)
8ms
Trial completion • Combination therapy • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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ER positive • HER-2 overexpression
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fulvestrant • letrozole • exemestane • sacibertinib (Hemay022)
9ms
Study Evaluating Hemay022 In Subjects With HER2-Positive Advanced Breast Cancer (clinicaltrials.gov)
P1, N=28, Completed, Tianjin Hemay Pharmaceutical Co., Ltd | Unknown status --> Completed | N=57 --> 28 | Trial completion date: Dec 2018 --> Sep 2023 | Trial primary completion date: Dec 2018 --> Sep 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 overexpression
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sacibertinib (Hemay022)
1year
Antitumor activity and safety of sacibertinib (Hemay022) in combination with endocrine therapy in patients with ER and HER2 both positive metastatic breast cancer: A phase Ib study (SABCS 2023)
This study aimed to explore the safety and efficacy of sacibertinib plus endocrine therapy in patients with estrogen receptor-positive ( PATIENTS AND METHODS Using a phase 1b 3+3 dose escalation and expansion study design, patients with ER+/ HER2+ MBC were treated with sacibertinib (200mg-500mg daily) plus endocrine therapy including exemestane, letrozole, fulvestrant. CONCLUSION Sacibertinib plus endocrine therapy had a favorable safety profile and antitumor activity in patients with ER+/ HER2+ MBC, 400-500mg daily showed more efficacy, supporting further assessment in randomized studies. This figure showed response of Sacibertinib plus endocrine therapy in ER+/ HER2+ metastatic breast cancer.
Clinical • P1 data • Combination therapy • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive
|
fulvestrant • letrozole • sacibertinib (Hemay022)
1year
Antitumor efficacy and safety of sacibertinib (Hemay022) in combination with endocrine therapy in patients with ER+ and HER2+ metastatic breast cancer: A phase Ib study (SABCS 2023)
PATIENTS AND METHODS Using a phase 1b 3+3 dose escalation and expansion study design, patients with ER+/ HER2+ MBC were treated with sacibertinib (200mg-500mg daily) plus endocrine therapy including exemestane, letrozole, fulvestrant . Summary of efficacy data(EAS) NOTE. NA, not available (because cannot be calculated) Treatment-Emergent Adverse Events Occurring in ≥ 10% of Patients in the Safety Population Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; Waterfall plot of best change rate in target-lesion size from baseline
Clinical • P1 data • Combination therapy • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HER-2 positive • ER positive
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fulvestrant • letrozole • sacibertinib (Hemay022)
over2years
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 overexpression
|
Herceptin (trastuzumab) • lapatinib • capecitabine • sacibertinib (Hemay022)
almost3years
New P3 trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 overexpression
|
Herceptin (trastuzumab) • lapatinib • capecitabine • sacibertinib (Hemay022)
over3years
Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov)
P1, N=48, Recruiting, Tianjin Hemay Pharmaceutical Co.,Ltd | Trial completion date: Jul 2021 --> Dec 2022 | Trial primary completion date: Feb 2021 --> May 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 overexpression
|
fulvestrant • letrozole • exemestane • sacibertinib (Hemay022)
almost4years
Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov)
P1, N=48, Recruiting, Tianjin Hemay Pharmaceutical Co.,Ltd | Trial completion date: Jul 2019 --> Jul 2021 | Trial primary completion date: Mar 2019 --> Feb 2021
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 overexpression
|
fulvestrant • letrozole • exemestane • sacibertinib (Hemay022)