The aim of this trial is to study the safety, pharmacokinetics and preliminary efficacy of the HER2-targeted antibody-drug conjugate GQ1001 in combination with pyrotinib in patients with HER2-positive metastatic breast cancer patients who had failed previous anti-HER2 treatment.

开始日期2022-10-01

申办/合作机构

复旦大学

[+1]

CTR20211739

/ Recruiting临床1期

靶向HER2抗体偶联药物GQ1001静脉输注液在HER2阳性晚期实体肿瘤受试者中的首次人体，国际多中心，开放I期临床试验

评估GQ1001的剂量限制性毒性（DLT）以确定最大耐受剂量（MTD）或扩展推荐剂量（DRDE）。评估GQ1001注射液在HER2阳性晚期实体肿瘤受试者中的安全性和耐受性.。考察不同剂量下，GQ1001注射液在HER2阳性晚期实体瘤受试者中的药代动力学（PK）特征。观察GQ1001注射液在HER2阳性晚期实体瘤受试者中的抗肿瘤活性

开始日期2021-09-09

申办/合作机构

启德医药科技（苏州）有限公司

NCT04450732

/ Recruiting临床1期

A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors

Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors

开始日期2020-07-07

申办/合作机构

启德医药科技（苏州）有限公司

100 项与 GQ-1001 相关的临床结果

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100 项与 GQ-1001 相关的转化医学

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100 项与 GQ-1001 相关的专利（医药）

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项与 GQ-1001 相关的文献（医药）

2025-02-01·JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Ligand-binding assays validated for quantitative bioanalysis of a novel antibody-drug conjugate in monkey serum and related application in a nonclinical study

Article

作者: Hou, Yingying ; Miao, Jie ; Qin, Qiuping ; Liu, Tingting ; Shi, Lili ; Li, Ziyi ; Sun, Yajun ; Gong, Likun ; Ouyang, Lu ; Chen, Xiaoqiang ; Qin, Gang

BACKGROUND:

Antibody-drug conjugates (ADCs) are an emerging class of targeted therapeutics and are receiving growing attention in the pharmaceutical field. Here we aimed to validate two ligand binding assays for the quantitation of GQ1001, an ADC made of Trastuzumab site-specifically conjugated with DM1, in cynomolgus monkey serum, and then apply the validated assays to a nonclinical study.

METHODS:

The quantitative methods for conjugated GQ1001 and total GQ1001 were validated against regulatory guidance documents on bioanalytical method validation under a Good Laboratory Practice (GLP)-compliant environment. The validated assays were applied to a single-dose pharmacokinetic (PK) study of GQ1001 conducted in cynomolgus monkeys.

RESULTS:

Both intra- and inter-assay precision and accuracy met the priori-defined acceptance criteria. Neither matrix effect nor hemolysis effect were observed, and the impact of specific interferents on the assays was evaluated. Dilution linearity was good with the expected dilution factors and no hook effect till up to 20.2 mg/mL of GQ1001 was noted. Besides, the stability of the ADC in monkey serum was found to be sufficient to cover the time required for sample storage and analysis. Furthermore, the assays demonstrated good parallelism determined with a study sample and good reproducibility acquired by incurred sample reanalysis (ISR). Using the validated assays, we obtained serum concentrations for the conjugated GQ1001 and the total GQ1001 in the single-dose PK study, and thereafter, evaluated their exposures over the dosing period.

CONCLUSIONS:

All tested performance parameters of the assays met the validation acceptance criteria, which supported the application of the two assays in the nonclinical PK study and allowed the evaluation of the related PK parameters for GQ1001.

2025-01-01·CHROMATOGRAPHIA

An UPLC Method for Determination of Structural Analogues of DM1: the Payload of Trastuzumab Emtansine (T-DM1)

作者: Yin, Daquan ; Zhu, Yang ; Yao, Junliang

Abstract: DM1, a derivative of maytansine, is the payload of trastuzumab emtansine (T-DM1).In this work, a new gradient reverse-phase ultra-performance chromatog. (RP-UPLC) method was proposed for anal. of five structural analogs (DM1-2, AP-3, DM1-4D, DM1-3D, and DM1-3L) of DM1.The chromatog. separation was accomplished by using a Waters BEH Ph column (50 x 2.1 mm, 1.7 μm), at the wavelength of 252 nm.Validation of the method was carried out according the ICH guidelines in terms of specificity, accuracy, precision, linearity and robustness.The developed method was proved to be convenient and reliable for quant. determination of the DM1 analog impurities.It can also be used for the related substances determination in DM1 bulk samples.

2024-11-20·BIOCONJUGATE CHEMISTRY

eSOMA-DM1, a Maytansinoid-Based Theranostic Small-Molecule Drug Conjugate for Neuroendocrine Tumors

Article

作者: Beekman, Savanne ; de Ridder, Corrina ; Li, Le ; Stuurman, Debra ; Piet, Amber ; Seimbille, Yann ; Chapeau, Dylan

Background: The main challenges of conventional chemotherapy lie in its lack of selectivity and specificity, leading to significant side effects. Using a small-molecule drug conjugate (SMDC) ensures specific delivery of a cytotoxic drug to the tumor site by coupling it to a targeting vector. This promising strategy can be applied to neuroendocrine tumors (NETs) by choosing a targeting vector that binds specifically to somatostatin receptor subtype 2 (SSTR2). Additionally, incorporation of a bifunctional chelate into the molecule enables complexation of both diagnostic and therapeutic radionuclides. Thus, it facilitates monitoring of the distribution of the SMDC in the body and allows for the implementation of combination therapy. In our study, we designed eSOMA-DM1, a SMDC combining the SSTR2-targeted octreotate peptide and the cytotoxic agent DM1 via a chelate-bridged linker (N₃-Py-DOTAGA). This approach warrants conjugation of the targeting vector and the drug at opposite sites to avoid undesired steric hindrance effects. Methods: Synthesis of the DM1 moiety (4) involved a three-step synthetic route, followed by the conjugation to the cyclic peptide, N₃-Py-DOTAGA-d-Phe-cyclo[Cys-Tyr-d-Trp-Lys-Thr-Cys]-Thr-OH, through a copper-free click reaction, resulting in eSOMA-DM1. Subsequent labeling with [¹¹¹In]InCl₃ gave a high radiochemical yield and purity. In vitro assessments of eSOMA-DM1 binding, uptake, and internalization were conducted in SSTR2-transfected U2OS cells. Ex vivo biodistribution and fluorescence imaging were performed in H69-tumor bearing mice. Results: eSOMA-DM1 exhibited an IC₅₀ value for SSTR2 similar to the gold standard DOTA-TATE. The uptake of [¹¹¹In]In-eSOMA-DM1 in U2OS.SSTR2 cells was 1.2-fold lower than that of [¹¹¹In]In-DOTA-TATE. Tumor uptake in H69-xenografted mice was higher for [¹¹¹In]In-eSOMA-DM1 at all-time points compared to [¹¹¹In]In-DOTA-TATE. Prolonged blood circulation led to increased accumulation of [¹¹¹In]In-eSOMA-DM1 in highly vascularized tissues, such as the lungs, skin, and heart. Excretion through the kidneys, liver, and spleen was also observed. Conclusion: eSOMA-DM1 is a SMDC developed for NET showing promising characteristics in vitro. However, the in vivo results obtained with [¹¹¹In]In-eSOMA-DM1 suggest the need for adjustments to optimize its distribution.

项与 GQ-1001 相关的新闻（医药）

2024-12-15

·ioncology

SABCS中国之声丨王碧芸教授：GQ1001联合吡咯替尼治疗既往接受过治疗的HER2+MBC药代动力学特征和初步疗效

编者按：HER2阳性乳腺癌的治疗一直是临床研究的热点。2024年SABCS大会上，复旦大学附属肿瘤医院王碧芸教授团队开展的新型HER2 ADC药物GQ1001与吡咯替尼联合应用，治疗既往经治的HER2阳性转移性乳腺癌患者的1b期研究结果公布（摘要号：P5-05-02）。该研究不仅评估了联合用药的药代动力学特征，还初步探讨了其临床疗效，本文特进行介绍。研究背景 GQ1001是一种创新的抗HER2抗体偶联药物（ADC），通过一种新颖、集成且稳定的酶偶联技术，将微管蛋白抑制剂（DM1）与经过工程改造的曲妥珠单抗相连接，其药物抗体比为2[1]。临床前研究表明，GQ1001在多种HER2阳性的患者来源异种移植（PDX）和细胞系来源异种移植（CDX）模型中展现出强大的抗肿瘤活性，并且在大鼠和食蟹猴中表现出优异的药代动力学特性和安全性特征。 Figure 1. The Structure and Characterize of GQ1001 GQ1001单药治疗HER2阳性晚期实体瘤的临床研究（NCT04450732）显示，GQ1001单药在经治的患者中具有优异的耐受性和有前景的抗肿瘤疗效[2]。体内研究还表明，GQ1001与吡咯替尼（一种不可逆的泛HER2受体酪氨酸激酶抑制剂）联合使用时，展现出协同抗肿瘤疗效[1]。因此，我们设计了一项1b期研究（NCT05575804），以探究GQ1001与吡咯替尼联用在经治HER2阳性转移性乳腺癌患者中的安全性和初步疗效。研究方法患者入组标准：经病理学确诊为HER2阳性转移性乳腺癌（MBC）的患者；既往接受过曲妥珠单抗和紫杉烷类药物标准治疗失败的患者；至少有一处可评估的病灶；ECOG为0-1。在“3+3”剂量递增阶段，GQ1001的剂量为6.0 mg/kg、7.2 mg/kg和8.4 mg/kg，每21天为一个周期进行静脉滴注，吡咯替尼以320 mg的固定剂量每日一次口服，每28天为一个周期。剂量递增或递减基于初始剂量组中指定剂量限制性毒性（DLTs）的发生率。在前21天内观察DLTs。主要评估指标：剂量限制性毒性（DLTs）、最大耐受剂量（MTD）或II期推荐剂量（RP2D）、安全性。次要评估指标：客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DOR）、无进展生存期（PFS）、药代动力学（PK）。探索性评估指标：筛选疗效预测分子标志物。 Figure 2. GQ1001-INV-BC-01 Study Design (NCT05575804) 在第1周期和第3周期给药前及给药结束（EOI）后10分钟内采集血液样本用于GQ1001和总抗体（TAb）的检测；在第1天和第8天给药前、给药后4小时和24小时采集血液样本用于吡咯替尼的检测。在给药前、给药结束后10分钟内、给药后0.5小时、2小时、8小时、24小时、48小时、72小时、168小时和336小时采集血液样本用于GQ1001、TAb及fDM1检测。使用酶联免疫吸附测法（ELISA）和液相色谱串联质谱法分别测定血清中GQ1001、TAb和吡咯替尼以及血浆中fDM1的浓度。研究结果共有15例HER2阳性转移性乳腺癌患者接受了GQ1001和吡咯替尼的治疗。所有患者（15/15）既往接受过曲妥珠单抗（或其生物类似物）治疗。33.3%的患者（5/15）既往接受过帕妥珠单抗治疗。本研究剂量递增阶段已完成，且未报告DLT。 Table 1. Demographics and Baseline Characteristics 15例患者的药代动力学数据表明，与既往报道的单药Ia期药代动力学数据相比，GQ1001联合吡咯替尼（320mg，qd）对GQ1001和游离DM1的血药浓度无显著影响。此外，在多次联合给药后，未观察到GQ1001的显著积累。GQ1001+吡咯替尼（320mg，qd）方案下的的吡咯替尼最大血药浓度范围约为103.0 ~ 169.5 μg/mL，与文献报道的吡咯替尼单药治疗的Cmax （143 μg/mL）相当[3]。表明GQ1001与吡咯替尼联用后，GQ1001[5]、DM1[6]和吡咯替尼[4]的血药浓度均未发生显著变化。在数据截止日期（2024年6月30日），中位随访时间为8.61个月（95% CI：6.83-15.08）。10例患者仍在接受治疗，最长治疗持续时间为523天。所有入组患者的12个月无进展生存期（PFS）率为73.5%，ORR为80%（12/15）。在6.0 mg/kg、7.2 mg/kg和8.4 mg/kg剂量水平下，ORR分别为75%（3/4）、100%（5/5）和66.7%（4/6）。未观察到新的不良事件。 Table 2. Summary of Overall Safety Table 3. Clinical Efficacy HER2-positive MBC Figure 3. Best Changess of Target Lesions in Evaluated MBC Figure 4. Treatment Duration and Response in Evaluated MBC 结论药代动力学结果表明，GQ1001和吡咯替尼之间的药物相互作用风险非常低，该联用方案在经治的HER2阳性转移性乳腺癌患者中显示出有前景的初步抗肿瘤活性。研究者说在今年SABCS上，由我们中心发起的GQ1001联用吡咯替尼的IIT研究结果备受关注，吸引了国内外众多专家驻足观看和讨论。GQ1001是启德医药利用iLDC技术平台开发的新一代HER2 ADC，单药的global研究中在多种HER2阳性实体瘤中展现了良好的安全性和有效性。此次我们报道的GQ1001联用吡咯替尼在曲妥珠单抗经治的HER2阳性晚期乳腺癌中的研究，联用的方案取得了很好的效果，安全性较好，没有新增的毒性发生。15例入组患者中，ORR达到80%，其中1例患者CR，4例患者在组超过1年，1例患者在组已接近2年，且在持续获益中。我们也期待能入组更多暴露过Her2-Dxd ADC药物，探索在这类ADC药物耐药人群中的应用，满足未被满足的治疗需求。参考文献上下滑动查看更多内容 [1]、HUANG L, SHI L, SUN Y, et al. Abstract 2702: GQ1001 is a next generation HER2-targeting ADC with excellent druggability, safety and potency [J]. Cancer Research, 2023, 83(7_Supplement): 2702-. [2]、LEMECH C, ZHOU C, ZHAN X, et al. Abstract CT178: GQ1001: A next generation HER2-targeting ADC that exhibits promising early clinical efficacy with excellent tolerance in a multi-center, Phase Ia study [J]. Cancer Research, 2023, 83(8_Supplement): CT178-CT. [3]、Ma F , Li Q , Chen S ,et al. Phase I Study and Biomarker Analysis of Pyrotinib, a Novel Irreversible Pan-ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer.[J].Journal of Clinical Oncology Official Journal of the American Society of Clinical Oncology, 2017, 35(27):JCO2016696179.DOI:10.1200/JCO.2016.69.6179. [4]、YAN M, BIAN L, HU X, et al. Pyrotinib plus capecitabine for human epidermal growth factor receptor 2-positivemetastatic breast cancer after trastuzumab and taxanes (PHENIX): A randomized, double-blind, placebo-controlledphase 3 study. Transl Breast Cancer Res, 2020, 1: 13. [5]、Charlotte Lemech, Chenfei Zhou.GQ1001: a next generation HER2-targeting ADC that exhibits promising early clinical efficacy with excellent tolerance in a multi-center,phase Ia study. AACR 2023# CT178. [6]、Sara A Hurvitz, Roberto Hegg, Wei-Pang Chung,et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised,open-label, phase 3 trial.Lancet 2023; 401: 105–17. 王碧芸教授复旦大学附属肿瘤医院肿瘤内科乳腺及泌尿肿瘤内科专科主任主任医师，硕士生导师中国临床肿瘤学会CSCO常务理事中国临床肿瘤学会CSCO青委会主任委员中国临床肿瘤学会CSCO患教专家委员会常务委员兼秘书长中国临床肿瘤学会CSCO乳腺癌专家委员会委员上海抗癌协会癌症康复与姑息治疗专委会CRPC主任委员上海市抗癌协会乳腺癌专业委员会常务委员龚成成复旦大学附属肿瘤医院肿瘤内科毕业于复旦大学上海医学院，以第一作者发表多篇SCI收录论文，参加多项国际、国内学术会议主持4项科研基金中国临床肿瘤学会CSCO青委会委员兼秘书中国女医师协会乳腺专业青委会青年委员上海市抗癌协会癌症康复与姑息治疗专业青年委员会委员上海市社会医疗机构协会肿瘤学分会乳腺肿瘤多学科专委会秘书长（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

抗体药物偶联物临床2期临床1期临床结果

2024-12-08

·ioncology

SABCS 2024丨盛幕将启，中国专家入选壁报展示（Poster Session 5上）

编者按：第47届圣安东尼奥乳腺癌研讨会（SABCS）将于当地时间2024年12月10日至13日在美国得克萨斯州圣安东尼奥举行。SABCS是全球最大的乳腺癌领域盛会，来自102个国家的超过1万名注册参会者将在为期四天的会议中展示1886篇被接受的论文摘要。肿瘤瞭望特别整理中国专家被收录的壁报内容，以飨读者。（注：因官网未公布详细作者单位，如有遗漏或错误，欢迎留言指正。）为深度报道此次盛会，《肿瘤瞭望》特此开设“瞭望联播”专栏，并荣幸邀请到江苏省人民医院殷咏梅教授担任特邀观察员。在会议期间，殷教授将连线SABCS现场的中国专家——复旦大学附属肿瘤医院张剑教授、浙江大学医学院附属第一医院傅佩芬教授、复旦大学附属肿瘤医院李俊杰教授、中山大学孙逸仙纪念医院刘强教授（按预计连线日期排序），每日实时传递会议的重磅研究成果与亮点发现。诚邀各位读者密切关注“瞭望联播”和《肿瘤瞭望》推出的栏目，共同见证SABCS大会的最新前沿进展，洞悉乳腺癌研究领域的未来趋势！ Poster Session 5 日期：12月13日时间：12:30～2:00 p.m. 地点：Halls 2-3 P5-01-04: Determination and clinical characteristics of bone pseudoprogression on advanced first-line therapy in metastatic breast cancer 转移性乳腺癌一线治疗中骨假性进展的确定和临床特征报告作者：Yuan Yuan P5-01-05: Clinicopathological features and outcomes of ERlow/HER2-low expression in de novo metastatic breast cancer: a preliminary cohort study 初发转移性乳腺癌ER低表达/ HER2低表达的临床病理特征和预后：一项初步队列研究报告作者：Chongxi Ren P5-01-16: m6A reader YTHDF3 promotes epithelial-mesenchymal transition and metastasis through facilitating Notch2 translation in breast cancer m6A解读器YTHDF3通过促进Notch2翻译促进乳腺癌上皮-间质转化和转移报告作者：Hong-Yu Chen P5-01-24: PPFIA4 mediates glucose metabolism reprogramming to alter the biological characteristics of breast cancer PPFIA4通过介导糖代谢重编程改变乳腺癌的生物学特性报告作者：Haochen Yu P5-01-25: Romidepsin Targets HDAC1/2 to Induce Ferroptosis in TNBC Enhancing Chemosensitivity to Eribulin Romidepsin靶向HDAC1/2诱导TNBC的铁死亡增强对艾立布林的化疗敏感性报告作者：Weipeng ZHAO P5-01-29: Development of a Novel Antigen Presentation Assay in Triple-negative Breast Cancer 三阴性乳腺癌新型抗原呈递检测方法的开发报告作者：Mei Li P5-02-24: Targeting FOXK2 signaling in breast cancers with FOXK2 amplification/overexpression and PIK3CA oncogenic mutations: a promising therapeutic strategy? 靶向FOXK2信号通路在具有FOXK2扩增/过表达和PIK3CA致癌突变的乳腺癌：一个有前景的治疗策略？报告作者：Hong Zhang P5-03-13: Trastuzumab emtansine versus disitamab vedotin for HER2-positive metastatic breast cancer: a multicenter retrospective real-world study 比较恩美曲妥珠单抗与维迪西妥单抗治疗HER2阳性转移性乳腺癌：一项多中心回顾性真实世界研究报告作者：Huihui Li P5-03-14: Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer in firstline/second-line setting 含inetetamab方案在HER2阳性转移性乳腺癌患者一线/二线治疗中的疗效和安全性报告作者：Yuxin Mu P5-03-25: Trastuzumab deruxtecan (T-DXd) in leptomeningeal metastases from HER2-altered cancers T-DXd治疗HER2突变癌症患者的软脑膜转移报告作者：Qian Ma P5-03-27: Updated Real-World Evidence on the Efficacy and Safety of Inetetamab-Based Therapy in HER2-Positive Metastatic Breast Cancer Patients Previously Treated with Trastuzumab 基于inetetamab治疗曲妥珠单抗治疗过的HER2阳性转移性乳腺癌患者有效性和安全性的最新真实世界证据报告作者：Yangyang Duan P5-04-16: Stromal tumor-infiltrating lymphocytes-based model predicts efficacy for neoadjuvant therapy in HER2-low early breast cancer 基于间质瘤浸润淋巴细胞的模型预测HER2低表达早期乳腺癌新辅助治疗的疗效报告作者：Zhuxi Duan P5-04-18: Clinical Validation of an Ultra-Sensitive ctDNA NGS Assay in HR-Positive, HER2-Negative Breast Cancer Patients 超敏感ctDNA NGS检测在HR阳性/HER2阴性乳腺癌患者中的临床验证报告作者：Haoran Tang P5-04-22: Prognostic value of circulating tumor DNA (ctDNA) in early triple-negative breast cancer (TNBC): A systematic review and meta-analysis 循环肿瘤DNA（ctDNA）在早期三阴性乳腺癌（TNBC）中的预后价值：一项系统综述和荟萃分析报告作者：Diana Zhang P5-04-25: Detection of Human Epidermal Growth Factor Receptor 2 (HER2) in Cultured Circulating Tumor Cells (CTCs) Isolated from Peripheral Blood of Breast Cancer Patients 从乳腺癌患者外周血分离培养的循环肿瘤细胞（ctc）中人类表皮生长因子受体2 （HER2）的检测报告作者：Ying Chang P5-04-26: Prevalence of BRCA1, BRCA2, and PALB2 genomic alterations among 924 Taiwanese breast cancer assays with tumor-only targeted sequencing: extended data analysis from the VGH-TAYLOR study 应用仅肿瘤靶向测序的924例台湾乳腺癌检测中BRCA1、BRCA2和PALB2基因组改变的患病率：来自VGH-TAYLOR研究的扩展数据分析报告作者：Han Fang Cheng P5-05-02: Pharmacokinetic profile and preliminary efficacy of GQ1001, a next generation HER2-targeting ADC, combined with pyrotinib in pretreated patients with HER2-positive metastatic breast cancer: A phase 1b clinical trial 下一代靶向HER2的ADC GQ1001联合吡咯替尼治疗既往接受过治疗的HER2阳性转移性乳腺癌患者的药代动力学特征和初步疗效：一项1b期临床试验报告作者：Biyun Wang P5-05-07: A prospective, multicenter, single-arm clinical study of inetetamab combined with pyrotinib and capecitabine/vinorelbine in the treatment of HER2-positive metastatic breast cancer resistant to previous trastuzumab treatment inetetamab联合吡咯替尼和卡培他滨/长春瑞滨治疗曲妥珠单抗耐药的HER2阳性转移性乳腺癌的前瞻性、多中心、单臂临床研究报告作者：Yan Xue P5-05-08: Inetetamab-base regimens for patients with HER2- positive metastatic breast cancer and brain metastases: a realworld retrospective study 以inetetamab为基础的方案治疗HER2阳性转移性乳腺癌和脑转移患者：一项真实世界回顾性研究报告作者：Liping Chen P5-05-09: Trastuzumab deruxtecan combined with pyrotinib in first-line HER2-positive unresectable or metastatic breast cancer: an exploratory, multi-center, single-arm, phase Ib/II study (TROPHY) 德曲妥珠单抗联合吡咯替尼一线治疗HER2阳性不可切除或转移性乳腺癌：一项探索性、多中心、单组、Ib/II期研究（TROPHY）报告作者：Ying Fan P5-05-12: Real-world outcome of patients with HER2-positive metastatic breast cancer who were treated with inetetamabcontaining regimens: A multicenter retrospective analysis conducted in China 含inetetamab方案治疗HER2阳性转移性乳腺癌患者的真实世界结局：一项中国多中心回顾性分析报告作者：Huihui Li P5-05-14: Real-World Treatment Patterns and Clinical Outcomes of Inetetamab combined with pyrotinib plus chemotherapy in Her-2 negative metastatic breast cancer patients : a multi-center retrospective study HER2阴性转移性乳腺癌患者Inetetamab联合吡咯替尼联合化疗的真实世界治疗模式和临床结局：一项多中心回顾性研究报告作者：Huanhuan Zhou P5-05-16: Real-world analysis of inetetamab-based therapy for the treatment of HER2-positive advanced breast cancer. 基于inetetamab治疗HER2阳性晚期乳腺癌的真实世界分析报告作者：Cailing Lin P5-05-17: Trastuzumab deruxtecan for HER2-positive and HER2- low breast cancer brain metastasis: Results from a singleinstitution retrospective study. 德曲妥珠单抗治疗HER2阳性和HER2低表达的乳腺癌脑转移：一项单机构回顾性研究结果报告作者：Chunfang Hao P5-05-22: ARX788 for patients with HER2-positive advanced breast cancer: characterization, time course, and monitoring and management of adverse event from the phase III ACE-Breast-02 study ARX788治疗HER2阳性晚期乳腺癌患者：ACE-Breast-02 III期研究的特征、时间进程以及不良事件的监测和管理报告作者：Jian Zhang P5-05-24: RC48-ADC (Disitamab vedotin, a HER2-directed antibody-drug conjugate) in Combination with Pyrotinib for Trastuzumab-treated HER2-Positive Recurrent or Metastatic Breast Cancer: A Phase Ib/II Study RC48-ADC （Diitamab vedotin，一种靶向HER2的抗体-药物偶联物）联合吡咯替尼治疗曲妥珠单抗经治的HER2阳性复发或转移性乳腺癌：一项Ib/II期研究报告作者：Xinrui Liang P5-05-29: Real-world efficacy and safety of inetetamab-based therapy in patients with HER2- positive metastatic breast cancer with prior trastuzumab exposure: A prospective real-world study 在曲妥珠单抗暴露的HER2阳性转移性乳腺癌患者中，基于inetetamab的治疗的真实世界疗效和安全性：一项前瞻性真实世界研究报告作者：Dedian Chen （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

2024-11-18

·恒瑞医药

2024 SABCS前瞻︱恒瑞医药创新药26项乳腺癌领域研究将闪耀国际学术盛会

2024年第47届圣安东尼奥乳腺癌研讨会（SABCS）将于12月10日至13日在美国圣安东尼奥举行。作为乳腺癌研究领域规模最大、最负盛名的学术盛会之一，SABCS旨在为国际学术界、医生和研究人员提供乳腺癌及癌前乳腺疾病的实验生物学、病因学、预防、诊断和治疗的最新相关信息。本次大会，恒瑞医药共有人表皮生长因子1/2/4（HER1/HER2/HER4）靶向药物吡咯替尼、CDK4/6抑制剂达尔西利、PD-1抑制剂卡瑞利珠单抗、多靶点受体酪氨酸激酶抑制剂法米替尼、TPO受体激动剂海曲泊帕、PARP抑制剂氟唑帕利、VEGFR2抑制剂阿帕替尼、HER2抗体偶联药物（ADC）SHR-A1811等8款创新药的26项研究入围[1]，其中3项口头报告，3项壁报焦点（Poster Spotlight），20项壁报展示。本文特做梳理，一同浏览恒瑞医药在乳腺癌领域的系列重磅创新成果。 1. 摘要号：GS3-06 文章题目：卡瑞利珠单抗联合化疗新辅助治疗早期或局部晚期三阴性乳腺癌：一项随机、双盲、III期试验 Neoadjuvant camrelizumab plus chemotherapy (chemo) for early or locally advanced triple-negative breast cancer (TNBC): a randomized, double-blind, phase 3 trial 汇报形式：口头报告作者：邵志敏单位：复旦大学附属肿瘤医院 2. 摘要号：GS1-03 文章题目：吡咯替尼或安慰剂联合曲妥珠单抗与多西他赛用于未经治疗的转移性HER2阳性乳腺癌：III期PHILA试验的无进展生存（PFS）预设最终分析 Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial 汇报形式：口头报告作者：徐兵河单位：中国医学科学院肿瘤医院 3. 摘要号：GS1-04 文章题目：HER2靶向抗体药物偶联物SHR-A1811新辅助治疗HER2阳性早期乳腺癌：一项前瞻性、随机、开放标签的II期试验 HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial 汇报形式：口头报告作者：李俊杰单位：复旦大学附属肿瘤医院 4. 摘要号：PS2-01 文章题目：达尔西利联合来曲唑或阿那曲唑作为一线治疗HR+/HER2-晚期乳腺癌：III期DAWNA-2试验无进展生存（PFS）预设的最终分析 Dalpiciclib versus placebo in combination with letrozole or anastrozole as first-line treatment for women with HR+/HER2- advanced breast cancer: prespecified final analysis of progression-free survival of the phase 3 DAWNA-2 trial 汇报形式：焦点壁报作者：徐兵河单位：中国医学科学院肿瘤医院 5. 摘要号：PS3-07 文章题目：SHR-A1811新辅助治疗HR阳性、HER2低表达乳腺癌患者：一项开放标签、单臂、二阶段II期临床试验的第一阶段结果 SHR-A1811 as Neoadjuvant Treatment in Patients with HR-Positive, HER2-low Breast Cancer: The first-stage results from an open-label, single-arm, two-stage, phase II clinical trial 汇报形式：焦点壁报作者：刘真真单位：河南省肿瘤医院 6. 摘要号：PS8-08 文章题目：SHR-A1811（一种抗HER2 ADC）在391例经多线治疗的HER2表达或突变的晚期实体瘤中的疗效与安全性：一项全球多中心首次人体临床I期研究 Efficacy and safety of SHR-A1811, an anti-HER2 antibody-drug conjugate (ADC), in 391 heavily pretreated multiple solid tumors with HER2-expression or mutations: a global, multi-center, first-in-human, phase 1 study 汇报形式：焦点壁报作者：姚和瑞单位：中山大学孙逸仙纪念医院 7. 摘要号：P1-02-12 文章题目：海曲泊帕治疗乳腺癌患者癌症治疗引起的血小板减少症的疗效与安全性：一项前瞻性II期研究 Prospective phase II study on the efficacy and safety of hetrombopag for the treatment of cancer therapy-induced thrombocytopenia in patients with breast cancer 汇报形式：壁报展示作者：姜晗昉单位：北京大学肿瘤医院 8. 摘要号：P1-04-12 文章题目：优化吡咯替尼在HER2阳性早期高风险乳腺癌中的耐受性：一项多中心、随机、三队列研究 Optimizing Tolerability of Pyrotinib in HER2-Positive Early-Stage High-Risk Breast Cancer: A Multicenter, Randomized, Three-Cohort Study 汇报形式：壁报展示作者：厉红元、程巧单位：重庆医科大学附属第一医院 9. 摘要号：P1-05-24 文章题目：SHR-A1811在HER2阳性乳腺癌新辅助治疗中疗效的生物标志物与空间决定因素 Biomarkers and Spatial Determinants of SHR-A1811 Efficacy in Neoadjuvant Treatment for HER2-Positive Breast Cancer 汇报形式：壁报展示作者：邵志敏单位：复旦大学附属肿瘤医院 10. 摘要号：P1-06-01 文章题目：卡瑞利珠单抗联合治疗三阴性乳腺癌的疗效与安全性：一项系统性综述与荟萃分析 Efficacy and Safety of Camrelizumab Combination Therapy in Triple-Negative Breast Cancer: A Systematic Review and Meta-Analysis 汇报形式：壁报展示作者：Moazzam Shahzad 11. 摘要号：P2-09-28 文章题目：达尔西利联合内分泌治疗晚期乳腺癌伴内脏危象患者：一项多中心、前瞻性、外部对照II期研究 Dalpiciclib plus endocrine therapy for visceral crisis in advanced breast cancer: a multicenter, prospective, external controlled phase 2 study 汇报形式：壁报展示作者：马飞、莫红楠单位：中国医学科学院肿瘤医院 12. 摘要号：P2-11-06 文章题目：新辅助化疗联合卡瑞利珠单抗对比单纯化疗治疗局部晚期免疫调节型三阴性乳腺癌患者：一项前瞻性、随机、开放标签II期试验 Neoadjuvant chemotherapy plus camrelizumab vs. chemotherapy in patients with locally advanced immunomodulatory triple-negative breast cancer: a prospective, randomized, open-label, phase 2 trial 汇报形式：壁报展示作者：陈力单位：复旦大学附属肿瘤医院 13. 摘要号：P2-12-22 文章题目：口服CDK4/6抑制剂达尔西利联合内分泌治疗在激素受体阳性、HER2阴性女性乳腺癌辅助治疗中的多中心、单臂Ⅱ期临床试验 A multicenter, single arm, phase II clinical trial of oral CDK4/6 inhibitor dalpiciclib in combination with endocrine therapy in adjuvant treatment for hormone receptor positive, HER2 negative female breast cancer 汇报形式：壁报展示作者：欧阳杰单位：东莞东华医院 14. 摘要号：P3-11-24 文章题目：白蛋白紫杉醇联合曲妥珠单抗和吡咯替尼新辅助治疗HER2阳性早期或局部晚期HER2富集亚型乳腺癌：一项多中心、单臂、II期试验 Neoadjuvant Nab-paclitaxel combined with Trastuzumab and Pyrotinib for HER2-enriched subtype of HER2-positive early or locally advanced breast cancer: A multicenter, single-arm, phase 2 trial 汇报形式：壁报展示作者：周文斌单位：江苏省人民医院 15. 摘要号：P3-11-26 文章题目：达尔西利联合来曲唑、帕妥珠单抗和曲妥珠单抗新辅助治疗HR+/HER2+乳腺癌的II期研究 A Phase II study of dalpiciclib combined with letrozole, pertuzumab and trastuzumab as neoadjuvant therapy in HR+/HER2+ breast cancer 汇报形式：壁报展示作者：曾晓华、梁新瑞单位：重庆市肿瘤医院 16. 摘要号：P3-12-22 文章题目：吡咯替尼、皮下曲妥珠单抗和卡培他滨新辅助治疗HER2阳性早期乳腺癌：一项前瞻性、单臂、多中心研究 Neoadjuvant Therapy with Pyrotinib, Subcutaneous Trastuzumab, and Capecitabine for HER2-Positive Early Breast Cancer: A Prospective, Single-Arm, Multicenter Trial 汇报形式：壁报展示作者：张丽娜单位：天津市肿瘤医院 17. 摘要号：P5-05-02 文章题目：GQ1001（新一代HER2靶向ADC）联合吡咯替尼治疗HER2阳性转移性乳腺癌经治患者的药代动力学特征和初步疗效：一项Ib期临床试验 Pharmacokinetic profile and preliminary efficacy of GQ1001, a next generation HER2-targeting ADC, combined with pyrotinib in pretreated patients with HER2-positive metastatic breast cancer: A phase 1b clinical trial 汇报形式：壁报展示作者：王碧芸单位：复旦大学附属肿瘤医院 18. 摘要号：P5-05-07 文章题目：伊尼妥单抗联合吡咯替尼和卡培他滨/长春瑞滨治疗曲妥珠单抗经治耐药的HER2阳性转移性乳腺癌的前瞻性、多中心、单臂临床研究 A prospective, multicenter, single-arm clinical study of inetetamab combined with pyrotinib and capecitabine/vinorelbine in the treatment of HER2-positive metastatic breast cancer resistant to previous trastuzumab treatment 汇报形式：壁报展示作者：薛妍单位：西安国际医学中心医院 19. 摘要号：P5-05-09 文章题目：德曲妥珠单抗联合吡咯替尼一线治疗HER2阳性不可切除或转移性乳腺癌：一项探索性、多中心、单臂、Ib/II期研究（TROPHY） Trastuzumab deruxtecan combined with pyrotinib in first-line HER2-positive unresectable or metastatic breast cancer: an exploratory, multi-center, single-arm, phase Ib/II study (TROPHY) 汇报形式：壁报展示作者：樊英单位：中国医学科学院肿瘤医院 20. 摘要号：P5-05-14 文章题目：伊尼妥单抗联合吡咯替尼和化疗治疗HER2阳性转移性乳腺癌患者的真实世界治疗模式与临床结果：一项多中心回顾性研究 Real-World Treatment Patterns and Clinical Outcomes of Inetetamab combined with pyrotinib plus chemotherapy in Her-2 positive metastatic breast cancer patients : a multi-center retrospective study 汇报形式：壁报展示作者：周欢欢单位：浙江省肿瘤医院 21. 摘要号：P5-05-24 文章题目：维迪西妥单抗（RC48-ADC）联合吡咯替尼治疗曲妥珠单抗经治的HER2阳性复发或转移性乳腺癌：一项Ib/II期研究 RC48-ADC (Disitamab vedotin, a HER2-directed antibody-drug conjugate) in Combination with Pyrotinib for Trastuzumab-treated HER2-Positive Recurrent or Metastatic Breast Cancer: A Phase Ib/II Study 汇报形式：壁报展示作者：周鑫、梁新瑞单位：重庆市肿瘤医院 22. 摘要号：P5-07-20 文章题目：伊尼妥单抗联合吡咯替尼和白蛋白结合型紫杉醇新辅助治疗HER2阳性早期及局部晚期乳腺癌患者的前瞻性、开放标签、单臂II期临床研究：临床试验最新进展 A prospective, open-label, single-arm phase II clinical study of inetetamab in combination pyrotinib & albumin-bound paclitaxel for neoadjuvant treatment of patients with HER2+ early & locally advanced breast cancer: updates on clinical trial 汇报形式：壁报展示作者：李南林单位：空军军医大学西京医院 23. 摘要号：P5-07-23 文章题目：吡咯替尼联合曲妥珠单抗和芳香化酶抑制剂新辅助治疗HER2+/HR+乳腺癌的疗效与安全性：一项单臂、多中心、II期探索性研究 Efficacy and Safety of Pyrotinib Combined with Trastuzumab and Aromatase Inhibitor in Neoadjuvant Treatment of HER2+/HR+ Breast Cancer: A Single-Arm, Multi-Center Phase II Exploratory Study 汇报形式：壁报展示作者：葛洁单位：天津市肿瘤医院 24. 摘要号：P5-09-17 文章题目：基于SNF分型的多组学精准医学在CDK4/6抑制剂治疗失败的HR+/HER2-晚期乳腺癌中的应用：Linux试验（产品：卡瑞利珠单抗、法米替尼、氟唑帕利、阿帕替尼） Precision medicine based on similarity network fusion (SNF) subtypes of multi-omics in CDK4/6 inhibitor failed HR+/ HER2- advanced breast cancer: the Linux trial 汇报形式：壁报展示作者：邵志敏单位：复旦大学附属肿瘤医院 25. 摘要号：P5-09-28 文章题目：吡咯替尼联合曲妥珠单抗及达尔西利、来曲唑术前治疗早期或局部晚期HR阳性、HER2阳性乳腺癌的Ⅱ期前瞻性探索性临床研究（Chefoo-TP48） A phase Ⅱ, prospective exploratory clinical study of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for patients with HR-positive, HER2-positive early or locally advanced breast cancer (Chefoo-TP48) 汇报形式：壁报展示作者：乔广东、丛义滋单位：烟台毓璜顶医院 26. 摘要号：P5-09-29 文章题目：曲妥珠单抗联合吡咯替尼和卡培他滨作为HER2阳性早期乳腺癌新辅助治疗后未达病理完全缓解的术后辅助治疗：一项多中心II期研究 Trastuzumab Combined with Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in NonPathological Complete Response HER2-Positive Early Breast Cancer Following Neoadjuvant Therapy: A Multicenter Phase II study 汇报形式：壁报展示作者：王川单位：福建医科大学附属协和医院本次SABCS，恒瑞医药将亮相的8款创新药的26项重磅研究，覆盖了多种乳腺癌亚型，涉及一线、辅助、新辅助等多个疾病阶段适应症人群，将展现公司多款不同作用机制的创新产品布局乳腺癌治疗领域的实力，也将向世界展示中国乳腺癌领域的研发创新力量。作为创新型国际化制药企业，恒瑞医药多年来深入践行“科技为本、为人类创造健康生活”的使命，针对高发肿瘤领域持续进行创新研发，已在国内获批上市17款1类创新药、4款自研2类新药。未来，恒瑞医药将继续坚持“以患者为中心”的理念，重创新，强研发，力争研制出更多更好的新药，努力守护患者健康生活和生命质量。参考资料： 1.https://sabcs.org/FullProgram 声明： 1.本新闻旨在分享学术前沿动态，仅供医疗卫生专业人士基于学术目的参阅，非广告用途。 2.恒瑞医药不对任何药品和/或适应症作推荐。 3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。撰稿：中央医学事务部排版：程梦真责编：李玉莹往期精选 | 研发创新 | 慢病创新里程碑！恒瑞首个自免创新药夫那奇珠单抗获批上市恒瑞医药新突破！中国首个自研阿片类镇痛创新药富马酸泰吉利定获批上市 | 国际化 | 海外BD再传捷报！恒瑞医药GLP-1类创新药组合实现海外许可恒瑞医药与默克达成合作，携手推进癌症创新疗法 | 重磅奖项 | 喜报！恒瑞医药荣获2023年度国家科技进步奖恒瑞医药连续六年入选全球制药企业50强榜单！ | 社会公益 | “健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

临床3期临床结果抗体药物偶联物临床2期临床成功

100 项与 GQ-1001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HER2阳性转移性乳腺癌	临床2期	中国	启德医药科技（苏州）有限公司	2022-10-01
晚期恶性实体瘤	临床1期	美国	启德医药科技（苏州）有限公司	2020-07-07
晚期恶性实体瘤	临床1期	中国	启德医药科技（苏州）有限公司	2020-07-07
晚期恶性实体瘤	临床1期	澳大利亚	启德医药科技（苏州）有限公司	2020-07-07
HER2阳性胆道肿瘤	临床1期	美国	启德医药科技（苏州）有限公司	2020-07-07
HER2阳性胆道肿瘤	临床1期	中国	启德医药科技（苏州）有限公司	2020-07-07
HER2阳性胆道肿瘤	临床1期	澳大利亚	启德医药科技（苏州）有限公司	2020-07-07
HER2阳性乳腺癌	临床1期	美国	启德医药科技（苏州）有限公司	2020-07-07
HER2阳性乳腺癌	临床1期	澳大利亚	启德医药科技（苏州）有限公司	2020-07-07
HER2阳性唾液腺癌	临床1期	美国	启德医药科技（苏州）有限公司	2020-07-07

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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


NCT04450732 (phase Ia study of a novel anti-HER2 antibody-drug conjugate GQ1001, Pubmed \| J Transl Med)	临床1期	HER2阳性实体瘤 HER2 positive	32	GQ1001 7.2 mg/kg	願鑰鹽構顧鹹衊構鹽糧(憲積醖艱醖簾齋鹽襯獵) = 4/32, 12.5% 齋鑰鹹構艱積鏇鏇衊構 (顧築夢鏇構窪蓋衊積願 )	积极	2025-01-09
				GQ1001 8.4 mg/kg
NCT05575804 (SABCS2024) 人工标引	临床1期	HER2阳性乳腺癌二线 HER2 Positive	15	GQ1001 6.0 mg/kg	膚範艱艱簾夢選繭衊憲(餘遞鬱膚餘鹹範鑰齋窪) = 淵製鹹淵觸觸鹽廠構淵鬱製艱遞壓獵齋窪鏇艱 (蓋築襯廠襯鑰觸膚醖製 )	积极	2024-11-26
				GQ1001 7.2 mg/kg	膚範艱艱簾夢選繭衊憲(餘遞鬱膚餘鹹範鑰齋窪) = 鏇選鏇憲網鑰餘襯壓鏇鬱製艱遞壓獵齋窪鏇艱 (蓋築襯廠襯鑰觸膚醖製 )
NCT04450732 (AACR2023) 人工标引	临床1期	HER2阳性实体瘤一线 HER2 Positive	15	GQ1001	憲鹹構餘觸鏇廠鹹觸糧(廠醖醖衊艱願醖築夢艱) = 選襯糧觸鏇糧蓋糧憲觸顧積壓齋憲鑰製壓淵齋 (餘選醖繭鬱鹽觸壓壓繭 ) 更多	积极	2023-04-14
				GQ1001	鬱窪鬱鑰窪憲鏇範鬱繭(鏇艱遞製襯構醖顧糧壓) = 顧糧製衊壓壓獵艱選壓艱願蓋築壓憲選夢淵鑰 (餘廠憲醖廠鬱鑰積簾糧 ) 更多