Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate (ADC)) for Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer

This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer. ARX788 is an antibody-drug conjugate (ADC) that is given by infusion (diluted and injected slowly into veins). Antibodies are proteins which are naturally produced by the body's immune system to help fight infections. ARX788 consists of antibodies that have been attached to a toxin that has the potential to kill cancer cells. ARX788 sticks to a protein called human epidermal growth factor receptor (HER2), which is found on some breast cancer cells. Giving ARX788 may be safe and effective in treating patients with HER2-low locally advanced unresectable metastatic breast cancer.

开始日期2025-10-01

申办/合作机构

The University of California, San Francisco

[+1]

ChiCTR2400092470

/ Not yet recruiting临床2期IIT

Evaluate the efficacy and safety of ARX788 given every 6 weeks in patients with HER2-positive advanced breast cancer

开始日期2024-11-20

申办/合作机构

浙江新码生物医药有限公司

NCT06663748

/ Not yet recruiting临床2期IIT

Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients with HER2-positive Advanced Breast Cancer

A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.

开始日期2024-11-20

申办/合作机构

河南省肿瘤医院

100 项与重组人源化抗HER2单抗-AS269偶联物(Ambrx) 相关的临床结果

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100 项与重组人源化抗HER2单抗-AS269偶联物(Ambrx) 相关的转化医学

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100 项与重组人源化抗HER2单抗-AS269偶联物(Ambrx) 相关的专利（医药）

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116

项与重组人源化抗HER2单抗-AS269偶联物(Ambrx) 相关的文献（医药）

2025-12-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Bystander effect in antibody-drug conjugates: Navigating the fine line in tumor heterogeneity

Review

作者: Li, Xuan ; Chen, Weijia ; Zhang, Xiaotao ; Liu, Yanhao ; Cheng, Xi ; Wang, Yiming

Antibody-drug conjugates (ADCs) represent a transformative advancement in targeted cancer therapy by combining monoclonal antibodies with cytotoxic payloads. A critical yet underexplored feature of ADCs is the bystander effect, wherein released payloads diffuse into neighboring cells regardless of target antigen expression. This review synthesizes current understanding of the mechanisms, clinical implications, and optimization strategies related to this phenomenon. Mechanistically, cleavable linkers, hydrophobic payloads, and internalization are critical for bystander activity. However, the characteristics of the tumor microenvironment-elevated interstitial fluid pressure, binding site barrier (BSB), and hypoxia-restrict ADC penetration. Clinically, ADCs with bystander effects (e.g., trastuzumab deruxtecan), demonstrate superior efficacy compared to non-bystander ADCs (e.g., trastuzumab emtansine). Despite these advantages, bystander effect raises concerns regarding off-target toxicity and variable efficacy depending on antigen expression. For instance, while the bystander effect allows payloads to penetrate BSB and increase the killing range, non-bystander ADCs like ARX788 may offer comparable efficacy with reduced toxicity in homogeneous settings. Current insights highlight the need to balance bystander potency with target specificity, particularly in tumors with low antigen density or heterogeneous spatial distribution. Future research should focus on three key areas: (1) quantifying bystander contributions in vivo; (2) clarifying spatiotemporal regulation of payload diffusion by TME factors such as hypoxia and binding-site barriers; and (3) validating combinatorial strategies, including Fc engineering, internalization induction, and TME remodeling, to maximize therapeutic indices. Bridging these gaps will refine ADC design paradigms, aligning with precision oncology's goal of optimizing efficacy while minimizing systemic toxicity.

2025-04-01·BREAST

Antibody-drug conjugates in elderly patients with breast cancer

Review

作者: Lay, Ludovica ; Puglisi, Fabio ; Esposto, Rocco ; Minisini, Alessandro Marco ; Aprile, Giuseppe ; Bonotto, Marta ; De Pieri, Giulia

Breast cancer remains a leading cause of cancer-related mortality worldwide, with elderly patients (aged >65 years) comprising a substantial portion of those affected. The treatment of breast cancer in this population is often complicated by frailty, comorbidities and polypharmacy. This review explores the application of antibody-drug conjugates (ADCs), such as trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), in treating breast cancer among elderly populations. The underrepresentation of older patients in clinical trials complicates efficacy and safety assessments in this group. Current evidence indicates that ADCs are both effective and tolerable in elderly patients, demonstrating improved progression-free survival (PFS) and overall survival (OS) alongside a manageable safety profile. Data from several trials like the EMILIA, TH3RESA and DestinyBreast studies demonstrate that T-DM1 and T-DXd maintained benefit in PFS and OS for HER2-positive breast cancer in older patients, despite a slight increase in adverse events. The ASCENT and TROPiCS-02 trials further confirm that SG provides significant improvements in PFS and OS in elderly patients at the cost of an increase in some toxicity. Emerging ADCs, including datopotamab deruxtecan and ARX-788, show promise but lack extensive geriatric-specific data. While the ADCs offer encouraging results in terms of efficacy and safety, with appropriate dose adjustments, further research is needed to optimize their use in elderly patients with breast cancer.

2023-04-06·Bioconjugate chemistry

One-Pot Assembly of Dual-Site-Specific Antibody-Drug Conjugates via Glycan Remodeling and Affinity-Directed Traceless Conjugation.

Article

作者: Jiang, Zhong-Xing ; Yao, Xu ; Tang, Feng ; Zeng, Yue ; Tang, Caihong ; Zhang, Jianxin ; Huang, Wei ; Zheng, Xing ; Shi, Wei

The drug-to-antibody ratio (DAR) value and dual-drug combination greatly influence the therapeutic index of antibody-drug conjugates (ADCs). The reported approaches usually require multifunctional branched linkers, a combination of complicated technologies, or protein-protein ligation, which may incorporate multihydrophobic fragments or result in low coupling efficiency. Herein, we developed a facile and efficient one-pot method to assemble dual-site-specific ADCs with defined DARs at both the N-glycosylation site and K248 site, either with the same payloads or with two types of payloads. The constructed dual-site ADCs showed acceptable homogeneity, excellent buffer stability, and enhanced in vitro and in vivo efficiency.

236

项与重组人源化抗HER2单抗-AS269偶联物(Ambrx) 相关的新闻（医药）

2025-10-08

·ioncology

ESMO 2025丨一文汇总乳腺癌领域中国专家入选的壁报研究

点击蓝字，关注我们编者按：2025年欧洲肿瘤内科学会年会（ESMO 2025）将于10月17日至21日在德国柏林召开，作为肿瘤学界的年度盛典，ESMO每年都会吸引上万名世界各地的肿瘤学专家参与，为全球学者提供了良好的交流平台。日前，ESMO已公布大会常规摘要（含Oral、Mini Oral、Poster三类）和“突破性摘要”（Late-Breaking Abstract，LBA）标题。肿瘤瞭望特将目前乳腺癌领域入选的中国专家投稿壁报研究进行汇总，并诚邀您持续关注重磅研究进展！ Breast cancer, early stage （早期乳腺癌） 298P - Development and validation of a novel HER2RI assay for predicting the risk of recurrence and survival in Asian population with HER2-positive breast cancer 用于预测亚洲HER2阳性乳腺癌患者复发和生存风险的新型HER2RI检测方法的开发和验证讲者：Yi-Kun Kang (Beijing, China) 300P - TIME-HER: A Dynamic Predictive Model for Prognosis of HER2-Positive Early Breast Cancer after HER2-targeted Therapy TIME-HER：HER2靶向治疗后HER2阳性早期乳腺癌预后的动态预测模型讲者：Qingyao Shang (Beijing, China) 305P - Neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer: three-year outcomes from the MUKDEN 01 study MUKDEN 01研究三年随访结果：吡咯替尼联合来曲唑及达尔西利新辅助治疗三阳性乳腺癌的疗效分析讲者：刘彩刚（中国医学大学附属盛京医院） 306P - Neoadjuvant SHR-A1811 with or without pyrotinib in HER2-positive breast cancer (MUKDEN 07): A multi-cohort, multicenter, phase II clinical trial MUKDEN 07研究：一项针对HER2阳性乳腺癌的多队列、多中心Ⅱ期临床试验，评估新辅助治疗中SHR-A1811联合或不联合吡咯替尼的疗效讲者：刘彩刚（中国医学大学附属盛京医院） 312P - Comparison of survival outcomes between neoadjuvant and adjuvant therapy in patients with T1c, lymph node-negative, and hormone receptor-negative breast cancer: a study based on the SEER database and a Chinese cohort T1c期、淋巴结阴性且激素受体阴性乳腺癌患者新辅助治疗与辅助治疗生存结局的对比研究：基于SEER数据库与中国队列的分析讲者：Shiyu Liang (Chengdu, China) 317P - Myeloprotection with Trilaciclib in Hormone Receptor (HR)-Negative early breast cancer receiving adjuvant therapy Trilaciclib在激素受体（HR）阴性早期乳腺癌辅助治疗中的骨髓保护作用讲者：Jiajia Huang (Guangzhou, China) 344P - Inadequate ovarian suppression in young premenopausal women with estrogen receptor-positive breast cancer on ovarian suppression therapy 接受卵巢功能抑制治疗的年轻绝经前雌激素受体阳性乳腺癌患者卵巢抑制不充分的现象讲者：Dar-Ren Chen (Changhua City, Taiwan) 348P - Ten-Year Outcomes of Epirubicin Plus Paclitaxel Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel in Hormone Receptor–Positive, ERBB2-Negative, Node-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial 表柔比星联合紫杉醇对比表柔比星联合环磷酰胺序贯紫杉醇治疗激素受体阳性、ERBB2阴性、淋巴结阳性乳腺癌的10年随访结局比较：一项3期随机临床试验讲者：Liuliu Quan (Beijing, China) 382P - A modern DCIS-IBC guide board for postoperative upgrading in ductal carcinoma in situ 导管原位癌术后升级为浸润性乳腺癌的现代风险评估指南框架讲者：Chenglong Duan (xian, China) 383P - Spatial transcriptomics reveals biological disparities in ipsilateral breast tumor recurrence after breast-conserving surgery 空间转录组学揭示保乳术后同侧乳腺肿瘤复发的生物学差异讲者：FEILIN QU (Shanghai, China) 385P - Is axillary intervention necessary for selected patients with cN0-1 breast cancer after neoadjuvant chemotherapy? 新辅助化疗后的cN0-1乳腺癌患者是否有必要进行腋窝干预？讲者：Yuhan Zhang (Xi'an, Shaanxi Province, China) 386P - The Innovative Lancet Technique for Breast-Conserving Oncoplastic Surgery in Small- to Medium-Sized Breasts with Tumors in the Lower Inner Quadrant: A Multicenter Retrospective Study (IOS Study) 针对中小乳房下内侧象限肿瘤的保乳整形手术创新Lancet技术：一项多中心回顾性研究（IOS研究）讲者：Wenjie Shi (Magdeburg, Germany) 389P - A Competing Risk Analysis Model to Explore the Impact of Postoperative Radiotherapy for Sentinel Lymph Node Micrometastases or ITCs in Female Breast Cancer 竞争风险分析模型探讨术后放疗对女性乳腺癌前哨淋巴结微转移或孤立肿瘤细胞（ITCs）的影响讲者：Yudong Zhou (xian, China) 391P - Application of Preoperative 3-dimensional Vascular Reconstruction Assessment in Preventing Ischemic Complications After Nipple-Sparing Mastectomy: A Randomized Controlled Trial 术前三维血管重建评估在预防保留乳头乳房切除术后缺血性并发症中的应用：一项随机对照试验讲者：Xiaoqi Zhang (Guangzhou, China) 398P - Patient-reported outcomes (PROs) with GnRHa as ovarian function suppression (OFS) treatment in pre-menopausal Chinese patients with hormone receptor-positive (HR+) early breast cancer (EBC): a real-world observational investigation GnRHa作为卵巢功能抑制（OFS）治疗绝经前激素受体阳性（HR+）早期乳腺癌（EBC）患者的患者报告结局（PROs）：一项真实世界观察性研究讲者：范蕾（复旦大学附属肿瘤医院） 403P - Axillary Lymph Node Dissection Offers No Survival Benefit in Breast Cancer Patients with Sentinel Lymph Node Micrometastases After Neoadjuvant Therapy 腋窝淋巴结清扫术对新辅助治疗后前哨淋巴结微转移的乳腺癌患者无生存获益讲者：Jianing Zhang (Xi'an, China) 414P - Prognostic Value of ER reduction rate between pre- and post- Neoadjuvant Chemotherapy in Patients with ER-Positive/HER2-Negative Breast Cancer 新辅助化疗前后ER降低率对ER阳性/ her2阴性乳腺癌患者的预后价值讲者：Shunyi Liu (Fuzhou, China) 416P - Diverse adjuvant treatment in triple-negative breast cancer patients with residual disease after neoadjuvant chemotherapy: A single center real-world study 新辅助化疗后残留病灶的三阴性乳腺癌患者的多样化辅助治疗：一项单中心真实世界研究讲者：Xi Chen (Beijing, China) 417P - Proteomic analysis of residual disease identifies potential prognostic biomarkers of triple-negative breast cancer after neoadjuvant chemotherapy 三阴性乳腺癌新辅助化疗后残留病灶的蛋白质组学分析确定潜在的预后生物标志物讲者：Xi Chen (Beijing, China) 418P - Impact of BRCAness Status on Prognosis and Chemotherapy Sensitivity in Non-pCR Triple-Negative Breast Cancer Patients After Neoadjuvant Treatment BRCA样状态对新辅助治疗后未达病理完全缓解（non-pCR）三阴性乳腺癌患者预后及化疗敏感性的影响讲者：Hangcheng Xu (Beijing, China) Breast cancer, locally advanced （局部晚期乳腺癌） 466P - Efficacy and Safety of JS105, a Selective Inhibitor of Mutant PI3Kα, in Patients with Advanced Cancer 选择性突变型PI3Kα抑制剂JS105在晚期癌症患者中的疗效与安全性研究讲者：闫敏（河南省肿瘤医院） 468P - The Clinical Significance and Prognostic Impact of stromal tumor infiltrating lymphocytes in HER2-Positive Breast Cancer: Including a Neoadjuvant Subgroup Analysis HER2阳性乳腺癌间质肿瘤浸润淋巴细胞的临床意义和预后影响：包括新辅助治疗亚组分析讲者：Yujing Chang (Chengdu, China) 470P - Neoadjuvant cadonilimab (anti-PD-1/CTLA-4 bispecific antibody) plus chemotherapy in early or locally advanced triple-negative breast cancer: supplementary biomarker analyses from CABIN trial 新辅助cadonilimab（抗pd -1/CTLA-4双特异性抗体）联合化疗治疗早期或局部晚期三阴性乳腺癌：来自CABIN试验的补充生物标志物分析讲者：TAO WU (Changde City, China) 472P - The mechanism and preclinical translational research of targeted inhibition of ATM enhancing the therapeutic efficacy of PD-1/PD-L1 inhibitors in triple-negative breast cancer by modulating CD8⁺T cells in the tumor immune microenvironment 靶向抑制ATM通过调控肿瘤免疫微环境中CD8⁺T细胞增强PD-1/PD-L1抑制剂治疗三阴性乳腺癌的机制及临床前转化研究讲者：Xiaojing Guo (Tianjin, China) 473P - Neoadjuvant Trilaciclib plus chemotherapy and anti-PD1-antibody for locally advanced triple-negative breast cancer: Preliminary short-term efficacy and safety results from a single-arm, multicenter, phase II trial 新辅助治疗中Trilaciclib联合化疗及抗PD-1抗体治疗局部晚期三阴性乳腺癌：一项单臂、多中心Ⅱ期试验的初步短期疗效与安全性结果讲者：Jiaxuan Liu (Beijing, China) 479P - H4K8la/CXCL10-driven M2 polarization via tumor cell-macrophage lactate feedback loop mediates doxorubicin resistance in TNBC H4K8la/CXCL10通过肿瘤细胞-巨噬细胞乳酸反馈回路驱动M2型巨噬细胞极化，介导三阴性乳腺癌对多柔比星的耐药性讲者：Qingqing Wang (Wuhan, China) Breast cancer, metastatic （转移性乳腺癌） 490P - Bireociclib plus Letrozole/Anastrozole versus Placebo plus Letrozole/Anastrozole for the Treatment of HR+/HER2- Advanced Breast Cancer: Interim Analysis of BRIGHT-3 study 吡洛西利联合来曲唑/阿那曲唑vs安慰剂联合来曲唑/阿那曲唑治疗HR+/HER2-晚期乳腺癌的比较：BRIGHT-3研究的期中分析讲者：张清媛（哈尔滨医科大学附属肿瘤医院） 495P - Safety and efficacy of nab-Sirolimus (HB1901) + endocrine therapy in HR+/HER2- advanced breast cancer after standard therapy failure: A multicenter, open-label, phase 2 study 白蛋白结合型西罗莫司（HB1901）联合内分泌治疗在标准治疗失败后的HR+/HER2-晚期乳腺癌中的安全性和有效性：一项多中心、开放标签、II期研究讲者：马飞（中国医学科学院肿瘤医院） 501P - Efficacy and Safety Outcomes across Young to Older Age Groups of Patients with HR+/HER2- Advanced Breast Cancer Treated with Bireociclib plus Endocrine Therapy: a Pooled Analysis of BRIGHT Studies 吡洛西利联合内分泌治疗HR+/HER2-晚期乳腺癌年轻和老年患者的疗效和安全性结局：BRIGHT研究的汇总分析讲者：张清媛（哈尔滨医科大学附属肿瘤医院） 505P - Safety and Preliminary Efficacy of a Novel CDK2/4 Inhibitor TYK-00540 in Patients with Advanced Solid Tumors: Results from a Phase I Dose-Escalation Study 新型CDK2/4抑制剂TYK-00540用于晚期实体瘤患者的安全性和初步疗效：来自1期剂量递增研究的结果讲者：孟艳春（复旦大学附属肿瘤医院） 509P - A Phase II Trial of Anlotinib and Fulvestrant in Patients with HR-Positive and HER2-Negative, Secondary Hormone Resistant, Metastatic Breast Cancer 安罗替尼+氟维司群治疗HR+/HER2-继发性激素抵抗性转移性乳腺癌患者的2期试验讲者：王晓稼（浙江省肿瘤医院） 513P - TY-302，a CDK4/6 inhibitor (CDK4/6i), combined with toremifene in patients with advanced solid tumors: Results from a phase Ia/Ib study. CDK4/6抑制剂（CDK4/6i）TY-302联合托瑞米芬治疗晚期实体瘤：Ia/Ib期研究结果讲者：马飞（中国医学科学院肿瘤医院） 518P - Efficacy and Safety of Treatments in HR+HER2- Advanced Breast Cancer After Cyclin-Dependent Kinase 4/6 inhibitors progression: A Network Meta-Analysis and Scoping Review CDK4/6抑制剂治疗进展后HR+/HER2-晚期乳腺癌治疗的疗效和安全性：一项网状meta分析和范围综述讲者：佟仲生（天津医科大学肿瘤医院） 525P - Efficacy and Safety of Post-CDK4/6 Inhibitor Treatment Options for HR-Positive, HER2-Negative Advanced Breast Cancer: A Network Meta-Analysis of Randomized Controlled Trials CDK4/6抑制剂后治疗方案对HR+/HER2阴-晚期乳腺癌的疗效和安全性：一项随机对照试验的网络荟萃分析讲者：Junxiao Wang (Fuzhou, China) 529P - PIK3CA Mutation Profiles in Primary and Metastatic Lesions in Chinese Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer 中国激素受体阳性、HER2阴性乳腺癌患者原发性和转移性病灶中PIK3CA的突变谱讲者：徐贵颖（吉林省肿瘤医院） 538P - Preliminary efficacy and safety of TQB2102 in patients with HER2 positive Recurrent/Metastatic Breast Cancer: Results from a phase Ib study TQB2102治疗HER2阳性复发/转移性乳腺癌患者的初步疗效和安全性：一项Ib期研究的结果讲者：张清媛（哈尔滨医科大学附属肿瘤医院） 545P - A Retrospective Multicenter Cohort Study on the Efficacy and Safety of Inetetamab and Pyrotinib Combined with Chemotherapy (IPyC) for HER2+ Metastatic Breast Cancer 伊尼妥单抗+吡咯替尼联合化疗（IPyC）治疗HER2+转移性乳腺癌的疗效和安全性回顾性多中心队列研究讲者：Wu Fan (Fuzhou, China) 546P - Efficacy and safety of Pyrotinib-based therapy after prior trastuzumab and pertuzumab in HER2-positive metastatic breast cancer: a multicenter, retrospective, real-world study 既往曲妥珠单抗和帕妥珠单抗治疗HER2阳性转移性乳腺癌后，接受以吡咯替尼为基础的治疗的有效性和安全性：一项多中心、回顾性、真实世界研究讲者：王涛（解放军总医院第五医学中心） 549P - Phase I study of ARX788 plus toripalimab in advanced solid tumors with expansion in HER2-low advanced breast cancer. ARX788联合特瑞普利单抗治疗HER2低表达的晚期实体瘤的I期研究讲者：王晓稼（浙江省肿瘤医院） 551P - SHR-A1811 combined with Adebrelimab in HR-/HR-low, HER2-low metastatic breast cancer: Preliminary results from an open-label, single-arm, phase II Trial SHR-A1811联合阿得贝利单抗治疗HR-/HR低表达、HER2低表达的转移性乳腺癌：开放标签、单臂、II期试验的初步结果讲者：Jiaxuan Liu (Beijing, China) 552P - Phase I study data of a novel eribulin-based HER2 ADC: Safety and efficacy of SMP-656 in HER2-expressing solid tumor 基于艾立布林的新型HER2 ADC的 I期研究数据：SMP-656在HER2表达实体瘤中的安全性和疗效讲者：张剑（复旦大学附属肿瘤医院） 556P - Updated Efficacy of Anti-TROP2 ADC ESG401 for First-Line Metastatic TNBC 抗TROP2 ADC ESG401治疗一线转移性TNBC的最新疗效讲者：邱福铭（浙江大学医学院附属第二医院） 559P - SHR-A1921, a novel trophoblast cell-surface antigen 2 targeted antibody-drug conjugate, with or without adebrelimab in advanced triple-negative breast cancer (TNBC): data from two open-label, multicenter clinical trials SHR-A1921，一种新型靶向滋养层细胞表面抗原2的抗体药物偶联物，联合或不联合阿得贝利单抗（adebrelimab）治疗晚期三阴性乳腺癌（TNBC）：两项开放标签、多中心临床试验的数据讲者：史业辉（天津医科大学肿瘤医院） 564P - Combined PD-1 Inhibition and Chidamide in Metastatic Triple-Negative Breast Cancer: A Phase II Clinical Trial PD-1抑制联合西达本胺治疗转移性三阴性乳腺癌：一项II期临床试验讲者：Sifen Wang (Guangzhou, China) 571P - Adebrelimab plus Apatinib and Etoposide in the Treatment of HER2-Negative Breast Cancer Brain Metastasis: A Phase II Study 阿得贝利单抗联合阿帕替尼和依托泊苷治疗HER2阴性乳腺癌脑转移：一项II期研究讲者：王涛（解放军总医院第五医学中心） 581P - Improving Survival in Heavily Treated Metastatic Breast Cancer Through Personalized Chemotherapy Selection Using Ex Vivo Expanded Circulating Tumor Cells 通过使用体外扩增的循环肿瘤细胞进行个体化化疗选择来改善重度治疗的转移性乳腺癌患者的生存讲者：Wen-Ying Lin (Taipei City, Taiwan) 595P - Efficacy and Safety of Rivaroxaban Prophylaxis on Catheter-Related Thrombosis in Breast Cancer Patients Undergoing Chemotherapy with PICC: A Prospective Cohort Study 利伐沙班预防乳腺癌化疗患者PICC导管相关性血栓形成的有效性和安全性：一项前瞻性队列研究讲者：Die Sang (Beijing, China) 598P - An observational clinical study to evaluate the consistency of PIK3CA mutations in tumor tissues and corresponding plasma circulating tumor DNA (ctDNA) of patients with HR+ mBC 一项观察性临床研究，旨在评估HR+mBC患者肿瘤组织中PIK3CA突变和相应血浆循环肿瘤DNA（ctDNA）的一致性讲者：欧阳取长（湖南省肿瘤医院） 599P - Efficacy and Safety of Dalpiciclib Combined with Endocrine Therapy After Progression on Prior CDK4/6 Inhibitors in HR+/HER2- Advanced Breast Cancer 在既往CDK4/6抑制剂经治的HR+/HER2-晚期乳腺癌发生进展后，达尔西利联合内分泌治疗的疗效和安全性讲者：李俏（中国医学科学院肿瘤医院） 600P - Matching-Adjusted Indirect Comparison of Bireociclib Plus Fulvestrant versus Dalpiciclib Plus Fulvestrant as Second-Line Treatment of HR+/HER2- Advanced Breast Cancer (ABC) 通过匹配校正间接比较吡洛西利+氟维司群与达尔西利+氟维司群作为HR+/HER2-晚期乳腺癌二线治疗的疗效（ABC）讲者：王佳玉（中国医学科学院肿瘤医院） 602P - VMP1 inhibits the progression of breast cancer via regulating PI3K/AKT and MEK/ ERK signaling pathway VMP1通过调控PI3K/AKT和MEK/ ERK信号通路抑制乳腺癌的进展讲者：Shuzhao Chen (Guangzhou, China) 609P - Real-world Application of 18F-FES PET/CT on HR+ Breast Cancer Patients with Brain Metastases 18F-FES PET/CT在HR+乳腺癌脑转移患者中的实际应用讲者：王碧芸（复旦大学附属肿瘤医院） 612P - Impact of Rivaroxaban on Prophylaxis Against Catheter-Related Thrombosis in Breast Cancer Patients: A cohort study 利伐沙班对预防乳腺癌患者导管相关血栓形成的影响：一项队列研究讲者：Yurong Zhang (Beijing, China) 625TiP - A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer Trop-2 ADC联合治疗晚期三阴性乳腺癌的多中心、前瞻性、队列研究讲者：郝春芳（天津医科大学肿瘤医院） 631eP - Real-world study on the efficacy and safety of Dalpiciclib in elderly patients with HR-positive, HER2-negative advanced breast cancer in the Xinjiang region 新疆地区老年HR+/HER2-晚期乳腺癌患者应用达尔西利疗效及安全性的真实世界研究讲者：Yan Li (Urumqi, China) 635eP - The necessity of adding anti-HER2 antibody to TKI in trastuzumab-resistant, HER2-positive ABC: a multicenter real-world study 曲妥珠单抗耐药的HER2阳性ABC患者中，TKI联合抗HER2抗体的必要性：一项多中心真实世界研究讲者：Ruixia Song (Beijing, China) 636eP - Real-world efficacy and safety of trastuzumab deruxtecan in HER2-positive and HER2-low metastatic breast cancer: Evidence from a Chinese population T-DXd在HER2阳性和HER2低表达转移性乳腺癌中的真实疗效和安全性：来自中国人群的证据讲者：张剑（复旦大学附属肿瘤医院） 637eP - Clinical Outcomes and Safety of Sacituzumab Govetican in Chinese Metastatic HER2 Negative Breast Cancer Patients: A Real World Study SG治疗中国转移性HER2阴性乳腺癌患者的临床结局和安全性：一项真实世界研究讲者：Yuxin Mu (Shanghai, China) 638eP - Construction of an Efficacy Prediction Model for T-DXd Treatment of HER2-Positive and HER2-Negative Breast Cancer Based on Hematological Indicators: A Multicenter Real-World Study 基于血液学指标构建T-DXd治疗HER2阳性和HER2阴性乳腺癌疗效预测模型：一项多中心真实世界研究讲者：Yanfang Su (Beijing, China) 647eP - Efficacy and safety profiles of PARP inhibitors in Chinese patients with metastatic breast cancer: a multi-center real-world study PARP抑制剂治疗中国转移性乳腺癌患者的疗效和安全性：一项多中心真实世界研究讲者：Xuenan Peng (Beijing, China) 648eP - Analysis of efficacy and safety of eribulin in the treatment of advanced breast cancer in the real-world 艾立布林治疗晚期乳腺癌的真实世界疗效和安全性分析讲者：Xiao Chen (Shenzhen, China) 652eTiP - A Phase 1b/2 study of FWD1802, a novel oral estrogen receptor (ER) degrader (SERD), in combination with multiple CDK4/6 inhibitors (CDK4/6i) and mTOR inhibitor in ER+/HER2- advanced or metastatic breast cancer (a/m BC) FWD1802（一种新型口服ER降解剂）联合多种CDK4/6抑制剂（CDK4/6i）和mTOR抑制剂治疗ER+/HER2-晚期或转移性乳腺癌（A /m BC）的1b/2期研究讲者：孟艳春（复旦大学附属肿瘤医院） 653eTiP - Translational study and First-in-Human (FIH) study design of KH815, a novel dual-payload TROP-2 targeted Antibody-Drug Conjugate (ADC), in patients with advanced solid tumors KH815是一种新型双有效载荷靶向TROP-2的抗体-药物偶联物（ADC），用于晚期实体瘤患者的转化研究和首次入人（FIH）研究设计讲者：马飞（中国医学科学院肿瘤医院）（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。

临床结果临床2期临床3期

2025-07-09

·ioncology

点击上方蓝字关注我们编者按：随着靶向治疗的不断发展创新，HER2阳性晚期乳腺癌的治疗模式也在不断的更新变化，形成了大分子单抗（mAB）、小分子酪氨酸激酶抑制剂（TKI）和抗体偶联药物（ADC）三足鼎立的格局。然而，对于这些抗HER2靶向治疗的排兵布阵，从指南共识到真实世界存在怎样的差异？近日，《肿瘤学前沿》（Frontiers in Oncology）刊载了中山大学肿瘤防治中心王树森教授团队的一项多中心回顾性研究，探讨了我国晚期乳腺癌的抗HER2治疗模式。该研究成果曾被2025年日本肿瘤内科学会（JSMO）年会收录。研究简介近年来，国内外涌现了许多性的晚期乳腺癌抗HER2治疗药物。由于指南共识推荐、药物可及性等多方面的差异，真实世界中的国内外晚期乳腺癌抗HER2治疗模式可能存在差异。这项多中心、非干预性、回顾性研究（NCT05769751），提取了来自中国5家中心的电子病历数据，以分析2020年1月1日至2022年8月31日收治的初诊HER2阳性转移性乳腺癌（HER2+ mBC）的治疗模式和疗效。研究共获得865例（100.00%）至少接受过一线晚期全身治疗的HER2+ mBC患者资料，其中38.15%的患者有二线治疗信息，15.05%的患者有二线后的治疗信息。考虑到真实世界使用情况的复杂性，将抗HER2治疗分为以下6组：mAB双靶治疗：98.45%为曲妥珠单抗联合帕妥珠单抗；mAB单靶治疗：83.39%为曲妥珠单抗，15.88%为伊尼妥单抗；单药TKI治疗：95.33%为吡咯替尼，3.73%为拉帕替尼；TKI＋mAB治疗：77.45%为吡咯替尼＋曲妥珠单抗，22.55%吡咯替尼＋伊尼妥单抗；ADC治疗：29.82%为德曲妥珠单抗（T-DXd），14.91%为维迪西妥单抗（RC48），11.4%为ARX788；非抗HER2治疗。图1展示了一线和二线治疗中这6种治疗模式的比例：在一线治疗中，最常见的治疗方案是mAB双靶治疗（36.7%）；而二线治疗最常见的则是单药TKI（34.45%）。图1. 一线和二线治疗模式图2展示了从一线到二线的抗HER2治疗转换模式。在mAB单靶或双靶治疗后，最常用的治疗药物是TKI；而TKI治疗后，最常用的治疗药物是mAB单靶或双靶治疗、ADC。图2.一线序贯二线治疗的常见治疗方案既往治疗是影响医生选择一线治疗的关键因素。图3显示了一线治疗选择的分布。在571例未经抗HER2治疗的患者中，mAB双靶治疗是最常见（42.91%）的一线选择；在294例抗HER2经治的患者中，最常见的治疗方案则是单药TKI（39.46%）和mAB双靶治疗（23.13%）。图3. 抗HER2初治或经治患者的一线治疗模式一线和二线治疗的中位真实世界无进展生存期（rwPFS）分别为11.04个月（95% CI：10.19-12.03）（图4）和7.59个月（95% CI：6.21-9.2）。在一线治疗的方案中，mAB双靶治疗患者的中位rwPFS最长，为13.57个月（95% CI：12.03-17.52），其次是TKI＋mAB单靶治疗，中位rwPFS为12.98个月（95% CI：11.04-20.08）（图4，表1）。在一线接受曲帕双靶而二线转换为单药TKI治疗的患者中，观察到最长的中位rwPFS2（24.32个月），尽管样本量较小。图4. 总体人群和不同方案一线治疗的PFS表1. 不同方案一线治疗的PFS多变量Cox回归模型分析显示，与（新）辅助治疗后＜6个月内复发患者相比，＞6个月复发患者的rwPFS更长（HR 0.65，P=0.008；校正HR 0.70，P=0.03）；相比接受双靶一线治疗的患者，接受非双靶一线治疗的患者疾病进展或死亡风险显著更高（HR 1.60，P＜0.001）。表2. 一线治疗方案与患者临床病理特征的多变量分析这项较大样本的多中心真实世界研究总结了我国HER2+ mBC的抗HER2治疗模式和疗效。在一线治疗中，最常使用的治疗方案是mAB双靶治疗，而经抗HER2治疗的患者常使用TKI；在二线治疗中，TKI也是最常见的治疗选择。这些数据凸显了我国HER2+ mBC的抗HER2治疗仍存在未被满足的治疗需求。研究者说HER2阳性乳腺癌约占所有乳腺癌的15%-20%[1]，此类肿瘤的侵袭性强、复发风险高、预后差，尤其mBC患者的5年生存率不足30%[2]，亟需高效且规范化的治疗方案以改善生存结局。自1998年首个HER2靶向药物曲妥珠单抗问世以来，抗HER2治疗模式经历了多次变迁：从曲妥珠单抗单靶治疗，到曲妥珠单抗联合帕妥珠单抗的双靶治疗，再到ADC的更新换代，而我国则在小分子TKI领域取得不少突破进展。近年来，III期DESTINY-Breast 03研究证实，新一代T-DXd用于HER2+ mBC二线治疗，可相较于既往标准治疗T-DM1显著改善PFS（29.0 vs 7.2个月；HR 0.30，95%CI：0.24-0.38）和OS（52.6 vs 42.7个月；HR 0.73，95%CI：0.56-0.94）[3]。在一线治疗方面，我国学者领导的III期PHILA研究显示，吡咯替尼和曲妥珠单抗联合化疗一线治疗中位PFS相较于曲妥珠单抗联合化疗延长近14个月（24.3 vs 10.4个月；HR 0.42，95% CI：0.32-0.53）[4]，但仍缺乏与曲帕双靶头对头比较的研究证据。因此，目前NCCN、ASCO、ESMO等国际指南共识主要推荐曲帕双靶一线治疗和T-DXd二线治疗。然而，由于药物可及性、医保覆盖和经济负担等差异，国内临床实践的真实世界治疗模式可能与国际指南推荐的标准治疗方案有所差异。笔者领导的这项多中心真实世界研究，揭示了我国HER2+ mBC治疗模式的三大特征。首先，一线治疗以曲帕等双靶治疗为主（占比36.7%），也有相当比例（14.10%）的mAB联合TKI，这一选择主要基于PHILA研究方案。再者，国内二线治疗仍以TKI单药常见（34.45%），ADC的应用仍有待提高（11.82%）。这主要由于T-DM1于2021年方才在国内被纳入医保目录，治疗可及性受限，而且后续的DB-03研究证实T-DXd的生存获益优于T-DM1，但T-DXd于2023年方才进入国内临床实践。第三，在抗HER2经治患者的一线治疗中，中国医生更倾向于TKI，也有部分选择mAB双靶治疗再挑战，实际上此类患者也应当是T-DXd这类新型ADC治疗的获益人群，因为DB-03研究亚组分析显示，既往（包括新辅助/辅助治疗在内的）0-1线（HR 0.33）或≥2线（HR 0.29）患者均有PFS获益[3]。自T-DXd进入国内临床实践以来，已深刻影响临床治疗格局，最新版的CACA指南和CSCO指南已将T-DXd作为HER2+ mBC二线治疗优选治疗方案之一；而且该治疗方案的HER2低表达适应症和HER2+ mBC二线治疗适应症均已经被纳入2025版国家医保目录。随着这些治疗格局的变化以及治疗可及性的提高，我国真实世界中的二线治疗模式有望进一步改变，T-DXd将满足更多的乳腺癌治疗需求。参考文献上下滑动查看更多内容[1]Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792. doi:10.1056/NEJM200103153441101[2]Dawood S, Broglio K, Buzdar AU, Hortobagyi GN, Giordano SH. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J Clin Oncol. 2010;28(1):92-98. doi:10.1200/JCO.2008.19.9844[3]Cortés J, Hurvitz SA, Im SA, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial. Nat Med. Published online June 2, 2024. doi:10.1038/s41591-024-03021-7[4]Ma F, Yan M, Li W, et al. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial [published correction appears in BMJ. 2023 Nov 16;383:p2665. doi: 10.1136/bmj.p2665.]. BMJ. 2023;383:e076065. Published 2023 Oct 31. doi:10.1136/bmj-2023-076065王树森教授中山大学肿瘤防治中心乳腺癌单病种首席专家香港大学临床肿瘤学系荣誉教授主任医师、博士生导师中国临床肿瘤协会(CSCO）乳腺癌专家委员会副主任委员中国研究型医院协会乳腺癌专业委员会副主任委员中国抗癌协会乳腺癌专业委员会常务委员广东省临床医学学会乳腺癌专委会主任委员广东省癌症中心乳腺癌诊疗质量控制专家委员会主任委员广东省胸部肿瘤防治研究会乳腺癌专业委员会主任委员现在主要从事乳腺癌内科的精准治疗、化疗、内分泌治疗及靶向治疗。主持国自然重点项目1项、面上项目1项，省科技厅项目3项，获国家科技重大专项资助1项。主编教材《临床肿瘤学（clinical oncology）》，参编教材或专著多部。作为主要执笔人或参与者制定了多项国家级的乳腺癌诊疗相关指南。在国内外期刊以第一作者或通讯作者发表论文多篇，其中近年以来以第一作者或通讯作者于JAMA、JCO、STTT、CANCER COMMUNICATIONS 等杂志发表SCI论文多篇。作为主要研究者牵头发起多中心临床研究30多项，其中包括I期临床试验6项目，Ⅱ、Ⅲ期大型多中心临床试验多项。黄嘉佳主任医师、硕士导师、医学博士从事乳腺癌临床工作，作为项目负责人承担国家自然、广东省自然科学项目、中山大学肿瘤防治中心优秀人才计划项目等课题多项，参加多项国际多中心新药注册临床试验。曾先后在南瑞士肿瘤研究所、加州大学圣地亚哥分校Moores Cancer Center从事访问学者进修。以第一作者或共同第一作者发表SCI论文多篇，其中包括《Annals of Oncology》、《Journal of the National Cancer Institute》、《Clinical Cancer Research》《Autophagy》等。中国老年保健协会肿瘤免疫治疗专业委员会副主任委员中国女医师协会第二届乳腺专业委员会常务委员广东省医疗行业协会乳腺肿瘤内科管理分会副主任委员广东省抗癌协会靶向与个体化治疗专业委员会青年委员会常务委员广东省抗癌协会分支华南乳腺癌临床研究协作组委员材料编码：CN-20250624-00009。本资料仅供医疗卫生专业人士参考，请勿向非医疗卫生专业人士发放（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结果

2025-07-03

·ioncology

Nature子刊：刘彩刚教授团队证实ADC+TKI双靶方案为HER2阳性乳腺癌新辅助治疗带来关键进展

点击蓝字，关注我们2025年7月1日，中国医科大学附属盛京医院刘彩刚教授团队在Nature Communications（IF=15.7）杂志发表MUKDEN 06研究成果。题目为：“Neoadjuvant ARX788 plus pyrotinib versus trastuzumab, pertuzumab, docetaxel and carboplatin for HER2-Positive Breast cancer: A randomised phase 2b trial”。这项多中心、随机对照Ⅱb期临床试验证实，ARX788联合吡咯替尼用于早期或局部晚期HER2阳性乳腺癌新辅助治疗，较传统标准方案病理完全缓解率（pCR）显著提升19.1%，为HER2阳性乳腺癌精准治疗开辟了新路径。背景：突破传统方案瓶颈，双靶策略崭露头角约20%的乳腺癌为HER2阳性。尽管曲妥珠单抗/帕妥珠单抗联合化疗（TCbHP）是新辅助治疗标准方案，但其pCR率仅约50%，近半数患者术后仍存在残留病灶，预后较差。抗体偶联药物（ADCs）如T-DM1、T-DXd在晚期HER2阳性乳腺癌中疗效卓越，但其在新辅助治疗中的作用尚未明确。基于此，刘彩刚教授团队设计MUKDEN 06 trial（NCT05426486），旨在探索ARX788联合吡咯替尼对比TCbHP方案的疗效与安全性。方法：多中心随机对照设计，聚焦高风险患者群体2022年5月至2023年10月，由盛京医院牵头，7家中心联合开展。研究纳入136例Ⅱ-Ⅲ期HER2阳性乳腺癌患者，随机分为两组。研究方案：ARX788联合吡咯替尼组：ARX788（1.5 mg/kg，静脉注射）+ 吡咯替尼（320 mg，口服），每3周1次，共6周期；TCbHP组：曲妥珠单抗/帕妥珠单抗联合多西他赛/卡铂，每3周1次，共6周期。主要终点为pCR率，次要终点包括乳腺病理完全缓解率（bpCR）、肿瘤残余负荷（RCB） 0-I比例、客观缓解率（ORR）及安全性等。结果：双靶向方案疗效显著，高风险患者获益更突出研究总计纳入 136名患者。ARX788联合吡咯替尼组pCR率达70.6%，较TCbHP组的51.5% 提升19.1%。亚组分析显示，淋巴结阳性（77.1% vs 48.9%）和Ⅲ期患者（74.2% vs 46.7%）获益更显著，提示该方案更适合高风险人群。ARX788联合吡咯替尼组常见不良反应为腹泻、肝功能异常，需特殊关注间质性肺病（ILD）和眼部毒性，以上不良事件多数可通过剂量调整或支持治疗缓解；TCbHP组常见不良反应为中性粒细胞减少、白细胞减少和疲劳。结论MUKDEN 06研究证实，ADC与TKI双靶向联合方案为HER2阳性乳腺癌患者带来了新的选择，尤其是淋巴结阳性、肿瘤负荷大的高风险患者。值得注意的是，应密切关注ILD和腹泻等不良反应，需加强规范化管理（如早期监测、剂量调整）。目前刘彩刚教授团队正在开展转化研究，筛选最能获益于此项创新方案的亚群和预测ILD的发生。近年来，刘彩刚教授牵头的东北肿瘤临床研究联盟始终致力于推动乳腺癌的精准诊疗，持续为患者提供“ MUKDEN ”系列创新诊疗策略，有力促进了乳腺癌诊疗水平的提升与发展。MUKDEN 系列临床研究列表（来源：东北肿瘤临床研究联盟）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结果临床3期

100 项与重组人源化抗HER2单抗-AS269偶联物(Ambrx) 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	申请上市	中国	浙江新码生物医药有限公司	2025-04-10
HER2阳性胃癌	临床3期	中国	浙江医药股份有限公司	2021-08-02
HER2阳性乳腺癌	临床3期	中国	浙江医药股份有限公司	2020-08-19
胃癌	临床3期	-	浙江医药股份有限公司	-
HER2低表达乳腺癌	临床2期	美国	Ambrx, Inc.	2025-10-01
HR阳性乳腺腺癌	临床2期	美国	Ambrx, Inc.	2025-10-01
HR阳性乳腺癌	临床2期	美国	Ambrx, Inc.	2025-10-01
三阴性乳腺癌	临床2期	美国	Ambrx, Inc.	2025-10-01
胆道癌	临床2期	美国	Ambrx, Inc.	2021-11-05
结直肠癌	临床2期	美国	Ambrx, Inc.	2021-11-05

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临床结果

适应症

分期

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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


ASCO2025	N/A	乳腺癌	9,307	sacituzumab govitecan (SG)	鬱餘製膚觸淵壓淵艱簾(壓壓襯蓋糧積積範選繭) = 襯鹽願鹽築襯膚壓襯構艱夢襯醖選齋築襯觸齋 (窪遞淵簾廠餘憲願鹹構, 26.7)	积极	2025-05-30
				trastuzumab deruxtecan (T-DXd)	膚蓋糧積鑰壓觸鏇壓獵(淵廠製築願鹽壓獵淵醖) = 網構願遞簾鹹襯觸鹽鑰醖願顧窪鹽繭餘襯積構 (觸顧襯淵鬱積襯窪餘鹽 )
CTR20201708 (ACE-Breast-02, Pubmed) 人工标引	临床3期	晚期 HER2 阳性乳腺癌 HER2 Positive	441	ARX788	壓襯遞簾壓衊淵繭衊夢(糧膚淵壓構網製夢壓網) = 廠鹽襯餘襯蓋網蓋廠蓋簾獵壓餘廠醖鏇鏇膚鏇 (餘選觸願夢窪襯鏇願選, 8.4 ~ 13.8) 更多	积极	2025-02-17
				lapatinib + capecitabine	壓襯遞簾壓衊淵繭衊夢(糧膚淵壓構網製夢壓網) = 壓膚簾鬱夢願鑰獵遞範簾獵壓餘廠醖鏇鏇膚鏇 (餘選觸願夢窪襯鏇願選, 6.9 ~ 8.7) 更多
CTR20201708 (ACE-Breast-02, SABCS2024) 人工标引	临床3期	晚期 HER2 阳性乳腺癌	220	ARX788	繭鹹製壓憲壓獵築觸遞(築窪糧鹽顧獵襯糧廠簾) = The overall incidence and incidence of grade ≥ 3 of treatmentrelated adverse events was 98.6% and 41.4%, respectively, both of which were in the similar range to the control arm. 憲鏇餘鹹夢鏇衊壓鹽膚 (襯簾選艱夢艱廠構醖築 )	积极	2024-11-26
				Lapatinib plus capecitabine
CTR20213419 (ACE-Breast-08a, SABCS2024) 人工标引	临床1/2期	晚期 HER2 阳性乳腺癌 HER2 Positive	138	ARX788 (IRC)	願築艱齋衊觸鹽醖壓製(窪構選鹹壓積積製襯淵) = 膚獵餘蓋遞壓獵築淵壓願願選鏇觸構壓獵積齋 (餘範膚窪範窪艱網襯蓋, 36.5 ~ 53.6) 更多	积极	2024-11-26
				ARX788 (investigators)	願築艱齋衊觸鹽醖壓製(窪構選鹹壓積積製襯淵) = 齋願鏇窪窪構衊蓋鏇選願願選鏇觸構壓獵積齋 (餘範膚窪範窪艱網襯蓋, 33.7 ~ 50.7) 更多
CTR20222247 (phase Ia/b trial of ARX788 combined with toripalimab, ASCO2024)	临床1期	HER2低表达乳腺癌 \| 实体瘤 HER2-low (IHC2+ and FISH- or IHC1+) \| HER2-expressing (IHC 2+ or 3+)	12	ARX788 1.3mg/kg + Toripalimab 240mg	獵積鹽鏇網鏇膚顧膚廠(鏇糧廠築餘鏇遞範獵顧) = 醖網遞顧繭膚鑰構糧鬱範餘觸願夢選鹽膚築衊 (構壓築窪膚顧蓋襯獵繭 ) 更多	积极	2024-05-24
				ARX788 1.5mg/kg + Toripalimab 240mg	獵積鹽鏇網鏇膚顧膚廠(鏇糧廠築餘鏇遞範獵顧) = 齋獵製醖憲醖鬱選鏇蓋範餘觸願夢選鹽膚築衊 (構壓築窪膚顧蓋襯獵繭 ) 更多
CTR20201708 (ASCO2024)	临床2/3期	HER2阳性乳腺癌 HER2+	-	ARX788	繭衊夢憲憲積衊積獵製(繭鬱醖襯遞鏇鬱築憲遞) = 繭顧膚廠願醖構築構觸鹽製糧醖鏇醖壓鹽廠築 (蓋鹽壓餘醖衊餘蓋鬱齋 )	积极	2024-05-24
				Lapatinib plus capecitabine	繭衊夢憲憲積衊積獵製(繭鬱醖襯遞鏇鬱築憲遞) = 觸願範糧製淵艱鏇餘夢鹽製糧醖鏇醖壓鹽廠築 (蓋鹽壓餘醖衊餘蓋鬱齋 )
Corporate Publications 人工标引	临床3期	HER2阳性转移性乳腺癌 HER2 Positive	441	ARX788	鹹繭鹽鏇淵餘憲繭鬱積(鏇製鑰憲製構廠製淵鏇) = The pivotal Phase 3 ACE-Breast-02 study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival benefit compared to the control 簾醖觸範繭憲鬱築鹽糧 (鹽窪鏇糧襯構壓製鹹鏇 ) 达到	积极	2023-01-03
				lapatinib+capecitabine
NCT04829604 (ACE-Breast-03, Corporate Publications) 人工标引	临床2期	HER2阳性转移性乳腺癌 HER2 Positive	7	ARX788	簾簾衊簾糧廠簾衊鑰艱(製襯鏇鏇餘衊壓積顧夢) = 餘鏇鹹夢鹽襯製淵艱艱觸淵顧膚齋願夢顧鑰構 (築網糧衊夢積網獵衊齋 ) 更多	积极	2022-12-09
CTR20190639 (ACE-Gastric-01, Pubmed) 人工标引	临床1期	HER2阳性胃癌 \| HER2阳性胃食管结合部腺癌 HER2 Positive	30	ARX 788	築餘觸鑰簾齋築繭蓋遞(鹽選窪網鬱壓獵遞簾壓) = 憲窪膚艱齋築選鑰廠襯選淵積願範範積網憲遞 (醖選膚淵淵衊糧糧淵築 ) 更多	积极	2022-11-15
NCT02512237 (Pubmed) 人工标引	临床1期	HER2阳性转移性乳腺癌 HER2 Positive	69	ARX788	艱鏇夢網鑰鏇壓醖鹹繭(獵壓襯窪顧願壓繭築衊) = 積簾遞膚蓋廠範鏇鬱網選選構繭糧築蓋淵繭遞 (糧襯鏇遞膚醖遞鹽簾餘, 10.09 ~ NR) 更多	积极	2022-05-26