伦康依隆妥单抗(Izalontamab Brengitecan) - 药物靶点：EGFR x HER3 x Top I_在研适应症：输卵管癌，卵巢上皮癌，铂类耐药性原发性腹膜癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Zalontamab brengitecan、BL B01D1、BL-B01D1

+ [2]

靶点

EGFR x HER3 x Top I

作用方式

拮抗剂、抑制剂

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、HER3拮抗剂(受体酪氨酸蛋白激酶erbB-3拮抗剂)、TOP1抑制剂(DNA拓扑异构酶I抑制剂)

治疗领域

肿瘤消化系统疾病口颌疾病+ [7]

在研适应症

输卵管癌卵巢上皮癌铂类耐药性原发性腹膜癌+ [56]

非在研适应症-

原研机构

在研机构

Bristol Myers Squibb Co.

+ [2]

非在研机构-

权益机构

四川百利天恒药业股份有限公司

Bristol Myers Squibb Co.

上海迈邦生物科技有限公司

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

特殊审评突破性疗法 (中国)

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结构/序列

使用我们的ADC技术数据为新药研发加速。

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Sequence Code 43254

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Sequence Code 10172664

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关联

55

项与伦康依隆妥单抗相关的临床试验

NCT06926868

/ Not yet recruiting临床2/3期

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

开始日期2025-07-15

申办/合作机构

Bristol Myers Squibb Co.

[+1]

NCT06978114

/ Recruiting临床2期

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

This study is a clinical study to explore the efficacy and safety of BL-B01D1+PD-1/PD-L1 monoclonal antibody in patients with advanced biliary tract cancer.

开始日期2025-06-10

申办/合作机构

四川百利药业有限责任公司

[+1]

NCT06986785

/ Not yet recruiting临床2期

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma

This study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with lenvatinib in patients with advanced hepatocellular carcinoma.

开始日期2025-06-01

申办/合作机构

四川百利药业有限责任公司

[+1]

100 项与伦康依隆妥单抗相关的临床结果

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100 项与伦康依隆妥单抗相关的转化医学

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100 项与伦康依隆妥单抗相关的专利（医药）

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2

项与伦康依隆妥单抗相关的文献（医药）

2024-07-01·CANCER TREATMENT REVIEWS

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Review

作者: Jiménez-Labaig, Pablo ; Braña, Irene ; Hernando-Calvo, Alberto ; Harrington, Kevin J ; Bhide, Shreerang ; Rullan, Antonio ; O'Leary, Ben ; Llop, Sandra

INTRODUCTION:

There is a need to improve the outcomes of patients with head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC), especially in recurrent unresectable and metastatic (R/M) setting. Antibody-drug conjugates (ADC) and bispecific antibodies (BsAb) may deliver promising results.

METHODS:

We conducted a systematic literature review to identify ADC and BsAb clinical trials, involving patients with HNSCC and NPC, from database creation to December 2023. We reported trial characteristics, overall response rate (ORR), overall survival (OS), and grade ≥ 3 treatment-related adverse events (trAEs).

RESULTS:

23 trials (65 % phase I) were found, involving 540 R/M patients (355 [20trials] HNSCC and 185 [5trials] NPC). There were 13 ADC (n = 343) and 10 BsAb (n = 197) trials. 96 % patients were refractory to standard of care treatments. ORR ranged from 0 to 100 %, with the highest ORR for GEN1042 plus chemoimmunotherapy. ORRs for monotherapies were 47 % for ADC, and 0-37 % for BsAb. MRG003 reached in HNSCC 43 % and NPC 47 %. BL-B01D1 54 % in NPC. Longest median OS was seen with MRG003 and KN046. Grade ≥ 3 trAEs were 28-60 % in ADC trials, and 3-33 % BsAb. Grade ≥ 3 myelosuppressive trAEs were typically seen in 8 ADC trials, while 4 BsAb showed infusion-related reactions (IRR). Four treatment-related deaths were reported (1 pneumonitis), all ADC trials.

CONCLUSION:

ADC and BsAb antibodies show promise in R/M HNSCC and NPC. Results are premature by small sample sizes and lack of control arm. ADC mainly caused myelosuppression and a pneumonitis case, and BsAb IRR. Further research is warranted in this setting.

2024-07-01·LANCET ONCOLOGY

BL-B01D1, a first-in-class EGFR–HER3 bispecific antibody–drug conjugate, in patients with locally advanced or metastatic solid tumours: a first-in-human, open-label, multicentre, phase 1 study

Article

作者: Chen, Likun ; Yang, Jun ; Guo, Ye ; Chen, Gang ; Zhou, Ningning ; Zhu, Yi ; Zhou, Huaqiang ; Yang, Kunyu ; Zhou, Ting ; Fu, Zhenming ; Zhang, Li ; Xiao, Sa ; Huang, Yan ; Zhao, Shen ; Zhao, Hongyun ; Li, Yongsheng ; Liu, Qianwen ; Fang, Wenfeng ; Zhang, Yaxiong ; Han, Yaqian ; Ma, Yuxiang ; Zhu, Hai ; Zhao, Yuanyuan ; Yang, Yunpeng ; Xue, Jinhui

BACKGROUND:

Antibody-drug conjugates have promising clinical activity in the treatment of solid tumours. BL-B01D1 is a first-in-class EGFR-HER3 bispecific antibody-drug conjugate. We aimed to assess the safety and preliminary antitumour activity of BL-B01D1 in patients with locally advanced or metastatic solid tumours.

METHODS:

This first-in-human, open-label, multicentre, dose-escalation and dose-expansion phase 1 trial was conducted in seven hospitals in China, enrolling patients aged 18-75 years (dose escalation; phase 1a) or older than 18 years (dose expansion; phase 1b), with a life expectancy of at least 3 months, an Eastern Cooperative Oncology Group performance status of 0-1, and histologically or cytologically confirmed locally advanced or metastatic solid tumours that had progressed on current standard treatment. In the phase 1a i3+3 design, patients received intravenous BL-B01D1 at three different schedules: 0·27 mg/kg, 1·5 mg/kg, and 3·0 mg/kg weekly; 2·5 mg/kg, 3·0 mg/kg, and 3·5 mg/kg on days 1 and 8 of each cycle every 3 weeks; or 5·0 mg/kg and 6·0 mg/kg on day 1 of each cycle every 3 weeks. The primary objectives of phase 1a were to identify the safety, maximum tolerated dose, and dose-limiting toxicity. In phase 1b, patients were treated in two schedules: 2·5 and 3·0 mg/kg on days 1 and 8 every 3 weeks, or 4·5, 5·0, and 6·0 mg/kg on day 1 every 3 weeks. The primary objectives of phase 1b were to assess the safety and recommended phase 2 dose of BL-B01D1, and objective response rate was a key secondary endpoint. Safety was analysed in all patients with safety records who received at least one dose of BL-B01D1. Antitumour activity was assessed in the activity analysis set which included all patients who received at least one dose of BL-B01D1 every 3 weeks. This trial is registered with China Drug Trials, CTR20212923, and ClinicalTrials.gov, NCT05194982, and recruitment is ongoing.

FINDINGS:

Between Dec 8, 2021, and March 13, 2023, 195 patients (133 [65%] men and 62 [32%] women; 25 in phase 1a and 170 in phase 1b) were consecutively enrolled, including 113 with non-small-cell lung cancer, 42 with nasopharyngeal carcinomas, 13 with small-cell lung cancer, 25 with head and neck squamous cell carcinoma, one with thymic squamous cell carcinoma, and one with submandibular lymphoepithelioma-like carcinoma. In phase 1a, four dose-limiting toxicities were observed (two at 3·0 mg/kg weekly and two at 3·5 mg/kg on days 1 and 8 every 3 weeks; all were febrile neutropenia), thus the maximum tolerated dose was reached at 3·0 mg/kg on days 1 and 8 every 3 weeks and 6·0 mg/kg on day 1 every 3 weeks. Grade 3 or worse treatment-related adverse events occurred in 139 (71%) of 195 patients; the most common of which were neutropenia (91 [47%]), anaemia (76 [39%]), leukopenia (76 [39%]), and thrombocytopenia (63 [32%]). 52 (27%) patients had a dose reduction and five (3%) patients discontinued treatment due to treatment-related adverse events. One patient was reported as having interstitial lung disease. Treatment-related deaths occurred in three (2%) patients (one due to pneumonia, one due to septic shock, and one due to myelosuppression). In 174 patients evaluated for activity, median follow-up was 6·9 months (IQR 4·5-8·9) and 60 (34%; 95% CI 27-42) patients had an objective response.

INTERPRETATION:

Our results suggest that BL-B01D1 has preliminary antitumour activity in extensively and heavily treated advanced solid tumours with an acceptable safety profile. Based on the safety and antitumour activity data from both phase 1a and 1b, 2·5 mg/kg on days 1 and 8 every 3 weeks was selected as the recommended phase 2 dose in Chinese patients.

FUNDING:

Sichuan Baili Pharmaceutical.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

409

项与伦康依隆妥单抗相关的新闻（医药）

5 小时之前

·药时代

一天双响！国产双抗ADC爆发期将至！

全文共3003字，共0图预计阅读时间：8分钟2025年7月3日，百利天恒宣布，其自主研发的全球首创、新概念且唯一进入III期临床阶段的EGFR×HER3双抗ADC（iza-bren）在鼻咽癌的III期临床试验中，期中分析达到主要终点，适应症为：既往经PD-1/PD-L1单抗治疗且经至少两线化疗（至少一线含铂）治疗失败的复发性或转移性鼻咽癌。这是iza-bren首个达到终点的III期临床，也是全球首个完成III期研究的双抗ADC。就在同一天，康方生物发布公告，宣布其双抗ADC药物AK146D1（Trop2/Nectin4 ADC），治疗晚期实体瘤的Ia期临床研究完成首例受试者入组。值得注意的是，这是康方生物首个进入临床阶段的双抗ADC药物。一天双响，是双抗ADC临床疗效的验证，也是双抗ADC热度的具体表现。一个毋庸置疑的事实是，作为肿瘤靶向治疗领域的重要突破，双抗ADC正吸引着全球医药界的广泛关注。在2025年的AACR上，包括信达生物、金赛药业、恒瑞医药、映恩生物、百奥塞图、多禧生物等超过25个药企展示其双抗ADC产品。如今随着百利天恒的产品得出后期积极结果以及更多像康方一样的后继者跟进，双抗ADC或将迎在不久后迎来一个不输ADC浪潮的爆发期！”双响”详解百利天恒：iza-bren （BL-B01D1）iza-bren是全球首创、新概念且唯一进入III期临床试验阶段的EGFR×HER3双抗ADC。iza-bren能够同时识别并结合肿瘤细胞上的EGFR和HER3两个关键靶点，这种双重靶向作用显著增强了药物的抗肿瘤效果。这款双抗ADC的小分子毒素部分为百利天恒自主研发的喜树碱衍生物ED-04，用酶可切割连接子，DAR值为8。据百利天恒信息，目前该药正在中国和美国进行40余项针对多种肿瘤类型的临床试验，且已有5项适应症被国家药品监督管理局药品审评中心纳入突破性治疗品种名单。iza-bren作为全球首创药物，研究成果也已在近两年全球学术盛会ASCO、ESMO大会陆续报道，并在顶级学术期刊The Lancet Oncology发表全文，展现出优秀的疗效信号和良好的安全性数据。百利天恒曾在ASCO 2023大会上公布iza-bren治疗鼻咽癌的I期研究数据。结果显示，24例鼻咽癌患者接受治疗后，ORR为45.8%，疾病控制率（DCR）为100%。就本次得出积极结果的III期研究，百利天恒公告中暂未有更多信息公布。不过相信随着III期研究达到主要重点，上市申请的提交和审批通过也就不远了。同时，根据百利天恒此前披露数据，此前iza-bren已经显示了其在EGFR野生型NSCLC、EGFR突变型NSCLC、鼻咽癌、食管鳞癌、胆管癌、乳腺癌、尿路上皮癌等多种实体瘤患者中的良好安全性和令人鼓舞的抗肿瘤活性。康方生物：AK146D1AK146D1是康方生物研发的创新型Trop2/Nectin4双抗ADC，通过可裂解的连接子MC-AAA（马来酰亚胺-丙氨酸-丙氨酸-丙氨酸）与拓扑异构酶Ⅰ抑制剂DXd偶联而成。这款双抗ADC的两个靶点Trop2和Nectin4均高表达于多种肿瘤类型，但相对较低表达于正常组织，是极具潜力的肿瘤靶点。康方生物资料显示，发挥Trop2和Nectin4的协同互补作用，有望提高ADC药物疗效，减少耐药性，降低药物毒性，同时更全面地覆盖各类型肿瘤疾病，克服单靶点 ADC 药物的治疗局限。目前全球已有靶向Trop2或Nectin4的单靶点ADC获批上市，但尚无同时靶向Trop2或Nectin4的双抗ADC药物获批临床。AK146D1的临床前研究显示，其对于表达Trop2或Nectin4的肿瘤具有强效的抗肿瘤活性和良好的安全性，具有巨大的肿瘤治疗潜力，有望成为ADC 端下一代产品，为全球患者带来新的希望。康方布局AK146D1，打的是“IO+ADC”2.0的明牌。在肿瘤治疗领域，目前已有IO+化疗、IO+ADC、IO 2.0+ADC这三种主流治疗方案类型。康方这次提出的“IO+ADC”2.0，简单来说就双抗+双抗ADC的治疗方案。此前，在IO方面，康方已有卡度尼利（PD-1/CTLA-4双抗）和依沃西（PD-1/VEGF双抗）获批上市，两款药势头都不错。尤其是依沃西，因在与K药头对头试验中的胜利，以一药之力，掀起了业内对双抗及中国创新药的讨论和追随热潮。作为全球唯一拥有2个肿瘤IO双抗的企业，康方已在IO 2.0+ADC的赛道中占尽优势，此次推出“IO+ADC”2.0显然是康方应对紧跟在后面的追随者的长远战略布局。眼光不可谓不前沿。关于双抗ADC的一些题外话所谓双抗ADC，具体指的是同时具有两个不同抗原结合位点的抗体与一个或多个细胞毒素分子共价连接而成的药物。这种设计使得药物能够同时针对两个不同的靶点，或是同一细胞上的两种不同抗原，从而增强其治疗效果。借助两个不同靶点的协同作用，更精确靶向肿瘤细胞，进一步提升药物肿瘤选择性、内吞效率、增强靶点低表达和异质患者应答。目前，凭借双靶点精准杀伤、克服耐药、潜在更低毒性等优势，双抗ADC正在快速从概念走向临床，甚至走向商业化。百利天恒的此次公布的iza-bren的喜讯便是对这句话的证明。根据今年AACR上各家披露的情况，在研的双抗ADC的靶点更多的集中在EGFR/cMET、EGFR/HER3、PD-L1/Trop 、B7H3/PSMA这几个组合上。另外的，还有诸如B7H3/DLL3、CDH6/FRa、PTK7/Trop2、EGFR/MUC1等小众靶点组合。就布局企业来看，国内企业仍然领跑。除上文提到的百利天恒和康方外，信达生物、金赛药业、恒瑞医药、映恩生物、百奥塞图、多禧生物等均有布局。照目前的发展势头，未来3-5年该领域将迎来爆发式增长。小结2020年前后，随着Enhertu、Trodelvy等重磅ADC药物的获批上市，ADC赛道迎来爆发式增长，成为最炙手可热的研发方向之一。这一时期，凭借早期技术积累、政策红利以及资本市场的持续加码，中国创新药企快速跟进ADC布局，荣昌生物、科伦药业、恒瑞医药等企业纷纷崭露头角。然而随着行业过热，ADC赛道也暴露出同质化竞争严重、靶点扎堆等问题。目前，在资本收紧和行业内卷背景下，双抗ADC、核素ADC等新技术成为破局关键。需要思考的是，这些技术的周期又能持续多长，又会为什么技术和疗法所迭代？参考资料：1.各公司官网2.其他公开资料图片来源：豆包AI首个！阿斯利康重磅产品突破膀胱癌治疗局限2025-07-047月1日后，必看的十项临床试验！2025-07-03未来三个月，有望获FDA批准的5大创新疗法！2025-07-04版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩！

ASCO会议临床结果临床3期抗体药物偶联物AACR会议

2025-07-02

·E药经理人

再燃“DS时刻”！全球首个EGFR/HER3双抗ADC达主要终点，来自中国成都百利天恒！

7月3日，百利天恒发布公告，公司自主研发的全球首创(First-in-class)、新概念(New concept)且唯一进入III期临床阶段的 EGFRXHER3 双抗 ADC(iza-bren)在鼻咽癌的III期临床试验(研究方案编号:BL-BO1D1-303)中，期中分析达到主要终点。适应症为：既往经PD-1/PD-L1单抗治疗且经至少两线化疗(至少一线含铂)治疗失败的复发性或转移性鼻癌。据悉，iza-bren 正在中国和美国进行 40 余项针对多种肿瘤类型的临床试验。截至目前，iza-bren 已有5项适应症被国家药品监督管理局药品审评中心纳入突破性治疗品种名单。Iza-bren由EGFR×HER3双特异性抗体通过基于四肽的稳定可裂解连接子与新型拓扑异构酶I抑制剂有效载荷（Ed-04）偶联而成。其抗体部分具有双重靶向能力，能够同时识别并结合肿瘤细胞表面过表达的EGFR和HER3受体。2023年底，百利天恒与BMS达成合作，BMS 以84亿美元总交易金额引进百利天恒HER3/EGFR双抗ADC产品iza-bren（BL-B01D1），成为中国首个授权合作的双抗ADC，创造了当时国产ADC新药预付款新纪录，还刷新了全球ADC领域最大BD交易额。推荐阅读百利天恒朱义：“内生式”创新是成为跨国药企的前提一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

抗体药物偶联物引进/卖出细胞疗法免疫疗法临床3期

2025-07-02

·FierceBiotech

Biokin, having landed BMS deal, posts ph. 3 cancer win for bispecific ADC

The study was designed to compare the effect of iza-bren to the physician’s choice of chemotherapy. \n A phase 3 trial of Biokin’s bispecific antibody-drug conjugate (ADC) has hit at least one primary endpoint, boosting the prospects of a candidate that Bristol Myers Squibb licensed outside of China for $800 million upfront.BMS paid the upfront sum, part of a deal worth up to $8.4 billion, in 2023 to secure ex-China rights to izalontamab brengitecan (iza-bren). The candidate is designed to engage EGFR and HER3, receptors involved in the survival and proliferation of epithelial tumors, and deliver a cytotoxic payload to cells that express the proteins.On Wednesday, Biokin reported (PDF) positive topline results from a phase 3 trial of the ADC. The study enrolled patients with recurrent or metastatic nasopharyngeal carcinoma who had received at least two lines of chemotherapy after trying a PD-1/L1 antibody.The study met at least one primary endpoint. Biokin is yet to share data from the trial. The study was designed to compare the effect of iza-bren to the physician’s choice of chemotherapy. Biokin’s Baili Pharmaceutical, the trial’s sponsor, selected objective response rate and overall survival as the primary endpoints for the study. BMS has made triple-negative breast cancer its lead indication for the asset, with a phase 2/3 trial scheduled to start this month, but its Chinese partner’s program could generate evidence to support use in a range of other tumor types. Baili is running studies in indications including cancers of the biliary tract, kidneys, liver, lung and ovaries.Meanwhile, other EGFRxHER3 ADCs are in development. Duality Biotherapeutics and Avenzo Therapeutics secured FDA clearance to start a phase 1/2 trial in May. Biocytogen published preclinical data on a candidate last year. And CStone Pharmaceuticals shared preclinical data on its contender in May.

临床3期抗体药物偶联物临床结果上市批准临床终止

100 项与伦康依隆妥单抗相关的药物交易

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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
输卵管癌	临床3期	中国	四川百利药业有限责任公司	2025-05-01
卵巢上皮癌	临床3期	中国	四川百利药业有限责任公司	2025-05-01
铂类耐药性原发性腹膜癌	临床3期	中国	四川百利药业有限责任公司	2025-05-01
复发性铂耐药性卵巢癌	临床3期	中国	四川百利药业有限责任公司	2025-05-01
膀胱尿路上皮癌	临床3期	中国	四川百利药业有限责任公司	2025-03-25
复发性小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2024-08-07
三阴性乳腺癌	临床3期	中国	四川百利药业有限责任公司	2024-06-21
EGFR突变的非小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2024-05-22
转移性非鳞状非小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2024-05-22
HR阳性乳腺癌	临床3期	中国	四川百利药业有限责任公司	2024-04-24

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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


NCT05194982 (Phase I study of iza-bren, ASCO2025)	临床1期	局部晚期非小细胞肺癌 EGFR exon 20 insertions \| non-classical EGFR mutations \| mutations in HER2 ... 更多	73	iza-bren (BL-B01D1) (EGFR exon 20 insertions)	願淵積範網網選網餘獵(網壓憲憲選構襯糧鬱糧) = Only 1 case of G2 ILD was observed 顧獵鹹衊醖壓鬱齋遞糧 (觸繭艱範選膚蓋鏇齋餘 ) 更多	积极	2025-05-30
NCT05194982 (Phase I study of iza-bren (BL-B01D1), ASCO2025)	临床1期	小细胞肺癌 EGFR \| HER3	58	Iza-bren 2.0 mg/kg	淵餘製鬱積艱衊衊壓鬱(製積齋網醖觸築窪觸蓋) = No ILD was observed 衊齋蓋願鏇壓築憲願鏇 (艱糧蓋構鹹獵遞鑰醖衊 ) 更多	积极	2025-05-30
	临床1期	小细胞肺癌 EGFR \| HER3	58	Iza-bren 2.5 mg/kg		积极	2025-05-30
NCT05470348 (Phase I study of iza-bren (BL-B01D1), ESMO_BC2025)	临床1期	局部晚期乳腺癌 HER2-negative	121	iza-bren 2.5 mg/kg	襯夢積遞廠憲憲範窪遞(積網壓夢獵構醖觸壓壓) = 44.6% 鹽積衊簾窪鹹鑰蓋選淵 (獵廠艱範窪鬱鏇觸製夢 ) 更多	积极	2025-05-16
NCT05262491 (ESMO2024) 人工标引	临床1期	食管鳞状细胞癌	83	BL-B01D1 2.0 mg/kg	淵衊網鹽糧鬱築願範網(夢獵壓選鑰衊憲廠鬱範) = The incidence of ≥ G3 TRAEs at 2.5 mg/kg was 53%, and the most common ≥G3 TRAEs were anemia (25%), leukopenia (18%), thrombocytopenia (18%), neutropenia (15%), lymphocyte count decreased (15%) 鹽襯壓餘醖艱遞範願鹹 (築鹹壓衊鹽願壓簾築鏇 ) 更多	积极	2024-09-16
NCT05262491 (ESMO2024) 人工标引	临床1期	食管鳞状细胞癌	83	BL-B01D1 2.5 mg/kg		积极	2024-09-16
NCT05262491 (BL-B01D1, ESMO2024) 人工标引	临床1期	胆道癌	39	BL-B01D1 2.5 mg/kg	夢積選衊願積鏇製構憲(製製襯窪製鹽廠壓鏇築) = 繭鏇襯醖鬱廠遞衊獵範鹽糧窪壓膚繭齋顧膚餘 (範鬱鏇齋糧糧淵觸齋網 ) 更多	积极	2024-09-16
NCT05785039 (BL-B01D1, ESMO2024)	临床1/2期	转移性尿路上皮癌	32	BL-B01D1 2.2 mg/kg	遞願觸膚窪蓋製壓衊築(窪製糧鹹構廠築淵鏇鹽) = 22%/0% at 2.2mg/kg 獵廠網夢構鏇壓蓋簾夢 (構觸襯壓積獵淵壓遞範 ) 更多	积极	2024-09-13
CTR20212923 \| NCT05194982 (Pubmed) 人工标引	临床1期	实体瘤	195	BL-B01D1 0.27 mg/kg	簾鏇憲衊構膚壓築窪積(築遞簾淵積範艱鑰廠獵) = 淵選餘膚鬱觸鏇衊願遞醖襯遞襯廠鏇襯衊齋衊 (構繭鏇膚願鹹鑰蓋夢構 ) 更多	积极	2024-07-01
NCT05470348 (PRNewswire) 人工标引	临床1期	乳腺癌 ER Negative \| HER2 Negative \| PR Negative \| ... 更多	127	BL-B01D1	窪鑰窪鑰蓋範網窪顧夢(糧範糧願膚餘觸觸範遞) = 襯獵網願襯衊顧夢繭窪齋淵網築糧鹹鏇鏇夢窪 (窪鬱窪獵範網網鬱淵鏇 ) 更多	积极	2023-12-05
NCT05194982 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	非小细胞肺癌 EGFR	114	BL-B01D1	顧鏇顧膚選鬱顧觸衊繭(艱餘淵範膚醖淵顧襯網) = 鹽壓餘鏇願齋壓廠壓顧鬱鏇獵衊壓齋繭製衊積 (壓齋壓築選衊糧糧夢夢 )	积极	2023-10-21
NCT05194982 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	非小细胞肺癌 EGFR	114	BL-B01D1 (EGFRmut)	鏇淵鹹範鬱選獵鏇醖顧(淵廠鏇顧鹽範糧觸鬱鏇) = 製淵鹽醖選齋鑰蓋齋廠鏇餘憲製窪簾鹹廠繭糧 (齋獵願觸衊餘願鹹繭醖, 75.2 ~ 97.1) 更多	积极	2023-10-21
NCT05194982 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	转移性实体瘤	120	BL-B01D1 (EGFRmut + NSCLC)	艱齋鏇餘衊壓醖製餘獵(顧淵憲蓋蓋艱襯壓廠蓋) = neutropenia, febrile neutropenia and thrombocytopenia at 3.0mg/kg QW and 3.5mg/kg D1D8 Q3W 繭積繭窪築壓襯簾範夢 (齋製淵繭觸醖鹹蓋壓夢 ) 更多	积极	2023-05-31
NCT05194982 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	转移性实体瘤	120	BL-B01D1 (EGFRwt + NSCLC)		积极	2023-05-31