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，铂耐药上皮性卵巢癌，铂耐药性输卵管癌_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

输卵管癌铂耐药上皮性卵巢癌铂耐药性输卵管癌+ [59]

非在研适应症-

原研机构

Systimmune, Inc.

四川百利药业有限责任公司

在研机构

Bristol Myers Squibb Co.

四川百利药业有限责任公司

四川百利天恒药业股份有限公司

+ [3]

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

57

项与伦康依隆妥单抗相关的临床试验

NCT07100080

/ Not yet recruiting临床2/3期

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy

开始日期2025-10-15

申办/合作机构

Bristol Myers Squibb Co.

NCT06994195

/ Recruiting临床3期

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer

This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.

开始日期2025-08-04

申办/合作机构

四川百利药业有限责任公司

[+1]

NCT06926868

/ 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]

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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4

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 ; Zhu, Yi ; Zhou, Ningning ; 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.

Cancer Discovery

Bispecific ADC “Really Strong” against ESCC

作者: Leslie, Mitch

A phase I study of the bispecific antibody–drug conjugate BL-B01D1 shows encouraging safety and effectiveness. The drug, which targets EGFR and HER3, triggered side effects in most patients, but at the higher of two doses tested, it spurred tumor responses in almost 40% of patients.

437

项与伦康依隆妥单抗相关的新闻（医药）

15 小时之前

·丁香园 Insight 数据库

84 亿美元授权 BMS！百利天恒双抗 ADC 获 FDA 突破性疗法认定

8 月 18 日，百利天恒宣布，美国 FDA 已授予 Izalontamab Brengitecan（iza-bren）突破性疗法认定，用于治疗携带 EGFR 19 号外显子缺失或 21 号外显子 L858R 置换突变、且在 EGFR-TKI 及铂类化疗后进展的局部晚期或转移性非小细胞肺癌患者。来源：百利天恒官微 Iza-bren 是一款潜在全球首创双抗 ADC，其载荷为拓扑异构酶 1 抑制剂，可同时靶向表皮生长因子受体和人表皮生长因子受体 3（EGFRxHER3）。Iza-bren 通过双重作用机制阻断 EGFR 和 HER3 向肿瘤细胞传递的信号，从而抑制其增殖与存活信号。此外，通过抗体介导的内吞作用，Iza-bren 释放的治疗性有效载荷可引发基因毒性应激，最终导致肿瘤细胞死亡。 2023 年 12 月，百利天恒与 BMS 达成合作，Iza-bren 在中国由百利天恒独家开发，在中国以外的地区由西雅图免疫与百时美施贵宝共同开发，总金额高达 84 亿美元，其中首付款 8 亿美元. 封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

突破性疗法引进/卖出抗体药物偶联物

18 小时之前

·抗体密码

映恩，康宁杰瑞公布双抗ADC临床前数据

ADC爆火之后，双抗ADC接踵而至，在今年的AACR会议上，共有32款双抗ADC相关研究披露临床前数据，其中EGFR，cMET，B7-H3和DLL3靶点组合占据了前四，并且根据相关数据库披露，临床前已经超过150款， 2024年一年有多达80款双抗ADC披露，并且逐渐进入临床，来年相信相关临床结果会逐渐披露。近日，映恩生物和康宁杰瑞相继发表文章分别披露了其双抗ADC DB-1419（B7-H3×PD-L1-ADC）和JSKN003（HER2/HER2-ADC）的临床前研究成果。首先看一下映恩生物的DB-1419（B7-H3×PD-L1-ADC），该双抗ADC裸抗为对称型双抗，PD-L1端为传统单抗，B7-H3端采用纳米抗体，来自于上海迈石生物。Payload为映恩生物的P1003并且通过可裂解linker偶联，结合活性方面，DB-1419对B7-H3和PD-L1的结合EC50分别为0.15 μg/ml和2.68 μg/ml，与裸抗相当。在物种交叉结合能力方面，DB-1419与猴子的B7-H3和PD-L1抗原具有较高的亲和力，而对小鼠或者大鼠抗原的结合能力较低或者没有结合能力。在稳定性方面，在人，猴及大鼠血清中，21天后linker和payload的释放量仍小于4.4%，证明该双抗ADC具有较高的稳定性。体外活性方面，DB-1419在多种肿瘤细胞系中展现较强的肿瘤的活性，如NCI-H358, NCI-H1568, Huh7, PC-3同时其在DMS53, A375，NCI-H441 及 MDA-MB-231, NCI-H82,KYSE-150, NCI-H1975肿瘤细胞系中展现了中等或者较弱的杀伤活性。而裸抗DB-141902在这些肿瘤细胞系中几乎没有活性。并且DB-1419的杀伤活性与其结合相关细胞系的能力相关，特别是PD-L1端的结合能力。在MOA方面，DB-1419通过多种机制对肿瘤细胞进行杀伤，如ADCC，Payload内吞介导的DNA损伤及细胞凋亡，同时也有旁观者效应。在体内活性方面，DB-1419无论是在肿瘤细胞Huh7 CDX模型还是在PDX模型中都展现了较强的抑制肿瘤活性，并且具有剂量依赖关系。而在毒性方面，无论是在低剂量还是高剂量中，小鼠体重都没有下降，说明DB-1419具有较好的安全性。Payload P1003含量方面，肿瘤组织相较于正常组织具有更高的浓度，这表明DB-1419在血液中具有较好的稳定性并且进入肿瘤后可以有效的被内吞释放毒素，从而对肿瘤细胞进行杀伤。同样，在免疫功能正常的肿瘤模型（利用PBMC重建）的多种模型中，如NCI-H82，NCI-H1975，A375等DB-1419同样展现了较强的抑制肿瘤活性及安全性，包括在PDX模型中具有较好的安全性和抗肿瘤能力。再来看看康宁杰瑞的JSKN003，其是康宁杰瑞基于HER2双抗KN026（anbenitamab）开发的一款ADC药物，其通过糖基定点偶联技术将拓扑异构酶I（Top I）抑制剂连接至KN026抗体的N糖基化位点处，DAR值约为4。成药性及血清稳定性：与基于半胱氨酸偶联的DS-8201相比，JSKN003在疏水性方面表现更好，这可能是因为DS-8201 DAR值更高且linker更加疏水，另外，在聚集性方面，高DAR值的DS-8201具有更强的聚集倾向，这主要是和其疏水性相关。而在血清稳定性方面，与血清在37℃孵育96小时后，DS-8201的DAR值有大幅度的下降，而JSKN003几乎不变，表明基于糖基偶联的ADC具有更强的稳定性。同样，在小鼠体内（下图E），给相同剂量的DS-8201和JSKN003（Day0和Day7两次给药），Day11血清检测表明，无论是抗体总量还是ADC总量，JSKN003要远高于DS-8201。 JSKN003发挥抗肿瘤效果的MOA：JSKN003基本上保留了其裸抗KN026的相关活性，包括结合能力方面，偶联payload后其结合能力没有受到影响，同时其内吞能力也没有受到影响，抗体结合靶标细胞后快速内吞。另外，其还具有ADCC活性，payload的DNA损伤及诱导的细胞凋亡，同时具有旁观者效应。在杀伤活性方面，JSKN003对HER2高表达的NCI-N87 ，BT474具有较强的杀伤能力，但是对于HER2低表达的BxPC-3体外杀伤能力较弱。但是在体内模型中，JSKN003对三种细胞模型都展现了较强的抑制活性。另外，其在PDX模型中也具有较强的抑制肿瘤活性。对于trastuzumab耐药的细胞株N87-RE，BT474-RE，JSKN003相较于DS-8201，保持更好的结合活性，同时也保持了较好的抑制活性。JSKN003通过双特异性抗体设计，在耐药肿瘤中保持了靶标结合、内化和细胞毒性的优势，展现出克服曲妥珠单抗耐药的临床潜力在小鼠和猴子体内，JSKN003展现了很好的稳定性并且有较长的半衰期总结双抗ADC已经逐渐进入临床，目前进展最快的是百利天恒宣布伦康依隆妥单抗（iza-bren，BL-B01D1），2025年7月2日，百利天恒宣布BL-B01D1治疗鼻咽癌的III期临床试验（研究方案编号：BL-B01D1-303）在期中分析达到主要终点。这是全球首个III期成功的双抗ADC。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，其有望成为首个上市的双抗ADC。我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！往期精彩回顾抗体密码文章合集双特异抗体平台靶点相关双特异抗体作用机制综述，行业概览抗体筛选技术相关公司技术汇总医药资讯因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作= 参考文献 1、DOI: 10.1039/d5cb00096c 2、doi/10.1158/1078-0432.

抗体药物偶联物AACR会议临床1期

20 小时之前

·药事纵横

肺癌将迎来全新疗法：EGFR/HER3双特异抗体ADC获FDA突破性疗法认定

2025年8月18日，SystImmune Inc与百时美施贵（BMS）联合对外宣布，美国食品药品监督管理局（FDA）已授予二者与百奥泰共同研发的izalontamab brengitecan 突破性疗法认定（BTD）。这是一种靶向于EGFR/HER3点的ADC，针对外显子19缺失或外显子21 L858R置换突变的患者，适用于经EGFR酪氨酸激酶抑制剂（TKI）和铂类化疗后疾病进展的局部晚期或转移性非小细胞肺癌（NSCLC）。 Izalontamab brengitecan 是一款潜在“首创”（first-in-class）的双特异性抗体药物偶联物（ADC），靶向表皮生长因子受体（EGFR）和人表皮生长因子受体3（HER3），并搭载拓扑异构酶1抑制剂有效载荷。该药物在中国由百奥泰（Biokin）开发，在中国以外地区由SystImmune与百时美施贵宝基于合作及独家许可协议共同开发。 FDA的决定基于三项进行中的临床试验的疗效和安全性数据，由中国四川百奥开展的BL-B01D1-101和BL-B01D1-203研究，以及由SystImmune在美国、欧洲和日本开展的全球性BL-B01D1-LUNG-101研究。在这些试验中，iza-bren在经第三代EGFR TKI和铂类化疗后进展的EGFR突变NSCLC患者中显示出疗效改善证据，且安全性可控。非小细胞肺癌（NSCLC）约占所有肺癌病例的80%，仍是全球癌症相关死亡的主要原因。在NSCLC患者中，西方人群有10%-15%、亚洲人群高达50%携带激活型EGFR突变。这类肿瘤多为非鳞状组织学类型，最初对奥希替尼等EGFR TKI有响应。然而，耐药性几乎普遍存在（通常在约18个月后发生），而TKI和铂类化疗以外的治疗方案临床获益有限且毒性显著，凸显了对新型有效疗法的迫切需求。信息来源：https://news.bms.com/news/corporate-financial/2025/Izalontamab-Brengitecan-EGFRxHER3-ADC-Granted-Breakthrough-Therapy-Designation-by-U-S--FDA-for-Patients-with-Previously-Treated-Advanced-EGFR-Mutated-Non-Small-Cell-Lung-Cancer/default.aspx 立即扫码加入药事纵横交流群

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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
晚期尿路上皮癌	临床3期	美国	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	日本	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	阿根廷	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	澳大利亚	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	奥地利	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	比利时	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	巴西	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	加拿大	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	法国	Bristol Myers Squibb Co.	2025-10-22
晚期尿路上皮癌	临床3期	德国	Bristol Myers Squibb Co.	2025-10-22

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临床结果

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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


NEWS 人工标引	临床3期	鼻咽癌	-	伦康依隆妥单抗	衊繭積網製願淵繭範齋(夢鹹糧積蓋繭鹽蓋齋築) = 伦康依隆妥单抗（Iza-bren，BL-B01D1）用于治疗鼻咽癌III期临床试验的期中分析达到主要终点廠衊淵遞廠窪遞襯衊齋 (夢夢壓獵範醖淵餘築鏇 ) 达到	积极	2025-07-16
NCT05262491 (Pubmed) 人工标引	临床1期	转移性食管鳞状细胞癌	82	BL-B01D1 2.0 mg/kg	繭襯築膚淵願淵膚構構(製簾艱築鬱艱網網顧獵) = established at 2.5 mg kg-1 D1D8 Q3W 遞遞鏇蓋蓋製鏇鏇艱淵 (觸鏇艱範構顧糧膚觸膚 ) 更多	积极	2025-07-10
NCT05262491 (Pubmed) 人工标引	临床1期	转移性食管鳞状细胞癌	82	BL-B01D1 2.5 mg/kg		积极	2025-07-10
NCT05194982 (ASCO2025) 人工标引	临床1期	小细胞肺癌	58	Iza-bren	鏇襯夢繭鬱獵壓積築憲(鬱廠範獵鹹廠夢糧鹽憲) = 築艱齋築願衊齋選製艱鹹餘艱獵鑰鹹網醖廠鏇 (衊憲簾築網築壓膚積網 ) 更多	积极	2025-05-30
NCT05194982 (ASCO2025) 人工标引	临床1期	小细胞肺癌	58	Iza-bren 2.5 mg/kg (only 1 prior line of PD(L)-1 and PBC combination treatmen)	鏇襯夢繭鬱獵壓積築憲(鬱廠範獵鹹廠夢糧鹽憲) = 製憲鬱製餘選憲積襯製鹹餘艱獵鑰鹹網醖廠鏇 (衊憲簾築網築壓膚積網 ) 更多	积极	2025-05-30
NCT05194982 (ASCO2025) 人工标引	临床1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) (Total)	積願襯壓遞膚鹽範觸艱(顧鬱鬱簾醖網鹹製範構) = 憲繭衊艱襯繭築糧廠遞網鏇繭淵願繭壓顧餘淵 (夢鬱衊繭遞製鏇鹽鬱窪 ) 更多	积极	2025-05-30
NCT05194982 (ASCO2025) 人工标引	临床1期		73	iza-breniza-bren (BL-B01D1) (EGFR mut exon20ins/non-classical)	積願襯壓遞膚鹽範觸艱(顧鬱鬱簾醖網鹹製範構) = 構糧鹽鹹願鏇構簾鹹壓網鏇繭淵願繭壓顧餘淵 (夢鬱衊繭遞製鏇鹽鬱窪 ) 更多	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	蓋製願範鬱鹽繭淵網餘(鹽壓獵糧遞廠淵蓋鏇蓋) = 44.6% 遞壓衊顧築鹹艱膚壓齋 (膚淵襯鹽積衊衊網選製 ) 更多	积极	2025-05-16
NCT05262491 (BL-B01D1, ESMO2024) 人工标引	临床1期	胆道癌	39	BL-B01D1 2.5 mg/kg	蓋壓顧鑰淵襯夢簾選簾(夢構醖廠選鹽鹹積鏇窪) = 築製襯壓壓構構窪膚顧夢觸積糧壓製鹹夢壓顧 (餘構憲餘網製鹹衊鹹繭 ) 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 2.0 mg/kg	鹹築齋繭範繭鑰醖觸蓋(糧壓鹽遞製膚夢選壓顧) = 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%) 觸願窪網選獵醖夢繭膚 (簾衊網餘憲醖積淵網鏇 ) 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
NCT05785039 (BL-B01D1, ESMO2024)	临床1/2期	转移性尿路上皮癌	32	BL-B01D1 2.2 mg/kg	艱積鹽願範艱衊膚鹹鹽(壓艱衊鏇獵膚醖構膚餘) = 22%/0% at 2.2mg/kg 壓壓膚襯衊夢壓膚鏇夢 (齋網構窪糧築衊選簾獵 ) 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	襯顧觸網範繭淵夢網餘(襯顧壓選鹽鑰遞獵艱艱) = 蓋壓繭鏇簾糧壓築選積餘獵廠艱製顧選夢選獵 (淵衊壓憲願鏇餘淵鑰範 ) 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	觸構遞膚窪鹽築獵窪繭(築夢窪築糧衊衊範衊糧) = 鬱鹽淵鹹網願築窪夢積糧簾淵糧廠積網鏇鬱壓 (襯鬱艱襯製網網繭鏇製 ) 更多	积极	2023-12-05