预约演示

更新于：2025-07-17

Izalontamab Brengitecan

伦康依隆妥单抗

更新于：2025-07-17

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

Systimmune, Inc.

四川百利药业有限责任公司

在研机构

Bristol Myers Squibb Co.成都百利多特生物药业有限责任公司

Systimmune, Inc.

+ [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。

或

查看完整样例数据

Sequence Code 43254

来源: *****

Sequence Code 10172664

来源: *****

关联

项与伦康依隆妥单抗相关的临床试验

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]

NCT07054567

/ Not yet recruiting临床2期

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + Pembrolizumab Dual Therapy With or Without Bevacizumab (BL-B01D1 + Pembrolizumab ? Bevacizumab) in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer

This Phase II study is a clinical trial to evaluate the efficacy and safety of BL-B01D1 + pembrolizumab dual therapy with or without bevacizumab (BL-B01D1 + pembrolizumab ? bevacizumab) in patients with recurrent or metastatic cervical cancer and endometrial cancer.

开始日期2025-07-01

申办/合作机构

四川百利药业有限责任公司

[+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]

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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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.

NATURE MEDICINE

A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial

Article

作者: Zhu, Yi ; Lu, Zhihao ; Liu, Chang ; Li, Jian ; Liu, Dan ; Ge, Sai ; Qi, Changsong ; Xiao, Sa ; Wang, Zhenghang ; Zhou, Jun ; Lu, Ming ; Sun, Meili ; Zhang, Miao ; Gao, Shegan ; Ji, Yinghua ; Zhu, Ji ; Shen, Lin ; Zhu, Hai ; Zhang, Panpan ; Wang, Yakun ; Yuan, Jiajia ; Ma, Xuelei ; Zhong, Diansheng ; Peng, Zhi ; Cao, Yanshuo ; Gong, Jifang ; Xue, Ran ; Zhang, Xiaotian

Research on patients with advanced esophageal squamous cell carcinoma (ESCC) who have progressed on immunotherapy remains limited. BL-B01D1 is a first-in-class antibody-drug conjugate consisting of an EGFR-HER3 bispecific antibody bound to a topoisomerase I inhibitor (Ed-04) payload via a cleavable linker. Here, we present safety and efficacy data from a phase 1 study of BL-B01D1, in 82 patients previously treated for ESCC. The primary endpoint was the recommended phase 2 dose. Administered doses were 2.0 (n = 22) and 2.5 (n = 60) mg kg^-1 D1D8 infusion every 3 weeks (Q3W). The confirmed objective response rate (cORR) was 29.3% (24 of 82) in all patients and 32.9% (24 of 73) among evaluable patients. For patients dosed at 2.5 mg kg^-1, cORR was 39.6% (21 of 53) and disease control rate was 79.2% (42 of 53). In the 2.0 mg kg^-1 group, cORR was 15.0% (3 of 20), and the disease control rate was 50.0% (10 of 20). The phase 2 dose was established at 2.5 mg kg^-1 D1D8 Q3W. The incidence of G3 treatment-related adverse events at 2.5 mg kg^-1 was 63.3%; most common adverse events were anemia (28.3%), leukopenia and thrombocytopenia (18.3%, each), and neutropenia (16.7%). Two cases of ≥G3 interstitial lung disease were observed. Overall, BL-B01D1 demonstrated promising efficacy and manageable safety in patients with metastatic ESCC. A further phase 3 clinical trial has already been initiated. ClinicalTrials.gov registration: NCT05262491 .

419

项与伦康依隆妥单抗相关的新闻（医药）

2025-07-14

·ioncology

Nature Medicine丨沈琳教授团队全球首发EGFR×HER3双抗ADC成果，助力破解食管鳞癌治疗瓶颈

点击上方蓝字关注我们编者按：《自然-医学》(Nature Medicine，IF=50.0 ) 于2025年7月10日在线发布了北京大学肿瘤医院沈琳教授团队牵头的“A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial”。该研究聚焦新型靶向EGFR和HER3的双靶点抗体-抗体偶联药物（ADC）BL-B01D1，初步验证了其在晚期食管鳞癌（ESCC）客观缓解率可达29.3%，安全性可控，具有良好的临床应用前景，为食管鳞癌患者提供了潜在的创新治疗方向。研究背景食管鳞癌（ESCC）是全球常见的恶性肿瘤，免疫联合铂类为其一线标准治疗方案，但仅有约10%-20%的患者可实现长期生存，大部分患者仍面临耐药困境。在二线治疗方面，伊立替康单药客观缓解率（ORR）不足10%，长期缺乏有效的治疗选择，患者生存改善举步维艰。因此，亟需开发创新治疗策略以破解现有疗法的双重困境——耐药瓶颈与生存获益局限，以提高食管鳞癌患者的生存率。值得注意的是，50%-70% ESCC存在EGFR过表达，此特征与肿瘤侵袭性强、预后不良密切相关。然而，传统抗EGFR药物（西妥昔单抗、帕尼单抗、吉非替尼等）临床获益有限。近期研究发现EGFR与HER3在消化道肿瘤共表达频率高，共同驱动疾病进展。临床前证据揭示同时阻断EGFR和HER3双靶点可有效克服耐药机制，更大程度杀伤肿瘤细胞，为破解治疗困局提供新方向。在此背景下，我国原研首创的EGFR×HER3双抗ADC药物BL-B01D1应运而生，由EGFR×HER3双特异性抗体与拓扑异构酶Ⅰ抑制剂Ed-04通过可裂解连接子偶联而成，药物抗体比（DAR）为8。EGFR×HER3双抗特异性结合EGFR和/或HER2受体，通过内吞作用进入肿瘤细胞，使四肽连接子裂解释放细胞毒载荷Ed-04。此外，EGFR×HER3双抗Fc区还可介导抗体依赖性细胞介导的细胞毒作用（ADCC），增强抗肿瘤效果。基于BL-B01D1在临床前研究中展现的对肺癌、鼻咽癌、尿路上皮癌等多瘤种治疗潜力，本研究评估了其对转移性ESCC的有效性与安全性。研究方法BL-B01D1-103研究是一项开放标签、多中心、两阶段设计的Ⅰa/Ⅰb期临床研究。根据Ⅰa期剂量探索研究的初步数据，将2.5mg/kg（第1、8天静脉输注，21天为一个治疗周期）确立为II期推荐剂量（RP2D）。考虑到转移性食管鳞癌患者普遍存在营养不良及治疗耐受性差等临床挑战，此项Ib期研究设置2.0mg/kg与2.5mg/kg两个剂量组，旨在评估RP2D对该人群的适用性，并系统考察BL-B01D1在转移性食管鳞癌患者中的安全性、耐受性及疗效，同时探索潜在的疗效预测标志物。研究结果2022年12月12日至2023年12月4日，研究共纳入82例转移性食管鳞癌患者，予以BL-B01D1 2.0mg/kg组（22例）或2.5mg/kg组（60例），37.8%的患者既往接受过1线系统治疗，62.2%的患者接受过≥2线系统治疗，95.1%的患者对既往免疫检查点抑制剂联合化疗方案（如PD-1/L1单抗联合铂类药物）耐药。截至2024年9月30日，仍有11例患者持续接受治疗。安全性分析显示，在2.5mg/kg剂量组中，所有等级治疗相关不良事件（TRAE）以血液学毒性为主，最常见的为贫血（85.0%）、血小板减少症（58.3%）、白细胞减少症（56.7%）及中性粒细胞减少症（46.7%）。≥3级TRAE发生率为63.3%，其中贫血为28.3%，白细胞减少和血小板减少症均为18.3%，中性粒细胞减少症为16.7%。43.3%的患者因TRAE下调剂量。在2.0mg/kg组中，最常见的所有等级TRAE为贫血（86.4%）、白细胞减少和乏力（各45.5%）。≥3级TRAE发生率为45.5%，其中贫血为27.3%、淋巴细胞计数减少为13.6%、白细胞减少和中性粒细胞减少均为9.1%。另外，全人群共报告3例间质性肺病（ILD），其中2.5mg/kg组出现1例2级和1例3级ILD（均有胸部放疗史，经糖皮质激素治疗后缓解），2.0mg/kg组发生1例5级致死性ILD（无放疗史，患者拒绝评估后进展为重症肺炎）。肿瘤缓解状况疗效方面，根据实体瘤疗效评价标准（RECIST）v1.1，共73例患者纳入分析。客观缓解率（ORR）为35.6%，确认的客观缓解率（cORR）为32.9%，疾病控制率（DCR）为71.2%，中位无进展生存期（mPFS）为4.2个月，中位总生存期（mOS）为6.9个月，中位缓解持续时间（mDOR）为6.7个月。2.0mg/kg和2.5mg/kg两剂量组间存在显著差异。在2.5mg/kg组的53例可评估患者中，cORR达39.6%，DCR 79.2%，mPFS 5.4个月，mOS 11.5个月；而2.0mg/kg组的20例可评估患者中，cORR仅为15.0%，DCR 50.0%，mPFS 2.7个月，mOS 5.6个月。值得注意的是，2.0mg/kg组患者基线治疗负担更重（45.5%接受≥3线治疗 vs 2.5mg/kg组23.3%）。两剂量组PFS 和 OS对2.5mg/kg和2.0mg/kg两剂量组进行综合评估：两剂量组TRAE均以可控的血液学毒性为主（2.5mg/kg组≥3级TRAE 63.3% vs 2.0mg/kg组45.5%），但2.5mg/kg组展现显著临床优势——cORR提高2.6倍（39.6% vs 15.0%），DCR提升29.2%（79.2% vs 50.0%），mOS实现翻倍增长（11.5 vs 5.6个月）。探索性分析表明，EGFR、HER3蛋白表达水平与临床疗效无显著相关性，亚组分析中各因素（包括年龄、ECOG评分、转移器官数量等）均未影响疗效趋势。基于上述证据，最终确立2.5mg/kg（第1、8天给药，21天周期）作为食管鳞癌患者的RP2D，相关III期注册临床研究已正式启动。研究结论基于本研究数据，BL-B01D1在经治转移性食管鳞癌患者中实现39.6%的cORR，较现有二线单药化疗（伊立替康ORR<10%）有极大提升，且安全性特征以可控的血液学毒性为主。尤其值得关注的是，入组患者中95.1%对PD-1/L1抑制剂联合化疗耐药，这意味着BL-B01D1或可克服免疫检查点抑制剂的原发/继发耐药困境。BL-B01D1在转移型食管鳞癌患者中展现出可控的安全性与显著抗肿瘤活性，尤其为既往免疫治疗失败人群提供了突破性治疗选择。为加速这一创新疗法的临床转化，由沈琳教授牵头的针对ESCC二线治疗的III期随机对照研究BL-B01D1-305（NCT06304974）已在全国多家中心启动，将加速填补ESCC双靶ADC治疗空白，为免疫耐药患者建立新治疗范式。参考文献：Liu, C., Liu, D., Ji, Y. et al. A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial. Nat Med (2025). https://doi.org/10.1038/s41591-025-03792-7阅读原文：https://www.nature.com/articles/s41591-025-03792-7#Sec2（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临床2期

2025-07-12

·药研发

【药研日报0712】甘李药业上半年净利同比翻倍大增

甘李药业上半年净利同比翻倍大增近日，甘李药业通过胰岛素集采实现量价齐升，业绩大幅增长，其研发管线丰富，1类新药博凡格鲁肽等产品进展顺利，有望进一步提升竞争力，未来发展备受期待。中国双抗ADC获突破引行业变革百利天恒的伦康依隆妥单抗（BL-B01D1）作为全球首个双抗ADC药物，在III期临床研究中取得成功，标志着中国药企在ADC领域实现从“跟随”到“引领”的飞跃。挚盟医药渐冻症新药在华获批临床近日，挚盟医药自主研发的KCNQ2/3开放剂CB03-154片，获中国药监局批准开展治疗肌萎缩侧索硬化（渐冻症）的2/3期临床。该药曾获FDA孤儿药资格，临床前研究显示能显著延缓疾病恶化。赛多利斯收购MatTek扩充细胞技术赛多利斯完成收购MatTek公司，该公司为全球人体细胞模型领先者，将整合至实验室部门，扩充细胞技术产品线，促进药物开发。泽璟制药ZG006拟纳入突破性治疗近日，泽璟制药ZG006拟纳入突破性治疗程序，用于三线及以上复发或进展的晚期小细胞肺癌患者。

抗体药物偶联物孤儿药并购临床2期引进/卖出

2025-07-11

·生物世界

创国产新药出海预付款纪录，百利天恒双抗ADC临床试验结果登上Nature Medicine

撰文丨王聪编辑丨王多鱼排版丨水成文食管癌是癌症相关死亡的第七大常见原因，其中，食管鳞状细胞癌（ESCC）是全球最常见的食管癌类型。免疫检查点抑制剂（例如抗 PD-1、PD-L1 和 CTLA-4 单抗）与基于铂类药物的化疗相结合，已成为晚期食管鳞状细胞癌的标准治疗方法，并带来了显著的生存获益。然而，仅有 10%-20% 的食管鳞状细胞癌患者能长期存活，因为大多数患者会对这些药物产生耐药性。晚期食管鳞状细胞癌的二线治疗采用伊立替康（Irinotecan），但其疗效也有限，客观缓解率（ORR）不超过 10%。因此，迫切需要开发新的有效治疗策略，以克服当前疗法的局限性，提高食管鳞状细胞癌患者的生存率。2025 年 7 月 10 日，北京大学肿瘤医院鲁智豪、沈琳、龚继芳等人在国际顶尖医学期刊 Nature Medicine 上发表了题为：A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial的研究论文。该研究报道了一种靶向 EGFR 和 HER3 的双特异性抗体药物偶联物（ADC）在转移性食管鳞状细胞癌的 1b 期临床试验结果，在转移性食管鳞状细胞癌患者中显示出良好的疗效和可控的安全性。对于免疫治疗后仍然病情进展的晚期食管鳞状细胞癌（ESCC）患者的研究非常有限。BL-B01D1 是一种首创（first in class）的抗体药物偶联物（ADC），由四川百利天恒药业股份有限公司研发，这也是全球首个进入临床试验阶段的 EGFR×HER3 双特异性抗体偶联药物（双抗ADC）。该药物由一个 EGFR×HER3 双特异性抗体通过可裂解连接子与拓扑异构酶 I 抑制剂（Ed-04）有效载荷连接而成。BL-B01D1 的结构值得一提的是，该药物与国际制药巨头百时美施贵宝（BMS）达成了总额高达 84 亿美元的合作，高达 8 亿美元的首付款刷新了国产创新药单个项目出海纪录。在这项最新研究中，研究团队展示了 BL-B01D1 在 82 名曾接受过治疗的食管鳞状细胞癌（ESCC）患者中进行的 1 期临床研究的安全性和有效性数据。主要终点是推荐的 2 期剂量，给药剂量为 2.0（n = 22）和 2.5（n = 60）mg/kg（D1D8 Q3W）。结果显示，所有患者的确认客观缓解率（cORR）为 29.3%（24/82），可评估患者中的 cORR 为 32.9%（24/73）。对于剂量为 2.5 mg/kg 的患者，cORR 为 39.6%（21/53），疾病控制率为 79.2%（42/53）。对于剂量为 2.0 mg/kg 的患者，cORR 为 15.0%（3/20），疾病控制率为 50.0%（10/20）。基于上述结果，2 期临床试验的剂量确定为每 3 周一次，第 1 天和第 8 天给药，剂量为 2.5 mg/kg。在 2.5 mg/kg 剂量下，3 级治疗相关不良事件的发生率为 63.3%；最常见的不良事件为贫血（28.3%）、白细胞减少和血小板减少（各 18.3%）以及中性粒细胞减少（16.7%）。整个研究中观察到两例 ≥3 级间质性肺病。总体而言，BL-B01D1 在转移性食管鳞状细胞癌患者中显示出良好的疗效和可控的安全性。研究团队已经启动了 3 期临床试验。论文链接：https://www.nature.com/articles/s41591-025-03792-7设置星标，不错过精彩推文开放转载欢迎转发到朋友圈和微信群微信加群为促进前沿研究的传播和交流，我们组建了多个专业交流群，长按下方二维码，即可添加小编微信进群，由于申请人数较多，添加微信时请备注：学校/专业/姓名，如果是PI/教授，还请注明。点在看，传递你的品味

抗体药物偶联物临床2期引进/卖出临床结果

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

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


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	艱製繭遞鬱鑰鏇製構憲(糧製鬱觸糧窪衊網襯膚) = established at 2.5 mg kg-1 D1D8 Q3W 夢鏇選蓋製糧淵築繭願 (艱淵願築鏇鑰壓築簾艱 ) 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 (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	壓繭築繭鑰醖齋衊願窪(鹹齋簾選艱觸簾積夢觸) = No ILD was observed 遞製餘簾範糧襯鬱糧鏇 (鹹觸網憲網觸獵廠獵鹽 ) 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
NCT05194982 (Phase I study of iza-bren, ASCO2025)	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) (EGFR exon 20 insertions)	鹹壓淵齋獵壓網廠鏇積(膚選膚築淵壓範構遞餘) = Only 1 case of G2 ILD was observed 蓋夢顧夢獵觸願鹹鹽餘 (艱鹹衊糧鹽艱齋鬱顧鏇 ) 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	廠鏇積繭廠鏇壓襯壓窪(醖餘衊築襯選鑰觸構艱) = 44.6% 鏇鑰廠衊願憲築醖願製 (窪窪衊鏇構顧製淵製鹹 ) 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	遞窪遞膚糧築網鹹鑰鬱(顧鏇鑰醖構憲觸醖網艱) = 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%) 憲遞醖選糧繭製鹽壓鹽 (醖窪範簾觸鑰網膚觸築 ) 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	膚獵鏇鬱膚築觸窪顧醖(繭範簾鬱獵簾壓艱構夢) = 蓋願膚觸蓋糧獵蓋顧築觸齋繭夢鏇夢鹽鏇製構 (顧繭憲築襯構艱顧糧鏇 ) 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	憲窪願醖淵衊製餘觸構(遞餘襯積簾顧築繭蓋襯) = 22%/0% at 2.2mg/kg 鏇鬱構襯遞觸顧廠鏇繭 (夢淵夢積遞糧廠獵積網 ) 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	鏇鏇艱構艱窪築蓋廠膚(範製網觸範艱衊遞繭醖) = 簾襯網壓製鏇餘鑰壓範觸淵壓觸範鑰醖廠遞膚 (網積憲艱鏇糧夢壓襯選 ) 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	壓網積遞襯鏇襯範網鑰(窪鬱艱繭築鏇積網簾淵) = 顧構鬱鑰衊簾製網膚積艱築顧齋鑰築廠夢製齋 (艱糧淵選齋壓簾壓艱餘 ) 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	襯積壓齋衊鹽鏇鹽顧衊(簾顧製選觸憲壓選製築) = 鹽繭築鹹壓膚餘鏇鹹齋網鏇餘製遞鹽餘襯積廠 (淵鬱憲製積衊夢憲鏇鹽 )	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)	蓋範糧衊築選衊醖襯艱(艱鑰蓋壓構觸積鹹範積) = 廠襯積遞鏇鹹觸齋衊醖窪醖夢簾鑰簾淵鹹淵構 (遞簾製遞蓋壓鹽範範觸, 75.2 ~ 97.1) 更多	积极	2023-10-21