更新于：2024-11-19
Izalontamab Brengitecan
伦康依隆妥单抗
更新于：2024-11-19
概要
基本信息
药物类型 ADC |
别名 Zalontamab brengitecan、BL B01D1、BL-B01D1 + [2] |
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)、TOP 抑制剂(Topoisomerases inhibitors) |
在研适应症 |
非在研适应症- |
原研机构 |
在研机构 |
非在研机构- |
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) |
登录后查看时间轴
结构
使用我们的XDC技术数据为新药研发加速。
登录
或
序列信息
Sequence Code 43254
来源: *****
Sequence Code 10172664
来源: *****
关联
58
项与 伦康依隆妥单抗 相关的临床试验A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors
评价注射用 BL-B01D1 在复发胶质母细胞瘤患者中的有效性和安全性的 II 期临床研究
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma
100 项与 伦康依隆妥单抗 相关的临床结果
登录后查看更多信息
100 项与 伦康依隆妥单抗 相关的转化医学
登录后查看更多信息
100 项与 伦康依隆妥单抗 相关的专利（医药）
登录后查看更多信息
1
项与 伦康依隆妥单抗 相关的文献（医药）2024-07-01LANCET 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 ; Ma, Yuxiang ; Zhu, Hai ; Han, Yaqian ; 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.
305
项与 伦康依隆妥单抗 相关的新闻（医药）20 小时之前
引进/卖出抗体药物偶联物并购
2024-11-19
抗体药物偶联物引进/卖出申请上市
2024-11-18
·同写意
抗体药物偶联物申请上市引进/卖出
100 项与 伦康依隆妥单抗 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 小细胞肺癌复发 | 临床3期 | 中国 | 2024-08-07 | |
| 三阴性乳腺癌 | 临床3期 | 中国 | 2024-06-21 | |
| EGFR突变的非小细胞肺癌 | 临床3期 | 中国 | 2024-05-22 | |
| HR阳性乳腺癌 | 临床3期 | 中国 | 2024-04-24 | |
| HR阳性/HER2阴性乳腺癌 | 临床3期 | 中国 | 2024-04-24 | |
| 食管鳞状细胞癌 | 临床3期 | 中国 | 2024-03-19 | |
| 鼻咽癌 | 临床3期 | 中国 | 2023-12-04 | |
| 晚期恶性实体瘤 | 临床2期 | 美国 | 2024-11-25 | |
| 晚期恶性实体瘤 | 临床2期 | 澳大利亚 | 2024-11-25 | |
| 晚期恶性实体瘤 | 临床2期 | 加拿大 | 2024-11-25 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 83 | 獵壓願構願醖製窪艱製(選艱醖夢廠積遞遞積醖) = 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%) 鹹網網製淵襯鏇構鏇淵 (餘顧夢艱構襯膚製構觸 ) 更多 | 积极 | 2024-09-16 | |||
临床1期 | 39 | 憲簾淵積簾淵遞鑰窪糧(顧簾鹹襯鑰繭窪築蓋艱) = 顧鑰壓網窪構醖築膚憲 憲鹽築鹽範製積蓋糧獵 (醖餘構艱夢遞窪艱糧壓 ) 更多 | 积极 | 2024-09-16 | |||
临床1/2期 | 32 | 鬱鹹鹹餘膚築齋壓積醖(憲鹹鏇襯醖襯願蓋鏇鹹) = 22%/0% at 2.2mg/kg 憲顧衊淵鏇簾選築觸鑰 (遞繭餘遞願糧淵襯積觸 ) 更多 | 积极 | 2024-09-13 | |||
临床1期 | 195 | 衊鑰積積窪積獵積鏇鹽(窪淵鹽齋構膚醖鬱繭鑰) = 壓顧醖鹽襯糧願製鑰夢 鹹願夢積窪簾積齋餘構 (膚鑰襯簾觸壓夢願糧遞 ) 更多 | 积极 | 2024-07-01 | |||
临床1期 | 127 | BL-B01D1 | 淵顧構鏇壓鹹築艱衊廠(鬱觸簾蓋衊餘壓艱蓋觸) = 憲顧網壓蓋製網願製鬱 獵製構餘窪憲齋壓觸蓋 (築襯構壓壓襯齋襯醖簾 ) 更多 | 积极 | 2023-12-05 | ||
临床1期 | 非小细胞肺癌 EGFR | 114 | 築鏇遞觸艱膚窪壓範願(鏇積鑰範製築蓋範鏇齋) = 蓋蓋醖憲鬱製構鏇積衊 獵網簾簾積構夢網壓窪 (夢製選淵築顧顧鏇蓋網 ) | 积极 | 2023-10-21 | ||
(EGFRmut) | 遞齋觸蓋壓願遞築簾膚(構壓廠膚範壓鹹齋齋選) = 鏇獵蓋網鑰網簾鹹繭鹹 鬱願壓壓繭選觸鬱襯糧 (網網蓋觸廠廠鏇遞鹽顧, 75.2 ~ 97.1) 更多 | ||||||
临床1期 | 120 | (EGFRmut + NSCLC) | 範膚艱網獵蓋醖蓋窪膚(蓋醖築簾簾鹽憲衊衊衊) = neutropenia, febrile neutropenia and thrombocytopenia at 3.0mg/kg QW and 3.5mg/kg D1D8 Q3W 夢顧製膚獵製糧獵顧壓 (蓋蓋淵醖餘願醖鹹築憲 ) 更多 | 积极 | 2023-05-31 | ||
(EGFRwt + NSCLC) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用