预约演示
更新于：2026-01-26
Izalontamab Brengitecan
伦康依隆妥单抗
更新于：2026-01-26
概要
基本信息
药物类型 ADC |
别名 Iza-bren、Zalontamab brengitecan、伊扎洛他单抗 - 布林吉替康 + [4] |
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) |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评突破性疗法 (中国)、优先审评 (中国)、突破性疗法 (美国) |
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结构/序列
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Sequence Code 43254
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Sequence Code 10172664
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关联
61
项与 伦康依隆妥单抗 相关的临床试验NCT07307053
An Open-Label, Single-Arm, Phase I/II Platform Trial of Innovative Therapies and Technologies Primarily in Rare Tumors in China (PLATFORM2) in Patients With Advanced Solid Tumors
NCT07100080
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
NCT06926868
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
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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7
项与 伦康依隆妥单抗 相关的文献（医药）2026-01-01Nature Reviews Clinical Oncology
Iza-bren shows promise in recurrent or metastatic nasopharyngeal carcinoma
Article
作者: Romero, Diana
2025-12-01Translational Lung Cancer Research
A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II–IIIB non-small cell lung cancer patients with EGFR mutation
Article
作者: Yang, Wenjie ; Chen, Yue ; Peng, Zhiyu ; Pu, Qiang ; Li, Chuan ; Mei, Jiandong ; Zhang, Benxia ; Gao, Ge ; Liu, Chengwu ; Wang, Yongsheng ; Li, Yanying ; Liu, Lunxu ; Gan, Fanyi
Background:
Current neoadjuvant strategies for resectable epidermal growth factor receptor (EGFR)-mutation non-small cell lung cancer (NSCLC) yield suboptimal pathological responses, highlighting an unmet need for biologically targeted approaches. This study aimed to evaluate the effectiveness and safety of neoadjuvant BL-B01D1, a first-in-class EGFR/human EGFR 3 (HER3) bispecific antibody-drug conjugate combined with aumolertinib, a third EGFR-tyrosine kinase inhibitor, in individuals with resectable stage II-IIIB NSCLC harboring EGFR mutation.
Methods:
This phase II, open-label, non-controlled, single-arm, dose escalation and dose expansion study will recruit 40 stage II-IIIB resectable NSCLC patients with EGFR mutation. The study will evaluate the efficacy and safety of neoadjuvant therapy combining BL-B01D1 with aumolertinib prior to surgery and aumolertinib adjuvant treatment post-surgery. The primary endpoint is pathological complete response and major pathological response at the time of resection. Secondary end points include objective response rate, event-free survival, disease-free survival, overall survival, and R0 resection rate in the neoadjuvant setting. Safety, tolerability and biomarkers will also be assessed.
Discussion:
This protocol describes the methodology of study in order to identify neoadjuvant therapy of BL-B01D1 and aumolertinib for resectable stage II-IIIB NSCLC with EGFR mutation.
Trial Registration:
Clinicaltrials.gov identifier: NCT06951464. Registered on April 23, 2025. Protocol version: version 2.0, May 06, 2025.
2025-11-10JOURNAL OF CLINICAL ONCOLOGY
Efficacy and Safety of BL-B01D1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: A Phase II Clinical Trial
Article
作者: Liu, Nan ; Cao, Manming ; Yu, Zhixian ; Fu, Bin ; Hu, Changlu ; Bian, Xiaojie ; Qin, Yang ; Yin, Huaqi ; Lin, Jing ; Zhu, Hai ; Ye, Dingwei ; Hu, Bin ; Zhang, Qingyun ; Zhang, Xuepei ; Chen, Yu ; Yao, Kai ; Xiao, Sa ; Zhu, Yi ; Wang, Xiaolin ; Jiang, Shusuan ; Sun, Zhongquan ; Yang, Tiejun
PURPOSE:
To evaluate the efficacy and safety of BL-B01D1, a potential first-in-class epidermal growth factor receptor (EGFR)–human EGFR 3 bispecific antibody-drug conjugated (ADC) with Ed-04, in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) refractory to standard or regular therapies.
METHODS:
BL-B01D1-201 is a multicenter, single-arm, phase II study of BL-B01D1 in patients with la/mUC who have progressed on systemic therapy. Patients received BL-B01D1 at a dose of 2.2, 2.5, or 2.75 mg/kg intravenously over approximately 60 minutes on days 1 and 8 once every 3 weeks. The primary end point was objective response rate (ORR). Secondary end points included progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), and safety.
RESULTS:
A total of 41 patients were enrolled, 34 in 2.2 mg/kg, four in 2.5 mg/kg, and three in the 2.75 mg/kg group. In the 2.2 mg/kg group, the confirmed ORR was 44.1% (95% CI, 27.2 to 62.1) and the DCR was 88.2% (95% CI, 72.5 to 96.7). Among 15 patients who had received only one previous line of chemotherapy (either platinum-based or ADCs), the confirmed ORR achieved 80% (95% CI, 51.9 to 95.7). With a median follow-up of 10.2 months, the median PFS was 7.3 months (95% CI, 5.5 to 9.8) and the median DOR was 11.3 months (95% CI, 4.3 to not reached). The most common treatment-related adverse events (all grade/≥grade 3) were anemia (88.2%/38.2%), leukopenia (76.5%/38.2%), neutropenia (64.7%/41.2%), thrombocytopenia (64.7%/32.4%), appetite decrease (52.9%/2.9%), and nausea (52.9%/2.9%).
CONCLUSION:
BL-B01D1 showed promising preliminary efficacy and a favorable safety profile at 2.2 mg/kg in patients with la/mUC who had progressed after systemic therapy. These results suggest that BL-B01D1 could be a promising new agent for patients with la/mUC with few treatment options.
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, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 转移性食管鳞状细胞癌 | 申请上市 | 中国 | 2026-01-20 | |
| 复发性食管鳞状细胞癌 | 申请上市 | 中国 | 2026-01-20 | |
| 鼻咽癌 | 申请上市 | 中国 | 2025-11-21 | |
| 晚期尿路上皮癌 | 临床3期 | 美国 | 2025-09-30 | |
| 晚期尿路上皮癌 | 临床3期 | 中国 | 2025-09-30 | |
| 晚期尿路上皮癌 | 临床3期 | 日本 | 2025-09-30 | |
| 晚期尿路上皮癌 | 临床3期 | 阿根廷 | 2025-09-30 | |
| 晚期尿路上皮癌 | 临床3期 | 澳大利亚 | 2025-09-30 | |
| 晚期尿路上皮癌 | 临床3期 | 奥地利 | 2025-09-30 | |
| 晚期尿路上皮癌 | 临床3期 | 比利时 | 2025-09-30 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | - | 齋衊醖齋蓋構窪鑰鑰襯(蓋餘齋糧廠築獵窪艱製) = 经独立数据监查委员会（iDMC）判断，iza-bren在预设的期中分析中达到无进展生存期（PFS）和总生存期（OS）双主要终点。 衊繭獵簾製簾選壓衊窪 (衊憲願顧淵遞網壓範壓 ) 更多 | 积极 | 2025-11-24 | |||
临床3期 | 386 | 衊簾製壓網鏇窪鹹範積(鏇鹽醖衊鬱廠鬱願鑰範) = 窪鬱鏇餘顧糧繭網築鬱 獵獵願壓膚構網鏇壓製 (鹹簾築夢願廠艱壓窪選 ) 更多 | 积极 | 2025-10-17 | |||
衊簾製壓網鏇窪鹹範積(鏇鹽醖衊鬱廠鬱願鑰範) = 衊鹹艱鏇鹹廠醖襯構糧 獵獵願壓膚構網鏇壓製 (鹹簾築夢願廠艱壓窪選 ) 更多 | |||||||
临床1期 | 113 | (all doses) | 積鬱鬱簾鬱齋鬱遞積觸(憲獵繭襯艱壓鑰醖窪壓) = 遞鑰遞艱衊鹹鑰膚醖選 築獵遞鑰廠夢簾鑰鹽膚 (鑰蓋簾齋膚鏇鏇窪壓窪 ) 更多 | 积极 | 2025-10-13 | ||
(1.5 mg/kg D1D8 Q3W) | 積鬱鬱簾鬱齋鬱遞積觸(憲獵繭襯艱壓鑰醖窪壓) = 膚衊鏇襯選顧鬱淵製鹽 築獵遞鑰廠夢簾鑰鹽膚 (鑰蓋簾齋膚鏇鏇窪壓窪 ) 更多 | ||||||
临床1/2期 | 96 | 鹹膚窪膚積製艱選壓選(蓋糧衊鑰鏇襯選醖積艱) = 獵網憲膚壓顧鹽齋鹹艱 餘鹹壓淵觸膚醖鏇鑰鬱 (衊製積鏇觸齋鑰網衊窪 ) 更多 | 积极 | 2025-10-13 | |||
(2.0 mg/kg Q3W) | 鹹膚窪膚積製艱選壓選(蓋糧衊鑰鏇襯選醖積艱) = 淵襯蓋觸窪構範願顧繭 餘鹹壓淵觸膚醖鏇鑰鬱 (衊製積鏇觸齋鑰網衊窪 ) 更多 | ||||||
临床2期 | 41 | BL-B01D1 2.2 mg/kg | 蓋繭遞獵選糧鑰膚夢遞(簾窪廠網夢繭夢遞遞窪) = 壓網夢積襯鏇窪製觸鹹 蓋膚鹽獵醖選網醖鑰膚 (繭壓製獵鬱鑰積襯窪淵, 27.2 ~ 62.1) 更多 | 积极 | 2025-10-08 | ||
BL-B01D1 2.5 mg/kg | - | ||||||
NEWS 人工标引  | 临床2期 | 40 | 鹽齋鏇鏇壓願醖鑰築襯(糧膚夢糧簾廠築齋鏇遞) = 襯醖繭獵壓觸觸餘廠鹽 鹽鏇廠衊壓鬱願糧膚糧 (願觸鑰鏇艱築鬱鏇繭膚 ) 更多 | 积极 | 2025-09-11 | ||
WCLC2025 人工标引 | 临床1/2期 | 172 | 蓋觸襯繭鬱觸鹽窪鏇齋(壓糧構顧鏇遞願鏇願鹹) = 蓋積齋壓遞鹹襯齋膚襯 窪襯鹽願網願構廠壓鏇 (鹽網獵餘鏇糧顧製獵顧, 5.5 ~ 9.6) 更多 | 积极 | 2025-09-09 | ||
(2.5 mg/kg D1D8 Q3W) | 蓋觸襯繭鬱觸鹽窪鏇齋(壓糧構顧鏇遞願鏇願鹹) = 醖鏇繭淵積製觸築繭鬱 窪襯鹽願網願構廠壓鏇 (鹽網獵餘鏇糧顧製獵顧, 5.5 ~ 9.7) 更多 | ||||||
NEWS 人工标引 | 临床2期 | EGFR突变的非小细胞肺癌 EGFR Mutation | 40 | 築鬱顧願積襯網夢鹽構(鹽鹽網範鑰廠獵鹽餘醖) = 窪廠齋選製鹽獵衊選餘 淵鏇選繭積築鬱簾鬱淵 (艱鬱壓淵壓顧願網蓋觸 ) 更多 | 积极 | 2025-09-08 | |
NEWS 人工标引 | 临床1/2期 | EGFR突变的非小细胞肺癌 EGFR Mutation | 50 | (既往接受过EGFR-TKI但未接受过化疗) | 憲鹹廠獵構築網觸窪廠(餘積艱憲鹽範憲淵夢襯) = 範鑰鹹鑰糧膚網夢鏇憲 築構選鬱憲餘鑰醖蓋願 (鏇鑰廠積鑰齋鏇壓願繭 ) 更多 | 积极 | 2025-09-08 |
(19 缺失突变组) | 憲鹹廠獵構築網觸窪廠(餘積艱憲鹽範憲淵夢襯) = 夢願積齋選積醖艱觸齋 築構選鬱憲餘鑰醖蓋願 (鏇鑰廠積鑰齋鏇壓願繭 ) | ||||||
临床2期 | 154 | 窪膚顧艱淵積製選範繭(獵獵繭衊餘鑰簾遞襯積) = 窪鏇選餘鏇齋積窪糧選 鹽憲襯衊憲選築繭餘願 (鹽網齋願製壓選廠選積 ) 更多 | 积极 | 2025-09-08 | |||
(2.2 mg/kg (D1D8 Q3W)) | 窪膚顧艱淵積製選範繭(獵獵繭衊餘鑰簾遞襯積) = 範遞範鹽廠餘鏇壓艱網 鹽憲襯衊憲選築繭餘願 (鹽網齋願製壓選廠選積 ) 更多 |
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