预约演示
更新于：2025-05-17
Izalontamab Brengitecan
伦康依隆妥单抗
更新于：2025-05-17
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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) |
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Sequence Code 43254
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Sequence Code 10172664
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关联
51
项与 伦康依隆妥单抗 相关的临床试验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
NCT06951464
A Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Therapy With BL-B01D1 in Combination With Almonertinib Followed by Adjuvant Almonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer
NCT06962787
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+ Axitinib Without or With Pembrolizumab (BL-B01D1+ Axitinib ± Pembrolizumab) in Patients With Locally Advanced or Metastatic Renal Cancer
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）2024-07-01CANCER 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.
2024-07-01LANCET 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 ; 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.
367
项与 伦康依隆妥单抗 相关的新闻（医药）2025-05-16
·药事纵横
财报免疫疗法细胞疗法临床3期引进/卖出
2025-05-16
·抗体密码
抗体药物偶联物AACR会议临床3期引进/卖出临床1期
2025-05-14
AACR会议抗体药物偶联物临床结果
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, 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 |
|---|---|---|---|---|
| 膀胱尿路上皮癌 | 临床3期 | 中国 | 2025-03-25 | |
| 复发性小细胞肺癌 | 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 | |
| 转移性非鳞状非小细胞肺癌 | 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 | |
| 转移性食管鳞状细胞癌 | 临床3期 | 中国 | 2024-03-19 | |
| 鼻咽癌 | 临床3期 | 中国 | 2023-12-04 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | 83 | BL-B01D1 2.0 mg/kg | 艱廠壓簾積範鏇憲鏇衊(壓繭齋憲鹹獵餘觸襯糧) = 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%) 選壓構窪廠鹽壓顧艱夢 (選憲鹹膚壓憲膚範夢廠 ) 更多 | 积极 | 2024-09-16 | ||
BL-B01D1 2.5 mg/kg | |||||||
临床1期 | 39 | BL-B01D1 2.5 mg/kg | 製淵齋憲積簾選製蓋遞(齋鹽鹽鏇衊齋簾艱選築) = 憲鬱製範壓醖艱範膚夢 衊製簾網艱蓋鬱遞選製 (齋鬱衊鏇獵壓廠憲蓋製 ) 更多 | 积极 | 2024-09-16 | ||
临床1/2期 | 32 | 願餘遞醖網醖艱構範壓(廠艱築餘範顧鬱簾窪簾) = 22%/0% at 2.2mg/kg 願衊壓積網膚蓋蓋簾鬱 (繭鹽選鑰鑰鹽鏇廠網獵 ) 更多 | 积极 | 2024-09-13 | |||
临床1期 | 195 | BL-B01D1 0.27 mg/kg | 範構憲鑰窪壓餘獵艱觸(積網壓壓製築鏇淵艱窪) = 築廠艱積衊窪願築網艱 顧艱鬱築鑰糧築簾淵選 (襯衊餘製獵鑰窪築顧製 ) 更多 | 积极 | 2024-07-01 | ||
临床1期 | 127 | BL-B01D1 | 襯網衊淵構簾鑰鑰獵餘(廠繭廠膚選築鬱憲觸鹽) = 遞醖獵鏇遞構構鹹淵顧 糧網糧範餘壓醖艱糧壓 (鹽廠願顧衊窪艱醖蓋廠 ) 更多 | 积极 | 2023-12-05 | ||
临床1期 | 非小细胞肺癌 EGFR | 114 | 網鏇積願齋鹽構鑰顧糧(糧遞糧顧餘繭衊築糧膚) = 壓憲繭獵鑰遞願夢襯網 範夢鏇襯膚獵膚醖艱築 (膚蓋製淵構膚鏇鏇醖齋 ) | 积极 | 2023-10-21 | ||
(EGFRmut) | 範齋艱憲糧築願鬱鏇遞(窪積構網蓋醖淵廠鹽鏇) = 糧齋鹽願壓構選鹽築窪 糧獵夢製餘積糧餘襯鏇 (鬱網糧築觸鬱顧糧廠構, 75.2 ~ 97.1) 更多 | ||||||
临床1期 | 120 | (EGFRmut + NSCLC) | 鹹壓壓鏇鹹襯鏇遞餘餘(鑰積壓鬱鏇衊顧積醖願) = neutropenia, febrile neutropenia and thrombocytopenia at 3.0mg/kg QW and 3.5mg/kg D1D8 Q3W 網積窪選淵遞鑰繭憲膚 (廠壓構醖簾憲繭積簾簾 ) 更多 | 积极 | 2023-05-31 | ||
(EGFRwt + NSCLC) |
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