预约演示
更新于：2025-12-01
Sevacizumab
苏维西塔单抗
更新于：2025-12-01
概要
基本信息
药物类型 单克隆抗体 |
别名 Suvemcitug、赛伐珠单抗、APX-003 + [4] |
靶点 |
作用方式 抑制剂 |
作用机制 VEGF-A抑制剂(血管内皮生长因子A抑制剂) |
在研适应症 |
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2025-06-30), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 631492344L
来源: *****
Sequence Code 801711022H
来源: *****
关联
8
项与 苏维西塔单抗 相关的临床试验NCT05148195
An Open Label, Multi-cohort, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Envofolimab in Combination With BD0801 Injection With/Without Chemotherapy in Patients With Advanced Solid Tumors
CTR20212879
恩沃利单抗联合注射用BD0801联合/不联合化疗在晚期实体瘤患者中的有效性和安全性的开放、多队列、多中心II期临床研究
NCT04908787
A Randomized, Double-blind, Phase III Study of BD0801 Injection Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Patients With Recurrent, Platinum-resistant Epithelial Ovarian, Fallopian Tube , or Primary Peritoneal Cancer.
100 项与 苏维西塔单抗 相关的临床结果
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100 项与 苏维西塔单抗 相关的转化医学
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100 项与 苏维西塔单抗 相关的专利（医药）
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4
项与 苏维西塔单抗 相关的文献（医药）2024-08-01GYNECOLOGIC ONCOLOGY
Suvemcitug plus chemotherapy for platinum-resistant epithelial ovarian, fallopian tube and primary peritoneal cancer: A phase 1b dose-escalation trial
Article
作者: Zheng, Hong ; Sun, Haolin ; Wu, Yan ; Zhang, Keqiang ; Yuan, Guangwen ; Zhang, Jiajing ; Sun, Xiyang ; Wu, Lingying
OBJECTIVE:
The use of bevacizumab has been hampered by safety concerns despite demonstrable progression-free survival (PFS) benefit in subjects with platinum-resistant ovarian cancer, highlighting the need for novel effective and safe antiangiogenic agents. This study aimed to characterize the tolerability, safety, and antitumor activities of escalating doses of anti-VEGF antibody suvemcitug plus chemotherapy in platinum-resistant ovarian cancer patients.
METHODS:
This open-label, dose-escalation trial enrolled adult patients (≥18 years) with platinum-resistant histologically or cytologically-confirmed epithelial ovarian, fallopian tube and primary peritoneal cancer. Eligible patients received paclitaxel or topotecan plus escalating doses of suvemcitug 0.5, 1, 1.5, or 2 mg/kg once every two weeks. The primary endpoints were safety and tolerability, and antitumor activities of suvemcitug.
RESULTS:
Twenty-nine subjects received paclitaxel (n = 11) or topotecan (n = 18). No dose-limiting toxicities occurred. The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. Nine subjects (31.0%, 95% CI 15.3-50.8) demonstrated investigators-confirmed objective response, including complete response in 1 and partial response in 8. The median PFS was 5.4 months (95% CI 2.2-7.4).
CONCLUSIONS:
Suvemcitug demonstrated an acceptable safety profile and promising antitumor activities in platinum-resistant ovarian cancer patients, supporting its further clinical development.
2023-06-01ESMO open
Suvemcitug as second-line treatment of advanced or metastatic solid tumors and with FOLFIRI for pretreated metastatic colorectal cancer: phase Ia/Ib open label, dose-escalation trials
Article
作者: Feng, X ; Zhang, Y ; Ji, D ; Zhang, J ; Cao, J ; Xu, N ; Wu, Y ; Mao, C ; Liu, L ; Song, W ; Song, L ; Ding, Y
BACKGROUND:
Suvemcitug (BD0801), a novel humanized rabbit monoclonal antibody against vascular endothelial growth factor, has demonstrated promising antitumor activities in preclinical studies.
PATIENTS AND METHODS:
The phase Ia/b trials investigated the safety and tolerability and antitumor activities of suvemcitug for pretreated advanced solid tumors and in combination with FOLFIRI (leucovorin and fluorouracil plus irinotecan) in second-line treatment of metastatic colorectal cancer using a 3 + 3 dose-escalation design. Patients received escalating doses of suvemcitug (phase Ia: 2, 4, 5, 6, and 7.5 mg/kg; phase Ib: 1, 2, 3, 4, and 5 mg/kg plus FOLFIRI). The primary endpoint was safety and tolerability in both trials.
RESULTS:
All patients in the phase Ia trial had at least one adverse event (AE). Dose-limiting toxicities included grade 3 hyperbilirubinemia (one patient), hypertension and proteinuria (one patient), and proteinuria (one patient). The maximum tolerated dose was 5 mg/kg. The most common grade 3 and above AEs were proteinuria (9/25, 36%) and hypertension (8/25, 32%). Forty-eight patients (85.7%) in phase Ib had grade 3 and above AEs, including neutropenia (25/56, 44.6%), reduced leucocyte count (12/56, 21.4%), proteinuria (10/56, 17.9%), and elevated blood pressure (9/56, 16.1%). Only 1 patient in the phase Ia trial showed partial response, [objective response rate 4.0%, 95% confidence interval (CI) 0.1% to 20.4%] whereas 18/53 patients in the phase Ib trial exhibited partial response (objective response rate 34.0%, 95% CI 21.5% to 48.3%). The median progression-free survival was 7.2 months (95% CI 5.1-8.7 months).
CONCLUSIONS:
Suvemcitug has an acceptable toxicity profile and exhibits antitumor activities in pretreated patients with advanced solid tumors or metastatic colorectal cancer.
2021-12-01BMC cancer2区 · 医学
Antiangiogenic antibody BD0801 combined with immune checkpoint inhibitors achieves synergistic antitumor activity and affects the tumor microenvironment
2区 · 医学
ArticleOA
作者: Li, Xinxin ; Tang, Renhong ; Yang, Wenqing ; Lu, Zhihong ; Wang, Qian ; Tang, Jianxing ; Yu, Xiaohong ; Xue, Liting ; Gao, Xingyuan ; Zhang, Haoyu ; Huang, Yue ; Li, Feng
Abstract:
Background:
Signaling through VEGF/VEGFR induces cancer angiogenesis and affects immune cells. An increasing number of studies have recently focused on combining anti-VEGF/VEGFR agents and immune checkpoint inhibitors (ICIs) to treat cancer in preclinical and clinical settings. BD0801 is a humanized rabbit anti-VEGF monoclonal antibody in the clinical development stage.
Methods:
In this study, the anti-cancer activities of BD0801 and its potential synergistic anti-tumor effects when combined with different immunotherapies were assessed by using in vitro assays and in vivo tumor models. Ex vivo studies were conducted to reveal the possible mechanisms of actions (MOA) underlying the tumor microenvironment modification.
Results:
BD0801 showed more potent antitumor activity than bevacizumab, reflected by stronger blockade of VEGF/VEGFR binding and enhanced inhibitory effects on human umbilical vein endothelial cells (HUVECs). BD0801 exhibited dose-dependent tumor growth inhibitory activities in xenograft and murine syngeneic tumor models. Notably, combining BD0801 with either anti-PD-1 or anti-PD-L1 antibodies showed synergistic antitumor efficacy in both lung and colorectal cancer mouse models. Furthermore, the mechanistic studies suggested that the MOA of the antitumor synergy involves improved tumor vasculature normalization and enhanced T-cell mediated immunity, including increased tumor infiltration of CD8+ and CD4+ T cells and reduced double-positive CD8+PD-1+ T cells.
Conclusions:
These data provide a solid rationale for combining antiangiogenic agents with immunotherapy for cancer treatment and support further clinical development of BD0801 in combination with ICIs.
100 项与 苏维西塔单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 复发性铂耐药性输卵管癌 | 中国 | 2025-06-30 | |
| 复发性铂耐药性卵巢癌 | 中国 | 2025-06-30 | |
| 复发性铂耐药性原发性腹膜癌 | 中国 | 2025-06-30 |
未上市
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 |
|---|---|---|---|---|
| 铂耐药上皮性卵巢癌 | 临床3期 | 中国 | 2021-06-05 | |
| 铂耐药性输卵管癌 | 临床3期 | 中国 | 2021-06-05 | |
| 铂类耐药性原发性腹膜癌 | 临床3期 | 中国 | 2021-06-05 | |
| 晚期恶性实体瘤 | 临床2期 | 中国 | 2021-12-13 | |
| 铂耐药性卵巢癌 | 临床1期 | 中国 | 2018-04-24 | |
| 输卵管癌 | 临床1期 | 中国 | 2018-04-04 | |
| 卵巢上皮癌 | 临床1期 | 中国 | 2018-04-04 | |
| 原发性腹膜癌 | 临床1期 | 中国 | 2018-04-04 | |
| 复发性卵巢癌 | 临床1期 | 中国 | 2018-04-04 | |
| 转移性结直肠癌 | 临床1期 | 中国 | 2015-10-13 |
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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 | 421 | 苏维西塔单抗(1.5 mg/kg Q2W)+化疗 | 網選廠簾衊鬱獵壓範艱(壓糧衊憲鹽醖衊範襯鏇) = 顧鑰遞鹹鑰鑰齋鹹淵顧 窪選蓋壓膚網艱壓糧鹹 (築網製選鹽襯範鏇壓構 ) 更多 | 积极 | 2025-09-13 | ||
安慰剂+化疗 | 網選廠簾衊鬱獵壓範艱(壓糧衊憲鹽醖衊範襯鏇) = 齋範襯顧選鑰築糧淵鏇 窪選蓋壓膚網艱壓糧鹹 (築網製選鹽襯範鏇壓構 ) 更多 | ||||||
临床3期 | 421 | Suvemcitug + Chemotherapy | 觸顧鏇壓衊糧餘淵襯淵(獵襯襯廠構製簾築淵鏇) = 觸齋廠壓廠膚築鹹鬱蓋 艱醖夢壓製網窪齋選選 (鏇製製膚衊膚醖艱鬱鹹, 4.93 ~ 6.64) 更多 | 积极 | 2025-05-30 | ||
Placebo + Chemotherapy | 觸顧鏇壓衊糧餘淵襯淵(獵襯襯廠構製簾築淵鏇) = 鏇選遞製膚艱糧鏇夢鏇 艱醖夢壓製網窪齋選選 (鏇製製膚衊膚醖艱鬱鹹, 1.94 ~ 3.75) 更多 | ||||||
临床3期 | 421 | 苏维西塔单抗+化疗 | 夢構窪顧壓觸衊顧製夢(獵廠製獵鹹艱製廠憲鹹) = 網膚築鏇築繭窪鏇製窪 膚範製觸廠獵鏇鹽製鬱 (簾蓋鬱淵醖鏇觸夢簾襯 ) | 积极 | 2024-09-27 | ||
安慰剂+化疗 | 夢構窪顧壓觸衊顧製夢(獵廠製獵鹹艱製廠憲鹹) = 壓顧艱蓋廠鹽醖膚壓網 膚範製觸廠獵鏇鹽製鬱 (簾蓋鬱淵醖鏇觸夢簾襯 ) | ||||||
临床3期 | 铂耐药性卵巢癌 二线 | 421 | Suvemcitug + chemotherapy | 糧壓淵窪繭糧餘廠積製(衊繭壓觸淵艱糧顧蓋廠) = 遞齋鏇顧艱艱衊願簾選 齋鹽鹽鬱網積觸網繭製 (範願鏇簾醖網範醖憲製, 4.93 ~ 5.95) 更多 | 积极 | 2024-06-02 | |
Placebo + chemotherapy | 糧壓淵窪繭糧餘廠積製(衊繭壓觸淵艱糧顧蓋廠) = 獵遞構觸廠範願選鏇獵 齋鹽鹽鬱網積觸網繭製 (範願鏇簾醖網範醖憲製, 1.94 ~ 3.75) 更多 | ||||||
临床1期 | 29 | 襯淵襯觸壓窪遞淵鏇壓(網壓繭夢積餘餘選糧衊) = The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. 鑰憲鹹鬱糧觸顧糧膚糧 (製積簾艱窪獵鑰觸獵願 ) | 积极 | 2024-05-27 | |||
临床3期 | - | 苏维西塔单抗+化疗 | 膚鹽選顧積觸壓壓糧選(鹽繭鑰憲製艱製鹽構艱) = SCORES研究达到基于盲态独立影像评估委员会(BIRC)依据RECIST 1.1 标准评估的PFS研究主要终点。对比安慰剂联合化疗组，苏维西塔单抗组PFS显示出具有统计学意义和临床意义的改善。苏维西塔单抗在所有亚组均显示出PFS临床获益的一致性。研究者评估的试验组PFS获益与BIRC评估获益相当； 願簾鏇蓋觸構糧鹽選餘 (網糧廠構網襯餘築簾構 ) 更多 | 积极 | 2024-01-04 | ||
安慰剂+化疗 | |||||||
临床2期 | 非小细胞肺癌 二线 | 40 | (IO treated NSCLC) | 糧夢廠齋構選積構繭製(醖鑰構淵壓繭獵餘鑰製) = 憲鏇窪築願積顧淵繭簾 鬱夢網範積淵顧鬱憲獵 (壓鹹淵鹽餘築壓積廠蓋 ) 更多 | 积极 | 2023-10-23 | |
(IO naïve NSCLC) | 糧艱築遞鑰廠艱糧遞鹹(範鹹壓淵窪餘鹽觸積夢) = 築鬱膚選鏇繭構築觸獵 襯齋顧餘齋積獵蓋觸醖 (製鬱齋製糧簾餘繭網鹽 ) 更多 | ||||||
临床2期 | 肝细胞癌 二线 | 20 | Suvemcitug+envafolimab | 築範積餘願壓淵網鹽製(夢構壓網簾顧願齋製餘) = 鹽淵襯鹹遞構鹽憲獵糧 壓構淵鑰觸醖鹽範艱構 (顧鹹餘繭鏇淵齋憲獵餘 ) 更多 | 积极 | 2023-10-23 | |
临床2期 | 20 | 繭廠窪艱蓋繭廠窪鏇範(鹽簾鹽襯艱顧鬱範窪範) = 餘糧夢壓廠顧鏇網壓鹽 醖簾夢窪顧鏇鬱壓憲夢 (鹹簾窪顧鹽繭鹹築糧鏇, 8.7 ~ 49.1) 更多 | 积极 | 2023-10-22 | |||
临床1期 | 29 | 鏇膚遞淵鏇夢選獵鑰齋(窪廠製艱網鏇鹹製製範) = 獵窪簾膚衊築襯襯鏇獵 壓獵廠製築網範襯獵選 (遞鑰鹽壓齋鹽積鹹夢網, 49.2 ~ 84.7) 更多 | - | 2021-09-25 |
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