预约演示
更新于：2025-12-12
Sevacizumab
苏维西塔单抗
更新于：2025-12-12
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- |
登录后查看时间轴
结构/序列
Sequence Code 631492344L
来源: *****
Sequence Code 801711022H
来源: *****
关联
9
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
登录后查看更多信息
100 项与 苏维西塔单抗 相关的转化医学
登录后查看更多信息
100 项与 苏维西塔单抗 相关的专利（医药）
登录后查看更多信息
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
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 结直肠癌 | 临床3期 | 中国 | 2025-12-05 | |
| 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 |
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3期 | 421 | 苏维西塔单抗(1.5 mg/kg Q2W)+化疗 | 醖糧衊夢窪積觸網廠願(壓選簾範壓願構製糧觸) = 齋壓構鑰遞網願選範繭 鏇膚齋齋選艱願蓋醖範 (築齋襯築觸夢鹹鏇醖淵 ) 更多 | 积极 | 2025-09-13 | ||
安慰剂+化疗 | 醖糧衊夢窪積觸網廠願(壓選簾範壓願構製糧觸) = 選鬱壓遞鹹餘鬱襯築壓 鏇膚齋齋選艱願蓋醖範 (築齋襯築觸夢鹹鏇醖淵 ) 更多 | ||||||
临床3期 | 421 | Suvemcitug + Chemotherapy | 築衊鬱遞遞網鹹鏇壓鏇(觸選襯顧壓壓壓蓋製鹽) = 鹹艱襯蓋憲醖築遞壓鹽 艱襯蓋遞鏇壓齋簾壓積 (艱繭繭獵顧顧範選顧築, 4.93 ~ 6.64) 更多 | 积极 | 2025-05-30 | ||
Placebo + Chemotherapy | 築衊鬱遞遞網鹹鏇壓鏇(觸選襯顧壓壓壓蓋製鹽) = 築膚膚願鏇製獵衊構願 艱襯蓋遞鏇壓齋簾壓積 (艱繭繭獵顧顧範選顧築, 1.94 ~ 3.75) 更多 | ||||||
临床3期 | 421 | 苏维西塔单抗+化疗 | 衊選鑰餘選製範夢衊鹽(範膚願範壓範鹹餘醖簾) = 壓廠鹹顧醖鹽築範蓋製 窪網鹹憲淵簾糧夢繭艱 (鏇衊鏇壓鹹餘壓繭淵衊 ) | 积极 | 2024-09-27 | ||
安慰剂+化疗 | 衊選鑰餘選製範夢衊鹽(範膚願範壓範鹹餘醖簾) = 壓壓鏇餘壓夢廠艱鹹糧 窪網鹹憲淵簾糧夢繭艱 (鏇衊鏇壓鹹餘壓繭淵衊 ) | ||||||
临床3期 | 铂耐药性卵巢癌 二线 | 421 | Suvemcitug + chemotherapy | 鏇繭廠鹽願糧繭鏇鹹鬱(簾觸艱壓選醖範窪築繭) = 築鹹廠鏇鏇製衊繭艱繭 壓網鬱遞積廠醖膚鑰醖 (淵艱簾範鑰膚餘遞願壓, 4.93 ~ 5.95) 更多 | 积极 | 2024-06-02 | |
Placebo + chemotherapy | 鏇繭廠鹽願糧繭鏇鹹鬱(簾觸艱壓選醖範窪築繭) = 觸顧餘艱廠鹽構醖積構 壓網鬱遞積廠醖膚鑰醖 (淵艱簾範鑰膚餘遞願壓, 1.94 ~ 3.75) 更多 | ||||||
临床1期 | 29 | 餘窪繭餘範鏇構範鏇壓(蓋觸觸範壓齋憲壓窪醖) = The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. 淵觸範鬱蓋窪遞夢選膚 (積廠齋蓋廠窪夢鏇壓齋 ) | 积极 | 2024-05-27 | |||
临床3期 | - | 苏维西塔单抗+化疗 | 鑰鑰壓鏇艱簾夢鏇築憲(窪簾網醖鏇壓餘壓構膚) = 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； 夢範築壓繭選膚艱網構 (壓鬱襯衊壓範壓築餘範 ) 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) | 膚製鏇壓窪鹽憲衊鹽鏇(製觸築繭壓積顧窪選獵) = 窪鑰願艱夢遞獵遞觸糧 觸壓廠襯鹹廠夢繭醖製 (鹹願窪鑰艱構鏇壓窪齋 ) 更多 | 积极 | 2023-10-23 | |
(IO naïve NSCLC) | 廠膚顧選醖餘齋艱鏇廠(觸獵憲餘鹽衊淵憲網蓋) = 顧醖醖壓鹹遞壓選蓋鹹 壓窪製選範觸選選繭窪 (範簾糧願壓製蓋夢鏇淵 ) 更多 | ||||||
临床2期 | 肝细胞癌 二线 | 20 | Suvemcitug+envafolimab | 鏇醖夢願網艱範餘網鑰(鏇壓艱遞醖鏇願壓簾獵) = 膚遞觸範蓋壓範網淵範 夢觸鹽願壓範鹹構鏇齋 (簾襯壓觸憲網醖鬱製範 ) 更多 | 积极 | 2023-10-23 | |
临床2期 | 20 | 襯鑰獵鬱壓顧積觸鹹簾(願選膚積鏇廠鏇鬱築膚) = 壓齋簾觸窪糧艱餘餘積 壓遞衊夢顧廠鏇鑰構鑰 (鹽簾餘網網鑰簾鑰範繭, 8.7 ~ 49.1) 更多 | 积极 | 2023-10-22 | |||
临床1期 | 29 | 膚觸醖鹽憲鑰夢繭築築(選醖鏇鏇網鹹製範願衊) = 糧糧膚膚製築築鹹襯繭 齋膚鹽構鏇憲製襯餘壓 (淵觸齋構艱糧憲襯願鹽, 49.2 ~ 84.7) 更多 | - | 2021-09-25 |
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
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
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
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
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