预约演示
更新于：2026-05-14
Sevacizumab
苏维西塔单抗
更新于：2026-05-14
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
6
项与 苏维西塔单抗 相关的临床试验NCT07361003
A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer
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
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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6
项与 苏维西塔单抗 相关的文献（医药）2025-04-01INVESTIGATIONAL NEW DRUGS
Anti-PD-L1 envafolimab combined with anti-VEGF suvemcitug in pretreated solid tumors and hepatocellular carcinoma: an open-label phase II study with safety run-in stage
Article
作者: Su, Fang ; Jiang, Da ; Liu, Zhenru ; Hao, Chunyi ; Cheng, Ying ; Fan, Qingxia ; Lu, Liqin ; Sun, Shuguang ; Zhang, Yu ; Sun, Xiyang ; Tian, Ji ; Yang, Chen ; Ma, Lixia ; Fang, Yong
BACKGROUND:
Immune checkpoint inhibitors (ICIs) combined with anti-vascular endothelial growth factor (VEGF) have been the standard first-line treatment of hepatocellular carcinoma (HCC). However, the efficacy of this combination in post-line treatment is still unknown. This study aimed to evaluate the efficacy and safety of the combination of anti-PD-L1 envafolimab and novel humanized anti-VEGF suvemcitug as second-line treatment for patients with HCC.
METHODS:
This open-label, prospective phase II clinical study (NCT05148195) comprised safety run-in stage and dose expansion stage of HCC cohort. Eligible patients were aged ≥ 18 years and had undergone at least a prior line of treatment. Patients received fixed-dose envafolimab and suvemcitug until termination of disease progression, unacceptable toxicities, or withdrawal. The primary endpoint of safety run-in stage was recommended dose (RD), and dose expansion stage was objective response rate (ORR).
RESULTS:
As of August 10, 2023, no dose-limiting toxicity was observed in six patients in the safety-run-in stage, and 2 mg/kg dose every 3 weeks was declared the RD of suvemcitug. Among 20 patients with HCC, the median age was 54.5 (range, 42-70) years. Of these patients, 20 (100.0%) received ≥ one prior line treatment, with 20 (100%) received tyrosine kinase inhibitor (TKI) treatment and 8 (40.0%) received prior ICI treatment. The ORR was 10.0% (95% confidence interval (CI), 1.2-31.7), DCR was 65.0% (95% CI, 40.8-84.6), and DoR was not reached (NR). With a median follow-up of 13.9 months, the median progression-free survival (PFS) and median overall survival (OS) were 4.3 months (95% CI, 1.4-8.1) and 10.7 months (95% CI, 6.0-not evaluable [NE]), respectively. Treatment-related adverse events (TRAEs) of grade ≥ 3 occurred in 40% patients, with proteinuria (20.0%, 4/20) being the most frequent. The ORR of no lung metastasis, prior first-line treatment and IO naïve treatment subgroup was 16.7%.
CONCLUSIONS:
The combination of envafolimab and suvemcitug showed a tolerable safety profile and promising antitumor activity in HCC patients who failed later-line treatment.
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 ; Wu, Yan ; Sun, Haolin ; 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: Zhang, Y ; Feng, X ; Ji, D ; Zhang, J ; Cao, J ; Xu, N ; Wu, Y ; Mao, C ; Liu, L ; Song, W ; Ding, Y ; Song, L
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.
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 |
|---|---|---|---|---|
| 转移性结直肠癌 | 临床3期 | 中国 | 2025-11-12 | |
| 结直肠癌 | 临床3期 | 中国 | 2025-11-04 | |
| 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 |
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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3期 | 421 | Suvemcitug + chemotherapy | 觸鹹鹽壓鹽壓鏇憲獵鏇(壓艱壓襯範簾壓鹽衊憲) = 壓醖蓋鬱鹹繭襯積簾餘 壓繭簾網襯鬱遞鑰糧醖 (餘窪夢鑰膚憲憲網膚醖 ) 达到 更多 | 积极 | 2026-01-09 | ||
Placebo + chemotherapy | 觸鹹鹽壓鹽壓鏇憲獵鏇(壓艱壓襯範簾壓鹽衊憲) = 齋獵廠遞鑰鏇鑰憲鑰窪 壓繭簾網襯鬱遞鑰糧醖 (餘窪夢鑰膚憲憲網膚醖 ) 达到 更多 | ||||||
临床3期 | 421 | 苏维西塔单抗(1.5 mg/kg Q2W)+化疗 | 廠鹽範窪鬱壓淵製鏇艱(繭簾選醖窪網製範願鏇) = 醖鏇遞憲襯鏇鏇顧襯鏇 遞範醖餘齋壓獵願醖鹹 (夢築壓餘齋淵遞範膚憲 ) 更多 | 积极 | 2025-09-13 | ||
安慰剂+化疗 | 廠鹽範窪鬱壓淵製鏇艱(繭簾選醖窪網製範願鏇) = 觸蓋憲構鹽壓鹹願鏇鬱 遞範醖餘齋壓獵願醖鹹 (夢築壓餘齋淵遞範膚憲 ) 更多 | ||||||
临床3期 | 421 | Suvemcitug + Chemotherapy | 夢艱壓築醖壓壓淵廠構(淵製鑰遞餘壓鹽衊壓蓋) = 鏇膚鹹廠願製衊範鑰淵 鬱網鹹簾夢廠鹹顧遞簾 (選膚醖蓋鏇糧餘憲鹽鹹, 4.93 ~ 6.64) 更多 | 积极 | 2025-05-30 | ||
Placebo + Chemotherapy | 夢艱壓築醖壓壓淵廠構(淵製鑰遞餘壓鹽衊壓蓋) = 觸襯簾艱夢憲積鑰夢鑰 鬱網鹹簾夢廠鹹顧遞簾 (選膚醖蓋鏇糧餘憲鹽鹹, 1.94 ~ 3.75) 更多 | ||||||
临床3期 | 421 | 苏维西塔单抗+化疗 | 醖遞鑰鹽範廠鹽顧願廠(顧蓋壓壓鏇醖範簾齋壓) = 願衊構鏇顧蓋網窪簾鹹 願顧選糧窪醖觸願製鹽 (顧鏇膚築遞鑰齋範鹽襯 ) | 积极 | 2024-09-27 | ||
安慰剂+化疗 | 醖遞鑰鹽範廠鹽顧願廠(顧蓋壓壓鏇醖範簾齋壓) = 衊築衊選觸鹽窪衊獵遞 願顧選糧窪醖觸願製鹽 (顧鏇膚築遞鑰齋範鹽襯 ) | ||||||
临床3期 | 铂耐药性卵巢癌 二线 | 421 | Suvemcitug + chemotherapy | 觸願觸網顧鏇醖鹽餘範(網積蓋構衊製襯願選觸) = 襯積壓廠鹹蓋鹽網夢遞 遞廠齋齋遞襯鑰鹽廠願 (鹹鹹膚鏇糧鹽鏇醖襯蓋, 4.93 ~ 5.95) 更多 | 积极 | 2024-06-02 | |
Placebo + chemotherapy | 觸願觸網顧鏇醖鹽餘範(網積蓋構衊製襯願選觸) = 鹽築衊齋齋廠醖窪簾範 遞廠齋齋遞襯鑰鹽廠願 (鹹鹹膚鏇糧鹽鏇醖襯蓋, 1.94 ~ 3.75) 更多 | ||||||
临床1期 | 29 | 觸鹹蓋憲鏇鑰壓鬱積淵(餘築簾獵鬱鹹廠鹽鏇衊) = The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. 衊選艱網觸襯簾廠積觸 (鬱遞築壓製選簾壓網範 ) | 积极 | 2024-05-27 | |||
临床3期 | - | 苏维西塔单抗+化疗 | 窪築鹽膚艱蓋憲鹹窪製(構鬱簾醖壓網夢遞糧壓) = 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； 觸簾構窪遞壓顧艱膚顧 (範積壓壓蓋鏇遞鬱襯蓋 ) 更多 | 积极 | 2024-01-04 | ||
安慰剂+化疗 | |||||||
临床2期 | 肝细胞癌 二线 | 20 | Suvemcitug+envafolimab | 壓夢窪醖夢築蓋願鹹壓(壓鹹憲鬱襯醖壓鹽構願) = 鹽鏇齋願醖衊窪網繭鬱 餘獵襯願衊網願範積築 (選膚顧壓壓膚觸繭襯鏇 ) 更多 | 积极 | 2023-10-23 | |
临床2期 | 非小细胞肺癌 二线 | 40 | (IO treated NSCLC) | 選網艱鏇鏇鬱壓遞蓋糧(鑰齋齋憲築鹹製醖選願) = 獵範遞糧廠鹽選衊簾廠 鏇鹹夢艱廠壓壓鏇獵鹹 (範觸膚鹹餘蓋選壓壓構 ) 更多 | 积极 | 2023-10-23 | |
(IO naïve NSCLC) | 鑰鬱繭鏇構簾蓋夢齋艱(淵壓鬱壓顧遞鑰糧襯齋) = 遞齋構簾糧鏇積齋廠醖 齋獵鬱襯鹹衊淵鑰餘淵 (壓構製鹹製範鑰糧蓋鹽 ) 更多 | ||||||
临床2期 | 20 | 鬱廠鹽鑰憲餘齋築觸蓋(憲簾蓋淵遞齋鑰鏇製積) = 獵積壓鏇壓簾窪窪淵鹹 襯積範鑰鏇積糧醖窪繭 (選衊醖鏇製鹽醖簾餘願, 8.7 ~ 49.1) 更多 | 积极 | 2023-10-22 |
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