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更新于：2025-08-09
Socazolimab
索卡佐利单抗
更新于：2025-08-09
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (中国)、附条件批准 (中国) |
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结构/序列
Sequence Code 616716146H
来源: *****
Sequence Code 616716147L
来源: *****
关联
22
项与 索卡佐利单抗 相关的临床试验NCT06459687
Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study
CTR20242900
索卡佐利单抗注射液加含铂化疗联合/不联合贝伐珠单抗对比安慰剂加含铂化疗联合/不联合贝伐珠单抗用于一线治疗持续、复发或转移性宫颈癌的随机、双盲III期临床研究
ChiCTR2300078237
A single-arm exploratory clinical study of nab-paclitaxel combined with subcutaneous PD-L1 monoclonal antibody in the treatment of advanced and posterior triple-negative breast cancer
100 项与 索卡佐利单抗 相关的临床结果
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100 项与 索卡佐利单抗 相关的转化医学
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100 项与 索卡佐利单抗 相关的专利（医药）
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381
项与 索卡佐利单抗 相关的文献（医药）2025-09-01DRUG RESISTANCE UPDATES
Metabolic reprogramming of tumor-associated macrophages via adenosine-A2AR signaling drives cross-resistance in non-small cell lung cancer
Article
作者: Liu, Guopin ; Yao, Xiangchao ; Lu, Jinjian ; Sun, Danyuan ; Wang, Yandong ; Mo, Jianshan ; Zhang, Qiyi ; Yue, Peibin ; Wu, Yanle ; Xue, Menghan ; Su, Yingxue ; Ding, Wen ; Zhu, Kai ; Zhang, Xiaolei ; Ye, Jiangling ; Hu, Wenhao ; Shi, Yanyu ; Zhang, Jian
Immunosuppression within the tumor microenvironment (TME) is frequently associated with chemoresistance. However, the mechanisms by which chemoresistance promotes immune evasion and impairs subsequent immunotherapy remain poorly understood, underscoring the urgent need for novel therapeutic strategies to counteract these effects. In this study, we observed that tumors exhibit cross-resistance to immunotherapy following chemoresistance in a non-small cell lung cancer (NSCLC) mouse model. The aberrant accumulation of tumor-associated macrophages (TAMs) and extracellular adenosine (Ado) were identified as mediators of immunosuppression, fostering cross-resistance to immunotherapy in the context of chemoresistance. Mechanistically, selective activation of the Ado/A2AR signaling pathway induced metabolic reprogramming of TAMs, thereby creating an immunosuppressive niche in cross-resistant NSCLC. Based on these findings, we designed a novel selective A2AR inhibitor DL082 and explored its therapeutic potential for treating cross-resistant NSCLC. The combination of DL082 with an anti-PD-L1 antibody significantly enhanced immune activation and inhibited tumor progression in cross-resistant NSCLC. These findings elucidate the specific mechanisms underlying cross-resistance between chemotherapy and immunotherapy in NSCLC and propose targeting the Ado-TAM axis as a potential strategy for overcoming resistance in NSCLC therapy.
2025-07-25Modern Rheumatology Case Reports
A case of irAE myositis with positive antistriational antibodies after anti-PD-L1 antibody administration: A case report
Article
作者: Yabe, Daisuke ; Hirose, Tokuyuki ; Honda, Makie ; Takao, Ken ; Kato, Takehiro ; Horikawa, Yukio ; Kubota, Saki ; Hirota, Takuo ; Mizuno, Masami ; Ando, Hironori
ABSTRACT:
Immune checkpoint inhibitors are widely used in clinical practice, necessitating appropriate management of immune-related adverse events (irAEs). Although severe neurologic irAEs are less common, they often lead to poor outcomes, requiring early detection and prompt intervention. An 88-year-old woman with invasive urothelial carcinoma received six cycles of gemcitabine plus carboplatin followed by avelumab, an anti-programmed cell death ligand 1 antibody, as maintenance therapy. One week later, she developed progressive limb weakness and was diagnosed with irAE myositis based on elevated creatine kinase (CK) levels and imaging findings. Early treatment with methylprednisolone pulse therapy, followed by prednisolone [1 mg/kg body weight (BW)], led to rapid improvement, and no relapse occurred after prednisolone completion at 4 months. IrAE myositis has clinical, pathological, and immunological features that differ from those of known inflammatory muscle diseases. In this case, the time to onset and the presence of antistriational antibodies were consistent with previous reports focusing on anti-programmed cell death 1 antibodies, whereas ocular symptoms, myocarditis, and myasthenia gravis, which are considered characteristic of irAE myositis, were not observed. Given the expected increase in high-grade neurological irAEs, accumulating case reports is essential to better understand the differences in clinical presentation and prognosis, which may vary depending on drug-specific effects and autoantibody profiles. Furthermore, this case suggests that some patients with irAE myositis may successfully taper or discontinue prednisolone earlier than traditionally expected.
2025-07-20JOURNAL OF CLINICAL ONCOLOGY
Phase II (Alliance A091802) Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma.
Article
作者: Phan, Minh D ; Rosenberg, Ari J ; Schwartz, Gary K ; Julian, Ricklie A ; Munster, Pamela N ; Saba, Nabil F ; Poklepovic, Andrew S ; Bauman, Jessica R ; Berg, Stephanie A ; Swiecicki, Paul ; Cordes, Julia ; Davar, Diwakar ; Rivera, Edgardo ; Zandberg, Dan P ; Kaczmar, John M ; Rowland, Kendrith ; Allred, Jacob B ; Ho, Alan L ; Zhang, Miao
PURPOSE:
Continued improvement in outcomes is needed for advanced cutaneous squamous cell carcinoma (cSCC).
METHODS:
Alliance A091802 is a randomized phase II trial of avelumab (800 mg IV once every 2 weeks) plus cetuximab (500 mg/m2 IV once every 2 weeks) versus avelumab alone once every 2 weeks for up to 2 years. Cetuximab was given for 1 year in the avelumab + cetuximab arm. Crossover at progression to avelumab + cetuximab was allowed. Randomization was 1:1, stratified by PD-L1 and HIV status. Patients had distant metastatic or unresectable locally advanced cSCC, were anti-PD-1/PD-L1 monoclonal antibody-naive, had no previous cetuximab in the advanced setting, had an Eastern Cooperative Oncology Group performance status of 0-2, and could be HIV+ (CD4 >200, viral load <200). Patients with chronic lymphocytic leukemia, immunosuppression, or active autoimmune diseases were excluded. The primary end point was progression-free survival (PFS; null hypothesis: median = 12 months v alternative hypothesis: 21 months or a 75% improvement, power of 80% with one-sided alpha .2, n = 57, 37 PFS events required). Secondary end points were overall survival, objective response rates (ORRs), clinical benefit rate, and toxicity.
RESULTS:
Sixty patients were enrolled; 57 patients were evaluable. The median age was 72 years, all were HIV-; 75.4% was PD-L1+, 84.2% had head/neck origin, 47.4% had distant metastasis, and there were no differences in baseline characteristics by arm. Avelumab + cetuximab significantly improved PFS versus avelumab (median, 11.1 [7.6-not reached (NR)] v 3.0 months [2.7-13.6] hazard ratio, 0.48 [95% CI, 0.23 to 0.97], P = .018). Avelumab patients who crossed over (n = 9) to combination had a median PFS after crossover of 11.3 months (5.8-NR). The confirmed ORR was 27.6% with avelumab + cetuximab and 21.4% with avelumab. Grade 3 treatment-related adverse events occurred in 48.3% and 21.5% of patients with avelumab + cetuximab (most common: rash [20.7%], infusion reaction [20.7%]) and avelumab, respectively.
CONCLUSION:
Avelumab + cetuximab significantly improved PFS versus avelumab alone in patients with advanced cSCC. Alliance A091802 supports a larger confirmatory study with the combination of cetuximab and PD-1:PD-(L)1 blockade.
100 项与 索卡佐利单抗 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 |
|---|---|---|---|
| 广泛期小细胞肺癌 | 中国 | 2025-07-29 | |
| 转移性宫颈癌 | 中国 | 2023-12-19 | |
| 复发性宫颈癌 | 中国 | 2023-12-19 |
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 |
|---|---|---|---|---|
| 子宫颈转移癌 | 临床3期 | 中国 | 2024-11-28 | |
| 骨肉瘤 | 临床3期 | - | 2020-06-01 | |
| 转移性黑色素瘤 | 临床2期 | 中国 | 2021-09-27 | |
| 食管鳞状细胞癌 | 临床2期 | 中国 | 2020-11-19 | |
| 转移性尿路上皮癌 | 临床2期 | 中国 | 2018-10-10 | |
| 膀胱尿路上皮癌 | 临床2期 | 中国 | 2018-10-10 | |
| 肝外胆管癌 | 临床1期 | 中国 | 2021-03-24 | |
| 胆囊肿瘤 | 临床1期 | 中国 | 2021-03-24 | |
| 胆管癌 | 临床1期 | 中国 | 2021-02-01 | |
| 晚期尿路上皮癌 | 临床1期 | 中国 | 2020-09-10 |
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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 | 广泛期小细胞肺癌 一线 | 498 | 鏇鹹糧製膚憲遞繭餘範(糧膚糧製簾齋鹽艱夢構) = 襯遞構糧膚鑰選顧糧窪 衊艱憲鹹遞製淵憲製範 (獵範夢淵鑰構醖夢壓鏇 ) 更多 | 积极 | 2025-01-13 | ||
鏇鹹糧製膚憲遞繭餘範(糧膚糧製簾齋鹽艱夢構) = 齋糧鏇淵鬱遞醖餘簾醖 衊艱憲鹹遞製淵憲製範 (獵範夢淵鑰構醖夢壓鏇 ) 更多 | |||||||
临床1期 | 晚期尿路上皮癌 一线 | 20 | 簾繭願製鑰積醖襯廠鹹(淵衊鬱製鏇膚鏇廠製鑰) = All patients had TRAEs, most of which were grade 1 or 2. The common TRAEs (≥20%) were peripheral neurotoxicity, alopecia, rash, increased ALT, weight loss, weakness, pruritus, increased AST, increased γGT, increased ALP, neutropenia, emesis, and anorexia. 膚壓獵獵蓋壓襯衊簾構 (簾選壓襯廠蓋網窪鑰鹹 ) 更多 | 积极 | 2024-10-17 | ||
临床2期 | 局部晚期食管鳞状细胞癌 新辅助 | 64 | 餘觸構鬱憲鏇積網繭糧(築窪廠壓襯壓憲鏇獵襯) = 鹹齋選繭願繭蓋築繭餘 繭築簾蓋衊獵窪築淵鏇 (鑰網獵觸膚膚遞窪觸遞 ) 更多 | 积极 | 2022-09-10 | ||
餘觸構鬱憲鏇積網繭糧(築窪廠壓襯壓憲鏇獵襯) = 膚積簾構觸網範鬱淵範 繭築簾蓋衊獵窪築淵鏇 (鑰網獵觸膚膚遞窪觸遞 ) 更多 | |||||||
临床1期 | 104 | ( dose-expansion phase) | 憲齋願憲顧鹽壓糧醖積(鹹糧積積鹹醖製艱餘製) = 齋構鹽鑰顧壓鹽鏇鹹選 願憲網襯糧淵繭簾蓋繭 (壓蓋夢鹽選鬱願蓋鏇觸 ) 更多 | 积极 | 2022-06-02 | ||
(CPS < 1) | 憲齋願憲顧鹽壓糧醖積(鹹糧積積鹹醖製艱餘製) = 淵壓鏇餘醖壓淵襯獵糧 願憲網襯糧淵繭簾蓋繭 (壓蓋夢鹽選鬱願蓋鏇觸 ) 更多 | ||||||
临床1期 | 晚期尿路上皮癌 一线 | 20 | 鏇襯糧齋餘選觸獵觸獵(製醖鑰鏇繭艱壓鏇範築) = 餘鬱選範鑰壓築網築遞 鹽簾繭築構構蓋鏇獵顧 (憲餘築繭襯鹹簾艱遞壓 ) 更多 | 积极 | 2022-06-02 | ||
临床1期 | 广泛期小细胞肺癌 一线 | 20 | 築憲鬱憲選餘觸遞夢顧(範糧鑰憲鏇醖壓襯獵夢) = 鹹襯鹽壓窪廠繭蓋繭齋 網繭夢糧製鑰願糧鹽廠 (繭襯簾願製憲顧築膚窪 ) 更多 | 积极 | 2022-04-03 | ||
临床1期 | 子宫颈转移癌 PD-L1-positive | - | 遞醖願餘網網夢夢網顧(襯顧蓋鏇選獵壓蓋鬱衊) = 衊襯觸網鑰範繭壓淵鏇 繭蓋壓獵選願範衊壓艱 (艱廠簾遞築顧壓憲齋獵, 10.9 ~ 27.4) 更多 | 积极 | 2021-11-01 | ||
临床1期 | 20 | ZKAB001+卡铂+依托泊苷 | 憲齋築膚憲廠糧糧廠範(醖觸製淵餘繭壓鏇觸醖) = 最常见治疗相关不良事件包括血小板计数降低(30.0%)、贫血(25%)、中性粒细胞计数降低(20%)、高血糖症(20%)和白细胞计数降低(20%) 簾衊鏇鑰範糧糧繭鑰窪 (鏇襯蓋襯蓋觸廠願鬱廠 ) | - | 2021-09-25 | ||
临床1/2期 | 11 | 鹽夢構簾構齋憲網網齋(夢繭淵簾憲構衊觸願餘) = 20% 蓋憲網製膚齋鹽願遞鑰 (積醖鑰廠製遞窪糧糧願 ) 更多 | - | 2020-09-19 | |||
临床2期 | 60 | 醖齋觸齋簾齋繭餘艱蓋(醖鑰鹽襯觸網鹹觸獵糧) = 31/60(51.7%)名患者出现一项或多项治疗相关不良反应(TRAEs)，大部分TRAEs为1或2级，仅有2患者(3.3%)出现3级或以上TRAEs。最常见的TRAEs包括状腺功能减退症(8例，13.3%)，白细胞计数降低(6例，10.0%)，类风湿因子升高(5例，8.3%)，贫血(4例，6.7%)和天门冬氨酸氨基转移酶升高(3例，5.0%)。1人因为不良事件而退组。 鬱範鏇鹽鹽積築夢壓顧 (範淵簾鏇襯夢鑰製鏇淵 ) 更多 | - | 2020-09-19 |
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