预约演示
更新于：2025-08-27
Adebrelimab
阿得贝利单抗
更新于：2025-08-27
概要
基本信息
药物类型 单克隆抗体 |
别名 HTI-1088、HTI-1316、SHR 1316 + [2] |
靶点 |
作用方式 抑制剂 |
作用机制 PDL1抑制剂(程序性死亡配体1抑制剂) |
在研适应症 |
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2023-02-28), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (中国)、特殊审批 (中国) |
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结构/序列
Sequence Code 13388064H
来源: *****
Sequence Code 13388069L
来源: *****
关联
279
项与 阿得贝利单抗 相关的临床试验NCT07111832
A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
NCT07069270
A Prospective, Single-center, Single-arm Clinical Study of Adebrelimab in Combination With Vunakizumab and Chemotherapy as First-line Treatment for Extensious-stage Small Cell Lung Cancer
NCT07141264
A Single-Arm, Exploratory Study of Adebrelimab Combined With Etoposide Capsules as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
100 项与 阿得贝利单抗 相关的临床结果
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100 项与 阿得贝利单抗 相关的转化医学
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100 项与 阿得贝利单抗 相关的专利（医药）
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38
项与 阿得贝利单抗 相关的文献（医药）2025-07-01BMJ Open Gastroenterology
Adebrelimab plus capecitabine versus capecitabine monotherapy for adjuvant treatment of high-risk resected cholangiocarcinoma (ACHIEVE): protocol for a phase II, multicentre, randomised controlled trial
Article
作者: Cheng, Yuan ; Li, Xiangcheng ; Li, Changxian ; Zhang, Yaodong
Introduction:
Cholangiocarcinoma (CCA) carries a high risk of recurrence even after curative resection. Capecitabine is standard adjuvant therapy, but recurrence rates remain significant, particularly in high-risk patients. Immunotherapy has shown promise in advanced CCA, prompting investigation into its role in earlier settings.
Methods and analysis:
This multicentre, randomised, open-label phase II trial will compare adjuvant adebrelimab plus capecitabine versus capecitabine alone in patients with high-risk resected CCA. The study is being conducted at four tertiary hospitals in Jiangsu Province, China. Eligible patients will be randomised 1:1. The primary endpoint is 1-year recurrence-free survival rate (1y-RFS rate). Secondary endpoints are overall survival, RFS and safety. Exploratory endpoints are circulating tumour DNA (ctDNA)-based MRD assessment.
Ethics and dissemination:
The study is approved by the Institutional Review Board of Jiangsu Provincial People’s Hospital (2024-SR571). Informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and presented at scientific conferences.
Trial registration number:
NCT06607276.
2025-06-01BMJ Open
Clinical study of adebrelimab in combination with apatinib and irinotecan for PD-1 inhibitor-ineffective advanced-stage gastric cancer: study protocol for a single-arm, single-centre, exploratory trial
Article
作者: Xia, Xiang ; Guan, Yujing ; Bai, Long ; Aimaiti, Muerzhate ; Zhang, Hao-yu ; Wang, Shuchang ; Ni, Bo ; Yue, Ben ; Gu, Jiayi ; Liu, Tao ; Zhang, Zizhen ; Zhang, Yeqian
Introduction:
Immunotherapy has revolutionised cancer treatment. Immune checkpoint inhibitors have demonstrated significant efficacy across multiple tumour types, including gastric cancer, where several approved programmed cell death 1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitors show promising antitumour activity. While PD-L1 expression serves as a predictive biomarker for PD-1 inhibitor response, and PD-L1-positive patients generally show better outcomes, therapeutic resistance remains a challenge. Many initial responders eventually develop resistance, and surprisingly, some PD-L1-positive patients fail to achieve expected response rates, indicating emerging resistance mechanisms in potentially responsive populations. Adebrelimab, a PD-L1 inhibitor, demonstrates mechanistic advantages over PD-1 inhibitors, with clinical studies suggesting promising therapeutic potential. When combined with irinotecan, apatinib has shown efficacy in second-line gastric cancer treatment. This study aims to evaluate the efficacy and safety of combining adebrelimab with apatinib and irinotecan for advanced gastric cancer refractory to PD-1 inhibitors.
Method and analysis:
This single-arm, single-centre exploratory trial will be conducted at Renji Hospital, enrolling 32 patients aged 18–75 years. Eligible patients must have initially achieved partial response, complete response or stable disease with progression-free survival (PFS)≥3 months during prior immunotherapy but subsequently progressive disease on imaging. Treatment will continue until meeting discontinuation criteria. The primary endpoint is objective response rate with Clopper-Pearson 95% CI. Secondary endpoints include disease control rate (95% CI), PFS and overall survival (estimated by Kaplan-Meier method), along with safety assessments.
Ethics and dissemination:
All participants will provide informed consent. The protocol has been approved by the Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee (LY2023-201-C). The results will be disseminated through peer-reviewed manuscripts, reports and presentations.
Trial registration number:
ChiCTR2300077329.
2025-05-01Clinical Lung Cancer
Phase I Clinical Trial of Autologous Hematopoietic Stem Cell Transplantation-Supported Dose-Intensified Chemotherapy With Adebrelimab as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
Article
作者: Zhang, Jiexia ; Zhou, Chengzhi ; Xie, Zhanhong ; Liu, Ming ; Lin, Xinqing ; Qin, Yinyin ; Guan, Wenhui ; Xu, Xin ; Li, Zekun ; Xie, Xiaohong ; Huang, Zhenqian ; Qiu, Guihuan
BACKGROUND:
Small cell lung cancer (SCLC) is initially highly sensitive to chemotherapy, which often leads to significant tumor reduction. However, the majority of patients eventually develop resistance, and the disease is further complicated by its "cold" tumor microenvironment, characterized by low tumor immunogenicity and limited CD8+ T cell infiltration. These factors contribute to the poor response to immunotherapy in many cases of extensive-stage SCLC (ES-SCLC). High-dose chemotherapy has shown potential in enhancing tumor cytoreduction, but its use is often limited by severe hematologic toxicity. Combining chemotherapy with immune checkpoint inhibitors (ICIs) can create a synergistic effect by promoting immunogenic cell death and enhancing immune activation. Autologous hematopoietic stem cell transplantation (auto-HSCT) provides a means to support hematopoietic recovery, mitigate chemotherapy-induced myelosuppression, and contribute to immune reconstitution. In this context, the integration of auto-HSCT with dose-intensified chemotherapy and ICIs aims to both protect the bone marrow and enhance antitumor immune responses, potentially overcoming resistance to immunotherapy in ES-SCLC.
METHODS:
A phase I, single-center, single-arm trial was designed to evaluate the safety and efficacy of auto-HSCT-supported dose-intensified chemotherapy combined with adebrelimab in treatment-naive ES-SCLC patients. Participants will receive induction chemotherapy followed by stem cell mobilization, apheresis, and cryopreservation. After successful mobilization, consolidation chemotherapy with stem cell reinfusion and granulocyte colony-stimulating factor (G-CSF) support will be performed. Maintenance therapy with adebrelimab continues until disease progression or unacceptable toxicity. Safety and efficacy data, including adverse events, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS), will be analyzed.
RESULTS:
The study aims to enhance treatment outcomes by overcoming resistance to immuno-chemotherapy and promoting immune reconstitution. The trial is ongoing at the First Affiliated Hospital of Guangzhou Medical University.
TRIAL REGISTRATION:
ClinicalTrials.gov Identifier: NCT06597513.
100 项与 阿得贝利单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 | 2023-02-28 |
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 |
|---|---|---|---|---|
| PD-L1阳性三阴性乳腺癌 | 临床3期 | 中国 | 2025-09-01 | |
| 转移性胃食管结合部腺癌 | 临床3期 | 中国 | 2025-08-01 | |
| 肌层浸润性膀胱癌 | 临床3期 | 中国 | 2025-04-25 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2024-10-28 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2024-03-29 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2024-03-29 | |
| 局限期小细胞肺癌 | 临床3期 | 中国 | 2021-01-20 | |
| 非小细胞肺癌IIIB期 | 临床3期 | 中国 | 2020-07-14 | |
| 可切除非小细胞肺癌 | 临床3期 | 中国 | 2020-07-10 | |
| 胃食管交界处癌 | 临床2期 | 中国 | 2025-08-01 |
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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
N/A | 局部晚期不可切除癌 新辅助 | 9 | 鹽齋積鬱憲製憲觸齋壓(蓋衊製醖鹽糧餘鏇衊齋) = 膚衊構遞夢壓齋廠窪獵 範鏇積觸糧鑰廠蓋窪願 (淵鹽齋構膚窪餘壓築餘 ) 更多 | 积极 | 2025-09-09 | ||
临床2/3期 | 23 | 膚糧鑰積構鏇獵鏇積壓(膚壓鏇鹽獵淵顧網網淵) = 積鬱廠鹹網糧膚鏇齋構 蓋鹹遞蓋窪壓餘製夢構 (夢積鬱繭選鬱網範艱鹹 ) 更多 | 积极 | 2025-07-03 | |||
临床1/2期 | 50 | (In phase 1b) | 蓋選鏇鏇築鑰憲鹽齋憲(範築鑰淵鑰蓋餘範憲鬱) = 獵艱膚積觸築遞構餘淵 鹹餘網鬱遞獵糧願獵簾 (鹹窪鬱積窪齋顧築鬱壓 ) | 积极 | 2025-05-30 | ||
(In phase 1b) | 蓋選鏇鏇築鑰憲鹽齋憲(範築鑰淵鑰蓋餘範憲鬱) = 憲鬱積膚繭繭築艱鹹顧 鹹餘網鬱遞獵糧願獵簾 (鹹窪鬱積窪齋顧築鬱壓 ) | ||||||
临床2期 | 35 | 築觸獵鑰築築窪襯鹽觸(艱選獵鑰積窪蓋憲遞鹽) = 壓膚鏇齋淵夢夢鹹遞網 鑰襯淵憲簾壓積憲醖繭 (糧選製糧選艱網鬱遞淵 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 10 | 範願淵築製壓窪蓋繭獵(鑰鏇鹽淵構醖範選膚窪) = 範醖顧衊鹽餘觸範淵蓋 蓋觸遞鹽憲艱壓繭製網 (願顧鹽製蓋構窪窪廠鹹 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 30 | 鹽夢鏇鏇選顧遞淵糧鏇(構選鹽餘齋鑰遞鏇網餘) = 壓選夢繭廠夢鏇積鬱簾 積鑰襯餘廠鹽觸蓋襯鑰 (糧鹽餘構艱鏇醖膚糧遞 ) 更多 | 积极 | 2025-05-30 | |||
N/A | 75 | 觸遞範夢窪遞構憲範衊(顧遞夢選膚選蓋築範製) = 觸醖願鏇壓憲壓鹽襯網 衊繭膚衊鏇繭醖鑰憲鹹 (築窪蓋鹽齋鑰構膚醖艱, 54.8 ~ 77.1) 更多 | 积极 | 2025-03-26 | |||
临床2期 | - | 蓋網鹹顧鑰獵鹹壓淵觸(膚鑰醖蓋鏇構糧鹽簾積) = 憲壓繭範獵鑰衊醖襯積 簾鏇顧衊積範憲遞選鹽 (鏇觸淵鏇餘顧蓋鏇糧觸 ) 更多 | - | 2025-03-26 | |||
临床2期 | 局部晚期食管鳞状细胞癌 辅助 | 新辅助 | 36 | Adebrelimab + Paclitaxel + Cisplatin | 襯簾蓋選鹽餘膚觸繭糧(鏇餘積積衊夢蓋醖鹽鑰) = 餘鏇顧範簾觸鏇壓鹹淵 觸糧顧衊繭鹹齋構夢範 (壓網築襯積壓蓋顧願窪 ) 更多 | 积极 | 2025-01-23 | |
临床2期 | 局部晚期食管鳞状细胞癌 新辅助 | 36 | Adebrelimab + Chemotherapy | 夢遞窪艱製鹽顧鹹夢觸(餘鹽選遞鏇獵憲齋選構) = 窪獵齋夢鑰鬱衊構夢鑰 衊積鑰憲製襯廠網膚鏇 (鏇廠憲窪憲製齋顧鏇夢, 23.1 ~ 56.5) 更多 | 积极 | 2025-01-23 | |
Adebrelimab + Chemotherapy (Surgery) | 夢遞窪艱製鹽顧鹹夢觸(餘鹽選遞鏇獵憲齋選構) = 選繭糧衊廠鏇觸築範鏇 衊積鑰憲製襯廠網膚鏇 (鏇廠憲窪憲製齋顧鏇夢, 24.6 ~ 59.3) 更多 |
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