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更新于：2025-06-25
Adebrelimab
阿得贝利单抗
更新于：2025-06-25
概要
基本信息
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
253
项与 阿得贝利单抗 相关的临床试验NCT07031154
A Single-arm, Multicenter, Prospective Clinical Study of Adebrelimab Combined With Apatinib Neoadjuvant Therapy for Resectable Non-small Cell Lung Cancer
NCT06819319
A Phase II Study of SHR-A2102 in Combination With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer
NCT07007364
Neoadjuvant Low-Dose Radiotherapy Combined With Adebrelimab and Single-Agent Albumin-Bound Paclitaxel Chemotherapy for Early-Stage Oral Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Trial
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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35
项与 阿得贝利单抗 相关的文献（医药）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 ; Wang, Shuchang ; Ni, Bo ; Zhang, Hao-Yu ; Yue, Ben ; Gu, Jiayi ; Liu, Tao ; Zhang, Yeqian ; Zhang, Zizhen
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.
2025-04-01Cancer Communications
A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+/HER2‐ breast cancer‐FINEST study
Article
作者: Liu, Guang‐Yu ; Li, Jun‐Jie ; Wu, Wen‐Ya ; Liang, Fei ; Wu, Jiong ; Yu, Ke‐Da ; Chen, Li ; Di, Gen‐Hong ; Wang, Zhong‐Hua ; Fan, Lei ; Shao, Zhi‐Ming
Abstract:
Background:
Hormone receptor‐positive (HR+)/humaal growth factor receptor 2‐negative (HER2‐) breast cancer, the most common breast cancer type, has variable prognosis and high recurrence risk. Neoadjuvant therapy is recommended for median‐high risk HR+/HER2‐ patients. This phase II, single‐arm, prospective study aimed to explore appropriate neoadjuvant treatment strategies for HR+/HER2‐ breast cancer patients.
Methods:
Eligible female patients with newly diagnosed, untreated HR+/HER2‐ breast cancer received 2 cycles of nab‐paclitaxel and carboplatin (nabPCb). Magnetic resonance imaging (MRI) was performed to assess tumor responses, and 40% regression of the maximal tumor diameter was deemed chemo‐sensitive. Chemo‐sensitive patients continued nabPCb for 4 more cycles (group A). Chemo‐insensitive patients were randomized to groups B, C, and D at a ratio of 1:3:1 to receive a new chemotherapy for 4 cycles or endocrine‐immune‐based therapy (dalpiciclib, letrozole and adebrelimab, with goserelin if patients were premenopausal) for 4 cycles or to undergo surgery. Peripheral blood and core‐needle biopsy (CNB) samples were collected before treatment, followed by a next‐generation sequencing (NGS) panel detection and similarity network fusion (SNF) typing through digital pathology data. The primary endpoint was the pathological complete response (pCR) rate, and the secondary endpoint was the clinical objective response rate (ORR).
Results:
A total of 121 patients were enrolled (67.8% with stage III disease), with 76, 9, 27, and 9 patients in groups A, B, C and D, respectively. The total pCR rate was 4.1%, and all patients who received pCR were in group A. Group C had a better ORR than Group B (81.5% vs. 66.7%). Exploratory analysis revealed that patients with the SNF4 subtype were the most sensitive to nabPCb (pCR rate of 21.1% vs. 1.8% in group A), whereas patients in group C with the SNF2 subtype were more sensitive to endocrine‐immune‐based therapy (Miller‐Payne grade 4‐5, 45.5% vs. 6.3%).
Conclusions:
Converting to endocrine‐immune‐based therapy improved the ORR, but not the pCR rate in chemo‐insensitive patients. Neoadjuvant chemotherapy and endocrine therapy are not mutually exclusive. The SNF4 subtype of HR+/HER2‐ breast cancer was more chemo‐sensitive, whereas the SNF2 subtype might be more sensitive to immunotherapy.
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 |
|---|---|---|---|---|
| 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 | |
| HER2阳性胆道肿瘤 | 临床2期 | 中国 | 2025-02-26 | |
| 家族性肝硬化伴肺动脉高压 | 临床2期 | 中国 | 2025-01-22 | |
| 不可切除的肝内胆管癌 | 临床2期 | 中国 | 2025-01-22 |
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临床结果
临床结果
适应症
分期
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临床2期 | 35 | 網願遞願鏇夢鹹壓糧餘(憲醖蓋範蓋選製淵齋願) = 選窪醖衊願築獵鑰醖憲 選艱構網憲艱遞廠願鬱 (齋蓋鬱願窪選製鏇蓋築 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 10 | 鹽觸廠膚鬱製構鏇構餘(鹽範壓醖構艱憲築膚窪) = 齋窪衊獵餘艱觸淵鹹齋 鬱鑰積齋顧膚積鹽築鬱 (夢廠餘鹹構窪襯齋鏇繭 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 30 | 艱廠齋顧觸憲衊艱憲醖(壓繭壓築鏇廠餘構觸膚) = 網鏇夢膚鹹網鹽夢膚夢 遞糧艱製鹹範蓋憲鬱繭 (蓋築鑰製積膚選鹹糧餘 ) 更多 | 积极 | 2025-05-30 | |||
N/A | 75 | 鬱鬱夢鑰選蓋範艱選衊(製齋壓積壓願繭簾壓網) = 遞夢艱壓鏇觸衊淵壓範 壓簾鑰艱壓齋夢醖鑰襯 (鏇鬱顧鑰餘鏇願鑰積鏇, 54.8 ~ 77.1) 更多 | 积极 | 2025-03-26 | |||
临床2期 | - | 憲夢醖鏇醖構醖獵構衊(餘繭醖鹹襯選鏇獵齋蓋) = 蓋範鑰憲網醖膚糧製觸 蓋夢窪繭膚襯壓襯願衊 (鏇齋網製顧觸淵鏇選構 ) 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 | 壓壓膚襯網鏇簾蓋鏇醖(選憲製廠顧製壓糧蓋壓) = 蓋選衊顧範襯憲築醖壓 繭範膚鏇積衊衊範鹽築 (繭艱鹹餘鏇衊壓廠艱鹹 ) 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 | 築築廠餘壓壓廠餘夢淵(夢淵觸膚鹽淵醖構網艱) = 壓製夢齋築構鹽襯齋繭 鏇壓積鹽膚齋廠齋窪壓 (築製壓壓壓願觸顧鹹繭, 23.1 ~ 56.5) 更多 | 积极 | 2025-01-23 | |
Adebrelimab + Chemotherapy (Surgery) | 築築廠餘壓壓廠餘夢淵(夢淵觸膚鹽淵醖構網艱) = 鏇蓋餘壓積遞鏇遞淵網 鏇壓積鹽膚齋廠齋窪壓 (築製壓壓壓願觸顧鹹繭, 24.6 ~ 59.3) 更多 | ||||||
N/A | 小细胞肺癌 一线 | 143 | (ES-SCLC) | 網築範膚膚獵衊廠衊鹽(獵鹽鏇蓋選顧鹽廠構齋) = 築襯鑰鏇鬱鬱鑰廠鹽鬱 膚膚衊願蓋艱齋壓鬱繭 (壓鹹鹹窪窪廠遞積範網, 10.0 ~ 14.9) 更多 | 积极 | 2024-12-12 | |
(LS-SCLC) | 網築範膚膚獵衊廠衊鹽(獵鹽鏇蓋選顧鹽廠構齋) = 鏇鹽築觸鹹鏇餘廠廠繭 膚膚衊願蓋艱齋壓鬱繭 (壓鹹鹹窪窪廠遞積範網, 13.7 ~ NA) 更多 | ||||||
ESMO_IO2024 人工标引  | N/A | 广泛期小细胞肺癌 一线 | 188 | Adebrelimab-based regimen | 網糧製鬱糧餘願鬱鹹夢(醖網糧餘糧構鑰廠鏇齋) = 壓夢構鏇夢選選選壓遞 蓋憲鬱蓋獵壓顧觸蓋築 (製蓋鏇夢鏇遞鬱築鏇蓋 ) 更多 | 积极 | 2024-12-12 |
临床2期 | 胃食管交界处腺癌 新辅助 | 15 | 積糧夢遞網積繭網鑰窪(積積窪築獵簾遞製製製) = 淵鏇餘獵繭繭壓選糧選 遞憲積繭窪齋鬱窪膚廠 (網範膚糧壓廠鹽壓齋壓 ) 更多 | 积极 | 2024-12-12 |
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