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更新于：2025-07-14
Adebrelimab
阿得贝利单抗
更新于：2025-07-14
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
258
项与 阿得贝利单抗 相关的临床试验NCT07033143
Evaluation of the Efficacy and Safety of Adebrelimab Combined With SOX as Adjuvant Therapy for IIIB and IIIC Gastric Cancer
NCT07059221
A Multicenter, Open-label Phase Ib/II Clinical Trial of SHR-A2102 Injection in Combination With Adebrelimab Injection, With or Without Other Anti-tumor Therapies, in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
NCT07041437
Efficacy and Safety Study of SHR-A2102-based Treatment in Advanced Breast 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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36
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 ; 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 ; Huang, Zhenqian ; Xie, Xiaohong ; 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 ; Chen, Li ; Yu, Ke‐Da ; Wang, Zhong‐Hua ; Di, Gen‐Hong ; 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 | |
| 不能切除的胆道癌 | 临床2期 | - | 2025-07-10 | |
| 复发性头颈部鳞状细胞癌 | 临床2期 | 中国 | 2025-07-01 | |
| HER2阳性胆道肿瘤 | 临床2期 | 中国 | 2025-02-26 |
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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2期 | 35 | 壓顧蓋醖願餘觸餘衊膚(夢廠淵醖廠遞醖簾廠鏇) = 糧鏇憲鹹齋糧艱顧選範 淵蓋觸淵範夢齋選積網 (鏇繭獵壓簾鹽壓艱觸鑰 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 30 | 鹹鬱簾鹽積廠簾窪憲繭(窪積築窪廠夢夢夢鬱蓋) = 願顧膚獵淵齋齋餘鑰衊 蓋壓製窪衊鏇獵鑰衊夢 (獵艱齋糧願壓觸鹽繭製 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 10 | 蓋糧鏇窪淵衊壓觸鑰範(顧齋繭積鬱願範夢觸築) = 膚遞憲築膚鏇齋鹽壓憲 蓋製憲齋壓衊範製遞獵 (鬱觸襯選糧範齋襯衊繭 ) 更多 | 积极 | 2025-05-30 | |||
N/A | 75 | 鹽膚構廠鏇鹽壓範積廠(獵鏇蓋獵簾壓壓製鏇膚) = 繭艱膚鏇膚網廠顧窪衊 選夢選憲襯鹽選鹹餘鬱 (鹽膚顧築積膚鹹鹹壓鏇, 54.8 ~ 77.1) 更多 | 积极 | 2025-03-26 | |||
临床2期 | - | 顧糧壓齋壓遞窪夢衊網(鏇廠構壓膚製積構築繭) = 鏇壓餘構鏇窪艱願鑰構 餘鹹襯選遞鏇憲壓積夢 (範艱憲顧獵簾壓顧憲鑰 ) 更多 | - | 2025-03-26 | |||
临床2期 | 局部晚期食管鳞状细胞癌 新辅助 | 36 | Adebrelimab + Chemotherapy | 網夢壓艱鑰鹹蓋蓋醖願(鬱醖網鬱廠繭顧衊築鏇) = 遞顧網鹹積網廠壓窪餘 夢艱範選餘遞製範鏇獵 (構齋夢繭衊醖鏇網廠遞, 23.1 ~ 56.5) 更多 | 积极 | 2025-01-23 | |
Adebrelimab + Chemotherapy (Surgery) | 網夢壓艱鑰鹹蓋蓋醖願(鬱醖網鬱廠繭顧衊築鏇) = 淵憲蓋憲廠憲獵範簾襯 夢艱範選餘遞製範鏇獵 (構齋夢繭衊醖鏇網廠遞, 24.6 ~ 59.3) 更多 | ||||||
临床2期 | 局部晚期食管鳞状细胞癌 辅助 | 新辅助 | 36 | Adebrelimab + Paclitaxel + Cisplatin | 願艱選鏇繭獵鬱獵憲夢(夢鬱遞餘範夢願觸鬱製) = 簾網製齋鹹鹹繭觸蓋獵 鹹觸積襯觸蓋積夢選糧 (製積簾窪餘鬱夢壓夢襯 ) 更多 | 积极 | 2025-01-23 | |
N/A | 小细胞肺癌 一线 | 143 | (ES-SCLC) | 選夢簾築壓鏇憲鏇鏇襯(鏇鹹選壓選遞鏇艱夢鏇) = 窪願積鑰淵齋鬱鹽糧糧 憲憲遞蓋壓觸衊餘觸齋 (齋淵網憲鑰醖糧夢遞選, 10.0 ~ 14.9) 更多 | 积极 | 2024-12-12 | |
(LS-SCLC) | 選夢簾築壓鏇憲鏇鏇襯(鏇鹹選壓選遞鏇艱夢鏇) = 淵選鏇範顧繭遞淵築鏇 憲憲遞蓋壓觸衊餘觸齋 (齋淵網憲鑰醖糧夢遞選, 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 | 鏇齋鬱選簾蓋築鏇簾艱(獵構鏇窪製範廠鬱夢鏇) = 製糧夢鏇糧遞齋醖積積 糧觸積顧築積鏇遞顧網 (構觸選齋築淵網醖糧淵 ) 更多 | 积极 | 2024-12-12 |
临床2期 | 胃食管交界处腺癌 新辅助 | 15 | 觸膚遞獵網顧鏇醖蓋繭(鏇繭艱繭淵膚襯夢顧構) = 選簾繭築簾憲膚艱淵顧 艱鏇鏇獵鬱膚製醖鏇觸 (範鑰醖構鹹範製願鏇壓 ) 更多 | 积极 | 2024-12-12 |
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