阿得贝利单抗(Adebrelimab) - 药物靶点：PDL1_在研适应症：广泛期小细胞肺癌，非小细胞肺癌，胃食管交界处癌_专利_临床

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

PDL1

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)

治疗领域

肿瘤呼吸系统疾病消化系统疾病+ [6]

在研适应症

广泛期小细胞肺癌非小细胞肺癌胃食管交界处癌+ [58]

非在研适应症

晚期食管鳞状细胞癌HR阳性/HER2低表达实体瘤局部进展期胃腺癌+ [2]

原研机构

在研机构

+ [2]

非在研机构

Atridia Pty Ltd.

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),

广泛期小细胞肺癌

最高研发阶段(中国)批准上市

特殊审评特殊审批 (中国)、突破性疗法 (中国)

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结构/序列

Sequence Code 13388064H

来源: *****

Sequence Code 13388069L

来源: *****

关联

416

项与阿得贝利单抗相关的临床试验

NCT07567326

/ Not yet recruiting临床2期IIT

A Phase II Study of Neoadjuvant Adebrelimab or Retlirafusp Alfa (SHR-1701) in Combination With Recaticimab and Chemotherapy for Resectable Non-small Cell Lung Cancer

Although phase III studies have confirmed the efficacy and safety of perioperative immunotherapy plus chemotherapy for resectable NSCLC, there remains room for improvement in both short-term efficacy and long-term survival. Preclinical evidence suggests that PCSK-9 inhibition may synergize with PD-1 inhibitors to suppress tumor growth in mouse models. To date, no data are available on neoadjuvant PCSK-9 inhibitor therapy combined with immunotherapy and chemotherapy in resectable NSCLC. Therefore, this phase II study aims to evaluate the efficacy and safety of neoadjuvant adebrelimab or retlirafusp alfa (SHR-1701) plus recaticimab and chemotherapy in patients with resectable NSCLC.

开始日期2026-07-01

申办/合作机构-

NCT07638436

/ Recruiting临床2期IIT

Phase II Trial of Adebrelimab Combined With Nab-paclitaxel and Carboplatin for Neoadjuvant Therapy in Patients With Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

This clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.

开始日期2026-06-17

申办/合作机构

中山大学

NCT07624201

/ Not yet recruiting临床2期IIT

Neoadjuvant Trastuzumab Rezetecan and Adebrelimab for HER2-positive Muscle-invasive Bladder Cancer: a Phase II, Prospective, Single-arm, Multicenter Trial

This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.

开始日期2026-06-01

申办/合作机构

哈尔滨医科大学

[+2]

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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45

项与阿得贝利单抗相关的文献（医药）

2026-05-01·International Journal of Surgery

Adebrelimab in combination with dalpiciclib and endocrine therapy as neoadjuvant treatment for HR+/HER2− early breast cancer: an exploratory study

Article

作者: Ren, He ; Xiao, Min ; Liu, Tong ; Lei, Bo ; Wang, Jinsong ; Han, Xinhao ; Zhang, Crystal Song ; Huang, Fanxuan

Background::

Hormone receptor–positive (HR + )/HER2 − breast cancer (BC) exhibits limited sensitivity to neoadjuvant chemotherapy, with low pathologic complete response (pCR) rates. While CDK4/6 inhibitors (CDK 4/6i) combined with endocrine therapy have demonstrated efficacy, the immunogenicity of HR + /HER2 − tumors remains low, limiting the benefit of immunotherapy. Emerging evidence suggests potential synergy between CDK4/6 inhibition and immune checkpoint blockade. This study explores the neoadjuvant combination of adebrelimab, dalpiciclib, and endocrine therapy in patients with stage II–III HR + /HER2 − BC.

Methods::

This single-arm, exploratory study enrolled postmenopausal women with histologically confirmed stage II–III HR + /HER2 − BC. Eligible patients received neoadjuvant therapy comprising adebrelimab (1200 mg intravenously, day 1), dalpiciclib (125 mg orally, once daily on days 1–21), and letrozole. Treatment was administered over five 28-day cycles prior to surgery. The primary endpoint was total pCR (tpCR; defined as ypT0-is/ypN0).

Results::

Between October 2024 and March 2025 patients (median age 61.5 years) with stage II–III HR + /HER2 − BC were enrolled. Most patients had T2 tumors (85%) and N1 disease (55%). All patients received ≥1 treatment cycle; 17 completed surgery. Radiological partial response was observed in 13 patients (65%), with an overall objective response rate (ORR) of 65%. One patient (5%) achieved tpCR. Three patients discontinued due to adverse events (AE; one death, one hepatitis, and one pneumonia). Common grade ≥ 3 AEs included neutropenia (50%), leukopenia (25%), and elevated liver enzymes.

Conclusion::

This triplet regimen demonstrated modest clinical activity in HR + /HER2 − early BC, with the safety profile of this regimen remains a concern and warrants particular attention in clinical practice.

2026-04-30·CURRENT MEDICINAL CHEMISTRY

Apatinib and Adebrelimab Exhibit Synergistic Antitumor effects in Small Cell Lung Cancer: An In Vitro Study

Article

作者: Huang, Laiquan ; Wu, Linfeng ; Wang, Yifan ; Cheng, Xiangwei ; Zhu, Yiping

Background::

Small cell lung cancer (SCLC) is a highly aggressive malignancy. This study investigated whether Apatinib (Apa) combined with Adebrelimab (Ade) exerted synergistic effects against SCLC.

Methods::

Half-maximal inhibitory concentration (IC50) value of Apa and Ade, administered alone or in combination, was determined in H446 and H1436 cells using cell counting kit-8 (CCK-8) assays. Synergistic effects were quantified by calculating fractional inhibitory concentration (FIC) indices. Cell proliferation, migration, and invasion were assessed by CCK-8, wound healing, and Transwell assays, respectively. After co-culture with CD8+ T cells, PD-L1 expression and CD8+ IFN-γ+ T cell proportion were measured by flow cytometry. TGF-β secretion and LDH release were detected using ELISA and LDH assay, respectively; the protein level of VEGFR2 and STAT3 was analyzed by western blot.

Results::

Apa alone exhibited IC50 values of 20.03 μM (H446) and 35.50 μM (H1436), while Ade alone exhibited 5.789 μM and 6.959 μM, respectively. The sum FIC values were 0.681 for H446 cells and 0.973 for H1436 cells. Compared with either monotherapy, combined treatment more effectively reduced cell viability, migration, and invasion. In co-culture experiments, the combination further suppressed PD-L1 expression and TGF-β secretion, increased CD8+ IFN-γ+ T cells and LDH release, and downregulated VEGFR2, p-STAT3, and PD-L1 protein levels.

Discussion::

This study demonstrated that the combination of Apa and Ade exerted synergistic anti-tumor effects against SCLC in vitro. Further investigation, including animal studies and clinical trials, is warranted to evaluate the efficacy and long-term safety of this combination therapy.

Conclusion::

In summary, the combination of Apa and Ade represented a promising innovative therapeutic strategy for SCLC.

2026-04-30·Journal of Gastrointestinal Oncology

Neoadjuvant adebrelimab combined with triplet chemotherapy for locally advanced resectable adenocarcinoma of esophagogastric junction: a prospective, single-arm, phase II feasibility and safety study.

Article

作者: Zhang, Rui ; Miao, Yan ; Zhang, Guangwen ; Wang, Mian ; Li, Zhenshun ; Zhou, Wei ; Hong, Liu ; Sun, Hao ; Yang, Li ; Liu, Shushang ; Liu, Jinqiang ; Fan, Aqiang

Background:

Immune checkpoint inhibitors (ICIs) in combination with chemotherapy have become the standard treatment for advanced adenocarcinoma of the esophagogastric junction (AEG). While perioperative fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) remains the global standard for locally advanced resectable AEG, its substantial hematologic toxicity and perioperative tolerability concerns may limit broader adoption in some Asian patients in real-world clinical practice. This study aimed to assess the perioperative feasibility and safety of neoadjuvant adebrelimab combined with chemotherapy (nab-paclitaxel, lobaplatin, and S-1) in patients with resectable, locally advanced AEG.

Methods:

Between November 2023 and April 2025, 24 patients with clinically staged cT3-4aNanyM0 or cT1-2N+M0 resectable AEG were prospectively enrolled at a single center. Patients received two 3-week cycles of neoadjuvant adebrelimab plus nab-paclitaxel, lobaplatin, and S-1, followed by surgery scheduled 4-6 weeks after treatment completion. Survival follow-up was censored on 19 October 2025. The primary endpoint was pathological complete response (pCR) rate.

Results:

Among the 24 enrolled patients, the median age was 62 years, 83.3% were male, 37.5% had Siewert type III tumors and programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥1. Twenty patients (83.3%) subsequently underwent surgery, all achieving R0 resection. In the intention-to-treat (ITT) population, the pCR and major pathological response (MPR) rates were 16.7% [95% confidence interval (CI): 4.7-37.4%] and 29.2% (95% CI: 12.6-51.1%), respectively. Corresponding rates in the surgery population were 20.0% (95% CI: 5.7-43.7%) and 35.0% (95% CI: 15.4-59.2%). The objective response rate (ORR) was 79.2%, and the disease control rate (DCR) was 100%. At a median follow-up of 9.1 months, the estimated 1-year event-free survival (EFS) and overall survival (OS) rates were 80.8% and 88.9%, respectively. Treatment-related adverse events (TRAEs) were predominantly grade 1-2, with only 1 patient (4.2%) experiencing a grade 3 TRAE. No grade 4-5 TRAEs or treatment-related deaths occurred. There was 1 patient (5.0%) who experienced a grade 3 surgical complication.

Conclusions:

Neoadjuvant adebrelimab combined with triplet chemotherapy demonstrated acceptable perioperative feasibility, manageable toxicity, and preliminary pathological antitumor activity in patients with locally advanced AEG. Given the exploratory single-arm design and short follow-up, the findings should be considered hypothesis-generating and require validation in larger multicenter randomized trials.

1,114

项与阿得贝利单抗相关的新闻（医药）

2026-06-16

·有驾

「Gemini完善版」AACR 2026年会涉及中国生物技术/制药公司药物的摘要汇总

使用Gemini直接在网页上汇总了来自中国生物科技与生物制药企业（含合作或中国研究机构主导使用国产管线）的临床试验结果与进展报告，结果看起来更加全面。按企业与药物管线分类如下：恒瑞医药 (Hengrui Pharmaceuticals) Adebrelimab (阿得贝利单抗 / PD-L1)：Abstract CT014：联合化疗在可切除II-III期非小细胞肺癌（NSCLC）围手术期的III期EFS中期分析及MRD分析。Abstract CT038：联合risvutatug rezetecan治疗既往接受过治疗且无可用靶向基因突变的晚期非鳞状NSCLC的I期研究初步结果。Abstract CT239：联合化疗在未经治疗的局部晚期头颈部鳞状细胞癌新辅助治疗中的单臂II期研究疗效与生物标志物分析。SHR-A1811 (HER2 ADC)：Abstract CT301探讨其单药或联合adebrelimab作为晚期HER2突变NSCLC一线治疗的Ib/II期队列结果。Dalpiciclib (达尔西利 / CDK4/6)：Abstract CT151探讨其联合mFOLFOX6治疗经治转移性结直肠癌的Simon两阶段II期研究结果。HRS-6209 (高选择性CDK4抑制剂)：Abstract CT117公布在晚期实体瘤患者中的I期研究。百济神州 (BeiGene) Tislelizumab (替雷利珠单抗 / PD-1)：Abstract CT007：联合研究药物作为复发和/或转移性头颈部鳞状细胞癌（R/M HNSCC）一线治疗的II期研究。Abstract CT085：联合吉西他滨、顺铂和白蛋白结合型紫杉醇（GENTIS方案）治疗晚期胆道癌的Ib/II期试验。Abstract CT122：联合个性化mRNA新抗原疫苗EVM16治疗晚期实体瘤的首次人体（FIH）研究。BGB-24714 (SMAC类似物)：公布其在实体瘤患者首次人体研究中的单药/联合化疗I期进展Abstract CT120及药效学特征Abstract CT121。君实生物 (Junshi Biosciences) JS207 (PD-1/VEGF 双抗)：Abstract CT152：联合化疗治疗转移性结直肠癌的安全性和疗效II期初步结果。Abstract CT159：联合JS007（anti-CTLA4）治疗晚期肝细胞癌的多中心II期随机研究。JS212 (EGFR/HER3 双抗ADC)：Abstract CT128公布治疗晚期实体瘤的首次人体I/II期初步结果。Toripalimab (特瑞普利单抗 / PD-1)：Abstract CT082探讨联合nadunolimab治疗化疗难治性转移性微卫星稳定（MSS）结直肠癌的Ib/II期研究。信达生物 (Innovent Biologics) Sintilimab (信迪利单抗 / PD-1)：Abstract CT150：联合顺铂和白蛋白结合型紫杉醇诱导治疗局部晚期临界可切除食管鳞癌的单臂前瞻性II期研究。Abstract CT160：联合索凡替尼和卡培他滨治疗经治转移性小肠腺癌和阑尾癌的Ib/II期更新分析。Abstract CT183：联合新型RNA溶瘤病毒IVX037治疗晚期MSS结直肠癌的Ib期临床评估。康方生物 (Akeso) Ivonescimab (依沃西单抗 / PD-1/VEGF)：Abstract CT277：治疗转移性内分泌难治性HR+/HER2-或三阴性浸润性小叶癌的II期试验（IvoLoC Trial）。Abstract CT281：治疗既往接受过治疗的胸腺癌的II期试验。Cadonilimab (卡度尼利单抗 / PD-1/CTLA-4)：Abstract CT145联合化疗一线治疗晚期胰腺导管腺癌的多中心开放标签II期研究（COMPASSION-26）。和黄医药 (HUTCHMED) Fruquintinib (呋喹替尼)：Abstract CT048（联合IMT-009）及Abstract CT083（联合ADG126及K药）在转移性MSS结直肠癌中的联合用药研究。Surufatinib (索凡替尼)：Abstract CT146（单药或联合AG方案一线治疗晚期胰腺癌）及Abstract CT160（联合信迪利单抗治疗小肠/阑尾癌）。Savolitinib (赛沃替尼)：Abstract CT247联合度伐利尤单抗治疗伴有MET异常的EGFR野生型晚期NSCLC的II期SOUND试验。贝达药业 (Betta Pharmaceuticals) / 葆元医药 (AnHeart) Dirozalkib (ALK抑制剂)：Abstract CT299及Abstract CT243分别报告其在晚期ALK阳性NSCLC中的多中心随机开放标签III期及II期试验结果。BPI-572270 (RAS多靶点抑制剂)：Abstract CT284报告治疗RAS突变晚期实体瘤的首次人体I/II期研究。Taletrectinib (ROS1抑制剂)：Abstract CT300及Abstract CT244公布其在TKI初治与经治ROS1阳性NSCLC患者中的TRUST-I和TRUST-II更新数据。再鼎医药 (Zai Lab) ZL-1310 (DLL3 ADC)：Abstract CT189报告其在神经内分泌癌及其他实体瘤中的Ib/II期初步结果；Abstract CT193报告其在伴有基线脑转移的广泛期小细胞肺癌患者中的颅内活性分析。映恩生物 (DualityBio) DB-1324 (CDH17 ADC)：Abstract CT086晚期胃肠道肿瘤的首次人体I/II期研究。DB-1317 (ADAM9 ADC)：Abstract CT092晚期实体瘤的首次人体Ia/Ib期研究。德昇济医药 (D3 Bio) Elisrasib / D3S-001 (KRAS G12C抑制剂)：Abstract CT303单药或联合西妥昔单抗治疗既往经治的转移性结直肠癌和胰腺癌I/II期安全性和疗效。D3S-002 (ERK1/2抑制剂)：Abstract CT060治疗具有MAPK通路突变的晚期实体瘤的首次人体I期研究。天演药业 (Adagene) Muzastotug / ADG126 (Masked Anti-CTLA-4)：Abstract CT054联合治疗不可切除局部晚期或转移性肝细胞癌的Ib/II期Morpheus肝脏研究结果；Abstract CT083联合帕博利珠单抗及呋喹替尼治疗晚期MSS结直肠癌的Ib期评估。其他中国企业管线与合作/自研疗法石药集团 (CSPC) - SYS6010 (EGFR ADC)：Abstract CT036治疗晚期鼻咽癌的首次人体研究结果。翰森制药 (Hansoh) - HS-10504：Abstract CT302治疗EGFR突变阳性局部晚期或转移性NSCLC的首次人体I期初步结果。艾博生物 (Abogen) - ABO2203 (mRNA)：Abstract CT032治疗复发/难治性B细胞非霍奇金淋巴瘤的首次人体初步结果。乐普生物 (Lepu) - Pucotenlimab (普特利单抗)：Abstract CT180联合标准化疗作为中高危横纹肌肉瘤患儿术前治疗的I/II期安全性与疗效。科望医药 (Elpiscience) - ES014 (CD39/TGF-β 双抗)：Abstract CT127单药治疗晚期实体瘤的首次人体研究。细胞疗法/创新制剂：Abstract CT027/Abstract CT078：北京大学肿瘤医院主导的LACO-Stim装甲靶向间皮素（Mesothelin）及CD70靶向（UCL70802）的CAR-T疗法实体瘤试验。Abstract CT195：针对亚洲患者的快速制造FAST-TIL治疗晚期黑色素瘤I期临床随访数据。Abstract CT291：IL-12前体药物KGX101在晚期黑色素瘤中的首次人体研究（北京大学肿瘤医院主导）。Abstract CT115：LYC001（靶向淋巴结的IL-2免疫疗法）I期初步安全性数据。

2026-06-16

·百度百家

「Gemini完善版」AACR 2026年会涉及中国生物技术/制药公司药物的摘要汇总

使用Gemini直接在网页上汇总了来自中国生物科技与生物制药企业（含合作或中国研究机构主导使用国产管线）的临床试验结果与进展报告，结果看起来更加全面。按企业与药物管线分类如下：恒瑞医药 (Hengrui Pharmaceuticals) Adebrelimab (阿得贝利单抗 / PD-L1)：Abstract CT014：联合化疗在可切除II-III期非小细胞肺癌（NSCLC）围手术期的III期EFS中期分析及MRD分析。Abstract CT038：联合risvutatug rezetecan治疗既往接受过治疗且无可用靶向基因突变的晚期非鳞状NSCLC的I期研究初步结果。Abstract CT239：联合化疗在未经治疗的局部晚期头颈部鳞状细胞癌新辅助治疗中的单臂II期研究疗效与生物标志物分析。SHR-A1811 (HER2 ADC)：Abstract CT301探讨其单药或联合adebrelimab作为晚期HER2突变NSCLC一线治疗的Ib/II期队列结果。Dalpiciclib (达尔西利 / CDK4/6)：Abstract CT151探讨其联合mFOLFOX6治疗经治转移性结直肠癌的Simon两阶段II期研究结果。HRS-6209 (高选择性CDK4抑制剂)：Abstract CT117公布在晚期实体瘤患者中的I期研究。百济神州 (BeiGene) Tislelizumab (替雷利珠单抗 / PD-1)：Abstract CT007：联合研究药物作为复发和/或转移性头颈部鳞状细胞癌（R/M HNSCC）一线治疗的II期研究。Abstract CT085：联合吉西他滨、顺铂和白蛋白结合型紫杉醇（GENTIS方案）治疗晚期胆道癌的Ib/II期试验。Abstract CT122：联合个性化mRNA新抗原疫苗EVM16治疗晚期实体瘤的首次人体（FIH）研究。BGB-24714 (SMAC类似物)：公布其在实体瘤患者首次人体研究中的单药/联合化疗I期进展Abstract CT120及药效学特征Abstract CT121。君实生物 (Junshi Biosciences) JS207 (PD-1/VEGF 双抗)：Abstract CT152：联合化疗治疗转移性结直肠癌的安全性和疗效II期初步结果。Abstract CT159：联合JS007（anti-CTLA4）治疗晚期肝细胞癌的多中心II期随机研究。JS212 (EGFR/HER3 双抗ADC)：Abstract CT128公布治疗晚期实体瘤的首次人体I/II期初步结果。Toripalimab (特瑞普利单抗 / PD-1)：Abstract CT082探讨联合nadunolimab治疗化疗难治性转移性微卫星稳定（MSS）结直肠癌的Ib/II期研究。信达生物 (Innovent Biologics) Sintilimab (信迪利单抗 / PD-1)：Abstract CT150：联合顺铂和白蛋白结合型紫杉醇诱导治疗局部晚期临界可切除食管鳞癌的单臂前瞻性II期研究。Abstract CT160：联合索凡替尼和卡培他滨治疗经治转移性小肠腺癌和阑尾癌的Ib/II期更新分析。Abstract CT183：联合新型RNA溶瘤病毒IVX037治疗晚期MSS结直肠癌的Ib期临床评估。康方生物 (Akeso) Ivonescimab (依沃西单抗 / PD-1/VEGF)：Abstract CT277：治疗转移性内分泌难治性HR+/HER2-或三阴性浸润性小叶癌的II期试验（IvoLoC Trial）。Abstract CT281：治疗既往接受过治疗的胸腺癌的II期试验。Cadonilimab (卡度尼利单抗 / PD-1/CTLA-4)：Abstract CT145联合化疗一线治疗晚期胰腺导管腺癌的多中心开放标签II期研究（COMPASSION-26）。和黄医药 (HUTCHMED) Fruquintinib (呋喹替尼)：Abstract CT048（联合IMT-009）及Abstract CT083（联合ADG126及K药）在转移性MSS结直肠癌中的联合用药研究。Surufatinib (索凡替尼)：Abstract CT146（单药或联合AG方案一线治疗晚期胰腺癌）及Abstract CT160（联合信迪利单抗治疗小肠/阑尾癌）。Savolitinib (赛沃替尼)：Abstract CT247联合度伐利尤单抗治疗伴有MET异常的EGFR野生型晚期NSCLC的II期SOUND试验。贝达药业 (Betta Pharmaceuticals) / 葆元医药 (AnHeart) Dirozalkib (ALK抑制剂)：Abstract CT299及Abstract CT243分别报告其在晚期ALK阳性NSCLC中的多中心随机开放标签III期及II期试验结果。BPI-572270 (RAS多靶点抑制剂)：Abstract CT284报告治疗RAS突变晚期实体瘤的首次人体I/II期研究。Taletrectinib (ROS1抑制剂)：Abstract CT300及Abstract CT244公布其在TKI初治与经治ROS1阳性NSCLC患者中的TRUST-I和TRUST-II更新数据。再鼎医药 (Zai Lab) ZL-1310 (DLL3 ADC)：Abstract CT189报告其在神经内分泌癌及其他实体瘤中的Ib/II期初步结果；Abstract CT193报告其在伴有基线脑转移的广泛期小细胞肺癌患者中的颅内活性分析。映恩生物 (DualityBio) DB-1324 (CDH17 ADC)：Abstract CT086晚期胃肠道肿瘤的首次人体I/II期研究。DB-1317 (ADAM9 ADC)：Abstract CT092晚期实体瘤的首次人体Ia/Ib期研究。德昇济医药 (D3 Bio) Elisrasib / D3S-001 (KRAS G12C抑制剂)：Abstract CT303单药或联合西妥昔单抗治疗既往经治的转移性结直肠癌和胰腺癌I/II期安全性和疗效。D3S-002 (ERK1/2抑制剂)：Abstract CT060治疗具有MAPK通路突变的晚期实体瘤的首次人体I期研究。天演药业 (Adagene) Muzastotug / ADG126 (Masked Anti-CTLA-4)：Abstract CT054联合治疗不可切除局部晚期或转移性肝细胞癌的Ib/II期Morpheus肝脏研究结果；Abstract CT083联合帕博利珠单抗及呋喹替尼治疗晚期MSS结直肠癌的Ib期评估。其他中国企业管线与合作/自研疗法石药集团 (CSPC) - SYS6010 (EGFR ADC)：Abstract CT036治疗晚期鼻咽癌的首次人体研究结果。翰森制药 (Hansoh) - HS-10504：Abstract CT302治疗EGFR突变阳性局部晚期或转移性NSCLC的首次人体I期初步结果。艾博生物 (Abogen) - ABO2203 (mRNA)：Abstract CT032治疗复发/难治性B细胞非霍奇金淋巴瘤的首次人体初步结果。乐普生物 (Lepu) - Pucotenlimab (普特利单抗)：Abstract CT180联合标准化疗作为中高危横纹肌肉瘤患儿术前治疗的I/II期安全性与疗效。科望医药 (Elpiscience) - ES014 (CD39/TGF-β 双抗)：Abstract CT127单药治疗晚期实体瘤的首次人体研究。细胞疗法/创新制剂：Abstract CT027/Abstract CT078：北京大学肿瘤医院主导的LACO-Stim装甲靶向间皮素（Mesothelin）及CD70靶向（UCL70802）的CAR-T疗法实体瘤试验。Abstract CT195：针对亚洲患者的快速制造FAST-TIL治疗晚期黑色素瘤I期临床随访数据。Abstract CT291：IL-12前体药物KGX101在晚期黑色素瘤中的首次人体研究（北京大学肿瘤医院主导）。Abstract CT115：LYC001（靶向淋巴结的IL-2免疫疗法）I期初步安全性数据。

2026-06-16

·北肿新指南

打破小细胞肺癌治疗瓶颈！恒瑞全新DLL3-TCE新药SHR-7787全国招募，初治/经治患者均可入组

小细胞肺癌（SCLC）素来被称为肺癌中的“顽疾”，恶性程度高、进展速度快、复发率高，且既往治疗手段十分有限。传统化疗、常规免疫治疗疗效逐渐触及天花板，尤其是经治患者后续治疗选择匮乏、生存获益不佳，临床长期存在巨大的治疗缺口。好消息！恒瑞医药自主研发的1类创新生物药SHR-7787（DLL3×CD3双特异性TCE）临床研究重磅重启，全国多中心招募正式开启！本次研究覆盖初治广泛期小细胞肺癌及多线治疗失败的经治患者，全新靶向免疫联合方案，三重机制协同增效，填补SCLC TCE疗法临床空白，为不同病程阶段患者带来全新生存希望。 01 黄金靶点DLL3：专为小细胞肺癌而生的理想靶点一款新药的疗效底气，源于优质的靶点选择，DLL3正是目前小细胞肺癌领域公认的“王牌靶点”。 DLL3是Notch信号通路的抑制性配体，具备天然差异化表达优势：在正常成人人体组织中几乎不表达、检测不到，极大规避了靶向治疗脱靶损伤正常器官的风险，安全性基础极佳。但在小细胞肺癌中，DLL3呈现超高表达特征，85%~96%的广泛期小细胞肺癌患者肿瘤细胞均高表达DLL3。这种“肿瘤高表达、正常组织零表达”的专属特性，让DLL3成为SCLC靶向治疗最完美、最具成药价值的靶点，也是近年全球SCLC创新药研发的核心突破口。 02 创新药物SHR-7787：新一代优化版TCE，疗效与安全双升级 SHR-7787是恒瑞自主研发的DLL3×CD3双特异性T细胞衔接器（TCE）1类新药，区别于传统免疫治疗，拥有颠覆性的杀瘤机制。传统免疫治疗依赖抗原呈递、MHC分子介导，极易被肿瘤免疫逃逸机制规避，疗效受限。而SHR-7787凭借独特双抗结构，可一端精准锁定肿瘤细胞表面DLL3抗原，另一端牢牢结合人体T细胞CD3受体，无需MHC参与，直接搭建免疫突触，快速募集、激活T细胞精准击杀肿瘤细胞，从根源突破肿瘤免疫逃逸，杀瘤效率更直接、更高效。针对当前全球同类TCE药物的核心痛点，SHR-7787完成关键安全性优化。目前全球首款上市的DLL3-TCE药物塔拉妥单抗，临床中近半数患者会出现不同程度细胞因子释放综合征（CRS），是制约患者治疗体验的主要副作用。而SHR-7787通过精细化优化CD3结合域，有效避免T细胞过度激活，大幅降低CRS等不良反应风险，在保障强效抗肿瘤效果的同时，实现安全性升级，更适配长期临床治疗。 03 权威数据佐证：DLL3靶点疗法实力碾压传统方案目前多款同靶点药物的重磅临床数据，已充分验证DLL3靶向疗法的突破性疗效，远超传统SCLC治疗方案，为SHR-7787的临床价值提供强力背书。▶ 同类TCE药物疗效对比（经治患者）全球首款DLL3-TCE塔拉妥单抗II期研究数据显示：在多线治疗失败的SCLC患者中，客观缓解率ORR达40%，疾病控制率DCR 70%，中位OS突破15.2个月，18个月生存率高达46%，大幅超越传统后线化疗的生存数据。▶ TCE+免疫联合方案（一线维持） 2025年WCLC公布的研究数据证实，TCE联合PD-L1抑制剂一线维持治疗，中位OS高达25.3个月，相较于传统一线方案10~15个月的生存期，延长近1年，且无5级严重不良反应，验证了TCE联合免疫方案的超强增效价值。▶ 恒瑞同靶点ADC药物实力佐证恒瑞另一款自主研发的DLL3 ADC药物SHR-4849，2025年WCLC数据惊艳全场：二线患者ORR高达73.2%，DCR 93%，即便针对难治性脑转移患者，仍展现出优异的抗肿瘤效果，充分证实DLL3靶点的可靠性与高效性。 04 双队列全新方案：初治+经治全覆盖，三重机制碾压传统治疗本次全国多中心II期临床研究，创新性设置两大治疗队列，覆盖不同病程患者，定制专属高效方案，依托三重协同机制，实现1+1+1>3的疗效突破，全面优于传统单一化疗、免疫单药方案。✨ 队列1：初治广泛期小细胞肺癌试验方案：SHR-7787 + 阿得贝利单抗 + 依托泊苷 + 铂类方案核心优势：阿得贝利单抗是恒瑞自研PD-L1抑制剂，为国内ES-SCLC一线标准基石药物，其III期研究证实ORR 70.4%，中位OS 15.3个月。四药联合实现三重杀瘤机制：TCE直接激活T细胞精准灭瘤、PD-L1抑制剂解除全身免疫抑制、化疗快速清除残余微小病灶，三重机制互补协同，有望打破一线治疗生存天花板。✨ 队列2：≤2线含铂+免疫治疗失败的SCLC患者试验方案：SHR-7787 + SHR-4849（DLL3 ADC）方案核心优势：双DLL3靶向药物强强联合，针对一线免疫+化疗耐药、复发的难治性患者，精准攻克耐药肿瘤病灶，为后线无药可用的患者开辟全新治疗通路。备注：不接受胃肠道不耐受患者 05 招募详情｜多中心开展，名额可报名 📌 试验标题：SHR-7787注射液联合其他抗肿瘤药物在恶性实体瘤患者中的多中心、开放Ⅱ期临床研究 📌 招募人群队列1：初治广泛期小细胞肺癌患者队列2：≤2线含铂+免疫治疗失败的复发/难治小细胞肺癌患者 📌 入组年龄：18-75周岁 📌 开展中心：上海、湖北、湖南、云南、安徽、四川、黑龙江、江西、江苏、山东、山西、福建、河南、广东、辽宁等全国多省市三甲医院📢 招募咨询若您或家属确诊小细胞肺癌，符合初治或经治耐药条件，想要尝试全新靶向免疫创新方案，获得免费新药治疗与专业随访管理，可随时咨询报名！温馨提示：所有临床试验均遵循自愿原则，受试者可随时无条件退出，全程保障患者合法权益。长按扫码报名参加临床招募咨询电话：15369281360 关于报名方式参与临床试验，获取国际前沿新药新疗法使用机会！为你的治疗保驾护航！【北肿健康】目前有肺癌、肝癌、肾癌、胃癌、肠癌、胰腺癌、妇瘤、泌尿肿瘤、血液肿瘤......等几乎涵盖所有癌种的临床试验正在招募患者！扫描下方二维码添加医学运营一对一咨询！我们将会在24小时内（工作日）与您电话或微信联系，请保持手机畅通！

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
-	-	-	DB16412

研发状态

批准上市

10 条最早获批的记录,

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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	上海盛迪医药有限公司	2023-02-28

未上市

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌	申请上市	中国	上海盛迪医药有限公司	2025-09-23
非小细胞肺癌	申请上市	中国	苏州盛迪亚生物医药有限公司	2025-09-23
胃食管交界处癌	临床3期	中国	上海盛迪医药有限公司	2026-05-07
胃食管交界处癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-05-07
局部晚期直肠癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-03-23
晚期胆道癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-01-21
晚期宫颈癌	临床3期	中国	上海盛迪医药有限公司	2025-10-08
局部晚期宫颈癌	临床3期	中国	上海盛迪医药有限公司	2025-10-08
PD-L1阳性三阴性乳腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-08-20
转移性胃食管结合部腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-08-18

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06776770 (ASCO2026)	临床1/2期	胃食管交界处腺癌 \| 转移性胃癌一线	15	Adebrelimab 10 mg/kg	糧夢膚糧夢繭壓鏇遞遞(衊窪繭繭憲鬱餘糧顧獵) = 願夢繭鏇艱憲繭齋選製願襯顧糧鏇廠選鏇遞顧 (齋鹹築鏇餘襯糧壓壓憲 )	积极	2026-05-29
NCT06776770 (ASCO2026)	临床1/2期	胃食管交界处腺癌 \| 转移性胃癌一线	15	Adebrelimab 20 mg/kg or 1200 mg	糧夢膚糧夢繭壓鏇遞遞(衊窪繭繭憲鬱餘糧顧獵) = 齋網構遞獵網顧壓壓繭願襯顧糧鏇廠選鏇遞顧 (齋鹹築鏇餘襯糧壓壓憲 )	积极	2026-05-29
ChiCTR2300072705 (ASCO2026)	临床2期	胸腺癌一线	37	Adebrelimab plus nab-paclitaxel and carboplatin (Advanced or recurrent thymic carcinoma)	獵齋積窪鏇鬱鏇艱夢獵(壓齋廠夢膚憲憲淵鬱憲) = 選鏇壓廠窪觸窪糧鬱繭積蓋簾膚醖醖範範鹽鏇 (餘衊膚範鑰獵鏇鹹鏇簾 ) 更多	积极	2026-05-29
NCT06454448 (ASCO2026)	临床1/2期	转移性胰腺癌一线	28	Decitabine + Adebrelimab + Nab-paclitaxel + Gemcitabine	積蓋選觸願繭餘糧鑰鹽(願選夢遞壓鹽膚遞膚夢) = 選簾餘鏇淵齋憲製網膚網範艱範鑰膚齋顧鹽糧 (窪積餘製艱構襯製選淵 ) 更多	积极	2026-05-29
NCT06277791 (ASCO2026)	临床2期	口腔鳞状细胞癌新辅助	25	Adebrelimab 1200 mg + cisplatin 75 mg/m2/docetaxel 75 mg/m2	襯觸構觸觸願繭夢積構(觸鹹蓋簾鹽糧獵積觸憲) = 觸選遞齋醖積製簾構蓋夢選壓選鬱願遞餘襯選 (範願蓋襯蓋蓋願糧遞壓 ) 更多	积极	2026-05-29
NCT06277791 (ASCO2026)	临床2期	口腔鳞状细胞癌新辅助	25	Adebrelimab 1200 mg + cisplatin 75 mg/m2/docetaxel 75 mg/m2 (cT4b)	襯觸構觸觸願繭夢積構(觸鹹蓋簾鹽糧獵積觸憲) = 遞願醖艱鏇衊鬱繭襯衊夢選壓選鬱願遞餘襯選 (範願蓋襯蓋蓋願糧遞壓 ) 更多	积极	2026-05-29
ChiCTR2500100571 (ASCO2026)	临床2期	可切除非小细胞肺癌新辅助	37	Adebrelimab+anlotinib+chemotherapy	窪蓋遞繭壓願鑰製糧淵(醖糧餘艱鬱齋鏇鹹積簾) = 網繭鹹膚齋鑰鬱網願憲艱積鹽膚艱憲構鹽製廠 (獵簾觸簾獵積鑰衊憲簾 ) 更多	积极	2026-05-29
NCT06208462 (NEO-ERA-01, ASCO2026)	临床2期	不可切除的肝内胆管癌新辅助	31	HAIC-GEMOX+Adebrelimab+Lenvatinib	獵築遞鏇遞顧憲糧糧齋(觸範壓醖範鹹築獵遞蓋) = 夢獵製餘膚顧繭襯鬱窪製網鏇積鹹襯構簾鏇淵 (願繭遞鹽蓋積觸鑰積壓 ) 更多	积极	2026-05-29
ChiCTR2500101774 (ASCO2026)	N/A	晚期恶性实体瘤	141	Adebrelimab	衊鏇獵壓淵襯範廠醖獵(糧蓋觸願範網糧獵艱膚) = not reached yet 觸襯願膚範繭廠衊願餘 (網醖憲蓋糧築鏇鏇鬱鹽 )	积极	2026-05-29
NCT06156267 (ASCO2026)	临床1期	胰腺导管腺癌辅助	16	RGL-270 + adebrelimab + mFOLFIRINOX	糧簾繭鬱膚壓遞獵醖製(廠願顧積築襯構鏇構遞) = 夢選艱願窪鹹顧糧膚糧艱遞衊憲製糧鬱餘憲簾 (廠築繭窪衊鬱齋鏇廠窪 ) 更多	积极	2026-05-29
ChiCTR2400085858 (ASCO2026)	临床2期	局部晚期食管鳞状细胞癌新辅助	43	Adebrelimab (anti-PD-L1 antibody) 1200 mg + Adebrelimab (anti-PD-L1 antibody) 1200 mg + Adebrelimab (anti-PD-L1 antibody) 1200 mg	選齋鹽網顧遞顧獵築憲(艱淵獵築廠廠鏇網艱願) = 鏇膚淵選廠淵齋範積襯選簾鹽鹽窪製顧簾範夢 (構衊築襯廠襯鹹憲衊壓 ) 更多	积极	2026-05-29
ChiCTR2600117031 (CONVERGE, ASCO2026)	临床2期	结直肠癌肝转移 Microsatellite stable (MSS)	45	Adebelimab + stratified targeted therapy + liposomal irinotecan-based chemotherapy	構鹽餘齋憲艱網膚齋顧(餘遞選壓繭構壓網齋鹹) = 築願遞遞襯範艱憲膚範鹹顧網糧顧鹹構襯廠襯 (獵鹹夢繭壓獵憲壓夢廠, 27.3 ~ 60.0) 更多	积极	2026-05-29