A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab (STRIDE) Plus Gemcitabine and Cisplatin (GEMCIS) in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma (cHCC-CCA)

This is a single arm phase 2 study of Single Tremelimumab with Regular Interval Durvalumab (STRIDE) plus Gemcitabine and Cisplatin (GEMCIS) in locally advanced unresectable/metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). Cycles 1 through 8 will be in 3 week intervals and Cycles 9+ will be in 4 week intervals. Tremelimumab is administered at 300mg intravenously once at Cycle 1. Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+. Gemcitabine is administered at 1000mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Cisplatin is administered at 25mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur at screening and then every 9 weeks until the end of Cycle 9. Disease assessments will then occur every 8 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months treatment from Cycle 1 Day 1 is allowed.

开始日期2026-05-01

申办/合作机构

Hoosier Cancer Research Network

[+2]

NCT07175441

/ Recruiting临床2期

A Phase 2a, Multicenter, Randomized, Open-Label Study to Assess the Efficacy, Safety, and Tolerability of RBS2418 in Combination With Tremelimumab Plus Durvalumab for Participants With Advanced Unresectable Hepatocellular Carcinoma

RBS2418 is a targeted immune modulator that inhibits ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1). It is designed to promote anti-tumor immunity by preserving endogenous 2'-3' cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis, thereby activating antigen-presenting cells and promoting robust T cell activation. Ideally, RBS2418 acts synergistically with CTLA-4 inhibitors, such as those in the STRIDE regimen (Tremelimumab plus Durvalumab). The hypothesis is that RBS2418 combined with STRIDE will be safe, well-tolerated, highly immunogenic, and enhance anti-tumor responses in adult participants with advanced, unresectable hepatocellular carcinoma (HCC) compared to STRIDE alone.

开始日期2026-04-10

申办/合作机构

Riboscience LLC

NCT07288034

/ Recruiting临床2期IIT

Immunotherapy Biomarker Collection for Metastatic NSCLC to Inform Adaptive Personalized Models Targeting Resistance (IMMUNO-BIOMAP)

This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD[L]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stage NSCLC, unlike other cancers, rely on response to first-line therapy. Immunotherapy with PD(L)1-based therapy, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. While immunotherapy has improved survival rate, the prognosis remains poor with most patients receiving chemotherapy after immunotherapy. Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid (DNA) which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. The first part of this trial, studying samples of blood and tissue in the laboratory from patients receiving immunotherapy may help doctors learn more about the effects PD(L)1-based therapy on cells. It may also help doctors understand how well patients respond to treatment and may help develop new individualized treatment strategies. The second part of this trial also tests the effect of second-line immunotherapy, such as tremelimumab and durvalumab or adagrasib and bevacizumab, in treating patients with NSCLC with specific genetic mutations that is growing, spreading or getting worse (progressive). Tremelimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adagrasib, a type of targeted therapy, may stop the growth of tumor cells by blocking a protein needed for tumor cell growth and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving second-line immunotherapy, tremelimumab and durvalumab or adagrasib with bevacizumab, may be safe, tolerable, and/or effective in treating patients with stage IIIB/IV NSCLC with specific genetic mutations.

开始日期2026-04-08

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与曲麦利尤单抗相关的临床结果

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100 项与曲麦利尤单抗相关的转化医学

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100 项与曲麦利尤单抗相关的专利（医药）

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613

项与曲麦利尤单抗相关的文献（医药）

2026-05-01·Liver International

Durvalumab–Tremelimumab in Advanced Hepatocellular Carcinoma: Real‐World Data From the LOR ‐ HCC (Lombardy Real‐World HCC Group)

Article

作者: Bruccoleri, Mariangela ; Corallo, Salvatore ; Pozzoni, Pietro ; Stagno, Annamaria ; Pino, Martina ; Riva, Alessia ; Tomasello, Gianluca ; Persano, Mara ; Grizzi, Giulia ; Costantino, Daniela ; Rimassa, Lorenza ; Mazzarelli, Chiara ; Vavassori, Sara ; Ansarin, Nasim ; Argiento, Lorenzo ; Camera, Silvia ; Gengarle, Rita ; Pressiani, Tiziana ; Iavarone, Massimo ; Bocchero, Elisa ; Casadei‐Gardini, Andrea ; Tosi, Federica ; Rimini, Margherita ; De Giorgio, Massimo ; Caremoli, Elena Rota ; Bencardino, Katia ; Torchio, Martina ; Canova, Lorenzo

ABSTRACT:

Background and Aim:

Dual immune checkpoint blockade with tremelimumab plus durvalumab (STRIDE) is an established first‐line therapy for unresectable hepatocellular carcinoma (uHCC); however, real‐world evidence on its safety, toxicity kinetics and liver function dynamics remains limited. We aimed to evaluate the tolerability and on‐treatment changes in hepatic function and effectiveness in a multicentre cohort of patients treated with STRIDE in routine practice.

Methods:

We conducted a retrospective analysis of prospectively collected data from 115 consecutive patients with uHCC treated with STRIDE across 12 centres in Lombardy, Italy. Clinical, biochemical and radiological variables were recorded at baseline and throughout the therapy. Adverse events were graded per CTCAE v5.0, and Child–Pugh was used to assess hepatic functional evolution. The temporal toxicity patterns were evaluated using smoothed hazard functions. Progression‐free survival (PFS), overall survival (OS) and competing‐risk cumulative incidences of progression and death were examined.

Results:

The median follow‐up was 8.9 months. More than 80% of the adverse events occurred within the first 2 months, and severe toxicities were infrequent. Child–Pugh deterioration from class A to B occurred in 7.8% of patients from baseline to day 28, increasing to 12.1% by day 56. PFS was 5.7 months; the median OS was not reached, with OS rates of 78.2% at 6 months and 53.3% at 18 months. Progression was the predominant early event, with a cumulative incidence of 49.2% at 6 months.

Conclusions:

In routine clinical practice, STRIDE shows reproducible effectiveness and a manageable safety profile, with an early and stabilising incidence of adverse events. Dynamic assessment of liver function shows that hepatic function declines modestly but is still clinically meaningful in affected patients.

2026-05-01·JHEP Reports

MVI-targeted carbon-ion radiotherapy combined with immunotherapy for advanced hepatocellular carcinoma: Phase Ib DEPARTURE trial

Article

作者: Kurokawa, Tomoya ; Paritala, Soumith ; Hanaoka, Hideki ; Nakagawa, Miyuki ; Kobayashi, Kazufumi ; Koroki, Keisuke ; Makishima, Hirokazu ; Yamada, Shigeru ; Kanzaki, Hiroaki ; Nakamoto, Shingo ; Ishikawa, Hitoshi ; Hoshida, Yujin ; Ozawa, Yoshihito ; Wakatsuki, Masaru ; Inaba, Yosuke ; Takahashi, Asahi ; Chen, Jingxuan ; Kondo, Takayuki ; Inoue, Masanori ; Fujiya, Makoto ; Kanogawa, Naoya ; Yumita, Sae ; Lee, Jeon ; Ogasawara, Sadahisa ; Nakamura, Masato

BACKGROUND & AIMS:

Advanced hepatocellular carcinoma (HCC) with macrovascular invasion (MVI) carries an extremely poor prognosis, necessitating novel therapeutic strategies. This phase Ib trial evaluated the safety and preliminary efficacy of combining carbon-ion radiotherapy (C-ion RT) with immune checkpoint inhibitors (ICIs) in patients with advanced HCC with MVI.

METHODS:

Fifteen patients with MVI-positive advanced HCC were enrolled (Cohort A: durvalumab monotherapy, n = 3; Cohort B: durvalumab plus tremelimumab, n = 12). C-ion RT (60 Gy, four fractions) was delivered to the MVI-containing primary tumor, while systemic therapy with durvalumab (+tremelimumab) was administered concurrently. The primary endpoints included dose-limiting toxicities and adverse events. Secondary endpoints included progression-free survival and overall survival.

RESULTS:

No dose-limiting toxicities were observed, and the combination exhibited a manageable safety profile. The most common adverse events were pyrexia, rash, and elevated lipase levels. Grade 3-4 adverse events occurred in 53.3%, including cytokine release syndrome and meningitis. Median progression-free survival and overall survival were 4.7 and 10.4 months, respectively. Although C-ion RT achieved effective local control of irradiated lesions, non-irradiated lesions showed limited systemic immune responses.

CONCLUSIONS:

The combination of MVI-targeted C-ion RT and immune checkpoint inhibitors demonstrated safe and effective local tumor control in advanced HCC. This novel approach of selective irradiation to MVI-containing tumors, combined with systemic immunotherapy, warrants further investigation to optimize the synergistic effects and enhance systemic efficacy in this poor-prognosis group.

IMPACT AND IMPLICATIONS:

Advanced hepatocellular carcinoma with macrovascular invasion (MVI) has a poor prognosis, highlighting the need for new therapeutic strategies. Our phase Ib study suggests that carbon-ion radiotherapy targeting MVI combined with immune checkpoint inhibitors is feasible and achieves sustained local tumor control. RNA-sequencing revealed that immune activation pathways were enriched in responders, while resistance was associated with mesenchymal and angiogenesis signatures. These results reinforce the potential of MVI-targeted irradiation combined with immune checkpoint inhibitors as a promising treatment strategy for these high-risk patients, warranting further investigation to improve systemic tumor control.

CLINICAL TRIALS REGISTRATION:

jRCT2031210046.

2026-04-15·INTERNAL MEDICINE

The Efficacy and Safety of Atezolizumab Plus Bevacizumab after Durvalumab Plus Tremelimumab for the Treatment of Hepatocellular Carcinoma

Article

作者: Katamura, Yoshio ; Fujii, Yasutoshi ; Uchikawa, Shinsuke ; Oka, Shiro ; Johira, Yusuke ; Takaki, Shintaro ; Miura, Ryoichi ; Kawaoka, Tomokazu ; Murakami, Eisuke ; Miki, Daiki ; Murakami, Serami ; Hashimoto, Kou ; Hayes, C. Nelson ; Tsuge, Masataka ; Ohya, Kazuki ; Tanaka, Aiko ; Nakahara, Hikaru ; Emori, Tomoaki ; Fujino, Hatsue ; Mori, Nami ; Tsuji, Keiji ; Ono, Atsushi

Objective This study aimed to evaluate the efficacy and safety of atezolizumab plus bevacizumab (Atez+Bev) as a 2nd line therapy after the administration of durvalumab plus tremelimumab (Dur+Tre) in patients with hepatocellular carcinoma. We focused on the treatment outcomes and adverse event profiles specific to this sequential regimen. Methods A retrospective analysis was conducted on 16 patients who received 2nd line Atez+Bev after Dur+Tre therapy between April 2023 and August 2024 in our hospital and associated institutions. The objective response rate (ORR), disease control rate (DCR), treatment duration, and adverse events were assessed. Results The ORR and DCR for 2nd line Atez+Bev were 25.0% and 75.0%, respectively, thus suggesting favorable disease control. Even among patients who were non-responsive to Dur+Tre, two achieved a tumor response and eight achieved disease control. Regarding safety, pruritus was a common adverse event for both regimens. Colitis and diarrhea were more frequent in the Dur+Tre group, whereas proteinuria, hyperammonemia, and bleeding were more common in the Atez+Bev group. Conclusion This study suggests that Atez+Bev remains a viable option for patients unresponsive to Dur+Tre. Prior Dur+Tre therapy may enhance the immune response within the tumor microenvironment, thereby augmenting the efficacy of Atez+Bev. However, it is important to pay attention to the differences in adverse effect profiles between the two regimens.

693

项与曲麦利尤单抗相关的新闻（医药）

2026-05-11

·医药健闻

跨国药企在中国 | 西门子医疗、GE医疗、飞利浦、贝克曼库尔特、赛诺菲、勃林格殷格翰、卫材、阿斯利康、拜耳、中美施贵宝、GSK等新动态

跨国药企在中国重点资讯文 | 苏丁企业动态西门子医疗新帅上任，黎海先生将掌舵西门子医疗诊断业务实验室解决方案中国区业务。黎海在医疗行业深耕逾二十年，在销售管理、市场策略及业务合作伙伴管理方面积累了丰富的经验。他拥有美国华盛顿大学圣路易斯奥林商学院EMBA学位。 GE医疗5月9日，由GE医疗主办的中国大健康产业领军人物千人大会暨第六届大健康领袖峰会在长春召开。同期，中国大健康产业高质量发展“价值共生计划（Value Alliance）”正式启动。该计划由GE医疗联合多家头部非公医疗机构倡议发起，旨在围绕价值医疗构建一整套可预期、可定制、可持续的服务与合作模式，打造非公医疗“价值共生”的生态伙伴关系。此次启动的“价值共生计划”包含四大板块：临床解决方案、金融解决方案、数字化/人工智能解决方案和战略咨询服务。GE医疗还与漫迪医疗、中国心磁技术专家协作组就心磁图项目签署战略合作。飞利浦 4月27日，飞利浦伟康深圳生产基地焕新启幕。飞利浦此次投资升级该基地，旨在进一步加强本土创新与智能制造布局，推动供应链升级。升级后的基地将聚焦高复杂度、高附加值环节，承担新产品导入、精密制造及自动化工艺研发等核心职能，产品销往北美、欧洲、亚太等全球市场。飞利浦目前在中国设有五大生产基地及多个研发中心，已实现中国研发与制造供应全球。贝克曼库尔特贝克曼库尔特生命科学宣布旗下Avanti J系列多用途高效离心机实现苏州本土化生产。三款国产机型Avanti JXN-30、Avanti JXN-26与Avanti J-26S XP面世。Avanti JXN-30智能型亚超速离心机，可实现外泌体、病毒及纳米颗粒等样品的高效纯化分离；Avanti JXN-26 GLP/GMP合规型高速离心机专为规范化实验室环境设计，标配符合GLP/GMP标准的完整追溯功能；Avanti J-26S XP 经典高效离心机延续经典旋钮控制面板设计，操作简便直观。杰特贝林生物技术公司杰特贝林出席2026 ChinaBio生物医药产业国际合作大会。值此进入中国市场40周年之际，杰特贝林全球机会探寻与评估负责人Stephen Pitt博士出席了主题为“新合作范式：从资产交易到生态联盟”的专题讨论，分享杰特贝林对中国市场的长期承诺、未来合作模式的洞察以及本土创新合作的新思路。杰特贝林此次参展，恰逢公司深耕中国市场四十周年。自1986年将公司第一批人血白蛋白引入中国以来，杰特贝林始终致力于服务罕见病及危重症患者。2025财年，公司已累计惠及逾400万中国危重症患者。赛诺菲在第二十八届中国北京国际科技产业博览会开幕之际，赛诺菲携全球创新成果再度亮相，重点展示其在免疫、心血管、罕见病及疫苗等重点领域的创新产品，以及深度融入中国医药创新生态、持续强化本土能力建设的最新实践。目前，赛诺菲已向中国引入60余种创新药物和疫苗，覆盖中国前十大致死疾病中的七种，为本土高发疾病患者带来更多突破性治疗选择。在本届科博会上，赛诺菲重点呈现9款代表性成果，覆盖免疫、呼吸、心血管代谢、移植、肿瘤及罕见病等多个疾病领域，包括在中国率先获批、实现“全球首发”的创新药物，以及已在国内获批多个适应症的重点产品。进入中国40余年来，赛诺菲持续加码本土投入，已构建覆盖研发、生产制造与商业运营的全产业链布局。勃林格殷格翰5月7日-10日，第六届TOPS它博会于国家会展中心举行。勃林格殷格翰携旗下创新驱虫产品超可信、博来恩，治疗产品勃欣定、圣咪乐等多元化产品组合以及数字化工具集中展出，展现公司以宠物全生命周期健康管理为核心，通过持续创新解决不同阶段宠物核心健康需求的愿景。中美施贵宝上海医药转让中美上海施贵宝30%股权尘埃落定——上海联合赛尔生物工程有限公司以10.23亿元底价接盘，上海联交所将全部股权转让款划转至上海医药指定账户。上海联合赛尔生物工程有限公司成立于1995年，是一家集基因工程疫苗、治疗用生物制品研发、生产、销售于一体的高新技术企业。卫材近日，复旦大学上海医学院举行2024-2025学年度卫材中国奖助学金颁奖仪式。从2006年开始，卫材中国在复旦大学基础医学院开始设立卫材中国奖助学金项目，每年捐赠10万余元人民币用于奖励品学兼优的学生完成学业，截至目前，已连续近20年共有680位学生获得卫材中国奖学金。阿斯利康在2026年5月10日世界狼疮日，由新华网和患者组织SLE解忧杂货铺联合主办、阿斯利康中国支持的「主场时刻」系统性红斑狼疮患者关爱行动在上海正式启幕。在全球范围内，阿斯利康持续聚焦系统性红斑狼疮患者的未尽之需，积极支持全球专家与患者组织开展交流与合作，共同推动诊疗理念更新和患者关爱实践，为提升疾病认知、优化管理理念和改善患者生存质量贡献建设性支持。 SCIEX2026年4月，SCIEX硬件研究团队的刘畅博士再次获得国际学术界重要认可，荣获2026年Analytical Sciences and Spectroscopy Award（分析科学与光谱学奖）。这是刘畅博士继2025年当选SLAS Fellow（国际实验室自动化与筛选学会会士）后，再度斩获国际权威学术荣誉，充分印证SCIEX在分析科学领域的技术实力与行业影响力。产业动态阿斯利康宣布，中国国家药品监督管理局已正式批准英飞凡（英文商品名：Imfinzi，中文通用名：度伐利尤单抗）联合英卓凡（英文商品名：Imjudo，中文通用名：曲麦利尤单抗）用于晚期或不可切除的肝细胞癌（HCC）成人患者的一线治疗。此外，度伐利尤单抗亦获批单药治疗作为晚期或不可切除的肝细胞癌（HCC）成人患者的一线治疗。拜耳公司宣布，asundexian（BAY 2433334片）“用于降低缺血性卒中或短暂性脑缺血发作（TIA）成人患者的卒中（复发）风险，不包含心源性栓塞性卒中患者”的上市申请已获国家药品监督管理局药品审评中心受理。史赛克本土创新——患者匹配聚醚醚酮颅骨板（悟空随形）正式获批上市。悟空随形是一款利用聚醚醚酮材料修复颅骨缺损的创新产品，通过减材制造技术，实现定制化的、与颅骨匹配的植入式解决方案。作为本土化创新产品，悟空随形深度融合史赛克全球经验与中国本土化需求，在个性化定制、数据安全、快速交付三大维度构建差异化聚合优势。时安生物宣布，与GSK就SA030达成一项全球独家许可协议（中国大陆、香港、澳门及台湾地区除外）。SA030是一款长效的小干扰RNA（siRNA），正处于开发阶段，用于治疗代谢与心血管疾病。SA030近期已进入1期临床试验，靶向激活素受体样激酶7（ALK7）。根据协议，GSK将支付首付款，以及未来基于成功达成的开发、注册与商业化里程碑付款，总额最高达10.05亿美元。时安生物将主导SA030的临床开发工作直至1期临床试验完成，在此之后，GSK将承担中国大陆、香港、澳门及台湾地区以外的开发、注册申报与商业化相关职责。苏州瑞博生物技术股份有限公司及其子公司Ribocure Pharmaceuticals AB（合称“瑞博生物”）共同宣布，其与勃林格殷格翰合作开展的肝脏疾病创新疗法项目再获重要突破，达成又一里程碑。这也是双方在包括代谢功能障碍相关脂肪性肝炎（ MASH ）在内的肝脏疾病创新疗法合作中，成功实现的第三个关键里程碑，标志着双方合作研发进程持续深入。联系美通社 +86-10-5953 9500 info@prnasia.com

2026-05-09

·卡梅德

CD152/CTLA-4作用机制与FDA批准检查点抑制剂的成功应用

点击蓝字，关注我们 CTLA-4（CD152）是免疫球蛋白超家族成员之一，其分子结构与共刺激因子CD28具有着高度的同源性。该蛋白主要表达于活化T细胞的表面，而在调节性T细胞（Treg）中呈组成性高表达状态。CTLA-4与CD28共用CD80、CD86两种配体，但却发挥着与CD28相反的免疫抑制作用，且结合亲和力显著高于CD28，因此在免疫调控中发挥着重要作用。 CTLA-4参与维持机体的免疫平衡与自身的免疫耐受，故其功能的缺陷会引发严重的自身免疫疾病。而使用CD152抗体阻断CTLA-4能够解除这种免疫抑制，增强机体针对肿瘤的免疫应答反应，这一机制推动着CTLA-4成为了首个成功被临床转化的免疫检查点靶点。 1.CTLA-4的多重抑制机制图1 CTLA-4细胞生物学示意图 CTLA-4介导免疫抑制的机制是多元且精密的，主要可归纳为以下两点：竞争性拮抗与信号干扰：CTLA-4对CD80/CD86具有高结合亲和力，可在免疫突触区域与CD28争夺结合位点，限制CD28对共刺激信号的识别接收，进而抑制T细胞活化。这一机制可调控机体免疫反应强度，并决定了T细胞活化信号水平。在这个过程中，CTLA-4自身不传递活化信号，仅通过物理占位阻断胞外共刺激信号向细胞内部的传递。主动清除配体的转内吞作用：CTLA-4并非仅进行被动结合竞争，还可主动剥离抗原呈递细胞（APC）膜表面配体。通过“转内吞”过程，表达CTLA-4的T细胞可捕获并降解APC表面的CD80/CD86蛋白，这种胞外作用模式赋予了CTLA-4高效的免疫抑制能力，即便是在配体高表达的条件下，仍可阻断共刺激信号的传递。此外，CTLA-4还可向TCR信号复合体募集SHP-2、PP2A等磷酸酶分子，直接抑制胞内下游信号传导，从胞内层面增强整体的免疫抑制作用。二、FDA批准的抗CTLA-4单抗 CTLA-4在机体自身免疫耐受维持中具备着核心功能，这一特性使其成为肿瘤免疫治疗的重要研究靶点。CTLA-4基因敲除小鼠可发生致死性自身免疫淋巴增殖性病变，这一结果直接证明了阻断CTLA-4功能可解除免疫耐受，提高机体抗肿瘤免疫应答水平。图2 CTLA-4功能及免疫检查点阻断的影响基于上述研究基础，靶向CTLA-4的单克隆抗体药物应运而生，其中伊匹木单抗（Ipilimumab）成为了应用效果突出的代表性药物。 Ipilimumab是一种全人源IgG1单克隆抗体，可特异性地结合CTLA-4，阻断其与配体CD80/CD86的相互作用。这种阻断带来了多方面的抗肿瘤效应：增强效应T细胞功能：通过解除CTLA-4介导的阻断，CD28共刺激信号可以得到恢复，促进了初始T细胞的活化、增殖以及向效应T细胞的分化，尤其是CD8+细胞毒性T细胞。重塑肿瘤微环境：Treg细胞是肿瘤微环境中免疫抑制的重要角色，它们通过高表达CTLA-4来抑制效应T细胞。Ipilimumab可以阻断Treg细胞的抑制功能，同时，其抗体的Fc段还可介导抗体依赖的细胞介导的细胞毒性作用（ADCC），有效清除肿瘤局部的Treg细胞，从而逆转免疫抑制微环境。 2011年，一项III期临床试验（MDX010-20）证明了Ipilimumab显著可延长晚期黑色素瘤患者的总生存期，自美国FDA正式批准其用于治疗晚期黑色素瘤，开启了免疫检查点抑制剂应用时代，并首次证实靶向CTLA-4的CD152抗体在恶性肿瘤治疗中具备重要应用价值。CD152抗体临床应用为肿瘤患者提供了新的治疗手段，同时也验证了增强机体免疫功能实现抗肿瘤治疗的科学可行性。三、CTLA-4靶向治疗的挑战与未来方向尽管Ipilimumab的成功开启了肿瘤免疫治疗的新纪元，但在临床应用中仍存在着多项局限。单药使用客观应答率仅10%-20% 并伴随高比例免疫相关不良反应，包括结肠炎、皮肤红斑、垂体炎等。这正是因为，阻断CTLA-4会打破机体免疫平衡，激活自身反应性T细胞，并损伤正常组织。为了提升药物的治疗效果并降低其毒性，研究人员探索了多种联合用药方案。其中，Ipilimumab与PD-1抑制剂的联合使用获得了良好疗效。CTLA-4参与T细胞早期活化调控；而PD-1在肿瘤微环境中限制效应T细胞活性。这两种药物的联合可通过启动与效应的双重通路激活肿瘤局部免疫反应，将免疫惰性肿瘤转化为免疫响应型肿瘤，整体提升机体的抗肿瘤应答水平。该联合用药方案已获美国FDA批准，用于黑色素瘤、肾细胞癌等多种恶性肿瘤临床治疗。图3 黑色素瘤患者CTLA-4阻断模型对CTLA-4蛋白空间结构的深入研究推动着多种CD152抗体及新型药物制剂的开发。例如，改造抗体的Fc段可提升抗体在肿瘤微环境中对Treg的ADCC清除效率、优化药物的代谢特性，成为了新一代抗体的研发重点。同时，CTLA-4抑制剂与化疗、放疗、溶瘤病毒等疗法的联合应用可在安全范围内提升抗肿瘤疗效，成为了当前临床研究的重点内容。 CTLA-4作为首个成功靶向的免疫检查点分子，改变了肿瘤治疗模式，为后续免疫靶点开发提供了重要实践依据。卡梅德生物凭借在蛋白表达、抗体开发等领域的技术积累，持续为疾病相关靶点的机制研究与药物研发提供关键支持，拥有抗体定制平台、蛋白表达平台、纳米抗体平台等多个平台，高效推动基础发现向临床转化迈进，为肿瘤免疫治疗带来更多可能。 CTLA-4（CD152）靶点相关产品包括 Protein Catalog Number Product Name Sequence Expression System KMP2860 Human CTLA-4 Protein, hFc Tag Met1-Phe162 HEK293 KMP2862 Human CTLA-4 Protein, His Tag Met1-Phe162 HEK293 Antibody Catalog Number Product Name Molecular Name Application YR1160 Anti-Human CD152 Recombinant Antibody Tremelimumab IF, IP, Neut, FuncS, ELISA YR1551 Anti-Human CD152 Recombinant Antibody Zalifrelimab WB 点击查看更多产品信息！ Rowshanravan B, Halliday N, Sansom DM. CTLA-4: a moving target in immunotherapy. Blood. 2018 Jan 4;131(1):58-67.、 Lingel H, Brunner-Weinzierl MC. CTLA-4 (CD152): A versatile receptor for immune-based therapy. Semin Immunol. 2019 Apr;42:101298. Hosseini A, Gharibi T, Marofi F, Babaloo Z, Baradaran B. CTLA-4: From mechanism to autoimmune therapy. Int Immunopharmacol. 2020 Mar;80:106221. Carreno BM, Bennett F, Chau TA, Ling V, Luxenberg D, Jussif J, Baroja ML, Madrenas J. CTLA-4 (CD152) can inhibit T cell activation by two different mechanisms depending on its level of cell surface expression. J Immunol. 2000 Aug 1;165(3):1352-6. 关于我们卡梅德生物科技（天津）有限公司自2014年成立以来，致力于成为卓越的药物抗体发现及相关配套服务的提供商。天津卡梅德科技发展有限公司隶属于卡梅德生物科技（天津）有限公司的子公司，在卡梅德生物的带领下，天津卡梅德科技发展以技术研发为核心，为全球科学家和研究机构提供高品质的CRO（合同研究组织）服务，旨在推动医药科技的发展和创新。作为一家高新技术企业，公司已通过国家专利试点单位认定及实验室ISO9001:2015质量管理体系认证，拥有30余项专利技术和多项注册商标。与国内外上千家医院、科研院校、生物医药企业建立合作，并提供近千项技术服务。公司以蛋白平台、抗体平台、抗体发现平台、细胞生物学平台、分子生物学平台这5大平台为核心，拥有近20个技术服务平台。在持续提供专业技术服务的同时，卡梅德始终秉持诚信、创新与卓越的核心价值观。不断推进技术研发与流程优化，为客户提供高效可靠的解决方案，在生物医药领域不断突破创新，为人类健康事业贡献力量。点击阅读原文，查看更多... 求点赞求分享求喜欢

免疫疗法

2026-05-09

·百度百家

4月新药数据出炉：184款获批临床，这6款上市新药，普通人该知道什么

每个月都有新药在诞生，但哪些真的和我们的生活有关？看看最新的数据，或许能发现一些希望的方向。上个月，国内有184款新药拿到了临床批件。这个数字比3月少了84款，但依然是个不小的量。仔细看里面的构成，化学药71款，生物制品占了98款，中药有15款。最引人注目的是，抗肿瘤和免疫调节类的药物，占了总数的61%，足足有106个受理号。神经系统药物也有18个。从剂型上看，注射剂最多，156个，片剂79个。这些冷冰冰的数字背后，是无数科研人员和患者的期待。真正走到上市这一步的，有6款创新药。每一款都值得说道说道。先说一个“首个”。瑞迪奥自家研发的1类放射性新药，锝[99mTc]佩昔瑞特加肽注射液，上市了。这是中国第一个自主研发的1类创新核药。它还是个“全球首个”——全球第一个用于SPECT显像的广谱肿瘤显像剂。什么意思呢？简单说，就是给肿瘤“拍照”的技术有了新突破。以前可能看不清、看不准的，现在这个药能帮医生看得更清楚，这为后续治疗方案的制定，提供了更精准的地图。对患者来说，诊断更准，意味着走弯路的可能性就更小。另一款重磅的，是阿斯利康的抗CTLA-4单抗，曲麦利尤单抗。它这次获批，主要是和另一款抗PD-L1单抗（度伐利尤单抗）联手，组成双免疫疗法。这个组合拳在国外已经获批，用来对付不可切除的肝癌和转移性非小细胞肺癌，而且是作为一线治疗。它的底气来自Ⅲ期多中心研究的数据，结果显示能显著延长患者的总生存期。肺癌和肝癌，都是咱们国家发病率和死亡率很高的癌种。多一种有效的治疗选择，哪怕只是延长一些生存时间，对患者和家庭都是莫大的慰藉。视线转到全球，4月份有27款药物获得了孤儿药、突破性疗法或快速通道这些特殊审评资格。这些资格就像“快车道”，目的是让治疗严重或罕见疾病的药物能更快来到患者身边。这里面，安领科生物的一款靶向ADC药物ALK201，拿到了FDA的孤儿药资格，针对的是胃癌。它瞄准的是FGFR2b这个靶点，这个靶点在多种恶性肿瘤里过度表达，往往预示着预后不太好。针对它开发新药，算是“精准打击”。全球的临床研究也在不断传来新消息。安进公司有一款叫TEPEZZA的药，皮下注射的3期临床成功了，治的是甲状腺眼病。数据显示，突眼反应率能达到77%，明显比安慰剂组好。更重要的是，它提供了皮下注射这种更便捷的给药方式，不用总跑医院输液，对患者生活质量的提升是实实在在的。赛诺菲的一款双抗药物lunsekimig，在哮喘和慢性鼻窦炎伴鼻息肉的II期研究里，都达到了主要终点，而且安全性耐受性看起来都不错。哮喘和严重的鼻窦炎，都是折磨人的慢性病，能有多一个安全有效的治疗选项，总是好的。研发管线里也有不少亮点。比如百济神州的注射用BG-C0979，这是一款ADC药物，靶点是ADAM9，刚获批临床，用于晚期实体瘤。这在国内是第二款针对这个靶点的ADC。 ADC药物这几年火得不行，它像“生物导弹”，能更准地把药送到肿瘤细胞，减少误伤。多一款，就多一分希望。施维雅的Vorasidenib片，被拟纳入优先审评，针对的是IDH1或IDH2基因突变的脑胶质瘤患者，用于术后治疗。这个药去年就在美国获批了，是第一个IDH1和IDH2双靶点抑制剂。脑胶质瘤治疗难度大，这种针对特定基因突变的药，代表了一种更精细的治疗思路。看下来，4月份全球和中国的新药研发，依然很活跃。抗肿瘤和免疫调节，毫无悬念还是绝对的重点。创新的核药、ADC这类“生物导弹”药物，表现特别抢眼。很多新药已经到了临床的关键阶段，一些还拿到了FDA的快速通道资格，临床数据也给人信心。更让人高兴的是，中国自己研发的创新药，正在一个个实现突破，特别是在核医学和靶向治疗这些前沿领域。我们普通人看这些新闻和数据，可能觉得离自己很远，都是分子、靶点、临床数据，看不懂。但其实，每一次获批，每一个积极的临床结果，都可能在未来某一天，变成我们或家人病历上的一线生机。医药的进步，从来都是一小步一小步累积起来的。这184个临床批件，6个上市新药，27个特殊审评资格，就是朝着更健康未来迈出的一小步又一小步。它们不只是纸面上的数字，更是无数人等待中的光。希望，总是在路上。点赞关注，一起看见更多改变生活的进步。关注我｜私信回复 666 有福利 #此篇话题：4月新药数据出炉：184款获批临床，这6款上市新药，普通人该知道什么猜你可能感兴趣的内容《身上沉得像裹湿棉被？菜市场这“两样菜”三天两头吃，大肚腩自己消了》《乙肝患者到底能不能吃鹅肉？不想肝病加重，这6样东西最好别碰》《10种治疗ED的药物，优缺点都给你列明白了，但记住，用之前必须看医生》《手麻无力别不当回事，这3个信号一出现，你的“鼠标手”可能不轻了》《谷雨前15天，抓紧吃这3样，养好肝脾阳气，夏天少生病》 #undefined#

100 项与曲麦利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06657	曲麦利尤单抗	-	DB11771

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
肝细胞癌	加拿大	AstraZeneca Canada, Inc.	2023-08-31
晚期肝细胞癌	欧盟	AstraZeneca AB	2023-02-20
晚期肝细胞癌	冰岛	AstraZeneca AB	2023-02-20
晚期肝细胞癌	列支敦士登	AstraZeneca AB	2023-02-20
晚期肝细胞癌	挪威	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	欧盟	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	冰岛	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	列支敦士登	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	挪威	AstraZeneca AB	2023-02-20
晚期非小细胞肺癌	日本	AstraZeneca KK	2022-12-23
非小细胞肺癌	美国	AstraZeneca AB	2022-11-10
不可切除的肝细胞癌	美国	AstraZeneca AB	2022-10-21

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	临床3期	美国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	日本	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	阿根廷	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	奥地利	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	巴西	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	加拿大	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	智利	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	法国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	德国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	希腊	AstraZeneca PLC	2021-08-05

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临床结果

适应症

分期

评价

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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


NCT06526104 (STRIDE in CP-B, AACR2026)	临床2期	肝细胞癌一线	30	Tremelimumab 300 mg + Durvalumab 1500 mg (Hepatocellular Carcinoma + Child-Pugh B cirrhosis)	壓糧醖顧鏇鏇憲範鹽築(構醖淵遞衊廠蓋簾襯蓋) = 糧鬱願積廠齋繭簾餘鹽廠築艱鏇鹹膚獵夢鹽構 (鑰鹽鬱積窪鹹鏇網夢願 ) 更多	积极	2026-04-21
NCT04817826 (INFINITY, AACR2026)	临床2期	MSI-H 胃癌 \| 胃食管交界处腺癌 microsatellite instability-high (MSI-H) \| mismatch repair deficient (dMMR) \| EBV-negative	18	Tremelimumab + Durvalumab	鹹膚淵膚壓鹽糧窪選淵(鏇繭選窪餘鹽鑰築鏇齋) = 積鏇窪夢網醖獵襯糧構鑰衊選鏇膚遞憲製淵淵 (廠鹽鹹蓋簾壓衊積構鹽 ) 更多	积极	2026-04-21
AACR2026	临床2/3期	膀胱癌一线	200	ICI-only regimen(Durvalumab, Durvalumab+Tremelimumab, Pembrolizumab)	艱膚範鬱積獵糧醖壓襯(簾願齋製顧淵衊顧醖築): HR = 1.92 (95.0% CI, 1.63 ~ 2.25) 更多	不佳	2026-04-21
				chemotherapy
AAD2026	N/A	黑色素瘤 PD-1 \| PD-L1 \| CTLA-4 ... 更多	24,720	LAG-3 inhibitors	憲醖衊簾鹹窪鹹餘糧襯(獵鏇鏇範糧構繭繭壓艱) = 憲鹽糧構窪繭鹹鹹遞築餘餘醖艱顧製製窪艱獵 (齋製鬱壓廠夢蓋獵廠蓋 ) 更多	积极	2026-03-27
NCT03043872 (CASPIAN, ESMO_ELCC2026)	临床3期	广泛期小细胞肺癌	805	durvalumab+tremelimumab+platinum-etoposide	鏇齋顧鏇範齋淵壓夢願(遞夢構繭積鑰製膚艱鏇): HR = 0.65 (95.0% CI, 0.48 ~ 0.87)	积极	2026-03-25
				durvalumab+platinum-etoposide
NCT05844046 (MONTBLANC, Pubmed \| Ther Adv Med Oncol)	临床2期	不可切除的肝细胞癌 programmed cell death ligand 1 \| cytotoxic T-lymphocyte-associated antigen-4 \| vascular endothelial growth factor	168	Durvalumab + Tremelimumab + Bevacizumab	選網願襯積窪顧顧顧鹽(網齋淵網鬱鬱醖廠願顧) = 範構網壓遞獵齋網鑰廠築簾鹹夢糧製築鏇範夢 (簾糧窪鏇鏇顧壓壓簾鏇 )	积极	2026-03-01
				Durvalumab + Tremelimumab	遞壓衊蓋夢壓獵鹽襯網(壓製鹹淵鬱壓觸鏇壓遞) = 衊築觸鏇獵夢襯築憲鹹積積鑰範構鏇鬱衊膚齋 (鏇範鏇夢築醖壓網積憲 ) 更多
NCT02962063 (ASCO_GI2026)	临床2期	食管腺癌	20	Durvalumab + Tremelimumab + PET-directed chemoradiation	鏇蓋鹽齋壓糧夢鏇製齋(醖選範醖範鑰遞鑰鏇膚) = 餘壓築鏇選餘範選衊製顧遞鑰淵鹹淵夢鹽繭觸 (糧糧顧衊廠範獵積遞壓 ) 更多	积极	2026-01-08
				Durvalumab + Tremelimumab + PET-directed chemoradiation (resected Pts)	鏇蓋鹽齋壓糧夢鏇製齋(醖選範醖範鑰遞鑰鏇膚) = 觸鏇簾鏇築獵簾壓餘糧顧遞鑰淵鹹淵夢鹽繭觸 (糧糧顧衊廠範獵積遞壓 )
IMbrave150 (ASCO_GI2026)	临床2/3期	晚期肝细胞癌一线	1,064	Tremelimumab + Durvalumab	顧膚觸憲製蓋糧顧淵艱(糧膚糧襯膚簾願鹹繭顧) = 壓製獵構夢鏇繭選窪壓鹽鹹蓋艱襯淵積鑰襯願 (願齋齋蓋獵鹹蓋廠廠願 ) 更多	积极	2026-01-08
				Atezolizumab + Bevacizumab	顧膚觸憲製蓋糧顧淵艱(糧膚糧襯膚簾願鹹繭顧) = 蓋鑰選壓製網鬱鏇窪餘鹽鹹蓋艱襯淵積鑰襯願 (願齋齋蓋獵鹹蓋廠廠願 ) 更多
ASCO_GI2026	N/A	晚期肝细胞癌一线	3,306	Bevacizumab-atezolizumab	壓衊蓋簾鹽齋鹽齋淵鏇(鏇製鑰廠醖夢願簾艱顧): HR = 0.873 (95.0% CI, 0.75 ~ 0.935), P-Value = 0.0016	积极	2026-01-08
				Lenvatinib
NCT03298451 (HIMALAYA, ESMO_ASIA2025)	临床3期	不可切除的肝细胞癌	321	Tremelimumab + Durvalumab	醖艱窪壓繭鏇積獵構網(繭網壓遞鹹顧簾製鏇糧) = 淵遞齋鬱蓋築廠獵醖構蓋繭繭鏇簾積夢選衊廠 (觸窪鹹觸廠憲鬱範衊憲, 14.46 ~ 33.35) 更多	积极	2025-12-05
				Durvalumab	醖艱窪壓繭鏇積獵構網(繭網壓遞鹹顧簾製鏇糧) = 構簾淵觸選鏇鏇鹽餘範蓋繭繭鏇簾積夢選衊廠 (觸窪鹹觸廠憲鬱範衊憲, 15.84 ~ 23.85) 更多