预约演示

更新于：2026-10-26

Paclitaxel

紫杉醇

更新于：2026-10-26

概要

基本信息

药物类型

小分子化药

别名

EmPAC、LDE-paclitaxel、NanoPac

+ [78]

靶点

Tubulin

作用方式

抑制剂

作用机制

微管蛋白抑制剂

治疗领域

肿瘤感染消化系统疾病+ [10]

在研适应症

转移性HER2阴性乳腺癌复发性HER2阴性乳腺癌晚期胃癌+ [172]

非在研适应症

异戊酸血症腺泡细胞癌急性淋巴细胞白血病+ [222]

原研机构

National Institutes of Health

在研机构

Alliance Foundation Trials LLC

NRG Oncology

杏辉药品工业股份有限公司

+ [54]

非在研机构

Hoffmann-La Roche, Inc.

University of Washington

Pfizer Inc.

+ [54]

权益机构

深圳市康哲药业有限公司

沈阳三生制药有限责任公司

Hanmi Pharmaceutical Co., Ltd.

+ [26]

最高研发阶段批准上市

首次获批日期

美国 (1992-12-29),

艾滋病相关性卡波西肉瘤乳腺癌卵巢癌

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)

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结构/序列

分子式C47H51NO14

InChIKeyRCINICONZNJXQF-MZXODVADSA-N

CAS号33069-62-4

关联

2,661

项与紫杉醇相关的临床试验

NCT07594548

/ Not yet recruiting临床1期IIT

A Phase I/Ib Dose Escalation Trial of Futibatinib in Combination With Paclitaxel/Ramucirumab in Second Line Confirmed Locally Advanced/Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.

开始日期2027-09-09

申办/合作机构

Northwestern University

[+1]

NCT07346196

/ Not yet recruiting临床2期IIT

A Randomized Phase II Trial of Induction Cemiplimab Plus Chemotherapy With or Without Fianlimab in Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer.

开始日期2027-02-07

申办/合作机构

The University of Chicago

NCT07753824

/ Not yet recruiting临床2期

A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)

To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).

开始日期2027-01-16

申办/合作机构

M.D. Anderson International España SA

[+2]

100 项与紫杉醇相关的临床结果

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100 项与紫杉醇相关的转化医学

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100 项与紫杉醇相关的专利（医药）

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49,981

项与紫杉醇相关的文献（医药）

2027-02-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

A leakage-controlled multiscale contextual involution-inception framework for spectral-spatial classification of neonatal hyperspectral images

Article

作者: Ceylan, Murat ; Cihan, Mücahit

Early and reliable assessment of neonatal conditions is important in neonatal intensive care units, where non-invasive imaging approaches may provide complementary information for clinical evaluation. Hyperspectral imaging provides a non-invasive means of capturing spatially resolved spectral information from neonatal tissue; however, its high dimensionality and the limited availability of clinical samples make robust model development challenging. This study proposes the Multiscale Contextual Involution-Inception Network (MC-I²Net), a leakage-controlled framework for neonatal HSI classification. The model combines spatially adaptive involution operators, Inception-based multiscale feature extraction, and contextual feature fusion to learn compact and discriminative spectral-spatial representations. A balanced six-class neonatal hyperspectral imaging dataset containing 240 samples was evaluated, including coarctation of the aorta, intracranial hemorrhage, necrotizing enterocolitis, pneumothorax, respiratory distress syndrome, and healthy control groups. Fixed signal-conditioning operations were applied using predefined processing rules, whereas PCA was treated as a data-adaptive transformation. PCA was fitted exclusively on each training fold, and the learned transformation was subsequently applied to the corresponding held-out test fold. All models were assessed using the same 5-fold cross-validation protocol repeated 10 times. MC-I²Net achieved an overall accuracy of 94.38 ± 4.60% and a Macro-F1 score of 94.35 ± 4.57%, with only small numerical differences in OA relative to MC-3DCNN, ViT-HSI, and Swin-HSI. The model used fewer trainable parameters than MC-3DCNN, ViT-HSI, and Swin-HSI and substantially fewer FLOPs than MC-3DCNN, supporting a favorable performance-complexity profile rather than a large predictive-performance margin. An additional anatomically controlled analysis restricted to PTX and RDS samples acquired from the same thoracic region retained an OA of 95.75 ± 6.49% and a Macro-F1 score of 95.66 ± 6.68%. Sequential nested cross-validation, with PCA dimensionality and involution hyperparameters selected using training data only, yielded a pooled outer out-of-fold OA of 95.00% and a Macro-F1 score of 94.98%. Ablation, sensitivity, calibration, nested-validation, runtime, and saliency analyses provided complementary evidence regarding architectural behavior, robustness, computational characteristics, and preliminary explainability. Overall, these findings support MC-I²Net as a proof-of-concept framework for neonatal HSI classification and provide a methodological basis for future prospective, multicenter, and cross-device evaluation.

2027-02-01·BIOMATERIALS

Paving the way for immunotherapy: Simvastatin-primed dual-targeting NPTAC overcomes immune resistance in hepatocellular carcinoma

Article

作者: Chen, Chen ; Yin, Dengke ; Li, Yunlong ; Huang, Danni ; Song, Zhengwei ; Yang, Wenshuo ; Liu, Kang ; Sun, Quanwei ; Yang, Ye ; Shen, Wei ; Niu, Wenjing ; Yu, Qiongliu

Immune checkpoint blockade (ICB)-based regimens, tyrosine kinase inhibitors, and transcatheter arterial chemoembolization (TACE) are major clinical options for unresectable hepatocellular carcinoma (HCC), yet their efficacy remains limited by poor tumor targeting, low response rates, insufficient immune activation, and systemic toxicity. To address these challenges, we establish a "Pave the Way Strategy" combining simvastatin (SIM) with a dual-targeted nanoparticle-mediated targeting chimera (Hs/αPD-L1-NPTAC). Oral SIM acts as a dual-function paving agent, it upregulates hepatic low-density lipoprotein receptor (LDLR) expression to enhance nanoparticle delivery, and depletes tumor cell membrane cholesterol to increase rigidity, boosting dendritic cell phagocytosis and antigen presentation. The LDLR/PD-L1 dual-targeted Hs/αPD-L1-NPTAC enables precise HCC targeting and synchronous intracellular functions. It releases paclitaxel (PTX), promotes intracellular downregulation of PD-L1 and LDLR through endolysosomal trafficking, and cooperates with SIM to establish dual metabolic intervention by simultaneously suppressing cholesterol synthesis and limiting exogenous cholesterol uptake. In immunocompetent orthotopic HCC models, this strategy potently inhibits tumor growth and lung metastasis, prolongs survival, enhances CD8⁺ cytotoxicity T cell, and remodels the immunosuppressive tumor microenvironment. This paradigm provides a promising approach to overcome ICB resistance and enable precision immunotherapy for HCC.

2027-02-01·BIOMATERIALS

Natural phenolic acid-based self-assembly promotes anti-tumor immune amplification by ATP-ADO axis regulation and its spiky structure

Article

作者: Zhao, Xiaomin ; Ruan, Xin ; Zhou, Guoliang ; Wang, Xin ; Yue, Zongxin ; Cao, Yuqi ; Deng, Dawei ; Liu, Xinhe ; Hu, Jia

The integration of bioactive micro-nano drug carrier components with rational design of morphological structures is poised to address the therapeutic challenge in anti-tumor immunotherapy focusing on immunogenic cell death (ICD). In this article, based on ATP-adenosine (ADO) axis regulation induced by ellagic acid (EA), the spiky self-assembly (EZ) was tailored with EA and Zn²⁺, and next engineered to construct ATP and pH dual-responsive EZ@MTPP for anti-tumor immune amplification. Following intratumoral injection, the spiky structure of EZ@MTPP enabled efficient local retention, then the ATP-sensitive spines of EZ slowly discharged EA and Zn²⁺ while scavenging ATP. EA silenced the ATP-ADO pathway, lowering immunosuppressive ADO and PD-L1 levels, and Zn²⁺ activated the cyclic guanosine monophosphate-adenosine monophosphate synthase (cGAS) stimulator of interferon genes (STING) signaling pathway cascade and downstream immunity. Concomitantly, acidification of the TME triggered detachment of microwave-induced tumor-derived microparticles loaded with paclitaxel (MTPP) from EZ, which were acquired by neighboring tumor cells to release paclitaxel (PTX) to elicit apoptosis and robust ICD. After coupling the spiky EA-based self-assembly with PTX-loaded MTPP, EZ@MTPP MPs eradicated tumor cells, relieved ADO-mediated immunosuppression and amplified ICD-driven immunity by components and morphological structures co-facilitation, offering an innovative paradigm for metabolism-focused cancer immunotherapy.

8,245

项与紫杉醇相关的新闻（医药）

2026-10-26

·PRNewswire

Mount Sinai Medical Center Physician Leads Global Phase 3 Trial Showing Chemotherapy-Free Treatment Improves Outcomes for Women with dMMR Endometrial Cancer

.release-content span.prnews_span{font-size:8pt;font-family:"Arial";color:black}.release-content a.prnews_a{color:blue}.release-content li.prnews_li{font-size:8pt;font-family:"Arial";color:black}.release-content p.prnews_p{font-size:0.62em;font-family:"Arial";color:black;margin:0in} KEYNOTE-C93/GOG-3064/ENGOT-en15 results presented in the ESMO 2026 Presidential Symposium and published simultaneously in The Lancet MIAMI BEACH, Fla., Oct. 26, 2026 /PRNewswire/ -- Women with advanced or recurrent mismatch repair deficient (dMMR) endometrial cancer who were treated with immunotherapy alone lived longer without their cancer progressing than women treated with chemotherapy, according to results of the global Phase 3 KEYNOTE-C93/GOG-3064/ENGOT-en15 trial presented today at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid. The trial was led by Brian Slomovitz, MD, Director of Gynecologic Oncology and Deputy Director of the Braman Comprehensive Cancer Center at Mount Sinai Medical Center, who served as global principal investigator on behalf of the GOG Foundation. The findings were published simultaneously in The Lancet. The randomized trial enrolled 299 patients and compared pembrolizumab (KEYTRUDA®), Merck's anti-PD-1 therapy, with carboplatin and paclitaxel chemotherapy as first-line treatment, the first therapy patients receive for advanced or recurrent disease. Pembrolizumab reduced the risk of disease progression or death by 43% compared with chemotherapy (hazard ratio 0.57). Overall survival data are still maturing, and follow-up continues. Patients treated with pembrolizumab also reported improved quality of life, with no new safety signals. Women treated at the Braman Comprehensive Cancer Center were among the trial's participants. Endometrial cancer is the most common gynecologic cancer in the United States and one of the few cancers with rising incidence and mortality, according to the American Cancer Society. dMMR tumors make up about 30% of endometrial cancers and are the subtype most responsive to immunotherapy. Pembrolizumab is already part of an established frontline treatment regimen with platinum doublet chemotherapy for patients with primary advanced or recurrent endometrial cancer regardless of mismatch repair status. KEYNOTE-C93 asked whether, for women with dMMR tumors, chemotherapy could be removed entirely. "These results highlight the potential of a chemotherapy-free approach for certain patients with dMMR advanced or recurrent endometrial cancer, with pembrolizumab monotherapy demonstrating a clinically meaningful benefit in progression-free survival along with a favorable quality of life compared to chemotherapy," said Dr. Slomovitz. "After years of platinum-based chemotherapy serving as the frontline standard, these findings could help provide an additional treatment option beyond carboplatin plus paclitaxel in combination with KEYTRUDA for these patients." Dr. Slomovitz serves on the Board of Directors of the GOG Foundation and is Uterine Cancer Lead for GOG Partners. He has served as national or global principal investigator on multiple GOG Partners, National Cancer Institute and Alliance Foundation trials. KEYNOTE-C93 was one of 12 studies selected from across the congress for presentation in the ESMO 2026 Presidential Symposia. "When oncologists from around the world gathered to hear what's next in women's cancer care, they heard it from one of our own," said Gino R. Santorio, President and Chief Executive Officer of Mount Sinai Medical Center. "Dr. Slomovitz's leadership means the women in our community have access to the research shaping cancer care everywhere, close to home." Dr. Slomovitz is available for interviews in Madrid and upon his return. For more information, please visit . KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Keynote C93 (GOG-3064/ENGOT-en15) KEYNOTE-C93 (GOG-3064/ENGOT-en15) is a global, randomized Phase 3 trial sponsored by Merck comparing pembrolizumab with chemotherapy in women with advanced or recurrent dMMR endometrial cancer. The results were published in The Lancet. About Mount Sinai Medical Center Founded in 1949, Mount Sinai Medical Center is the largest independent, private, not-for-profit teaching hospital in South Florida. Mount Sinai's mission is to provide quality health care to a diverse community enhanced through teaching, research, charity care, and financial responsibility. Mount Sinai's Centers of Excellence combine technology, research, and academics to provide innovative and comprehensive care in cardiology, neuroscience, oncology, urology, and orthopedics. One of the original statutory teaching hospitals in the state of Florida, Mount Sinai is the hospital of choice for those who seek the level of expertise and care that only a teaching hospital can offer. Mount Sinai currently offers ten convenient locations in Miami-Dade County, including four emergency centers, and five specialty care offices in Monroe County. SOURCE Mount Sinai Medical Center

临床3期临床结果免疫疗法

2026-10-26

·医脉通

ESMO 2026｜CG-01研究登顶主席论坛：Sone-Ve（CLDN18.2-ADC）突破胃癌2L+生存瓶颈，拓宽晚期胃癌获益边界

引言晚期胃癌患者在一线治疗进展后，仅部分HER2阳性患者有靶向治疗可选，但这一人群占比非常有限；对于临床中占多数的HER2阴性患者，二线及后线（2L+）治疗仍多为化疗，中位总生存期（OS）不足10个月[1-3]。CLDN18.2是继HER2之后胃癌靶向治疗又一经Ⅲ期验证的靶点；但一线治疗的高表达筛选标准仅覆盖约30%的患者，获益人群仍较为有限。在此背景下，Sonesitatug vedotin（Sone-Ve）作为一款CLDN18.2靶向抗体药物偶联物（ADC），通过可裂解连接子将靶向抗体与微管抑制剂MMAE偶联，有望为CLDN18.2阳性患者的2L+治疗提供新的精准选择[4]。在2026年欧洲肿瘤内科学会（ESMO）年会期间，全球Ⅲ期CLARITY-Gastric01（CG-01）研究以突破性摘要（LBA7）形式发布了详细结果，是本届大会胃癌领域唯一入选主席论坛的研究。该全球III期试验证实Sone-Ve在2L+治疗的CLDN18.2过表达（IHC检测≥25%肿瘤细胞膜染色，任意染色强度）晚期胃癌患者中，显示出具有统计学显著性和重要临床意义的OS改善。在2L+治疗的患者中，2L+人群中位OS达到 10.6个月，相比研究者选择治疗组（对照组）提升4个月，死亡风险降低42%；在三线及以上患者中，中位OS实现倍增，由5.0个月延长至10.0个月，死亡风险降低53%。CG-01研究结果证实，Sone-Ve成为全球首个且唯一*在CLDN18.2过表达胃癌2L+治疗中证实OS获益的ADC药物，重新定义了抗CLDN18.2治疗的获益边界，将覆盖人群从约30%扩大至约60%，为CLDN18.2表达≥25%（任意染色强度）的晚期胃癌患者提供新的精准治疗选择[5]。全球视野，严谨求证 CLARITY-Gastric01研究设计 CLARITY-Gastric01（NCT06346392）是一项全球、多中心、随机、开放标签的Ⅲ期研究，旨在评估CLDN18.2靶向ADC Sone-Ve，用于晚期胃癌、胃食管交界部癌或远端食管腺癌2L+治疗的疗效与安全性。研究共入组594例患者。入组患者须在既往接受至少一线含氟嘧啶和铂类的治疗后发生疾病进展，肿瘤细胞CLDN18.2膜染色比例≥25%（任意染色强度）[5]。在剂量选择阶段，患者按1∶1∶1随机接受Sone-Ve 2.2 mg/kg、Sone-Ve 1.8 mg/kg（均每3周静脉给药）或对照组；确定2.2 mg/kg为后续研究剂量后，1.8 mg/kg组停止入组，随机分配改为Sone-Ve 2.2 mg/kg与对照组1∶1。最终三组分别入组267例（Sone-Ve 2.2 mg/kg组）、62例（Sone-Ve 1.8 mg/kg组）和265例（对照组）；正式疗效比较纳入Sone-Ve 2.2 mg/kg组的267例与对照组的265例患者[5]。对照治疗依据治疗线数和地区选择：二线可采用雷莫西尤单抗联合紫杉醇；对雷莫西尤单抗有禁忌者可选择紫杉醇或多西他赛；三线及后线可选择伊立替康、TAS-102（中国以外）或阿帕替尼（仅中国）[5]。研究采用双主要终点设计：双主要终点分别为三线及后线人群OS和总体人群BICR评估无进展生存期（PFS）。关键次要终点为总体人群的OS；其他终点包括三线及后线人群的BICR评估PFS、客观缓解率（ORR）、缓解持续时间及安全性等。研究还预设了按CLDN18.2表达水平及临床特征开展的分析，并通过显著性水平分配与回收程序控制多重检验[5]。图1. CG-01研究设计[5] 生存翻倍，突破边界 CLARITY-Gastric01研究主要结果重磅公布基线特征两组基线特征总体均衡，患者中位年龄均为57岁（范围24～82岁），男性占比分别为56.2%和60.0%；地域分布均衡，日本/韩国约占20%，其他亚洲地区约占40%，世界其他地区约占40%。原发肿瘤部位以胃为主（79.8% vs 73.2%），胃食管交界部/食管癌约占20%～27%。值得注意的是，整体研究人群，特别是Sone-Ve组腹膜转移患者比例较高（61.0% vs 55.8%），提示入组人群肿瘤负荷较重、预后较差。两组CLDN18.2表达分布相似，≥75%肿瘤细胞膜染色的患者占比分别为68.5%和73.2%，≥25%～<75%染色的患者均约占1/3。总体而言，ITT人群的人口学与基线疾病特征在两组间平衡良好，为疗效比较提供了可靠基础[5]。图2. CG-01研究ITT人群基线特征[5] 关键信息总结作为双主要终点之一，三线及后线人群的OS率先交出亮眼答卷：与对照组相比，Sone-Ve组患者生存显著改善，中位OS翻倍，高达10.0个月（vs 5.0个月），死亡风险降低53%（HR 0.47，95%CI 0.36～0.62，P<0.000001）；12个月OS率翻倍有余，高达38.1%（vs 18.1%）。OS曲线自治疗早期即分离并持续保持，提示获益明确而持久[5]。图3. CG-01研究三线及后线人群OS Kaplan-Meier曲线[5] 亚组分析显示所有临床相关亚组的HR点估计均偏向Sone-Ve组，其中腹膜转移（HR 0.31，95%CI 0.22～0.45）和≥3个器官转移（HR 0.40，95%CI 0.25～0.61）等高危人群获益尤为突出[5]。图4. CG-01研究三线及后线人群OS亚组分析森林图[5] 关键次要终点——ITT总体人群（2L及3L+）OS同样达到统计学显著：在Sone-Ve组患者中，中位OS高达10.6个月，较对照组（6.4个月）提升4.2个月，降低42%死亡风险（HR 0.58，95%CI 0.47～0.73，P=0.000004）；两组12个月OS率分别为42.6% vs 27.8%[5]。图5. CG-01研究ITT人群OS Kaplan-Meier曲线[5] 按CLDN18.2表达水平分层，获益保持一致：≥75%高表达亚组中位OS 10.6 vs 6.4个月（HR 0.59，95%CI 0.45～0.78）；≥25%～<75%中低表达亚组10.5 vs 6.2个月（HR 0.63，95%CI 0.42～0.94），提示新阈值（≥25%任意强度）筛选出的患者中低表达者有同等强度获益[5]。图6. CG-01研究ITT人群按CLDN18.2表达水平分层的OS Kaplan-Meier曲线[5] PFS方面，作为双主要终点之一的ITT人群BICR评估PFS为4.2 vs 3.8个月，Sone-Ve组患者的疾病进展或死亡风险降低23%（HR 0.77，95%CI 0.62~0.96，P=0.053），95%置信区间上限<1；作为探索性终点的ITT人群研究者评估PFS为4.4 vs 3.0个月，HR 0.59（95%CI 0.48～0.73）。图7. CG-01研究ITT人群BICR评估与INV评估的PFS Kaplan-Meier曲线[5] 肿瘤缓解与疾病控制方面（ITT人群，两组基线可测量病灶各189例），Sone-Ve组ITT人群的确认ORR为23.3%，明显高于对照组的13.8%；完全缓解（CR）率为3.7%（7例）vs 0.5%（1例）；疾病控制率（DCR）为70.4% vs 55.6%；中位缓解持续时间（DoR）为8.5个月（95%CI 5.8～NC）vs 6.8个月（95%CI 2.9～NC），提示Sone-Ve不仅带来更高的缓解率、CR率和DCR，缓解也更为持久[5]。图8. CG-01研究ITT人群肿瘤缓解与疾病控制情况[5] 总体来看，CG-01以“OS翻倍”的硬核生存获益为核心，辅以一致的亚组获益、更高的缓解率和更长的缓解持续时间，构成了Sone-Ve用于2L+ CLDN18.2过表达晚期胃癌的完整疗效证据链；在双主要终点和关键次要终点中，两个OS终点均达到统计学显著；BICR评估PFS（ITT）提示疾病进展或死亡风险降低23%（HR 0.77，95%CI 0.62～0.96），INV评估的PFS更是达到 4.4 vs 3.0个月，HR 0.59（95%CI 0.48～0.73），与OS获益趋势一致，为生存获益提供了疾病控制层面获益的支持性信息；而三线及后线人群BICR-PFS及研究者评估PFS虽未正式检验，均提示获益[5]。安全性分析总体安全性方面，两组任意级别AE发生率相近，分别为97.3%和94.0%（治疗相关AE：85.8% vs 81.3%），严重AE发生率（34.9% vs 31.3%）、导致停药的AE发生率同样相近（5.0% vs 4.4%）。值得关注的是，Sone-Ve组≥3级AE（52.9% vs 61.1%）、治疗相关≥3级AE（36.4% vs 44.8%）、导致剂量中断/延迟（36.4% vs 40.5%）和减量（21.1% vs 23.0%）的AE等多项发生率均更低[5]。图9. CG-01研究安全性分析集不良事件（AE）[5] 从常见AE谱来看，Sone-Ve组消化道AE更常见，多为低级别，包括恶心、食欲下降、呕吐、便秘等，符合该靶点药物的预期安全性特征。特殊的是，Sone-Ve组血液学毒性较对照组明显更低，主要体现为中性粒细胞相关毒性发生率更低：两组≥3级中性粒细胞减少分别为10.3% vs 25.4%、中性粒细胞计数下降分别为6.9% vs 18.7%[5]。图10. CG-01研究最常见不良事件（AE）对比[5] 总体而言，在暴露时间更长的情况下，Sone-Ve组≥3级AE发生率低于对照组，毒性谱以可管理的低级别消化道反应为主，血液学毒性负担更轻，整体安全性可控，与其作为2L+人群潜在新治疗选择的获益-风险特征相符。亮点聚焦关注研究设计：让关键问题得到可靠回答晚期胃癌的一线治疗不断进步，但一线治疗疾病进展后的治疗选择仍较为有限，延长2L+患者生存仍是重要临床需求。Sone-Ve在早期研究中已显示出抗肿瘤活性，而随全球Ⅲ期CG-01研究结果的发布，Sone-Ve成为全球首个且唯一*在CLDN18.2过表达胃癌2L+治疗中证实OS获益的ADC药物，为任何染色强度下肿瘤细胞膜染色比例≥25%的晚期胃癌患者提供精准诊疗方案[4,5]。 CG-01在19个国家、144个中心纳入594例患者，覆盖二线及更后线治疗，并将入组标准设为至少25%的肿瘤细胞呈任意强度CLDN18.2膜染色，这使研究能够评价更宽表达范围内的治疗价值。在疗效数据的亚组分析中，不同CLDN18.2表达水平的亚组均观察到OS获益，不仅为拓展潜在获益人群提供了积极信号，另一方面也提示CLDN18.2的靶向治疗价值可以结合不同药物形式开展进一步探索[5]。同时，研究设计充分考虑了2L+治疗的复杂性。剂量选择阶段前瞻性比较Sone-Ve 1.8 mg/kg与2.2 mg/kg，为后续确定研究剂量提供依据；对照组则根据治疗线数和地区选择临床常用方案，使研究回答的问题更贴近实际诊疗。终点设置同样有针对性：以三线及后线人群的OS和总体人群经BICR评估的无进展生存期PFS为双主要终点，并将总体人群OS列为关键次要终点。这样的安排既聚焦治疗需求最迫切的人群，也检验获益能否延伸至更广泛的2L+患者[5]。聚焦疗效结果：以生存获益为核心，完整看待证据 CG-01最有分量的结果是OS改善：三线及后线人群的中位OS由5.0个月延长至10.0个月（HR 0.47），实现翻倍；2L+总体人群由6.4个月延长至10.6个月（HR 0.58），两项OS分析均在预设统计框架下达到显著性。对于治疗选择有限的2L+患者，OS直接回答了治疗能否延长生命这一核心问题。Sone-Ve ORR也高于对照组，为其抗肿瘤活性提供了支持。同样值得关注的是，CLDN18.2表达≥75%高表达亚组和≥25%～<75%中低表达亚组均观察到一致且显著的OS获益。这样的疗效价值，将CLDN18.2靶向治疗的惠及患者从染色强度2+/3+肿瘤细胞表达≥75%，拓宽至任何染色强度下肿瘤细胞比例≥25%，覆盖人群从约30%扩大至约60%，实现翻倍。同时另一项主要终点，ITT人群BICR评估的PFS虽未达到统计学显著，但治疗效应方向与同一人群的OS结果一致，为生存获益提供了疾病控制层面的支持性信号。值得关注的是，研究者评估的ITT人群PFS显示出较BICR评估更明显的治疗获益。虽然这一结果属于探索性证据，不能替代BICR评估的主要终点；但在日常诊疗中，疾病进展通常由临床医生判断，因此研究者评估结果仍具有实践参考价值[5]。生存获益还要落实到患者能否持续接受治疗。Sone-Ve组≥3级不良事件发生率为52.9%，对照组为61.1%，在实现OS突破的情况下，Sone-Ve治疗组具有更低的3级及以上不良事件发生率；与此同时，恶心、食欲下降和呕吐在Sone-Ve组常见，而血液毒性较对照组更低[5]。这一特点提示，治疗管理应充分关注胃肠道耐受性及营养状态，通过早期识别、及时对症处理和营养支持，帮助患者维持治疗。展望未来，CG-01为CLDN18.2靶向ADC提供了随机Ⅲ期生存证据；规范检测、明确既往CLDN18.2靶向治疗后的序贯策略，以及探索更早线次的应用，将是把研究结果转化为个体化治疗选择的关键。总结 CG-01研究结果证实，Sone-Ve成为全球首个且唯一*在CLDN18.2阳性胃癌2L+治疗中确证OS获益的ADC药物，且三线及后线人群中位OS实现翻倍；与此同时，研究还将CLDN18.2表达筛选标准拓宽至≥25%肿瘤细胞膜染色阳性（任意染色强度），使获益人群从约30%扩大至约60%，让精准治疗真正惠及更广泛的患者。凭借确证的生存获益与拓展的获益人群，Sone-Ve有望重塑CLDN18.2过表达晚期胃癌的治疗格局，成为未来2L+治疗的新标准治疗，开启全球CLDN18.2靶向治疗的新篇章。参考文献 1. Wilke H, et al. Lancet Oncol. 2014;15(11):1224–1235. 2. Shitara K, et al. Lancet Oncol. 2018;19(11):1437–1448. 3. Van Cutsem E, et al. Gastric Cancer. 2015;18(3):476–484. 4. Ruan DY, et al. Lancet Oncol. 2025;26(2):227–238. 5. Xu RH, et al. ESMO 2026. LBA7. 6. Fuchs CS, et al. J Gastric Cancer. 2017;17(2):132–144. *截至2026年10月26日撰写：Frank 审校：Nico 排版：Zelda 执行：Zelda 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

临床3期抗体药物偶联物临床结果临床成功

2026-10-26

·三生制药

ESMO 2026 |三生制药PD-1/VEGF双特异性抗体SSGJ-707公布联合化疗一线治疗非小细胞肺癌II期临床研究结果

News 2026年10月26日，三生制药(01530.HK)宣布，公司PD-1/VEGF双特异性抗体SSGJ-707 (PF-08634404/SSGJ-707) 一项入选2026年欧洲肿瘤内科学会(ESMO)年会的临床研究获壁报展示。此次会议上公布了SSGJ-707(PF-08634404/SSGJ-707) 的通用名为tivunatamig。三生制药入选2026 ESMO年会的壁报核心信息如下：壁报展示 Phase 2 trial of the PD-1/VEGF bispecific antibody, tivunatamig(PF-08634404/SSGJ-707), plus chemotherapy in advanced NSCLC: updated results PD-1/VEGF双特异性抗体tivunatamig(PF-08634404/SSGJ-707)联合化疗治疗晚期非小细胞肺癌的II期临床研究最新结果摘要编号：2660P 展会形式：壁报展示(Poster Session) 分会场标题：314 Monday Poster Display session 5 报告时间： 2026年10月26日12:00 - 12:45(欧洲中部时间) 2026年10月26日19:00 - 19:45(北京时间) 第一作者：邬麟教授，湖南省肿瘤医院核心要点：这是一项tivunatamig(PF-08634404/SSGJ-707)联合化疗一线治疗晚期非小细胞肺癌的II期临床研究，本次更新长期随访数据。本研究共纳入的261例患者中，122例为非鳞状(nsq) NSCLC，139例为鳞状(sq) NSCLC。有效性：截至2026年8月6日，在nsq-NSCLC中，tivunatamig(PF-08634404/SSGJ-707)10mg/kg Q3W组的cORR为77.5%，替雷利珠组为44.7%，中位PFS分别为13.8和9.7个月。在sq-NSCLC中，tivunatamig(PF-08634404/SSGJ-707)10mg/kg Q3W联合卡铂+紫杉醇组的cORR为80.7%，替雷利珠组为67.7%，中位PFS分别为13.6和8.3个月。安全性： tivunatamig联合铂类化疗治疗的3级TRAE与替雷利珠对照组相当，安全性良好。相比2025SITC公布的数据，本次ESMO报告中tivunatamig(PF-08634404/SSGJ-707)整体ORR较前表现更优，显示出tivunatamig优异的临床响应率和可控的安全性。目前，tivunatamig(PF-08634404/SSGJ-707)多项全球关键III期研究正在进行中。关于PF-08634404/SSGJ-707(tivunatamig) PF-08634404/SSGJ-707(tivunatamig)是三生制药基于CLF2专利平台开发的靶向PD-1/VEGF双特异性抗体，可同时抑制PD-1和VEGF双靶点。2025年5月和7月，三生制药(01530.HK)及附属子公司沈阳三生、三生国健与辉瑞签署协议，独家授予辉瑞SSGJ-707在中国以外市场的开发、生产、商业化权利，以及中国市场的选择权；三生制药成为SSGJ-707在中国内地的首选药品生产商，并保留中美以外地区供应SSGJ-707的药品的权利。关于三生制药三生制药（股票代码：01530.HK）是一家集研发、生产和销售为一体的生物制药领军企业，致力于以高品质的药品提高患者生存质量，为人类健康造福。目前，公司拥有近200项国家发明专利授权，近40种上市产品，25种在研产品，覆盖肾科、血液肿瘤、自身免疫性疾病、眼科及皮肤减重等多种治疗领域。公司拥有抗体药物国家工程研究中心以及生物药和化药双平台的6大研发基地，4大生产基地及4大CDMO基地。未来，三生制药将继续秉持“珍爱生命、关注生存、创造生活”的理念，全力打造全球领先的中国生物制药企业。请访问www.3sbio.com获取更多信息。 About 3S Bio 警示说明及前瞻性陈述本新闻稿包含前瞻性陈述，例如涉及业务和产品前景,或公司的意图、计划、认知、预期及策略。该等前瞻性陈述是根据本公司现有的资料，并按本新闻稿发布时的展望陈述。该等前瞻性陈述基于若干预测、假设及前提，其中一些是主观性的或不受我们控制。该等前瞻性陈述可能被证明是不正确的，或将来可能无法实现。就任何新产品或产品的新适应症, 我们无法确保其将能成功开发或最终上市销售。该等前瞻性陈述受各种风险及不明朗因素影响。我们的其他公开披露文件可能提供该等风险及不明朗因素的更多信息。所涉及之科学信息可能只是初步的和研究性的。本公司股东及潜在投资者在买卖本公司股份时，请务必谨慎行事。

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适应症	国家/地区	公司	日期
转移性HER2阴性乳腺癌	中国	DAE HWA PHARM Co., Ltd.	2026-09-29
复发性HER2阴性乳腺癌	中国	DAE HWA PHARM Co., Ltd.	2026-09-29
晚期胃癌	中国	DAE HWA PHARM Co., Ltd.	2024-09-19
晚期胃癌	中国	上海海和药物研究开发股份有限公司	2024-09-19
转移性胰腺腺癌	欧盟	Accord Healthcare SL	2024-01-05
转移性胰腺腺癌	冰岛	Accord Healthcare SL	2024-01-05
转移性胰腺腺癌	列支敦士登	Accord Healthcare SL	2024-01-05
转移性胰腺腺癌	挪威	Accord Healthcare SL	2024-01-05
铂类耐药性原发性腹膜癌	欧盟	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	冰岛	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	列支敦士登	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	挪威	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	欧盟	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	冰岛	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	列支敦士登	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	挪威	Inceptua SA	2018-11-20
铂敏感性输卵管癌	欧盟	Inceptua SA	2018-11-20
铂敏感性输卵管癌	冰岛	Inceptua SA	2018-11-20
铂敏感性输卵管癌	列支敦士登	Inceptua SA	2018-11-20
铂敏感性输卵管癌	挪威	Inceptua SA	2018-11-20

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适应症	最高研发状态	国家/地区	公司	日期
胰腺癌	申请上市	欧盟	Accord Healthcare SL	2023-11-09
转移性胰腺癌	临床3期	中国	上海谊众药业股份有限公司	2025-01-21
高级别胶质瘤	临床3期	中国	浙江大学	2024-04-01
HEGF2阴性乳腺癌	临床3期	中国	上海谊众药业股份有限公司	2023-09-25
皮肤鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
下咽癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
转移性头颈部鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
下咽部鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
喉鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
口腔鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08

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临床结果

适应症

分期

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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


NCT05002127 (ASPEN-06, Pubmed \| Nat Med)	临床2/3期	HER2阳性胃癌 HER2-positive	127	Evorpacept plus Trastuzumab, Ramucirumab, and Paclitaxel	製蓋願構夢衊餘範簾壓(夢願窪構衊憲範糧簾遞) = 齋選鏇憲醖艱獵鹽遞憲鬱夢膚壓齋壓糧壓壓壓 (獵餘壓遞鏇繭範獵衊壓 ) 更多	积极	2026-09-24
NCT05002127 (ASPEN-06, Pubmed \| Nat Med)	临床2/3期	HER2阳性胃癌 HER2-positive	127	Trastuzumab, Ramucirumab, and Paclitaxel	製蓋願構夢衊餘範簾壓(夢願窪構衊憲範糧簾遞) = 憲選壓鑰艱壓蓋憲艱遞鬱夢膚壓齋壓糧壓壓壓 (獵餘壓遞鏇繭範獵衊壓 ) 更多	积极	2026-09-24
CSCO2026	N/A	非精原细胞生殖细胞肿瘤	64	High Dose Chemotherapy (HDCT) + Peripheral Blood Stem Cell Transplantation (PBSCT)	廠醖範蓋鏇築壓築艱窪(鏇醖簾構構齋壓網餘構) = 廠窪範齋廠簾膚廠網鬱膚鹹選齋積餘蓋獵餘顧 (餘選膚選願範製鹹憲積 ) 更多	积极	2026-09-11
NCT02905591 (XACT-LUNG, CTgov)	临床2期	非小细胞肺癌	43	Radiation therapy+Ascorbic Acid+Carboplatin+Paclitaxel	網積顧鬱壓鏇壓獵構夢 = 鹽積鑰網遞積製衊鹽衊構襯鹹廠簾鬱遞膚艱醖 (廠淵齋醖積夢艱選壓鹽, 願選壓襯餘膚鏇鑰築蓋 ~ 網餘網醖淵糧憲鏇顧繭) 更多	-	2026-07-31
NCT04776447 (APOLLO \| APOLO, CTgov)	临床2期	可切除非小细胞肺癌 \| 非小细胞肺癌IIIA期 \| 支气管癌 ... 更多	38	Carboplatin+Placlitaxel+Atezolizumab	餘獵顧積鑰顧獵鹹網網 = 網網獵繭鹹範簾衊餘憲窪製鏇醖憲簾繭齋繭壓 (鬱遞壓鹽網簾鬱鹽願膚, 繭願廠衊憲繭願廠糧範 ~ 鹽網糧鹽壓糧淵襯夢選) 更多	-	2026-07-22
NCT04527900 (CTgov)	临床2期	晚期子宫内膜癌	2	pelvic IMPT (Intensity Modulated Proton Therapy)+carboplatin+paclitaxel	選鏇願憲築築糧構積醖 = 願選艱鬱積鑰鏇獵餘餘簾衊鑰積艱醖鑰顧選憲 (築襯觸範艱淵獵餘遞襯, 鏇蓋膚艱觸築鬱蓋壓選 ~ 淵網簾鬱築鹹遞醖鬱製) 更多	-	2026-07-08
NCT05519241 (Pubmed \| Nanomedicine (Lond))	临床1期	非肌层浸润性膀胱肿瘤	3	PLZ4-coated paclitaxel-loaded micelles (PPM)	鹹製襯糧艱獵繭鑰鑰願(遞廠齋醖夢淵齋網艱襯) = No drug-related adverse event was observed 鬱獵鑰醖醖鑰製獵窪網 (蓋鹹顧簾蓋顧艱襯顧淵 )	积极	2026-07-03
NCT04929392 (CTgov)	临床2期	食管腺癌 \| 胃食管交界处癌 \| 食管鳞状细胞癌 ... 更多	3	External Beam Radiation Therapy+Carboplatin+Paclitaxel+Pembrolizumab+Lenvatinib Mesylate	餘選鏇顧積鬱壓廠襯糧 = 積構醖網窪襯醖鹹憲淵積鹽鹽顧膚選蓋獵鑰醖 (襯窪築蓋積膚積憲憲繭, 鹹鹽壓壓築醖繭獵鑰獵 ~ 願積築積構獵餘簾選觸) 更多	-	2026-06-23
ASCO2026	N/A	肛门鳞状细胞癌一线	54	Q3-week carboplatin-paclitaxel	構糧製積鑰壓餘積網憲(膚窪網鏇艱艱製夢觸鏇) = 築範遞鬱衊鏇壓繭膚齋夢鬱壓淵鹹糧蓋願淵鹽 (鑰蓋觸築範獵膚壓構遞, 15.7 ~ NR) 更多	积极	2026-05-29
ASCO2026	N/A	肛门鳞状细胞癌一线	54	Standard (d1,8,15 Q28-day cycle) carboplatin-paclitaxel	構糧製積鑰壓餘積網憲(膚窪網鏇艱艱製夢觸鏇) = 窪製鹹願膚觸糧構築廠夢鬱壓淵鹹糧蓋願淵鹽 (鑰蓋觸築範獵膚壓構遞, 11.2 ~ NR) 更多	积极	2026-05-29
NCT06332092 (FID-007-003, ASCO2026)	临床2期	头颈部鳞状细胞癌	45	FID-007 75 mg/m2	窪顧夢蓋獵衊選構壓繭(網觸襯鑰構糧鬱膚鏇鹹) = 築製糧鏇襯夢鹽廠憲衊艱糧艱蓋遞遞淵齋製遞 (網糧顧鹽廠構廠餘餘鹹 ) 更多	积极	2026-05-29
NCT06332092 (FID-007-003, ASCO2026)	临床2期	头颈部鳞状细胞癌	45	FID-007 125 mg/m2	窪顧夢蓋獵衊選構壓繭(網觸襯鑰構糧鬱膚鏇鹹) = 窪觸夢網膚網觸鏇範醖艱糧艱蓋遞遞淵齋製遞 (網糧顧鹽廠構廠餘餘鹹 ) 更多	积极	2026-05-29
NCT04090398 (ETCTN 10302, ASCO2026)	临床2期	转移性乳腺癌 HER2-negative	70	Radium-223 dichloride + Paclitaxel	淵鑰繭糧醖襯鑰簾憲壓(醖築繭選淵鹽夢鬱顧淵) = 窪獵襯遞願鹽糧觸蓋鬱獵淵衊糧鹹範膚網艱範 (獵顧製遞鬱遞願窪醖窪 ) 更多	不佳	2026-05-29
NCT04090398 (ETCTN 10302, ASCO2026)	临床2期	转移性乳腺癌 HER2-negative	70	Paclitaxel	淵鑰繭糧醖襯鑰簾憲壓(醖築繭選淵鹽夢鬱顧淵) = 廠簾簾鹽鹽網觸範選範獵淵衊糧鹹範膚網艱範 (獵顧製遞鬱遞願窪醖窪 ) 更多	不佳	2026-05-29