An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates

The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.

开始日期2025-05-01

申办/合作机构

迈威（上海）生物科技股份有限公司

NCT06926998

/ Not yet recruiting临床1/2期

An Open-Label, Multicenter Phase Ib/ll Clinical Study Evaluating the Safety and Efficacy of 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors

To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.

开始日期2025-04-15

申办/合作机构

迈威（上海）生物科技股份有限公司

NCT06947226

/ Not yet recruiting临床1/2期

A Phase Ib/ll Clinical Study of Safety and Efficacy of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.

开始日期2025-04-01

申办/合作机构

迈威（上海）生物科技股份有限公司

100 项与 Bulumtatug fuvedotin 相关的临床结果

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100 项与 Bulumtatug fuvedotin 相关的转化医学

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100 项与 Bulumtatug fuvedotin 相关的专利（医药）

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563

项与 Bulumtatug fuvedotin 相关的文献（医药）

2025-04-01·BIOORGANIC & MEDICINAL CHEMISTRY

Fine-tuning phenoxy silyl scaffolds for the development of glutathione-responsive prodrugs and antibody–drug conjugates

Article

作者: Qi, Cheng ; Jiang, Yuecheng ; Yu, Xianqiang ; Chen, Hongli ; Wei, Ding ; Wang, Huihui ; Huangfu, Shangwei ; Jiang, Biao

Silyl ether is particularly attractive for application in drug development for its easy preparation, non-toxicity and remarkable biocompatibility. Earlier studies relied on the use of intracellular acidic conditions to induce the cleavage of alkoxy silyl ethers. However, acidic conditions are not suitable to trigger the release of phenoxy silyl ethers, since they are more stable under acidic conditions compared with neutral conditions. We explored the vulnerability of the phenoxy silyl ether towards biological nucleophilic reagents and found that glutathione (GSH) could effectively and selectively induce the cleavage of phenoxy silyl ether. We also demonstrated that the rate of cleavage was controllable by adjusting the substituents on the phenyl ring. Phenoxy silyl ether-based prodrugs and antibody-drug conjugates (ADCs) were designed and synthesized, which could be effectively activated in cells with high GSH levels and there was an obvious therapeutic window between cells with different GSH levels.

2025-02-19·BIOCONJUGATE CHEMISTRY

A Unique Prodrug Targeting the Prostate-Specific Membrane Antigen for the Delivery of Monomethyl Auristatin E

Article

作者: Bomba, Hunter N. ; Langton-Webster, Beatrice ; Fulton, Melody D. ; Berkman, Clifford E. ; Savoy, Emily A.

Monomethyl auristatin E (MMAE) is a promising treatment option for patients diagnosed with prostate cancer (PCa); however, toxicities prevent MMAE from being administered as free drug. No MMAE-based treatment is currently marketed for PCa. Herein, we describe a small-molecule-drug conjugate, CTT2274, for the selective delivery of MMAE. CTT2274 is composed of a prostate-specific membrane antigen (PSMA)-binding scaffold, a biphenyl motif, a pH-sensitive phosphoramidate linker, and MMAE payload. We demonstrate that CTT2274 shows selective binding to PSMA, which is overexpressed on PCa cells, and induces tumor cell death in vitro. In a patient-derived xenograft tumor model of PCa in mice, we show that weekly intravenous dosing of CTT2274 at 3.6 mg/kg for six weeks is superior to treatment with free MMAE at equivalent doses. Mice treated with CTT2274 experienced prolonged tumor suppression and significantly greater overall survival than mice treated with PBS. Additionally, the safety of CTT2274 compared to an equivalent dose of MMAE was assessed in healthy, non-tumor-bearing mice. Our results demonstrate that CTT2274 therapy is as efficacious as MMAE, results in superior overall survival, and has a more favorable safety profile. Together, these data indicate that CTT2274 is a candidate for clinical translation for the treatment of PCa.

2025-02-18·ACS Nano

Nanobody-Mediated Cellular Uptake Maximizes the Potency of Polylysine Dendrimers While Preserving Solid Tumor Penetration

Article

作者: Fletcher, Nicholas L. ; Humphries, James ; Yuen, Daniel ; Hufton, Richard ; Porter, Christopher J.H. ; Johnston, Angus P.R. ; Feeney, Orlagh M. ; Houston, Zachary H ; McLeod, Victoria M. ; Thurecht, Kristofer J. ; Owen, David J. ; Tsegay, Sammi ; Shengule, Sudhir ; Cullinane, Carleen ; Reitano, Pauline ; Noi, Leo

Dendrimers are branched macromolecular structures that are useful nanocarriers for small-molecule drugs, such as cancer therapeutics. Their small size permits penetration into solid tumors, coupled with functionalization with a low-fouling PEG coating that minimizes transient cellular interactions and enhances plasma circulation time. While PEGylated dendrimers show significant promise as anticancer therapeutics, there is potential to increase tumor cell specificity and drive uptake of drugs into cells by conjugating cell-targeting ligands onto the dendrimers. To achieve this, we used an expanded genetic code and bio-orthogonal click chemistry to functionalize monomethyl auristatin E (MMAE)-loaded PEGylated dendrimers with a single tumor cell-targeting nanobody per dendrimer. The uniform addition of a single nanobody ligand facilitated greater intracellular uptake of the drug payload into HER2-positive target cells, while preserving the desirable circulatory characteristics of dendrimers. While the nanobody-dendrimer conjugates show similar levels of tumor infiltration over 24 h compared to unmodified dendrimers, the targeted dendrimers had significantly greater inhibition of tumor growth and long-term retention in the tumors. Our results highlight that biodistribution studies alone are poor predictors of therapeutic performance. The controlled conjugation strategy presented here preserves the size advantage and tissue penetration of dendrimers while maximizing targeted cellular uptake and potency in difficult-to-access solid tumor tissue.

108

项与 Bulumtatug fuvedotin 相关的新闻（医药）

2025-04-26

·肿瘤界

2025 ASCO | 74项中国研究亮相ASCO口头报告，这波“研”值拉满啦！

点击蓝字关注我们前言作为肿瘤学领域的国际盛会，ASCO年会每年都吸引着来自世界各地的顶尖学者、临床专家与科研团队，共同分享最新研究成果、探讨创新疗法、展望未来趋势。随着2025年ASCO年会完整日程的正式公布，全球肿瘤学界的目光再次聚焦于此。在这场学术盛宴中，中国研究者交出了一份令人瞩目的成绩单。数据显示，有34项中国研究入选口头报告，32项中国研究入选快速口头报告，8项中国研究入选临床科学研讨会，从基础研究到临床转化，从精准医疗到免疫治疗，全方位展现了中国肿瘤学研究的深度与广度。汇总如下，让我们先睹为快！肺癌01摘要号：LBA8004报告类型：Oral Abstract Session研究名称（英文）：R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy.研究名称（中文）：R-ALPS研究：贝莫苏拜单抗（TQB2450）联合或不联合安罗替尼维持治疗经同步或序贯放化疗后无进展的局部晚期不可切除（III期）NSCLC患者的随机、双盲、安慰剂对照、多中心III期临床试验讲者：陈明中山大学肿瘤防治中心02摘要号：8007报告类型：Oral Abstract Session研究名称（英文）：A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer.研究名称（中文）：ZG006（一种靶向CD3/DLL3/DLL3的三特异性T细胞接合器）单药治疗晚期小细胞肺癌（SCLC）的II期剂量扩展研究讲者：艾星浩上海交通大学医学院附属胸科医院03摘要号：8012报告类型：Rapid Oral Abstract Session研究名称（英文）：The preliminary results of a randomized phase II trial evaluating induction toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab in bulky unresectable stage III non-small-cell lung cancer (InTRist).研究名称（中文）：一项评估特瑞普利单抗联合诱导化疗，随后同步放化疗及特瑞普利单抗巩固治疗用于巨大不可切除的Ⅲ期NSCLC的随机II期试验的初步结果讲者：Yu Wang 中国医学科学院肿瘤医院04摘要号：8017报告类型：Rapid Oral Abstract Session研究名称（英文）：Integrin αVβ3-targeted imaging for identification of lung cancer and mapping of lymph-node metastases: A prospective, multicenter, self-controlled phase 3 trial (TRIIL study).研究名称（中文）：靶向整合素αVβ3的成像用于肺癌的识别和淋巴结转移的定位：一项前瞻性、多中心、自身对照的III期试验（TRIIL研究）讲者：Rongxi Wang 北京协和医院05摘要号：LBA8502报告类型：Oral Abstract Session研究名称（英文）：CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC): A randomized, single-blind, multicenter phase 3 study.研究名称（中文）：CAMPASS研究：贝莫苏拜单抗联合安罗替尼对比帕博利珠单抗一线治疗晚期NSCLC：一项随机、单盲、多中心III期研究讲者：韩宝惠上海交通大学医学院附属胸科医院06摘要号：8504报告类型：Oral Abstract Session研究名称（英文）：SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease.研究名称（中文）：SOHO-01研究：BAY 2927088治疗既往接受过治疗但未接受HER2靶向治疗或未接受过任何治疗的晚期HER2突变NSCLC患者的疗效和安全性研究讲者：Herbert H. Loong 香港中文大学07摘要号：LBA8505报告类型：Oral Abstract Session研究名称（英文）：Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.研究名称（中文）：赛沃替尼联合奥希替尼对比化疗治疗EGFR-TKI治疗进展后EGFR突变伴MET扩增的晚期NSCLC：来自III期随机SACHI研究结果讲者：陆舜上海交通大学医学院附属胸科医院08摘要号：8506报告类型：Oral Abstract Session研究名称（英文）：Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) after a third-generation EGFR TKI: The phase 3 HERTHENA-Lung02 study.研究名称（中文）：Patritumab-deruxtecan（HER3-DXd）治疗第三代EGFR-TKI治疗后耐药的EGFR突变晚期NSCLC：III期HERTHENA-Lung02研究讲者：莫树锦香港中文大学09摘要号：8507报告类型：Oral Abstract Session研究名称（英文）：Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.研究名称（中文）：芦康沙妥珠单抗（sac-TMT）治疗既往接受过治疗的晚期EGFR突变NSCLC：来自OptiTROP-Lung03随机研究的结果讲者：张力中山大学肿瘤防治中心10摘要号：8509报告类型：Clinical Science Symposium研究名称（英文）：First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC).研究名称（中文）：首创新药PD-1/IL-2双特异性抗体IBI363治疗经免疫治疗的晚期NSCLC患者讲者：周建娅浙江大学医学院附属第一医院11摘要号：8511报告类型：Clinical Science Symposium研究名称（英文）：First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma.研究名称（中文）：首个评估BNT327/PM8002联合化疗作为不可切除恶性胸膜间皮瘤一线治疗的II期试验的疗效及安全性结果报告讲者：程颖吉林省肿瘤医院12摘要号：8514报告类型：Rapid Oral Abstract Session研究名称（英文）：Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).研究名称（中文）：贝莫苏拜单抗联合化疗，随后序贯联合安罗替尼一线治疗局部晚期或转移性鳞状NSCLC的III期研究讲者：石远凯中国医学科学院肿瘤医院13摘要号：8516报告类型：Rapid Oral Abstract Session研究名称（英文）：Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.研究名称（中文）：NSCLC患者免疫化疗时间与无进展生存期及总生存期相关性的随机试验讲者：张永昌湖南省肿瘤医院14摘要号：8517报告类型：Rapid Oral Abstract Session研究名称（英文）：Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial.研究名称（中文）：缺氧反应型CEA CAR-T细胞疗法治疗复发或难治性NSCLC：一项单臂、开放标签、I期试验讲者：魏双华中科技大学同济医学院附属同济医院15摘要号：8520报告类型：Rapid Oral Abstract Session研究名称（英文）：Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study.研究名称（中文）：Sosimerasib单药治疗KRAS G12C突变NSCLC：II期研究的主要结果讲者：王洁中国医学科学院肿瘤医院乳腺癌01摘要号：LBA500报告类型：Oral Abstract Session研究名称（英文）：De-escalated neoadjuvant taxane plus trastuzumab and pertuzumab with or without carboplatin in HER2-positive early breast cancer (neoCARHP): A multicentre, open-label, randomised, phase 3 trial.研究名称（中文）：多中心、开放标签、随机、III期neoCARHP研究：紫杉类联合曲妥珠单抗和帕妥珠单抗联合或不联合卡铂降阶梯治疗HER2阳性早期乳腺癌讲者：王坤广东省人民医院02摘要号：515报告类型：Rapid Oral Abstract Session研究名称（英文）：Dalpiciclib (Dalp) plus endocrine therapy (ET) as adjuvant treatment for HR+/HER2– early breast cancer (BC): The randomized, phase 3, DAWNA-A trial.研究名称（中文）：随机、III期DAWNA-A研究：达尔西利（Dalp）联合内分泌治疗（ET）辅助治疗HR+/HER2 -早期乳腺癌（BC）讲者：邵志敏复旦大学附属肿瘤医院03摘要号：1017报告类型：Rapid Oral Abstract Session研究名称（英文）：HER2-ADC trastuzumab rezetecan (SHR-A1811) in HER2-positive breast cancer with brain metastases: Update results from REIN trial.研究名称（中文）：REIN研究最新结果：HER2-ADC瑞康曲妥珠单抗（SHR-A1811）治疗伴脑转移的HER2阳性乳腺癌讲者：闫敏河南省肿瘤医院04摘要号：1018报告类型：Rapid Oral Abstract Session研究名称（英文）：A phase II clinical study of adebrelimab and bevacizumab combined with cisplatin/carboplatin in triple-negative breast cancer patients with brain metastases.研究名称（中文）：阿得贝利单抗和贝伐珠单抗联合顺铂/卡铂治疗三阴性乳腺癌脑转移患者的II期临床研究讲者：李婷复旦大学附属肿瘤医院05摘要号：1019报告类型：Rapid Oral Abstract Session研究名称（英文）：Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from the phase II OptiTROP-Breast05 study.研究名称（中文）：II期OptiTROP-Breast05研究初步结果：芦康沙妥珠单抗（sac-TMT）一线治疗不可切除的局部晚期/转移性三阴性乳腺癌（a/mTNBC）讲者：殷咏梅江苏省人民医院胃肠道肿瘤01摘要号：LBA3502报告类型：Oral Abstract Session研究名称（英文）：Anlotinib versus bevacizumab added to standard first-line chemotherapy among patients with RAS/BRAF wild-type, unresectable metastatic colorectal cancer: A multicenter, prospective, randomised, phase 3 clinical trial (ANCHOR trial).研究名称（中文）：安罗替尼对比贝伐珠单抗联合一线标准化疗应用于RAS/BRAF野生型、不可切除的转移性结直肠癌：一项多中心、前瞻性、随机、III期临床试验（ANCHOR）讲者：丁克峰浙江大学医学院附属第二医院02摘要号：LBA3516报告类型：Rapid Oral Abstract Session研究名称（英文）：JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC): Results of a randomized, controlled, open-label, phase II study.研究名称（中文）：JMT101联合伊立替康和SG001对比瑞戈非尼治疗转移性结直肠腺癌：一项随机、对照、开放标签、II期研究的结果讲者：许剑民复旦大学附属中山医院03摘要号：3519报告类型：Rapid Oral Abstract Session研究名称（英文）：Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01).研究名称（中文）：短程放疗序贯信迪利单抗联合CAPOX作为局部晚期直肠癌患者的全程新辅助治疗：一项前瞻性、随机、对照试验（SPRING-01）讲者：靖昌庆山东第一医科大学附属省立医院04摘要号：4003报告类型：Oral Abstract Session研究名称（英文）：Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01).研究名称（中文）：Claudin18.2特异性CAR T细胞（Satri-cel）对比医生选择的治疗方案应用于既往接受过治疗的晚期GC/GEJC患者：随机、开放标签、II期CT041-ST-01试验的主要结果讲者：齐长松北京大学肿瘤医院05摘要号：4010报告类型：Clinical Science Symposium研究名称（英文）：Efficacy and safety of cafelkibart (LM-108), an anti-CCR8 monoclonal antibody, in combination with anti-PD-1 therapy in patients with pancreatic cancer: Results from phase 1/2 studies研究名称（中文）：抗 CCR8 单克隆抗体 cafelkibart (LM-108) 与抗 PD-1 疗法联合治疗胰腺癌患者的疗效和安全性：I/II期研究结果讲者：龚继芳北京大学肿瘤医院06摘要号：LBA4012报告类型：Rapid Oral Abstract Session研究名称（英文）：Disitamab vedotin (DV) plus toripalimab (Tor) and chemotherapy (C)/trastuzumab (Tra) as first-line (1L) treatment of patients (pts) with HER2-expressing locally advanced or metastatic (la/m) gastric cancer.研究名称（中文）：维迪西妥单抗联合特瑞普利单抗和化疗/曲妥珠单抗作为局部晚期或转移性HER2表达胃癌患者的一线（1L）治疗讲者：沈琳北京大学肿瘤医院07摘要号：4015报告类型：Rapid Oral Abstract Session研究名称（英文）：Decoding the response and resistant features to the Claudin18.2-specific CAR-T cell CT041 in gastric cancer: A multi-omics exploratory biomarker analysis of the phase 1 clinical trial.研究名称（中文）：揭秘胃癌中Claudin18.2特异性CAR-T细胞CT041的应答和耐药性特征：I期临床试验的多组学探索性生物标志物分析讲者：彭昊昕北京大学肿瘤医院08摘要号：4016报告类型：Rapid Oral Abstract Session研究名称（英文）：Cosiporfin sodium (DVDMS)-mediated photodynamic therapy (PDT) versus treatment of physician's choice (TPC) in patients (pts) with advanced esophageal cancer (aEC): A phase III, randomized, open-label, multicenter trial.研究名称（中文）：华卟啉钠介导的光动力疗法（PDT）对比医师选择治疗（TPC）治疗晚期食管癌患者：一项III期、随机、开放标签、多中心试验讲者：周军北京大学肿瘤医院09摘要号：4017报告类型：Rapid Oral Abstract Session研究名称（英文）：Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): Results from a phase I dose expansion cohort evaluating IBI343.研究名称（中文）：Claudin18.2在胰腺导管腺癌中的表达和疗效：来自评估IBI343的I期研究剂量扩展队列的结果讲者：虞先濬复旦大学附属肿瘤医院头颈肿瘤01摘要号：LBA6003报告类型：Oral Abstract Session研究名称（英文）：PD-1 blockade with toripalimab incorporated into induction chemotherapy and radiotherapy with or without concurrent cisplatin in locoregionally advanced nasopharyngeal carcinoma (DIAMOND): A multicenter, non-inferiority, phase 3, randomized controlled trial.研究名称（中文）：特瑞普利单抗联合诱导化疗和放疗，含或不含同步顺铂治疗局部晚期鼻咽癌：一项多中心、非劣效性、III期、随机对照试验（DIAMOND）讲者：马骏中山大学肿瘤防治中心02摘要号：6004报告类型：Oral Abstract Session研究名称（英文）：Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study.研究名称（中文）：Tagitanlimab对比安慰剂联合吉西他滨和顺铂作为复发或转移性鼻咽癌（R/M NPC）的一线治疗：来自一项随机、双盲、III期研究的结果讲者：石远凯中国医学科学院肿瘤医院03摘要号：LBA6005报告类型：Oral Abstract Session研究名称（英文）：Becotatug vedotin vs. chemotherapy in pre-heavily treated advanced nasopharyngeal carcinoma: A randomized, controlled, multicenter, open-label study.研究名称（中文）：Becotatug vedotin 与化疗在既往重度治疗晚期鼻咽癌中的对比：一项随机、对照、多中心、开放标签研究讲者：韩非中山大学肿瘤防治中心04摘要号：6006报告类型：Oral Abstract Session研究名称（英文）：SHR-A1811 in HER2-expressing salivary gland cancers: Preliminary efficacy and safety results.研究名称（中文）：SHR-A1811 在表达 HER2 的唾液腺癌中的疗效和安全性结果讲者：季冬梅复旦大学附属肿瘤医院05摘要号：6014报告类型：Rapid Oral Abstract Session研究名称（英文）：A randomized, open-label, multicenter, blank-controlled, phase IV clinical trial of Biyan Qingdu Granula in attenuating acute nose and oral damage in patients undergoing radiotherapy for nasopharyngeal carcinoma.研究名称（中文）：鼻咽清毒颗粒减轻鼻咽癌放疗患者急性鼻腔和口腔损伤的随机、开放标签、多中心、空白对照、IV 期临床试验讲者：刘志刚南方医科大学第十附属医院（东莞市人民医院）06摘要号：6018报告类型：Rapid Oral Abstract Session研究名称（英文）：Neoadjuvant PD-1 inhibitor combined with Nab-paclitaxel and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NCT05522985): A randomized, controlled, open label, phase II clinical trial.研究名称（中文）：新辅助 PD-1 抑制剂联合白蛋白结合型紫杉醇和顺铂治疗可切除的局部晚期头颈部鳞状细胞癌（NCT05522985）：一项随机、对照、开放标签、II 期临床试验讲者：王红玲天津医科大学肿瘤医院07摘要号：6010报告类型：Clinical Science Symposium研究名称（英文）：Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in nasopharyngeal carcinoma: The EP-STAR trial.研究名称（中文）：动态循环肿瘤DNA驱动的风险适应性系统治疗在鼻咽癌中的应用：EP-STAR试验讲者：孙颖中山大学肿瘤防治中心08摘要号：6011报告类型：Clinical Science Symposium研究名称（英文）：REMATCH201:A phase l study on reducing surgical margins in HPv-negative advanced HNscc with neoadjuvant PD-1 inhibitor and AP chemotherapy.研究名称（中文）：REMATCH2201研究：新辅助PD-1抑制剂联合AP方案化疗用于HPV阴性晚期头颈部鳞癌以缩小手术切缘的I期临床试验讲者：杨坤禹华中科技大学同济医学院附属协和医院妇科肿瘤01摘要号：LBA5501报告类型：Oral Abstract Session研究名称（英文）：Sentinel lymph node biopsy versus pelvic lymphadenectomy in cervical cancer: The PHENIX trial.研究名称（中文）：PHENIX研究：宫颈癌前哨淋巴结活检与盆腔淋巴结切除术的比较讲者：刘继红中山大学肿瘤防治中心02摘要号：5508报告类型：Oral Abstract Session研究名称（英文）：Benmelstobart plus carboplatin/paclitaxel with or without anlotinib, followed by maintenance benmelstobart with or without anlotinib, as first-line treatment for advanced or recurrent endometrial cancer: A randomized, open-label, phase II trial.研究名称（中文）：贝莫苏拜单抗联合卡铂/紫杉醇，联合或不联合安罗替尼，序贯贝莫苏拜单抗联合或不联合安罗替尼维持治疗作为晚期或复发性子宫内膜癌的一线治疗：随机、开放标签、II期研究讲者：陈晓军同济大学附属第十人民医院03摘要号：5509报告类型：Rapid Oral Abstract Session研究名称（英文）：Cadonilimab plus platinum-based chemotherapy ± bevacizumab for persistent, recurrent, or metastatic cervical cancer: Subgroup analyses of COMPASSION-16.研究名称（中文）：COMPASSION-16研究亚组分析：卡度尼利单抗和铂类化疗联合或不联合贝伐珠单抗治疗持续性、复发性或转移性宫颈癌讲者：吴小华复旦大学附属肿瘤医院04摘要号：5510报告类型：Rapid Oral Abstract Session研究名称（英文）：Nimotuzumab combined with chemotherapy in the first-line treatment for patients with stage IVB, recurrent or persistent cervical squamous cell carcinoma: A multi-center, randomized, double-blind, and controlled study.研究名称（中文）：尼妥珠单抗联合化疗一线治疗IVB期复发或持续性宫颈鳞状细胞癌——一项多中心、随机、双盲、对照研究讲者：Zexuan Liu 中国医学科学院肿瘤医院05摘要号：5517报告类型：Rapid Oral Abstract Session研究名称（英文）：Safety and efficacy of BAT8006, a folate receptor α (FRα) antibody drug conjugate, in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial.研究名称（中文）：BAT-8006-001-CR研究剂量优化/扩展队列的更新：叶酸受体α (FRα)抗体药物偶联物BAT8006用于铂类耐药卵巢癌患者的安全性和疗效讲者：张松灵吉林大学第一医院肉瘤01摘要号：11500报告类型：Oral Abstract Session研究名称（英文）：Pimicotinib in tenosynovial giant cell tumor (TGCT): Efficacy, safety and patient-reported outcomes of phase 3 MANEUVER study.研究名称（中文）：Pimicotinib治疗腱鞘巨细胞瘤 (TGCT) ：III期 MANEUVER 研究的疗效、安全性和患者报告结果讲者：牛晓辉北京积水潭医院02摘要号：11501报告类型：Oral Abstract Session研究名称（英文）：Anlotinib in combination with epirubicin followed by maintenance anlotinib versus placebo plus epirubicin as first-line treatment for advanced soft tissue sarcoma (STS): A randomized, double-blind, parallel-controlled, phase III study.研究名称（中文）：安罗替尼联合表柔比星序贯安罗替尼维持治疗，对比安慰剂联合表柔比星作为晚期软组织肉瘤（STS）的一线治疗：一项随机、双盲、平行对照的 III 期研究讲者：周宇红复旦大学附属中山医院03摘要号：11502报告类型：Oral Abstract Session研究名称（英文）：Eribulin plus anlotinib in advanced soft tissue sarcoma (ERAS): Updates on efficacy and biomarkers研究名称（中文）：艾立布林联合安罗替尼治疗晚期软组织肉瘤（ERAS）：疗效和生物标志物的最新进展讲者：邓窈窕四川大学华西医院04摘要号：11503报告类型：Oral Abstract Session研究名称（英文）：Camrelizumab plus apatinib in patients with advanced or refractory chordoma: A single-arm, open-label, phase 2 trial.研究名称（中文）：卡瑞利珠单抗联合阿帕替尼治疗晚期或难治性脊索瘤患者：一项单臂、开放标签、 II期试验讲者：杨诚海军军医大学长征医院05摘要号：11509报告类型：Rapid Oral Abstract Session研究名称（英文）：Evaluation of the safety and efficacy of ALMB-0168, a novel monoclonal antibody activating Cx43 hemichannel, for osteosarcoma after standard therapy failure: A multicenter, open-label, single agent, phase 1/2 study (ACE study).研究名称（中文）：ALMB-0168（一种新型Cx43半通道激活单克隆抗体）应用于标准治疗失败后的骨肉瘤患者中的安全性和有效性：一项多中心、开放标签、单药的I/II期研究（ACE研究）讲者：沈靖南中山大学附属第一医院06摘要号：11510报告类型：Rapid Oral Abstract Session研究名称（英文）：Phase Ib trial of C019199, an oral TME modulator targeting CSF-1R/DDRs/VEGFR2, in relapsed or refractory osteosarcoma研究名称（中文）：C019199（一种针对 CSF-1R/DDRs/VEGFR2 的口服 TME 调节剂）治疗复发或难治性骨肉瘤的 Ib 期试验讲者：叶峰厦门大学附属第一医院泌尿生殖系统肿瘤01摘要号：4519报告类型：Rapid Oral Abstract Session研究名称（英文）：9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study.研究名称（中文）：9MW2821，一种新型的 Nectin-4 抗体药物偶联物（ADC），与特瑞普利单抗联合用于初治的局部晚期或转移性尿路上皮癌（la/mUC）患者：一项 Ib/II 期研究的结果讲者：盛锡楠北京大学肿瘤医院黑色素瘤 / 皮肤癌01摘要号：9512报告类型：Oral Abstract Session研究名称（英文）：Neoadjuvant camrelizumab plus apatinib and temozolomide for resectable stage II/III acral melanoma: The CAP 03-NEO trial.研究名称（中文）：新辅助卡瑞利珠单抗联合阿帕替尼和替莫唑胺治疗可切除的 II/III 期肢端黑色素瘤：CAP 03-NEO 试验讲者：毛丽丽北京大学肿瘤医院血液系统恶性肿瘤01摘要号：7001报告类型：Oral Abstract Session研究名称（英文）：Revision of staging system for natural killer T-cell lymphoma: A multicenter study from the Chinese Southwest Oncology Group and Asia Lymphoma Study Group研究名称（中文）：自然杀伤T细胞淋巴瘤分期系统的修订：中国西南肿瘤协作组和亚洲淋巴瘤协作组的多中心研究讲者：林桐榆四川省肿瘤医院02摘要号：7002报告类型：Oral Abstract Session研究名称（英文）：Molecular landscape of distinct follicular lymphoma histologic grades: Insights from genomic and transcriptome analyses研究名称（中文）：不同组织学分级滤泡性淋巴瘤的分子特征：来自基因组和转录组分析的见解讲者：孙聪天津医科大学肿瘤医院03摘要号：7006报告类型：Oral Abstract Session研究名称（英文）：Sintilimab (anti-PD-1 antibody) combined with chidamide (an oral subtype-selective HDACi) followed by P-GemOx regimen in patients with treatment-naïve extranodal natural killer/T cell lymphoma (TN-ENKTL): A multicenter, open-label, single-arm, phase II study (SCENT-2 trial)研究名称（中文）：信迪利单抗（抗PD-1抗体）联合西达本胺（一种口服亚型选择性组蛋白去乙酰化酶抑制剂）序贯 P-GemOx 方案治疗初治的结外自然杀伤 / T 细胞淋巴瘤（TN-ENKTL）患者：一项多中心、开放标签、单臂 Ⅱ 期研究（SCENT-2 试验）讲者：黄慧强中山大学肿瘤防治中心04摘要号：7007报告类型：Oral Abstract Session研究名称（英文）：Sintilimab (anti-PD-1) plus ifosfamide, carboplatin, and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind phase 3 study (ORIENT-21)研究名称（中文）：信迪利单抗（抗PD-1抗体）联合异环磷酰胺、卡铂和依托泊苷（ICE 方案）用于二线治疗经典型霍奇金淋巴瘤（cHL）：一项多中心、随机、对照、双盲 Ⅲ 期研究（ORIENT-21）的结果讲者：刘鹏中国医学科学院肿瘤医院05摘要号：7010报告类型：Rapid Oral Abstract Session研究名称（英文）：Phase 1/2 studies of DZD8586 in CLL/SLL patients after covalent or non-covalent BTK inhibitors and BTK degraders研究名称（中文）：DZD8586应用于经共价/非共价BTK抑制剂及BTK降解剂治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者中的I/II期研究讲者：李建勇江苏省人民医院06摘要号：7012报告类型：Rapid Oral Abstract Session研究名称（英文）：A phase 1/2 study to evaluate the safety and efficacy of XNW5004, a selective EZH2 inhibitor, in subjects with relapsed/refractory non-Hodgkin lymphoma研究名称（中文）：一项 Ⅰ/Ⅱ 期研究：评估选择性 EZH2 抑制剂 XNW5004 在复发 / 难治性非霍奇金淋巴瘤受试者中的安全性和有效性讲者：邱录贵中国医学科学院血液病医院（中国医学科学院血液学研究所）07摘要号：7013报告类型：Rapid Oral Abstract Session研究名称（英文）：CD79b-targeted antibody-drug conjugate (ADC) SHR-A1912 in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) in relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL): Data from a phase 1b/2 study研究名称（中文）：CD79b 靶向抗体偶联药物（ADC）SHR-A1912 联合利妥昔单抗、吉西他滨和奥沙利铂（R-GemOx 方案）治疗复发或难治性（r/r）弥漫性大 B 细胞淋巴瘤（DLBCL）：来自一项 Ⅰb/Ⅱ 期研究的数据讲者：李亚军湖南省肿瘤医院08摘要号：7016报告类型：Rapid Oral Abstract Session研究名称（英文）：Worldwide experience of chronic active EBV infection: Retrospective cohort study研究名称（中文）：慢性活动性EBV感染的全球经验：回顾性队列研究讲者：王欣然华中科技大学同济医学院附属同济医院中枢神经系统肿瘤01摘要号：LBA2000报告类型：Oral Abstract Session研究名称（英文）：Efficacy and safety of STUPP regimen with or without anlotinib for newly diagnosed glioblastoma: Results of a multicenter, double-blind, randomized phase II trial.研究名称（中文）：STUPP方案联合或不联合安罗替尼治疗新诊断的胶质母细胞瘤的疗效和安全性：多中心，双盲，随机II期试验的结果讲者：陈媛媛中山大学肿瘤防治中心02摘要号：2004报告类型：Oral Abstract Session研究名称（英文）：A phase II study of asandeutertinib (TY-9591) in advanced NSCLC patients with EGFR-positive mutations and brain metastases.研究名称（中文）：asandeutertinib（TY-9591）应用于EGFR阳性突变型晚期NSCLC脑转移患者的II期研究讲者：石远凯中国医学科学院肿瘤医院03摘要号：2012报告类型：Oral Abstract Session研究名称（英文）：Utidelone in combination with etoposide and bevacizumab in HER2-negative breast cancer patients with brain metastasis: A prospective, single-arm, phase II trial.研究名称（中文）：优替德隆联合依托泊苷和贝伐珠单抗治疗HER2阴性乳腺癌脑转移患者：一项前瞻性单臂II期临床试验讲者：史业辉天津医科大学肿瘤医院癌症照护和管理策略01摘要号：1503报告类型：Oral Abstract Session研究名称（英文）：Electronic patient-reported outcome-based weight management versus usual care during induction chemotherapy followed by concurrent chemoradiotherapy in nasopharyngeal carcinoma: A phase II randomized controlled trial.研究名称（中文）：基于电子患者报告结局的体重管理与常规护理在鼻咽癌诱导化疗联合同步放化疗期间的对比：一项II期随机对照试验讲者：陈秋燕中山大学肿瘤防治中心在研疗法 - 免疫治疗01摘要号：2500报告类型：Oral Abstract Session研究名称（英文）：Assessment of efficacy of LBL-024, a novel and uniquely designed bispecific antibody against PD-L1 and 4-1BB, combined with etoposide/platinum-based chemotherapy in treatment-naive advanced extrapulmonary neuroendocrine carcinoma (EP-NEC): A multicenter phase Ib/II trial.研究名称（中文）：新型结构PD-L1/4-1BB双特异性抗体LBL-024联合依托泊苷/铂类化疗治疗初治晚期肺外神经内分泌癌（EP-NEC）的疗效评估：一项多中心Ib/II期临床试验讲者：张盼盼北京大学肿瘤医院02摘要号：2502报告类型：Oral Abstract Session研究名称（英文）：Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients (pts) with immunotherapy-treated, advanced acral and mucosal melanoma.研究名称（中文）：首创新药PD-1/IL-2α偏倚型双特异性抗体融合蛋白IBI363应用于免疫治疗后的晚期肢端型与黏膜型黑色素瘤患者的疗效与安全性结果讲者：郭军北京大学肿瘤医院03摘要号：2506报告类型：Oral Abstract Session研究名称（英文）：Effect of erythrocyte-antibody conjugates on cancers resistant to checkpoint blockade immunotherapy: A phase I trial.研究名称（中文）：红细胞-抗体偶联物在免疫检查点抑制剂耐药性肿瘤中的作用：一项I期临床试验讲者：聂小千西湖大学04摘要号：2514报告类型：Rapid Oral Abstract Session研究名称（英文）：Preliminary results from the dose-escalation stage of a phase I trial of an anti-CCR8 antibody in patients with relapsed/refractory cutaneous T-cell lymphoma (R/R CTCL).研究名称（中文）：抗 CCR8 抗体在复发/难治性皮肤 T 细胞淋巴瘤（R/R CTCL）患者中的 I 期试验剂量递增阶段的初步结果讲者：李志铭中山大学肿瘤防治中心在研疗法 - 分子靶向药物和肿瘤生物学01摘要号：3001报告类型：Oral Abstract Session研究名称（英文）：Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations.研究名称（中文）：EGFR x HER3双特异性ADC药物iza-bren（BL-B01D1），应用于携带经典EGFR突变以外驱动基因改变的局部晚期或转移性NSCLC的I期研究讲者：杨云鹏中山大学肿瘤防治中心02摘要号：3002报告类型：Oral Abstract Session研究名称（英文）：Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC).研究名称（中文）：EGFR x HER3双特异性ADC药物iza-bren（BL-B01D1），应用于局部晚期或转移性小细胞肺癌（SCLC）患者的I期研究讲者：黄岩中山大学肿瘤防治中心03摘要号：3003报告类型：Oral Abstract Session研究名称（英文）：Safety and efficacy of TQB2102, a novel bispecific anti-HER2 antibody–drug conjugate, in patients with advanced solid tumors: Preliminary data from the first-in-human phase 1 trial.研究名称（中文）：新型双特异性抗HER2 ADC药物TQB2102在晚期实体瘤患者中的安全性和有效性：首次人体I期试验的初步数据讲者：徐瑞华中山大学肿瘤防治中心04摘要号：3013报告类型：Rapid Oral Abstract Session研究名称（英文）：A first-in-human phase I/II study of GFH375, a highly selective and potent oral KRAS G12D inhibitor in patients with KRAS G12D mutant advanced solid tumors.研究名称（中文）：高度选择性和强效口服KRAS G12D抑制剂GFH375应用于KRAS G12D突变晚期实体瘤患者的首次人体I/II期研究讲者：艾星浩上海交通大学医学院附属胸科医院特别会议01摘要号：104报告类型：Clinical Science Symposium研究名称（英文）：Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer研究名称（中文）：IBI363单药治疗或联合贝伐珠单抗治疗晚期结直肠癌患者的疗效及安全性讲者：林振宇华中科技大学同济医学院附属协和医院02摘要号：106报告类型：Clinical Science Symposium研究名称（英文）：Phase 1 study of SHR-1826, a c-MET–directed antibody-drug-conjugate (ADC), in advanced solid tumors研究名称（中文）：靶向c-MET的ADC SHR-1826治疗晚期实体瘤的I期研究讲者：张阳中山大学肿瘤防治中心03摘要号：107报告类型：Clinical Science Symposium研究名称（英文）：Phase 1 trial of SHR-A2102, a nectin-4–directed antibody drug conjugate (ADC), in advanced solid tumors研究名称（中文）：靶向nectin-4的ADC SHR-A2102在晚期实体瘤中的I期试验讲者：钟润波上海交通大学医学院附属胸科医院症状科学与姑息治疗01摘要号：12012报告类型：Rapid Oral Abstract Session研究名称（英文）：Efficacy of treatment with traditional Chinese medicine (Renshen Yangrong Tang granules) for cancer-related fatigue in patients with platinum-based chemotherapy: A randomized, double- blinded, placebo-controlled, multicenter trial.研究名称（中文）：中药（人参养荣汤颗粒）治疗铂类化疗患者癌因性疲劳的疗效：一项随机、双盲、安慰剂对照、多中心试验讲者：许轶琛北京大学肿瘤医院备注：如有遗漏或任何问题，请给我们留言~声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通肿瘤科编辑：lagertha审核：南星

ASCO会议临床3期临床结果临床1期免疫疗法

2025-04-24

·PRNewswire

Mabwell to Present Clinical Data of 9MW2821 Combined with Toripalimab in Patients with UC in an Oral Presentation at 2025 ASCO

SHANGHAI, April 24, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with an entire industry chain, announced that the Phase Ib/II clinical study results of the novel Nectin-4-targeting ADC 9MW2821 combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, USA, May 30-June 3, 2025. Clinical data from 3 ADC clinical studies will also be published as poster presentations at the meeting. Oral Presentation 1. Title: 9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naive patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study. Abstract Number for Publication: 4519 Presenter: Prof. Sheng Xinan, Chief Physician, Dept. of Urologic Oncology (Beijing Cancer Hospital) Session Type and Title: Rapid Oral Abstract-Genitourinary Cancer-Kidney and Bladder Session Date and Time: 5/31/2025, 1:15 PM-2:45 PM CDT Poster Presentation 1. Title: Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with advanced solid tumors. Abstract Number: 3035 Session Type and Title: Poster Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology Poster Board: 350 Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT 2. Title: Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with lung cancer. Abstract Number: 3036 Session Type and Title: Poster Session - Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Poster Board: 351 Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT 3. Title: A first-in-human clinical study of 9MW2921, a novel TROP-2 antibody-drug conjugate (ADC), in patients with advanced solid tumors. Abstract Number: 3029 Session Type and Title: Poster Session - Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Poster Board: 344 Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCO会议抗体药物偶联物临床1期

2025-04-14

·药智网

ADC新锐加码AI制药

今日，迈威生物宣布与深势科技达成战略合作。双方将充分发挥各自在生物药研发和人工智能（AI）大模型领域的优势，共同打造生物药研发大模型平台。而就在不久前，迈威生物宣布与英矽智能达成战略合作，基于双方各自在ADC研发和人工智能（AI）领域的技术优势，以AI赋能ADC创新药研发。1ADC收获在即迈威生物成立于2017年，在ADC技术平台构建、单/双抗分子发现等领域具备突出优势，并已打通ADC药物从研发到生产的全产业链。自主研发的IDDC™平台与Mtoxin™毒素技术已在多项目中得到验证。现有16个品种处于不同阶段，包括12个创新品种和4个生物类似药。在研管线中ADC疗法最为亮眼，其中9MW2821被寄予厚望。该药是一款采用化学修饰偶联技术且具有自主知识产权的创新型定点抗体偶联药物，作用靶点为Nectin-4。药智数据显示，目前全球已有超过10种用于治疗实体瘤的靶向Nectin-4 ADC管线正在临床开发中。其中Padcev是美国及中国批准的唯一一种靶向Nectin-4 ADC药物，用于治疗尿路上皮癌及或膀胱癌，2024年该药销售额超过20亿美元。而迈威生物的9MW2821已有多个适应症进入3期阶段，处于全球前列。表1 全球处于临床阶段的Nectin-4 ADC管线数据来源：药智数据根据迈威生物新闻稿，9MW2821注射入人体后，可与肿瘤细胞表面的Nectin-4结合并进入细胞，通过酶解的作用，定向释放细胞毒素，从而实现对肿瘤的精准杀伤。此外，9MW2821还具有组分均一，纯度较高以及便于产业化等特点.目前，该药在多适应症展现BIC潜力：针对尿路上皮癌，单药、联合PD-1单抗治疗均挺进Ⅲ期进度位居全球第二；针对宫颈癌，全球首个且唯一一个挺进Ⅲ期的Nectin-4 ADC。2押注AI，加速研发创新目前迈威生物已在ADC领域积累一定优势，而其近期在AI领域的频繁动作，有望进一步巩固其在新药研发领域的综合竞争力。据悉，深势科技凭借其自主研发的Uni-Smart科学文献多模态大模型、Uni-Mol分子构象大模型和Uni-Fold蛋白折叠大模型等一系列生命科学大模型，构建了完整的微观世界认知与计算体系。此次合作将融合迈威生物ADC技术优势与深势科技RiDYMO®平台优势，共同探索突破创新靶点机制研究，加速药物分子从0到1的发现，推动生物药研发从“实验驱动”迈向“计算驱动”，进一步提升研发效率。而英矽智能是生成式人工智能驱动药物研发领域的先锋，已构建覆盖生物、化学、临床医学和科学研究的一体化药物研发平台Pharma.AI。其中生物板块下属PandaOmics、Generative Biologics等引擎，通过赋能药物靶点识别和从头生成分子片段提升研发效率。根据合作协议，双方将结合各自的平台优势，开发具有全新生物机制、创新结构和药学活性的新一代毒素载荷，提升ADC创新效率，并助力AI平台升级迭代。AI与ADC的协同效应，有望助力迈威生物构建更高的技术壁垒，在ADC赛道从跟随者向引领者跃迁的同时，开辟AI医药创新生态的新战场。参考来源：1.迈威生物：迈威生物与深势科技达成战略合作，共筑AI for Science大模型驱动的创新药研发新范式2.迈威生物：AI赋能ADC创新药研发，迈威生物宣布与英矽智能达成战略合作3.药智数据权威榜单定义行业标杆，赋能企业品牌价值！识别二维码，解锁年度惊喜！声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

抗体药物偶联物临床3期临床结果生物类似药引进/卖出

100 项与 Bulumtatug fuvedotin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
子宫颈转移癌	临床3期	中国	迈威（上海）生物科技股份有限公司	2024-09-10
宫颈癌	临床3期	中国	江苏迈威康新药研发有限公司	2024-09-10
尿路上皮癌	临床3期	中国	迈威（上海）生物科技股份有限公司	2023-12-29
子宫内膜癌	临床2期	中国	江苏迈威康新药研发有限公司	2025-03-26
卵巢癌	临床2期	中国	江苏迈威康新药研发有限公司	2025-03-26
肾盂和输尿管尿路上皮癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2025-01-17
膀胱尿路上皮癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2025-01-17
复发性尿路上皮癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2025-01-17
晚期恶性实体瘤	临床2期	中国	迈威（上海）生物科技股份有限公司	2022-06-11
食管鳞状细胞癌	临床2期	中国	迈威（上海）生物科技股份有限公司	-

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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


NCT06079112 (PRNewswire) 人工标引	临床3期	不可切除的尿路上皮癌一线	40	9MW2821 + Toripalimab	鹽廠遞網鏇願淵鏇壓窪(醖膚衊餘鹹築鏇壓網壓) = 衊憲製構餘鏇壓積鑰憲鑰憲窪獵艱鏇積膚願願 (觸憲繭廠餘繭築膚蓋蓋 ) 更多	积极	2025-01-09
PRNewswire 人工标引	N/A	宫颈癌 PVRL4	53	9MW2821	壓壓餘襯窪淵衊鹽遞選(積網鏇餘膚憲襯窪顧憲) = 膚遞簾醖襯簾鬱鏇顧鏇壓襯鹽範鑰顧蓋鹽艱衊 (鹽窪獵鬱製範積膚廠鬱 ) 更多	积极	2024-08-23
PRNewswire 人工标引	N/A	宫颈癌 PVRL4	53	9MW2821 (Nectin-4 IHC 3+)	壓壓餘襯窪淵衊鹽遞選(積網鏇餘膚憲襯窪顧憲) = 鬱淵餘餘願醖壓遞鹽齋壓襯鹽範鑰顧蓋鹽艱衊 (鹽窪獵鬱製範積膚廠鬱 )	积极	2024-08-23
NCT05216965 (NEWS \| ASCO2024) 人工标引	临床1/2期	食管癌 \| 晚期恶性实体瘤 \| 三阴性乳腺癌 ... 一线 Nectin-4 positive 更多	240	9MW2821 at 1.25mg/kg or above (UC)	憲餘鏇鬱顧積築壓醖鬱(蓋顧顧壓糧積觸糧獵醖) = 鹽獵繭鏇蓋鬱淵鬱鹽衊齋蓋網顧襯蓋構衊夢繭 (繭鏇築鹹構網鏇獵顧觸, 44.76 ~ 77.54) 更多	积极	2024-05-25
NCT05216965 (NEWS \| ASCO2024) 人工标引	临床1/2期	食管癌 \| 晚期恶性实体瘤 \| 三阴性乳腺癌 ... 一线 Nectin-4 positive 更多	240	9MW2821 at 1.25mg/kg or above (CC)	憲餘鏇鬱顧積築壓醖鬱(蓋顧顧壓糧積觸糧獵醖) = 醖鹽襯構築廠製簾繭構齋蓋網顧襯蓋構衊夢繭 (繭鏇築鹹構網鏇獵顧觸, 23.77 ~ 53.46) 更多	积极	2024-05-25
NCT05216965 (PRNewswire) 人工标引	临床1/2期	转移性三阴性乳腺癌 \| 晚期三阴性乳腺癌	20	9MW2821	築廠積製觸憲繭蓋淵簾(選廠蓋選觸築齋膚網簾) = 蓋艱獵膚網餘廠範鑰憲窪艱淵膚觸築廠糧齋獵 (糧壓顧憲遞簾鹹餘憲醖 ) 更多	积极	2024-05-13
Corporate Publications 人工标引	临床1/2期	宫颈癌 NECTIN4 Positive	40	9MW2821	鑰壓範餘獵醖顧窪積願(製鹽壓積窪構獵壓築壓) = 鏇鑰網鏇鏇衊壓淵鹹鏇構鹹餘鹹獵艱醖蓋醖築 (繭製廠願淵糧獵艱範鏇 ) 更多	积极	2024-03-18
NEWS 人工标引	临床2期	尿路上皮癌	-	9MW2821 1.25mg/kg	窪築願選襯鏇廠憲窪鑰(憲願蓋餘構築遞餘遞鏇) = 餘製鏇膚壓淵製餘糧願遞範製獵築範齋積網鏇 (簾蓋範齋蓋鑰廠餘觸壓, 44.8 ~ 77.5) 更多	积极	2023-12-07
NCT05216965 (ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	实体瘤	-	9MW2821	餘壓衊廠製鏇齋網憲艱(積襯築壓願鹹積廠衊顧) = 憲膚鹽餘觸淵鹹憲淵網鑰壓範構衊艱膚簾範鬱 (願衊膚鹽襯獵繭淵鬱蓋 ) 更多	积极	2023-10-23