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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583

项与 Bulumtatug fuvedotin 相关的文献（医药）

2025-12-31·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Barzaghi-Rinaudo, Patrizia ; Korn, Joshua ; Sagar, Vivek ; Hainzl, Dominik ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; D’Alessio, Joseph A. ; Synan, Alyssa

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

2025-05-21·BIOCONJUGATE CHEMISTRY

Easy Access to Bioorthogonal Click-to-Release Reagent Bishydroxy-trans-cyclooctene (C₂TCO) and Harnessing of Its Rapid Labeling and Dissecting Feature in Multicycle Imaging

Article

作者: Kim, Wook ; Yoo, Tae Hyeon ; Kim, Eunha ; Arun, V. ; Choi, Junwon ; Lee, Sangwoo ; Choi, Hongseo ; Lee, Minju

Bifunctional trans-cyclooctene (bTCO) with a carbamate or carbonate at the allylic position and tetrazine provide a promising bioorthogonal click chemistry pair for the click-to-release approach, successfully employed in various biotechnological applications. Herein, we demonstrate a simple and straightforward method to synthesize C₂TCO, a symmetrical bTCO derivative with two hydroxyl groups at the allylic positions. The efficiently synthesized C₂TCO at first was selectively functionalized with a fluorophore (C₂TCO-FL), and the conjugate was labeled onto monoclonal antibodies (Ab-C₂TCO-FL). The fluorophore of Ab-C₂TCO-FL was easily removed from the antibody through the mild treatment of tetrazine, enabling multicycle fluorescent bioimaging. Next, an antibody-drug conjugate targeting PD-L1 was prepared using the linker based on C₂TCO. The cytotoxic payload was efficiently released from the antibody upon tetrazine treatment, which induced cellular cytotoxicity.

2025-05-21·BIOCONJUGATE CHEMISTRY

Elucidating Critical Factors of Internalization and Drug Release of Antibody-Drug Conjugates (ADCs) Using Kinetic Parameters Evaluated by a Novel Tool Named TORCH

Article

作者: Hannewald, Jens ; Shan, Min ; Deutsch, Carl ; Hecht, Stefan ; Sweeney-Lasch, Stanley ; Kolmar, Harald ; Rasche, Nicolas ; Quillmann, Marie ; Anderl, Jan ; Piater, Birgit ; Dickgiesser, Stephan

During the past decade, antibody-drug conjugates (ADCs) have emerged as new drugs in cancer therapy with 15 ADCs already approved such as Kadcyla, Enhertu, and Adcetris. ADCs contain a cytotoxic drug that is linked to an antibody, allowing for specific delivery of the warhead to tumor cells. Typically, the antibody targets a tumor-specific antigen expressed on the cell surface. After the internalization of ADCs into cells, the linker is often cleaved by enzymes in the lysosomal compartment of the cell, releasing the warhead and thereby allowing for its interaction with, for example, the DNA or the tubulin cytoskeleton, which finally leads to cell death. Consequently, binding, internalization, and drug release are key attributes for the efficacy of ADCs. Here, we describe a novel molecule named TORCH (Turn On after Release by CatHepsins) that contains a fluorescence quencher system that is separated by a cathepsin B-cleavable linker. When conjugated to an antibody, the TORCH molecule allows one to gain valuable insights on the internalization and drug release of ADCs. While we cannot exclude the influence of other factors such as receptor recycling, we have found that the receptor density is directly related to the amount of payload released intracellularly, meaning that the internalization per receptor is very similar for all investigated antibodies and cell lines.

123

项与 Bulumtatug fuvedotin 相关的新闻（医药）

2025-06-18

·ioncology

ASCO国际视野丨Thomas Powles教授：靶向及免疫治疗进展迅速，EV和度伐利尤单抗等方案改善尿路上皮癌患者生存

编者按：在近日举行的2025年ASCO大会上，伦敦大学泌尿生殖系癌症教授、巴特癌症中心主任Thomas Powles教授的一项III期NIAGARA研究入选了口头报告（摘要号4503），探讨了度伐利尤单抗联合新辅助化疗（NAC）及根治性膀胱切除术（RC）治疗肌层浸润性膀胱癌（MlBC）患者的无病生存期（DFS）结局；同时，ASCO大会也公布了EV-302临床试验中达到深度缓解患者的探索性分析。《肿瘤瞭望-泌尿时讯》特邀Thomas Powles教授，就NIAGARA试验以及EV-302试验的试验结果和临床意义进行深入交流，以期为临床医生提供见解与指导。研究者说01《肿瘤瞭望-泌尿时讯》NIAGARA III期试验结果公布，哪些数据支持度伐利尤单抗成为MIBC围手术期治疗的新标准？相较于传统新辅助化疗，该方案的优势体现在哪些方面？Thomas Powles 教授伦敦大学泌尿生殖系癌症教授、巴特癌症中心主任NIAGARA研究是一项随机、开放标签、多中心的III期临床试验，汇报了围手术期度伐利尤单抗联合新辅助化疗（NAC）及根治性膀胱切除术（RC）治疗符合顺铂方案的MlBC患者的DFS结局。该研究共纳入1063例患者，按1：1的比例随机分为治疗组（n=533）和对照组（n=530），其中165例患者的肿瘤分化程度不同或存在其他组织学亚型。结果显示，在接受RC的患者中，与对照组相比，治疗组的生存期得到延长，OS的改善达到了25%，pCR率提高了10%（42% vs 33%）；在行RC且术后进行基线检查的患者中，治疗组患者的疾病复发或死亡风险比对照组低31%（DFS HR：0.69；95% CI：0.51 - 0.93；P=0.014）；对照组在不同亚组中均观察到了DFS获益，包括分化程度不同/其他组织学亚型的患者（HR：0.45；95% CI：0.19 - 0.99）。与对照组相比，治疗组患者在pCR组（HR：0.58；95% CI：0.33 - 1.00）和非pCR组（HR：0.82；95%CI：0.64 - 1.05）中均获得了更大的DFS获益。值得注意的是，该研究并未增加与化疗安全性相关的毒性，也未出现新的安全信号。该研究是首个MIBC患者总生存期得到改善的围手术期试验。基于该研究结果，FDA于2025年3月28日批准度伐利尤单抗联合吉西他滨和顺铂作为新辅助治疗，随后以单药作为RC后的辅助治疗，用于治疗MIBC成人患者。因此，对于适合顺铂治疗的MIBC患者，应将其视为标准治疗方案。Prof. Thomas Powles：Firstly, thank you for asking me here. The NIAGARA study is a randomized phase 3 study of neoadjuvant chemotherapy and cystectomy plus or minus perioperative durvalumab before and after cystectomy. It's a randomized phase 3 study of a thousand patients, it's a large trial, and it showed a improvement in overall survival by 25%. It showed a reduction in the risk of event-free survival with a hazard ratio of 0.68. It showed a 10% higher pathological complete response rate. It also showed no increase in the toxicity associated with surgical safety and no new safety signals. And because it's the first perioperative trial with an overall survival signal, it has level 1A evidence. It's been approved by the FDA, and it's supported by a plethora of guidelines. And therefore should be considered for cisplatin-eligible muscle-invasive bladder cancer patients as standard of care.So the advantages against standard chemotherapy is simple. Patients are living longer. There's improved overall survival.A 25% improvement in survival.Also, we know there was no increased complications from a surgical perspective, and we also know the pathological complete response rate is 10% higher.So there's lots of data to support this as a standard of care.02《肿瘤瞭望-泌尿时讯》NIAGARA研究结果表明该方案的不良反应与既往经验一致，其免疫相关事件（如甲状腺功能减退、肺炎）发生率如何？对于接受新辅助化疗联合免疫治疗的患者，术前安全性监测需要进行哪些特殊管理措施？Thomas Powles 教授伦敦大学泌尿生殖系癌症教授、巴特癌症中心主任免疫相关不良事件（irAE）是免疫治疗的重要并发症。单独来看，肺炎、糖尿病、心脏毒性、神经毒性等较为罕见。但综合起来，大约有10%的患者可能出现显著的irAE。需要将这一情况与化疗和手术的毒性进行对比，化疗和手术各有其自身的毒性。我和我的同事们认为，化疗的毒性至少与度伐利尤单抗联合方案相当，甚至可能更强。手术的毒性也不容小觑。在新辅助化疗联合免疫疗法的治疗方案中，度伐利尤单抗可能是相对容易管理的部分。在新辅助治疗阶段，除了化疗之外，我认为并不需要额外增加太多监测措施。而在化疗期间，我们原本就是每三周随访患者一次，术前也会综合评估。从手术评估的角度来看，这种治疗方案并未带来特定的手术相关毒性。但我需要强调的是，如果患者在围手术期因免疫治疗出现irAE，我会停止免疫治疗，优先确保手术安全进行。例如，如果患者因irAE在第2周期就开始使用糖皮质激素治疗，我们可能会决定不再给予第3周期的免疫治疗，但可以在辅助治疗阶段重新开始免疫治疗。总之，确保患者安全接受手术是最重要的。Prof. Thomas Powles：Immune-related adverse events are an important complication of immune checkpoint inhibition. What we know is individually, pneumonitis, diabetes, cardiac toxicity, neurotoxicity, together they're quite rare. But when you pull them all together, it probably comes to about 10% of patients get significant immune-related adverse events. When you that needs to be put in context that chemotherapy's got its own toxicity, surgery has its own toxicity. So in my opinion, and actually of my colleagues, the chemotherapy is at least if not more toxic than the durvalumab. The surgery is also challenging. The durvalumab is probably the easiest part of the triplet. So I think there isn't that much additional monitoring in the neoadjuvant period above chemotherapy. We see patients every three weeks on chemotherapy anyway. We see them before surgery. The surgical assessment, there are no specific surgical toxicities associated with this. But what I would say is if patients are getting into trouble with immunotherapy, with immune-related adverse events in this perioperative period, I wouldn't continue the immunotherapy. I would get the surgery done safely. So that's an important message, we said this in the trial. If patients are on steroids because of immune-related adverse events from cycle 2, you might say we're not going to give cycle 3 immunotherapy. You can restart it in the adjuvant period. But getting to that operation safely is very important.03《肿瘤瞭望-泌尿时讯》不仅是免疫治疗，EV等ADC药物也显著改善了晚期UC患者治疗结局，进入多个国家临床实践。今年ASCO大会也公布了EV-302深度缓解的探索性分析。这为临床带来哪些启示？Thomas Powles 教授伦敦大学泌尿生殖系癌症教授、巴特癌症中心主任维恩妥尤单抗联合帕博利珠单抗（EV+P）有望取代以铂类为基础的化疗方案，成为局部晚期或转移性尿路上皮癌（la/mUC）的标准一线治疗方案。在这一领域，我的中国同道，北京大学肿瘤医院的郭军教授主导的RC48-C017研究，深入探讨了特瑞普利单抗（T）联合维迪西妥单抗（DV）新辅助治疗序贯特瑞普利单抗辅助治疗HER2表达的MIBC患者的疗效与安全性。该试验取得了显著的阳性结果，令我们倍感振奋。我认为，尿路上皮癌领域的治疗格局正在经历重大变革。目前，EV+P方案处于领先地位，特瑞普利单抗联合维迪西妥单抗紧随其后，而以铂类为基础的化疗方案将被逐步替代。当前已有EV+P新辅助治疗的相关试验，希望未来会有DV+P新辅助治疗开展的大规模随机试验。我们正处在一个充满希望和机遇的时期，不断探索和推进这一领域的治疗进展。此次ASCO会议，Shilpa Gupta教授汇报了EV-302试验的探索性分析结果（摘要号：4502）。数据显示，EV+P治疗后有30.4%的患者实现了已确诊完全缓解（cCR），且持久性良好，75%的患者在两年后仍维持缓解状态。在我刚进入尿路上皮癌研究领域时，患者的中位总生存期仅有一年，如今不仅有75%的患者可以维持两年缓解，而且已经开始能够治愈转移性膀胱癌患者，并且有望在围手术期设置中实现同样目标。中国在这其中发挥的作用同样重要。例如，盛锡楠教授在ASCO大会上的口头报告中汇报了一项中国自主研发的新型Ncetin-4 ADC（9MW2821）联合特瑞普利单抗用于la/mUC一线治疗的1b/2期研究，该联合方案治疗下确认的客观缓解率（cORR）达到了80.0%，疾病控制率达到了92.5%，中位无进展生存期（PFS）达到了12.5个月。这些临床数据与国际上同类免疫联合ADC的数据相当。总之，尿路上皮癌治疗领域正迎来变革，越来越多的治疗方案有望超越传统的化疗。在这个进程中，中国发挥着极其重要的作用，为全球尿路上皮癌治疗的进步做出了显著贡献。Prof. Thomas Powles：So, infortumab vedotin and pembrolizumab is the standard of care for metastatic urothelial cancer.There's a press release from China with my fabulous colleagues from from Beijing, who have the DV-Toripalimab randomized phase 3. And we know from a press release, that's positive. We're very excited. Professor Guo, we're very excited about seeing that data.I think this is a transformation going on in this disease.EV-Pembrol is leading that at the moment. DV-Toripalimab will also take part in that. We'll stop using platinum chemotherapy in advanced disease. And we also have now trials in the neoadjuvant space with EV-Pembrol. And I hope to see trials with DV, big randomized trials in this space also. It's a very exciting time. In the data presented here by Shilpa Gupta at ASCO, we saw those complete responses with EV-Pembrol, those 30% of complete responses. We showed really great durability. 75% of patients maintaining their response at two years. We have to remember when I started doing urothelial cancer, median overall survival was only one year. We now have 30% of the patients, 75% maybe at two years without without progression. We're beginning to cure bladder cancer in metastatic. We'll do the same in the perioperative setting. China's playing a really important role with that. I also saw that Xinan Shen, he presented his data here today, beautifully as well. And what he showed was a new, I'd call it MW9, a new nectin-4 ADC, and his nectin-4 ADC showed response rates of 81% with with Toripalimab.That looks the same from the distance as EV-Pembrol.There are a number of regimens which will beat chemotherapy in the space.There's going to be a transformation in the disease. China's playing an incredibly important role in that journey.04《肿瘤瞭望-泌尿时讯》但在中国，EV获批用于治疗la/mUC的时间并不长。关于EV联合帕博利珠单抗的治疗方案，您能提供哪些见解或最佳实践？哪些患者适合在初期接受EV治疗，以及如何控制不良反应？Thomas Powles 教授伦敦大学泌尿生殖系癌症教授、巴特癌症中心主任目前，在全球范围内，EV + P治疗方案是被广泛认可并采用的标准治疗方案。在现阶段，尚未有任何数据能够在疗效方面与之相媲美。我们满心期待未来能够有更多的随机临床试验结果揭晓，同时，也确实有一些其他的药物正在这一领域积极探索。但就目前而言，EV + P联合治疗方案在中位PFS、中位OS方面均显著获益。更为关键的是，该联合治疗方案实现长期持久的完全缓解，彻底改变了这一疾病的治疗格局。此外，我们在今年的ASCO会议上认识到了该方案的毒性问题。该方案通常会持续使用两年，我们对于免疫相关毒性的管理也已经积累了一定的经验。但ADC药物维恩妥尤单抗与早期皮肤毒性有关，这种皮肤毒性一般会在治疗的前3个周期内出现，这就要求我们根据患者的具体情况进行剂量调整或者中断治疗。此外，该药物还与逐渐积累的周围神经病变相关，一旦出现这种情况，往往需要暂停治疗，切勿强行继续治疗，否则只会徒增患者的痛苦。如果处理不当，情况会变得相当棘手，所以，我们必须给予高度重视。此外，在治疗周期上，也并不固定。个人认为一年以上的治疗时间比较理想，但也不排除部分患者仍然需要长时间的持续治疗，而另外一部分患者则可能因为神经病变等不良反应不得不停止治疗。这确实需要一定的技巧和经验，而我们作为医疗专业人士，需要不断积累经验。Prof. Thomas Powles：EV-Pembrol as it currently stands is the global standard of care. There's no data out there that rivals it as it currently stands. We await other randomized trials in the future, and there are other drugs which have exploring this space. But as it currently stands, EV-Pembrol is associated with hazard ratios of less than 0.5 for OS and PFS in the initial analysis.The durability data shows durable complete responses. It's a transformative regimen, but we also learnt at the meeting at ASCO 2025 that toxicity requires careful assessment. Pembrolizumab is given for two years and is relatively straightforward to give in the knowledge about giving treating immune-related toxicity. Enfortumab vedotin, enfortumab vedotin is associated with early skin toxicity in the first three cycles, and dose reductions and interruptions are required. It also is associated with an accumulating peripheral neuropathy, and that again requires treatment breaks. Don't treat through the neuropathy. It's quite difficult if you do that. So that's really important. There's no right number of cycles. My feeling is that at least a year of therapy is ideal. Two years feels long, five years much too long. But I think for individual patients, some go on for as long as that. Others have to stop early because of the neuropathy. And there's a real skill, but that's what we do for a living. There's a real skill in giving these drugs. I don't think guidelines, like riding a bike, you have to practice it, but once you have the hang of it, I think it's much easier to give. I think it's much easier to give than chemotherapy.研究简介英文标题：Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA中文标题：接受围手术期度伐利尤单抗（D）治疗的肌层浸润性膀胱癌（MIBC）患者的循环肿瘤 DNA（ctDNA）——NIAGARA试验摘要号：4503研究背景在适用顺铂方案的肌层浸润性膀胱癌（MIBC）患者中开展的III期NIAGARA试验（NCT03732677）中，与新辅助化疗（NAC）相比，NAC联合围手术期度伐利尤单抗在无事件生存期（EFS）和总生存期方面均显示出具有临床意义的显著改善，病理完全缓解率（pCR）提高10%，安全性可控且不影响手术可行性。本文报告了NIAGARA 试验中ctDNA的预设探索性分析及其与临床结局的关联。研究方法NIAGARA试验纳入了适用顺铂方案的MIBC (cT2-T4aN0/1M0) 患者，计划接受根治性膀胱切除术 (RC)。患者按 1:1 随机分组，分别接受新辅助化疗 (D)（1500 mg 静脉注射，每3周1次）联合新辅助化疗(NAC)（顺铂 + 吉西他滨，静脉注射，每 3 周 1 次）治疗 4 周期后行 RC，之后接受辅助化疗 (D) 单药治疗（1500 mg 静脉注射，每 4 周 1 次），疗程8个周期（D 组），或仅接受 NAC 后行 RC（对照 [C] 组）。双重主要终点为 pCR 和 EFS，无病生存期（DFS）为次要终点。采用Signatera 个性化肿瘤信息分子残留病 (MRD)检测系统对血浆ctDNA 进行评估。在基线（筛选或新辅助治疗 C1D1，n = 460）、新辅助治疗后RC前（RC 前，n = 422）以及辅助治疗期的 C1D1（RC 后，n = 345）时评估ctDNA。研究结果共1063例患者，其中包含462例生物标志物可评估人群（D 组 237 例；C 组 225 例）。患者特征与意向治疗（ITT）人群相似。总体而言，基线 ctDNA 阳性率为 57%（260/460），新辅助治疗后 RC 前降至 22%（94/422）。从基线到 RC 前的 ctDNA 清除率在D组为41%，C组为31%。RC前ctDNA 阳性患者的非 pCR 率为 97%（86/89）。RC 后总体 ctDNA 阳性率为 9%（31/345）。无论基线 ctDNA 阳性或阴性，D 组较 C 组均显示 EFS 获益（见表）；基于 RC 后 ctDNA 状态，围手术期D治疗在 DFS 方面也呈现类似获益趋势（见表）。研究结论在该探索性分析中，RC 前 ctDNA 阳性与非 pCR 相关。D 组患者从基线到 RC 前 ctDNA 清除率更高，表明 D 联合 NAC 疗法优于单纯 NAC 疗法。围手术期 D 治疗为基线 ctDNA 阳性和阴性患者均带来 EFS 获益，基于 RC 后 ctDNA 状态的 DFS 分析也观察到相似趋势。这些结果进一步支持围手术期度伐利尤单抗方案用于MIBC患者。Thomas Powles 教授伦敦大学泌尿生殖系癌症教授、巴特癌症中心主任Thomas Powles教授是伦敦大学泌尿生殖系统肿瘤教授和巴茨癌症研究所负责人。他在泌尿系统癌症生物标志物和新药策略的开发方面发挥了重要作用，特别是肾细胞癌的一线免疫/靶向治疗组合、膀胱癌的免疫检查点抑制剂单独或联合用药等。Thomas Powles教授领导了多项临床试验（包括21项随机试验）和转化肿瘤学研究项目，这些项目均刊登在主要期刊上。Powles教授现任《肿瘤学年鉴》（Annals of Oncology）主编、ESMO理事会成员以及EAU肾癌指南的成员。目前的工作重点是早期膀胱癌和肾癌的新型辅助/新辅助疗法，以及术后复发风险患者的识别。（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息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，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果ASCO会议临床3期

2025-06-07

·ioncology

ASCO中国之声丨郄云凯教授分享天津医科大学第二医院团队成果，聚焦非肌层浸润性尿路上皮癌的诊疗优化

编者按：在2025年美国临床肿瘤学会（ASCO）年会上，天津医科大学第二医院胡海龙及郄云凯教授团队的研究成果入选了本次大会的壁报交流，分别探讨了尿液肿瘤DNA（utDNA）用于指导非肌层浸润性膀胱癌（NIMBC）患者的二次电切，以及非肌层浸润性上尿路上皮癌（UTUC）的组织学亚型与预后的相关性分析。《肿瘤瞭望》特邀郄云凯教授介绍这些研究成果，并分享此次ASCO大会尿路上皮癌领域的研究热点。持续探索液体活检应用场景utDNA检测筛选NMIBC二次电切最适人群《肿瘤瞭望》：utDNA在尿路上皮癌的诊疗中具有独特价值，您及团队的相关研究也入选今年ASCO大会。请您分享下相关研究成果？郄云凯教授天津医科大学第二医院液体活检（liquid biopsy）主要是指包括血液、尿液等体液的液体活检，当然最近报道还有针对唾液的液体活检报道。其中尿液液体活检作为一种完全无创的检测方式，具备完全无创、采样便捷、采集量大、背景低等优点。而膀胱肿瘤可以与尿液直接接触，使其具备尿液液体活检的天然优势。尿液中的肿瘤DNA（utDNA）浓度高且片段完整，与组织检测一致性可达 86.7%；而且背景低，能有效克服肿瘤异质性。目前，基于utDNA的液体活检已经在膀胱癌的早期诊断、病情监测及预后评估等方面展现出巨大潜力。前期，我们天津医科大学第二医院胡海龙教授团队联合多家医疗中心及企业开发了两种基于基因组学与AI技术的无创尿液液体活检模型utLIFE-UC和UI-Seek，这两种模型在膀胱癌的早期诊断中的敏感性分别高达94.3%和91.37%，特异性分别高达98.7%和95.09%，显著优于传统脱落细胞学及肿瘤标志物检测方法，并能够先于膀胱镜3-6个月发现肿瘤。鉴于utDNA基因检测在膀胱癌诊断及预后评估中的良好应用，能否利用utDNA指导膀胱癌的治疗？其应用前景值得期待。二次电切在非肌层浸润性膀胱癌（NMIBC）中的应用目前仍存在争议，在欧美国家，对于T1或者Ta期高级膀胱癌、初次电切标本中不含肌层的或者手术信息不明确的膀胱癌患者都要进行常规二次电切，而在中国，由于阳性率不高、患者对二次手术的接受程度有限、存在并发症以及经济因素等原因，绝大多数医学中心仅一部分病人进行高度选择性电切，比如：针对一些初次电切标本不含肌层的、肿瘤比较大或者多发的高危患者进切。那么我们在想，有没有一种工具，可以帮助我们筛选出那些真正需要做二次电切的膀胱癌患者，从而做到精准的实施二次电切，避免盲目的手术？我们或许从utDNA中找到了答案。在今年的ASCO年会中，我们团队报告了一项回顾性研究“使用utDNA检测识别需要进行二次电切的非肌层浸润性膀胱癌患者”。我们回顾性分析了我们中心130例完成utDNA检测和二次电切的非肌层浸润性膀胱癌患者，其中39例患者utDNA检测阳性，在这39例阳性患者中35例患者的二次电切病理检测出了肿瘤残留，也就是说utDNA对于二次电切病理的阳性预测值为89.7%。阴性预测值为87.9%。因此，utDNA可以作为筛选工具用于指导NMIBC患者的二次电切，此外utDNA也是NMIBC患者预后的独立预测因素。△可独立预测复发风险的因素为了进一步研究utDNA在二次电切中的指导意义，我们已经发起了一项前瞻性随机对照研究（TRUCE-LB1），也期望明年能够有机会跟大家一起分享该研究的最新结果。为个体化治疗提供依据非肌层浸润性UTUC的组织学亚型分析《肿瘤瞭望》：在UTUC领域，您和团队也报告了一项研究，请您具体分享下非肌层浸润性UTUC组织学亚型对患者预后的影响，对临床实践有哪些价值？郄云凯教授天津医科大学第二医院上尿路上皮癌（UTUC）相对于膀胱癌的发病率相对偏低，但是有明显的地域差异。例如，UTUC在我国的发病率约占所有尿路上皮癌的17%，显著高于欧美等国家的5%-10%。而且中国女性患者比例较高，女性与男性的比例约为 1.3:1，而欧美国家则以男性为主。UTUC 的组织学亚型和膀胱癌类似，主要包括鳞状分化、腺样分化、肉瘤样分化、神经内分泌分化，以及微乳头状、浆液样、嵌套型、透明细胞型等。在膀胱癌中，已经有很多研究证实组织学亚型与患者预后的密切相关，具有变异组织学的 UTUC 患者通常表现出更高级别的肿瘤、更高的淋巴结转移率和更差的生存预后。例如，鳞状分化、肉瘤样分化和神经内分泌分化与较差的无进展生存期（PFS）、癌症特异性生存期（CSS）和总生存期（OS）相关。然而在UTUC，尤其是对于非肌层浸润性UTUC组织学亚型与预后之间的相关性研究还鲜见报道。在本次ASCO年会中，我们报道了一项针对339例非肌层浸润性UTUC患者的回顾性研究。我们发现相对于纯尿路上皮癌（pure UTUC），存在组织学亚型的非肌层浸润性UTUC（hsUTUC）的复发风险显著增加，而且膀胱腔内的复发风险也相应增加。但不影响癌症特异性生存。△hsUTUC对比pUTUC的癌症特异生存（CSS）、无复发生存（RFS）、无膀胱浸润性生存（IVRFS）风险这些发现对我们今后的临床实践带来了一定的指导意义，要对具有组织学亚型的UTUC患者进行量身定制的监测和更积极的管理策略。例如，以前对于UTUC尤其是非肌层浸润性UTUC，术后常规不进行辅助治疗，并且膀胱内只进行1次即刻灌注，术后的随访复查也是比较简单。那么对于有组织学亚型的患者，我们可能要根据患者的具体情况，进行术后辅助治疗（如化疗、免疫治疗以及靶向治疗等），或者应用多种手段进行更加积极的检测随访（如utDNA、ctDNA等）。尿路上皮癌治疗进展众多在ASCO多学科视角下汲取研究经验《肿瘤瞭望》：目前EV等ADC药物治疗晚期尿路上皮癌的疗效显著，同时也有研究分析了ADC治疗UTUC的疗效。您认为ADC药物对于未来的尿路上皮癌治疗策略有哪些影响？郄云凯教授天津医科大学第二医院尿路上皮癌从最早的化疗时代，到以免疫检查点抑制剂为代表的免疫治疗治疗，现在已经到了以HER2、Trop2以及Nectin4为靶点的靶向治疗时代。尤其是EV301/302临床研究结果的披露，直接将晚期尿路上皮癌的客观缓解率和总生存率相较于传统GC化疗提升了1倍。而在本届ASCO大会的泌尿肿瘤领域，北京大学肿瘤医院郭军教授/盛锡楠教授团队作为唯一入选的中国口头报告，展示了我国自主研发的一种新型Nectin-4抗体偶联药物（ADC）9MW2821与特瑞普利单抗联合用于治疗未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）患者的Ib/II期研究结果：其客观缓解率（ORR）高达87.5%，显示了积极的疗效和安全性。目前，针对该方案的3期研究正在进行中。此外，ADC联合免疫治疗在UTUC新辅助以及保肾治疗中也展现出了不错的效果，比如华西医院鲍一歌教授团队利用维迪西妥单抗联合特瑞普利单抗对局晚期高危UTUC患者开展的保肾治疗研究，1年的保肾率（CFS）为93.75%；我们针对UTUC发起的TRUCE-UTUC新辅助研究的pCR率可达33.3％。昨天在ASCO会议中的新药研究会场，也有针对HER3的新的ADC药物的临床研究结果披露。总之，ADC联合免疫治疗在尿路上皮癌的治疗中展现出了前所未有的疗效，相信随着新靶点及新药物的出现会给尿路上皮癌的治疗带来更多选择，为患者带来更多的获益。《肿瘤瞭望》：今年参加ASCO带给您哪些启发？未来将在尿路上皮癌领域开展哪些进一步探索？郄云凯教授天津医科大学第二医院这是我本人第一次在现场参加ASCO年会，泌尿系统肿瘤尤其是尿路上皮癌在会议中的占比并不是很高，但是通过这次线下会议我也有机会现场聆听了其他肿瘤领域的相关会议，这些学科间的交叉思维碰撞给我带来了很多灵感和收获。比如ctDNA的检测在结肠癌领域的应用现状及困境，可能会启发我们如何将ctDNA应用在晚期或者局晚期尿路上皮癌患者的诊疗当中。此外，针对HER2 的ADC药物本来也是受乳腺癌诊疗的影响而在尿路上皮癌中大放异彩，那么是不是还有其他潜在的药物可以用于尿路上皮癌的治疗，比如PARP抑制剂、激酶靶向药等。总之，通过此次年会使我对未来针对尿路上皮癌的研究思路更加清晰，也对我们尿路上皮癌PI胡海龙教授给我们确定的研究方向更加有信心，因为我发现好多想法跟世界各地顶级泌尿系肿瘤专家都是不谋而合的，有英雄所见略同的感觉。接下来，我们团队将重点针对液体活检（包括utDNA和ctDNA）在尿路上皮癌检测、用药指导、预后判断等方面的应用，以及保器官策略（包括保膀胱、UTUC保肾）、还有卫生经济学等方面进行深入研究，期望和全世界泌尿系统肿瘤专家致力于提高抗肿瘤治疗的疗效和安全性，改善患者的生活质量，也为“健康中国2030”行动中使总体癌症5年生存率提升至46.6%的目标贡献一份力量。参考文献上下滑动查看更多内容[1]Ng K, Stenzl A, Sharma A, Vasdev N. Urinary biomarkers in bladder cancer: A review of the current landscape and future directions. Urol Oncol. 2021;39(1):41-51. doi:10.1016/j.urolonc.2020.08.016[2]Hailong Hu, et al.Clinical utility of urine tumor DNA in bladder cancer patients.J Clin Oncol 40, 2022 (suppl 16; abstr e16560)[3]Zhisong He,et al.Clinical utility of urine DNA for noninvasive detection and minimal residual disease monitoring in urothelial carcinoma.J Clin Oncol 40, 2022 (suppl 16; abstr 4583)[4]Zihan Xue, et al.Postoperative assessment using urinary tumor DNA (utDNA) to identify potential candidates for repeat transurethral resection of bladder tumor (re-TURBT) in non-muscle invasive bladder cancer (NMIBC): A retrospective analysis.ASCO 2025;Abstract #4587[5]Shiwang Huang,et al.Prognostic impact of histological subtypes in non-muscle-invasive UTUC: Propensity matched analysis.ASCO 2025;Abstract #4592[6]Powles T, Valderrama BP, Gupta S, et al. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024;390(10):875-888. doi:10.1056/NEJMoa2312117[7]Xinan Sheng, et al.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.ASCO 2025;Abstract #4519[6]鲍一歌.基于ADC药物的UTUC围手术期个体化治疗及华西经验.第八届华西泌尿肿瘤天府学术大会.https://mp.weixin.qq.com/s/yJZFzhUMPXg3mOHuaiufLA胡海龙教授天津医科大学第二医院泌尿外科主任医师主任医师、副教授、博士研究生导师天津市泌尿外科研究所基因工程实验室副主任天津医科大学第二医院泌尿外科行政副主任天津医科大学第二医院临床技能中心主任天津市中西医结合学会泌尿外科专委会主委中国中西医结合学会泌尿外科专委会常务委员中华医学会泌尿外科专委会机器人学组委员《中华泌尿外科杂志》第十一届青年编委天津市医师学会泌尿外科专业委员会常务委员天津市泌尿外科质控中心副主任委员主要研究方向为膀胱癌的表观遗传学调控、肿瘤微环境调控及个体化精准治疗，作为负责人主持TRUCE系列研究郄云凯教授天津医科大学第二医院泌尿外科主治医师主治医师/讲师，医学博士，国家纳米科学中心博士后，尿路上皮癌亚专业专病医师。天津市“131”创新型人才、天津市医师协会泌尿外科分会委员、天津市中西医结合学会泌尿外科专业委员会青年委员、天津医科大学第二医院泌尿外科教学秘书，荣获天津市科技进步三等奖。长期从事膀胱、肾盂及输尿管肿瘤的临床诊治及科研工作，以第一作者在Clinical Cancer Research，Nature communication，Nano today，中华泌尿外科杂志及中华外科杂志等国内外高水平期刊发表论著10余篇。（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息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，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议

2025-06-05

·PRNewswire

Highlights in Oral Presentation of Mabwell's 9MW2821 at 2025 ASCO

SHANGHAI, June 5, 2025 /PRNewswire/ -- At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA, from May 30 to June 3, the results of the Phase Ib/II clinical study of 9MW2821 in combination with Toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC) were presented by Prof. Xinan Sheng, Chief Physician of the Department of Urologic Oncology, Beijing Cancer Hospital, on behalf of the research team, with key highlights as below: Oral Presentation Background: Urothelial carcinoma (UC) is a common malignant tumor worldwide. Global cancer statistics released in 2024 showed that bladder cancer is the ninth most commonly diagnosed cancer in the world, with about 614,000 new cases and 220,000 deaths annually. The burden and morbidity of bladder cancer is significantly higher in men than in women. It is the sixth most common cancer and the ninth leading cause of cancer death in men [1]. 9MW2821 (Bulumtatug Fuvedotin, BFv) is a next-generation Nectin-4 targeting antibody-drug conjugate. Previous study of BFv has shown promising efficacy in la/mUC patients who progressed on/after platinum-based chemotherapy and immune checkpoint inhibitors [2]. A pivotal phase 3 study of BFv is ongoing in China (NCT06196736, CTR20234024). Toripalimab is a novel recombinant humanized anti-PD-1 monoclonal antibody that has been approved in multiple countries including China and the USA. It is the first time to report in detail on the efficacy and safety of 9MW2821 in combination with Toripalimab in patients with la/mUC. Method: This is a phase Ib/II, open-label, multicenter study of BFv and Toripalimab in la/mUC in China. Every 21 days per cycle, patients received BFv (1.0 or 1.25mg/kg, on day 1 and 8) and Toripalimab (240mg, on day 1). Treatment until disease progression or unacceptable toxicity. Results: As of Apr. 30, 2025, 52 patients with la/mUC were enrolled. Among the 40 assessable patients (treatment-naive for la/mUC) with the median age of 67, 70% of patients were male, 72.5% had an Eastern Cooperative Oncology Group (ECOG) score of 1, 55% with tumor primary site at upper urinary tract, 15% had liver metastases, 82.5% were Nectin-4 positive and 20% were PD-L1 positive. The Objective Response Rate (ORR) was 87.5% (95% CI: 73.2, 95.8), confirmed ORR was 80%, complete response (CR) rate was 12.5%, Disease Control Rate (DCR) was 92.5% (95% CI: 79.6, 98.4). 97.5% of assessable patients had tumor reduction, 57.5% of assessable patients had tumor reduction of 50% above. The ORR in selected subgroups was consistent with results in overall population. Different subgroups of treatment-naive patients could benefit from BFv and Toripalimab regardless of primary tumor site, liver metastasis, expression of Nectin-4 and PD-L1. The ORR was 100% (24/24) in patients older than 65, 94.44% (17/18) in patients with tumor primary site at lower urinary tract, 83.33% (5/6) in patients with liver metastasis, 100% (7/7) in nectin-4 negative patients, and 100% (8/8) in PD-L1 positive patients. As of April 30, 2025, 45% (18/40) of subjects experienced disease progression or death, with a median progression-free survival (mPFS) of 12.5 months (95% CI: 6.47-NA), and a median duration of response (mDoR) that has not been reached. Median follow-up time was 10.8 months, thus mPFS and mDoR was not mature. The incidence rate of treatment-related adverse events (TRAE) was 98.1%, and most of the TRAEs were grade 1-2. The incidence rate of TRAEs ≥grade 3 was 42.3%, mainly characterized by neutrophil counts decreased (11.5%), alanine aminotransferase increased (5.8%), and white blood cell decreased (5.8%). The incidence rate of serious TRAEs was 28.8%, and no TRAEs leading to death occurred. BFv and Toripalimab showed well-tolerated safety profile. No new safety signals of BFv or Toripalimab were observed in this study. Conclusion: BFv combined with Toripalimab has demonstrated encouraging efficacy and manageable safety profile in la/mUC. Patients with advanced age, liver metastases and negative expression of Nectin-4 also achieved considerable response in this study, suggesting that BFv in combination with Toripalimab may provide a new treatment option for patients with advanced UC who are intolerant of or potentially have a poor prognosis with platinum-based chemotherapy. A pivotal phase 3 study of BFv combined with Toripalimab vs platinum-based chemotherapy is ongoing in China (NCT06592326, CTR20242828). About 9MW2821 9MW2821 is a novel Nectin-4 targeting ADC, which achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process of Mabwell. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. And it's the first Nectin-4 targeting ADC to disclose clinical efficacy data in cervical, esophageal, and breast cancers. 3 Phase III pivotal clinical trials are ongoing. Its monotherapy and combination therapy with Toripalimab for UC have been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It has also been granted Fast Track Designations (FTD) for 3 indications and Orphan Drug Designation (ODD) for 1 indication by the U.S. Food and Drug Administration (FDA). 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, 4 products have been approved and commercialized, 1 product filed for pre-NDA meeting, 2 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

临床结果突破性疗法临床3期快速通道ASCO会议

100 项与 Bulumtatug fuvedotin 相关的药物交易

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研发状态

10 条进展最快的记录,

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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
膀胱尿路上皮癌	临床3期	中国	迈威（上海）生物科技股份有限公司	2024-08-22
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
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
晚期三阴性乳腺癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2024-07-26
转移性三阴性乳腺癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2024-07-26
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

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临床结果

适应症

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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


NCT06592326 (ASCO2025 \| PRNewswire) 人工标引	临床1/2期	尿路上皮癌一线	40	9MW2821 + toripalimab	鹹憲積範餘顧獵膚構憲(鬱襯蓋壓築顧製鏇鏇餘) = 網網壓範構齋襯構鏇遞獵艱襯鑰獵鏇膚鹽蓋齋 (願鬱遞鑰願淵襯淵鑰鹽 ) 更多	积极	2025-05-30
NCT05216965 (9MW2821, Pubmed \| Ann Oncol)	临床1/2期	晚期恶性实体瘤 Nectin-4	274	9MW2821 0.33mg/kg	顧壓築鬱膚獵選築遞衊(積鬱鹽築鹹簾鹹獵廠醖) = 鏇製膚構繭構廠蓋製齋糧鏇衊獵積繭衊淵淵鏇 (鹹製夢醖製夢餘廠繭窪 ) 更多	积极	2025-04-01
NCT05216965 (9MW2821, Pubmed \| Ann Oncol)	临床1/2期	晚期恶性实体瘤 Nectin-4	274	9MW2821 1.5mg/kg	顧壓築鬱膚獵選築遞衊(積鬱鹽築鹹簾鹹獵廠醖) = 鬱顧淵積獵築夢遞蓋壓糧鏇衊獵積繭衊淵淵鏇 (鹹製夢醖製夢餘廠繭窪 ) 更多	积极	2025-04-01
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	鏇繭網築顧窪製鑰繭窪(鑰夢遞鑰膚艱範夢廠鑰) = 構艱簾窪壓壓衊鹹廠鹽襯網膚壓夢糧窪襯窪憲 (衊獵顧遞鑰夢蓋觸鑰願 ) 更多	积极	2025-01-09
PRNewswire 人工标引	N/A	宫颈癌 PVRL4	53	9MW2821	鬱鏇鬱夢鬱範簾鹹築簾(襯窪網衊鏇膚襯淵膚繭) = 鑰鹽築鑰蓋鹽夢範願淵廠繭衊夢蓋鹽膚鏇願衊 (廠膚艱壓簾範鬱構窪構 ) 更多	积极	2024-08-23
PRNewswire 人工标引	N/A	宫颈癌 PVRL4	53	9MW2821 (Nectin-4 IHC 3+)	鬱鏇鬱夢鬱範簾鹹築簾(襯窪網衊鏇膚襯淵膚繭) = 艱壓夢積艱窪醖構觸築廠繭衊夢蓋鹽膚鏇願衊 (廠膚艱壓簾範鬱構窪構 )	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)	齋鬱鑰襯鑰鏇積選簾鹽(選襯獵顧鬱獵壓遞艱鹹) = 選簾廠願簾艱夢鬱選糧觸顧醖鏇獵觸膚構糧壓 (範構簾積膚繭衊顧積餘, 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)	齋鬱鑰襯鑰鏇積選簾鹽(選襯獵顧鬱獵壓遞艱鹹) = 選獵築積憲繭築蓋襯構觸顧醖鏇獵觸膚構糧壓 (範構簾積膚繭衊顧積餘, 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	醖範製繭膚網願蓋憲觸(繭衊築壓鏇選蓋築夢網) = 鑰遞艱築鏇壓衊餘鏇糧餘蓋鹽鏇築糧構構網築 (夢鏇積淵齋觸鏇簾襯選 ) 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	衊鹹糧鬱獵選夢鹹鑰壓(糧構淵膚鹽選遞壓鏇夢) = 壓積範膚積艱鬱壓夢願蓋夢鹹鬱糧願淵艱鏇窪 (壓鏇構範廠壓鏇壓鏇選 ) 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	糧廠糧選鑰夢繭壓醖簾(範觸襯齋築築製糧壓遞) = 鹽構鏇艱鑰鏇齋襯觸艱鏇鹽觸構醖網繭築築糧 (願壓遞願選積餘獵構選, 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	窪蓋窪顧簾鑰簾鹽鑰蓋(鬱製選憲鏇觸憲觸窪選) = 夢艱網艱鹹衊積顧構壓餘願窪鹽衊鬱獵範構築 (鏇鏇構淵鏇鏇選醖簾網 ) 更多	积极	2023-10-23