A Randomized, Open-label, Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy as First-line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

The aim of this study is to evaluate the efficacy and safety of ESG401 as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer.

开始日期2025-09-01

申办/合作机构

上海诗健生物科技有限公司

NCT06383767

/ Recruiting临床3期

A Open-label, Randomized, Multicenter Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.

开始日期2024-07-11

申办/合作机构

上海诗健生物科技有限公司

CTR20241439

/ Recruiting临床3期

评估ESG401对比研究者所选化疗方案治疗既往接受过至少一线系统性化疗的激素受体阳性、人表皮生长因子受体2阴性（HR+/HER2-）的局部晚期或转移性乳腺癌的开放、随机、多中心III期研究

主要目的：对比ESG401与研究者所选化疗方案由独立中心影像评估的无疾病进展时间（PFS）。次要目的：对比ESG401与研究者所选化疗方案由研究者评估的无疾病进展（PFS），总生存期（OS），客观缓解率（ORR），临床获益率（CBR），缓解持续时间（DOR）。

开始日期2024-06-25

申办/合作机构

东曜药业有限公司

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100 项与 ESG-401 相关的临床结果

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100 项与 ESG-401 相关的转化医学

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100 项与 ESG-401 相关的专利（医药）

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2,359

项与 ESG-401 相关的文献（医药）

2025-06-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and optimization of a high-throughput LC-MS/MS method for the simultaneous determination of Exatecan and its Cathepsin B-sensitive prodrug, and ARV-825 in rat plasma: Application to pharmacokinetic study

Article

作者: Li, Jing ; Zhang, Tianhong ; Ran, Xiaohua ; Jiang, Qikun ; Yan, Qing ; Liu, Yangyang ; Zhang, Jiaming ; Xu, Xiaolan ; Bai, Chenxia

For most cancers, the combination of chemotherapy drugs is a promising approach. The combination of DNA damage agent Exatecan and proteolysis targeting chimera (PROTAC) agent ARV-825, which is a selective bromodomain-containing protein 4 degrader, can further improve efficacy through the DNA damage-repair mechanism. The Cathepsin B-sensitive prodrug with high albumin affinity of Exatecan (C14-VC-PAB-Exa) was introduced and co-encapsulated with ARV-825 into the nano-drug delivery system for improving the physicochemical properties of the two drugs. To promote the translation of Exatecan and the PROTAC into the clinics, it is important to develop a reliable and high-throughput bioanalytical method for the simultaneous determination of Exatecan, C14-VC-PAB-Exa, and ARV-825 that can evaluate the pharmacokinetic behaviors of the analytes. In this study, an HPLC-MS/MS method after preparation by one-step protein precipitation was developed and fully validated. The analytes were eluted completely on a ZORBAX SB-C18 column by gradient elution. Multiple reaction monitoring mode with positive electrospray ionization was applied to quantify the analytes. The validated method on selectivity, linearity (r ≥ 0.995), precision and accuracy (< 15 %), extraction recovery (> 88.0 %), matrix effect (< 9.1 %), carry-over, and stability were within the predefined acceptance criteria. The method was successfully applied to the pharmacokinetic study of Exatecan, C14-VC-PAB-Exa, and ARV-825 in rats for the first time. The proposed robust and economical method will be an alternative bioanalytical procedure for Exatecan and ARV-825 in the future. What is more, the present work could provide a reference for the clinical combination of the two drugs.

2025-05-05·ONCOGENE

CREB1-BCL2 drives mitochondrial resilience in RAS GAP-dependent breast cancer chemoresistance

Article

作者: Song, Dong ; Koh, Siang-Boon ; Man, Ki-Fong ; O'Connor, Charlotte ; Patel, Rajnikant ; Hong, Jinghui ; Ellisen, Leif W ; Darweesh, Omeed ; Melkonyan, Mark N ; Bonaldo, Chiara ; Robinson, Tim ; Thompson, Alexandra ; Sun, Mo

Abstract:

Triple-negative breast cancer (TNBC) is an aggressive and heterogenous breast cancer subtype. RASAL2 is a RAS GTPase-activating protein (GAP) that has been associated with platinum resistance in TNBC, but the underlying mechanism is unknown. Here, we show that RASAL2 is enriched following neoadjuvant chemotherapy in TNBC patients. This enrichment is specific to the tumour compartment compared to adjacent normal tissues, suggesting that RASAL2 upregulation is tumour-selective. Analyses based on 2D/3D cultures and patient-derived xenograft models reveal that RASAL2 confers cross-resistance to common DNA-damaging chemotherapies other than platinum. Mechanistically, we found that apoptotic signalling is significantly downregulated upon RASAL2 expression. This feature is characterised by substantial alterations in the expression of anti-versus pro-apoptotic factors, pointing to heterogeneous mechanisms. In particular, RASAL2 upregulates BCL2 via activation of the oncogenic transcription co-factor YAP. CREB1, a YAP-interacting protein, was identified as the common transcription factor that binds to the promoter regions of RASAL2 and BCL2, driving their collective expression. A subset of RASAL2 colocalises with BCL2 subcellularly. Both proteins decorate mitochondria, where the high levels of mitochondrial RASAL2-induced BCL2 expression render the organelles refractory to apoptosis. Accordingly, mitochondrial outer membrane permeabilisation assay using live mitochondria from RASAL2-high/chemoresistant tumour cells demonstrated attenuated release of death signal, cytochrome c, when exposed to pro-apoptotic factors BAX and tBID. Similarly, these cells were more resilient towards chemotherapy-induced mitochondrial depolarisation. Together, this work reveals a previously undocumented molecular link between RAS GAP and apoptosis regulation, providing a new mechanistic framework for targeting a subset of chemorefractory tumours.

2025-05-03·Journal of biomolecular structure & dynamics

Synergy between human DNA ligase I and topoisomerase 1 unveils new therapeutic strategy for the management of colorectal cancer

Article

作者: Maurya, Pooja ; Sashidhara, Koneni V. ; Gupta, Sampa ; Rawat, Rohit Singh ; Krishna, Shagun ; Siddiqi, Mohammad Imran ; Banerjee, Dibyendu

DNA topoisomerase 1 (Topo 1) is a pivotal player in various DNA processes, including replication, repair, and transcription. It serves as a target for anticancer drugs like camptothecin and its derivatives (Topotecan and SN-38/Irinotecan). However, the emergence of drug resistance and the associated adverse effects, such as alopecia, anemia, dyspnea, fever, chills, and painful or difficult urination, pose significant challenges in Topo 1-targeted therapy, necessitating urgent attention. Human DNA Ligase 1 (hLig I), recognized primarily for its role in DNA replication and repair of DNA breaks, intriguingly exhibits a DNA relaxation activity akin to Topo 1. This raised the hypothesis that hLig I might compensate for Topo 1 inhibition, contributing to resistance against Topo 1 inhibitors. To explore this hypothesis, we assessed the efficacy of hLig I inhibition alone and in combination with Topo 1 in cancer cells. As anticipated, the overexpression of hLig I was observed after Topo 1 inhibition in colorectal cancer cells, affirming our hypothesis. Previously identified as an inhibitor of hLig I's DNA relaxation activity, compound 27 (C 27), when combined with Topotecan, demonstrated a synergistic antiproliferative effect on colorectal cancer cells. Notably, cells with downregulated hLig I (via siRNA, inhibitors, or genetic manipulation) exhibited significantly heightened sensitivity to Topotecan. This observation strongly supports the concept that hLig I contribute to resistance against clinically relevant Topo 1 inhibitors in colorectal cancers. In conclusion, our findings offer evidence for the synergistic impact of combining hLig I inhibitors with Topotecan in the treatment of colorectal cancers, providing a promising strategy to overcome resistance to Topo 1 inhibitors.

项与 ESG-401 相关的新闻（医药）

2025-04-24

·药融圈

美国biotceh靠中国ADC，上市失败

▲8月1-2日 2025生物医药创新博览会扫码报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融圈监测显示：此前在去年的2024年12月27日，美国纳斯达克上市Vincerx Pharma公告将被临床阶段ADC公司Oqory Inc.收购整合，借壳上市：原来的Ahmed Hamdy博士辞去CEO，首席财务官Alexander Seelenberger也离任。代理上任的Vincerx CEO Izumi表示：Oqory Inc.的TROP2 ADC在临床上显示出积极信号。Vincerx当时称未来公司最快的资产将是处于临床试验3期阶段，TROP2 ADC代号为OQY-3258。药融云数据，www.pharnexcloud.com；改名后为摩熵医药数据Oqory Inc.的创始人也是华人，资本市场的老手Henry Ji（季红俊）；复旦大学毕业后在美工作创业等，此前是Sorrento/索伦托的创始人（Sorrento亦是黄埔军校，出来不少华人科学家）。Oqory Inc.持有的ADC靶点涉及CD38,BCMA,2款TROP2，ROR1,CD25，B7H3等。OQY-3258研发代号此前为ESG401（ESG401由中国潜力药企诗健生物授权）。不过在2025年2月28日，双方反向并购的合作终止。期待Oqory Inc.的资本市场更进一步，以及更加聚焦做新药惠及患者。近期，Vincerx Pharma宣布终止了与QumulusAI的合并协议（non-bingding TS）。公司将继续寻求现有上市公司管线资产变现和对外授权的机会。在两次与其他公司（被）合并的尝试都失败后，Vincerx Pharma即将关门清算。截至2月底，公司银行账户中仅剩的390万美元预计将在第2季度末耗尽。附分享：发送 TROP2（请正确复制）至下方药融圈微信公众号后台可获得Oqory Inc.公司ADC布局原文件。仅供学习交流分享，不做投资建议！About Oqory, Inc.Oqory, Inc. is an innovator in the field of ADCs with expertise in advancing targeted cancer therapies. The Company’s pipeline includes multiple ADC programs, with two currently in clinical development and several next-generation ADCs in preclinical stages. These programs are designed to address critical unmet needs in indications such as breast cancer, non-small cell lung cancer, small cell lung cancer, multiple myeloma, and other metastatic solid tumors. Powered by a proprietary ADC platform, Oqory is delivering therapies that have demonstrated promising efficacy and safety paving the way for improved patient outcomes.参考：NMPA/CDE；摩熵医药数据pharma.bcpmdata.com（原药融云数据）；FDA/EMA/PMDA；https://investors.vincerx.com/；https://oqory.com/；https://oqory.com/news-events/；info@oqory.com；https://www.nasdaq.com/articles/vincerx-pharma-inc-announces-proposed-merger-oqory-inc；https://www.sec.gov/Archives/edgar/data/1796129/000119312524285929/d875384dex101.htm；Binding ；等等。此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐。更多药企信息交流或合作可后台留下名片。会议推荐 | 点击查看详情植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

抗体药物偶联物临床3期并购引进/卖出

2025-02-12

·癌度

《癌度早报2025年2月12日》

一、新药快讯 1、局限期小细胞肺癌治疗药物QL1706开启三期临床试验 2025年2月11日，根据药物临床试验登记与信息公示平台官网显示，一个靶向PD-1和CTLA-4的双靶点免疫药物QL1706启动了三期临床试验，单药用于巩固治疗局限期小细胞肺癌。局限期小细胞肺癌在经过同步或序贯放化疗之后未出现疾病进展，则使用QL1706或QL1604单药巩固治疗，该研究由80家医疗机构参与，计划入组636人。 2、埃万妥单抗在中国获批，用于EGFR基因20外显子插入突变肺癌 EGFR基因20外显子插入突变是EGFR的第三大突变类型，埃万妥单抗是双特异性抗体药物，在2021年成为世界上首个获批用于EGFR基因20外显子插入突变，刚刚这款药在中国正式获批，即埃万妥单抗联合卡铂和培美曲塞一线治疗EGFR基因20号外显子插入突变的非小细胞肺癌。这一适应症基于的临床试验证据表明，相比化疗的中位无进展生存期为6.7个月，埃万妥单抗联合化疗的中位无进展生存期达到了12.3个月。 3、OQY-3258对于多种乳腺癌亚型有效，80%患者病灶缩小根据最近公布的一项早期人体临床试验，抗体偶联药OQY-3258在多种乳腺癌亚型显示出积极的疗效。对于之前未接受治疗的三阴性乳腺癌治疗应答率为76%，疾病控制率达到了100%。对于晚期激素受体阳性HER2阴性乳腺癌，治疗应答率达到了29%，平均缓解持续时间达到了8个月，中位无进展生存时间达到了7.4个月。也就是这款药对多种乳腺癌亚型都有治疗效果，之前未曾用药的乳腺癌患者效果更好。二、新药快讯 1、微创联合疗法为复发小肝癌患者带来希望近日，中山大学肿瘤防治中心肝脏外科的医生团队在国际著名学术期刊《放射学》发布研究成果，首次通过随机对照临床试验对比了肝动脉栓塞化疗联合射频消融与手术切除，对于复发小肝癌中的疗效和安全性。结果表明两组患者的总生存率和无复发生存率无显著差异，但接受肝动脉栓塞化疗联合射频消融治疗的患者并发症发生率更低，也就是生活质量更好。

临床3期临床结果免疫疗法

2025-02-02

·药明康德

疾病控制率100%的ADC疗法；潜在“first-in-class”多肽疗法早期临床结果积极…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 靶向TROP2的抗体偶联药物（ADC）OQY-3258在1期临床试验中表现亮眼，在初治三阴性乳腺癌患者中达到100%疾病控制率（DCR）。 2. 潜在“first-in-class”β连环蛋白多肽拮抗剂ST316在1期临床试验中获得作用机制验证。 3. 双功能性抗体疗法ficerafusp alfa与PD-1抑制剂pembrolizumab联用，在治疗二线及以上鳞状细胞肛管癌（SCAC）患者的1/1b期临床试验中，达到25.0%的确认客观缓解率（ORR）。药明康德内容团队整理 ST316：公布1期临床试验数据 Sapience Therapeutics公司汇报了在研潜在“first-in-class”β连环蛋白（catenin）多肽拮抗剂ST316的1期临床试验安全性和生物标志物数据。ST316通过破坏β连环蛋白与BCL9的相互作用，抑制Wnt/β-连环蛋白信号通路。数据显示，在所有测试剂量下，ST316均表现出良好的安全性和耐受性。接受ST316单药治疗的患者中所观察到的长期疾病稳定（SD）与ST316早期抗肿瘤活性信号相一致。接受治疗后，在7例接受评估的患者中，有4例显示β连环蛋白从细胞核转移至细胞质/膜，表明ST316能够进入肿瘤组织并成功与靶点结合。在1期试验中，ST316显著降低了患者的免疫抑制细胞表达，显示出潜在的免疫调节效应。 ETH47：公布1期临床试验顶线结果 Ethris公司宣布，其主打mRNA候选药物ETH47，在健康受试者中的进行的1期临床试验中获得积极的顶线数据。 ETH47旨在靶向哮喘急性加重的上游触发因素，它编码的干扰素λ（IFNλ）是一种在呼吸道抗病毒免疫中起关键作用的蛋白。本次试验数据显示，ETH47在鼻腔衬液中剂量依赖性诱导了IFNλ的产生，并且显著激活鼻拭子样本中抗病毒干扰素刺激基因mRNA的表达。安全性方面，ETH47在所有剂量水平上均表现出良好的安全性和耐受性。无严重或重度不良事件，也无因不良事件导致的试验中断。未检测到mRNA、IFNλ蛋白或专有脂类化合物的全身性吸收，这有效降低了脱靶效应的风险。 OQY-3258：1期临床试验结果公布 Vincerx Pharma和Oqory公司公布了在研抗体偶联药物OQY-3258用于治疗实体瘤患者的1a/1b期临床试验结果。OQY-3258又名ESG401，是一款靶向TROP2的抗体偶联药物。截至2024年8月，约150名实体瘤患者入组这一临床试验，在多种乳腺癌亚型患者中观察到可喜结果。在初治三阴性乳腺癌患者中（n=25），确认ORR为76%，疾病控制率为100%，中位缓解持续时间（DOR）和无进展生存期（PFS）尚未达到。截至2025年1月的最新数据显示确认ORR提高到80%。在HR阳性/HER2阴性乳腺癌患者中，确认ORR为39%，DCR为78%。中位PFS为7.4个月。 Ficerafusp alfa（BCA101）：公布1/1b期临床试验数据 Bicara Therapeutics公司公布了在研双功能性抗体疗法ficerafusp alfa与PD-1抑制剂pembrolizumab联用，治疗二线及以上鳞状细胞肛管癌患者的1/1b期临床试验的扩展队列试验数据。截至2024年12月5日，确认的ORR为25.0%（7/28例），其中包括6例部分缓解（PR）和1例完全缓解（CR）。此外，还有1例患者正在等待确认PR。中位PFS为2.9个月，在可评估的27例患者中，12个月的无进展生存率为40.7%。 SAB-142：1期临床试验结果公布 SAB BIO公司公布了在研人类抗胸腺细胞免疫球蛋白疗法SAB-142在健康志愿者中进行的1期临床试验的积极顶线结果。这一研究达到安全性和药代动力学活性的主要终点，支持SAB-142进入2b期临床开发阶段，用于治疗1型糖尿病。 1期临床试验数据显示，SAB-142表现出良好的安全性特征，支持长期给药。并且生物标志物研究显示SAB-142表现出持久的免疫调节作用。SAB-142是一种人类多克隆免疫球蛋白，可针对多种杀伤胰岛β细胞的免疫细胞，调节它们的活性，从而起到保护胰岛β细胞的作用。 TX45：公布1b期临床试验数据 Tectonic Therapeutic宣布，其主打候选药物TX45在1b期急性血流动力学临床试验中取得积极中期数据。在患有2型肺动脉高压合并射血分数保留型心力衰竭（PH-HFpEF）的患者中，单次静脉输注TX45可显著改善左心室功能和肺部血流动力学。在整个研究人群中，TX45使肺毛细血管楔压（PCWP）降低17.9%，PCWP已被证明与患者的运动耐受、发病率和死亡率相关。在合并毛细血管前肺动脉高压和毛细血管后肺动脉高压（CpcPH），且患者肺血管阻力（PVR）升高的患者亚组中，TX45使PVR降低超过30%，这一指标同PCWP一样，与患者的运动耐受及生存预后密切相关。 TX45是一款长效Fc-款松弛素（relaxin）融合蛋白。它的独特作用机制不仅改善肺部血流动力学，还能增强左心室功能。现有的肺动脉高压药物主要为肺血管扩张剂，尚未在PH-HFpEF患者中显示对左心室功能的改善。Tectonic Therapeutic官网表示，TX45具有成为“best-in-class”疗法的潜力。 CELZ-201-DDT：公布1/2期临床试验初步数据 Creative Medical Technology Holdings公司宣布，其基于干细胞的创新疗法CELZ-201-DDT，在治疗退行性椎间盘疾病（DDD）导致的慢性背痛的1/2期临床试验中取得积极的初步数据。首批患者共10例患者中8例接受CELZ-201-DDT的治疗，2例接受安慰剂治疗。安全性数据显示：未发生剂量限制性毒性，无严重不良事件。盲态数据分析显示，CELZ-201-DDT在缓解背痛和恢复功能方面表现出可喜的治疗潜力。在对首批数据进行全面安全性评估后，独立数据安全监测委员会（DSMB）建议按计划推进临床试验至下一患者队列。 CELZ-201-DDT是Creative Medical Technology Holdings研发的基于干细胞的治疗产品，旨在修复受损椎间盘组织、减轻慢性背痛并恢复患者功能。 ALLO-329：IND申请获FDA许可 Allogene Therapeutics公司宣布，在研同种异体CAR-T细胞疗法ALLO-329用于治疗多种自身免疫性疾病的1期临床篮子试验的IND申请已经获得美国FDA的许可。这项名为RESOLUTION的1期篮子试验将在系统性红斑狼疮、特发性炎症性肌病和系统性硬化症患者中评估ALLO-329的疗效和安全性，预计在2025年年中展开。 ALLO-329是一款靶向CD19和CD70两个靶点的CAR-T细胞疗法，可靶向CD19阳性B细胞和CD70阳性激活T细胞。这一策略可能同时针对B细胞和T细胞功能失常，从而带来更好的治疗效果。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] SAB BIO Announces Positive Topline Phase 1 Clinical Results. Retrieved January 28, 2025, from https://www.globenewswire.com/news-release/2025/01/28/3016248/0/en/SAB-BIO-Announces-Positive-Topline-Phase-1-Clinical-Results-with-Potentially-Disease-Modifying-T1D-Therapy-SAB-142.html [2] Allogene Therapeutics Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune Diseases. Retrieved January 28, 2025, from https://www.globenewswire.com/news-release/2025/01/28/3016394/0/en/Allogene-Therapeutics-Secures-U-S-FDA-IND-Clearance-for-ALLO-329-Advancing-its-Next-Generation-Allogeneic-CAR-T-into-Autoimmune-Diseases.html [3] Vincerx Pharma, Inc. and Oqory, Inc. Highlight Promising Data for Oqory’s TROP2 Antibody Drug Conjugate, OQY-3258. Retrieved January 29, 2025, from https://investors.vincerapharma.com/news-releases/news-release-details/vincerx-pharma-inc-and-oqory-inc-highlight-promising-data-oqorys [4] Bicara Therapeutics Presents Phase 1/1b Dose Expansion Results with Ficerafusp Alfa in Advanced Squamous Cancer of the Anal Canal at the 2025 ASCO Gastrointestinal Cancers Symposium. Retrieved January 29, 2025, from https://ir.bicara.com/news-releases/news-release-details/bicara-therapeutics-presents-phase-11b-dose-expansion-results [5] GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-3650, Second-Generation TriKE for the Treatment of Hematologic Malignancies. Retrieved January 29, 2025, from https://www.gtbiopharma.com/news-media/press-releases/detail/288/gt-biopharma-announces-first-patient-dosed-in-phase-1-trial [6] Sapience Therapeutics Presents ST316 Phase 1 Dose Escalation Data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium. Retrieved January 29, 2025, from https://sapiencetherapeutics.com/sapience-therapeutics-presents-st316-phase-1-dose-escalation-data-at-the-2025-american-society-of-clinical-oncology-asco-gastrointestinal-gi-cancers-symposium/ [7] Tectonic Therapeutic Announces Positive Interim Data from Phase 1b Trial for TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF. Retrieved January 30, 2025, from https://www.globenewswire.com/news-release/2025/01/30/3017839/0/en/Tectonic-Therapeutic-Announces-Positive-Interim-Data-from-Phase-1b-Trial-for-TX45-in-Patients-with-Group-2-Pulmonary-Hypertension-in-HFpEF.html [8] Tubulis Announces First Patient Dosed in Phase I/IIa Trial Evaluating ADC TUB-030 in Advanced Solid Tumors. Retrieved January 30, 2025, from https://www.businesswire.com/news/home/20250130888316/en [9] Creative Medical Technology Holdings Announces Positive Initial Safety, Tolerability, and Efficacy Data from First Cohort in Phase 1/2 Trial of CELZ-201-DDT for Chronic Back Pain. Retrieved January 30, 2025, from https://www.globenewswire.com/news-release/2025/01/30/3018142/0/en/Creative-Medical-Technology-Holdings-Announces-Positive-Initial-Safety-Tolerability-and-Efficacy-Data-from-First-Cohort-in-Phase-1-2-Trial-of-CELZ-201-DDT-for-Chronic-Back-Pain.html [10] Ethris Presents Positive Topline Phase 1 Data with mRNA Lead Candidate ETH47 for Uncontrolled Asthma. Retrieved January 30, 2025, from https://www.businesswire.com/news/home/20250130943965/en [11] Owkin Announces First Patient Dosed in Phase I AI-optimized Clinical Trial of OKN4395, a First-in-Class EP2/EP4/DP1 Triple Inhibitor for Patients with Solid Tumors. Retrieved January 30, 2025, from https://www.businesswire.com/news/home/20250130436779/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床1期抗体药物偶联物临床结果信使RNA

100 项与 ESG-401 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
三阴性乳腺癌	临床3期	中国	上海诗健生物科技有限公司	2025-09-01
晚期三阴性乳腺癌	临床3期	中国	上海诗健生物科技有限公司	2025-04-03
转移性乳腺癌	临床3期	中国	上海诗健生物科技有限公司	2024-07-11
HR阳性/HER2阴性乳腺癌	临床3期	中国	上海诗健生物科技有限公司	2024-06-25
HR阳性/HER2阴性乳腺癌	临床3期	中国	东曜药业有限公司	2024-06-25
膀胱癌	临床2期	中国	上海诗健生物科技有限公司	2021-09-14
结直肠癌	临床2期	中国	上海诗健生物科技有限公司	2021-09-14
非小细胞肺癌	临床2期	中国	上海诗健生物科技有限公司	2021-09-14
卵巢癌	临床2期	中国	上海诗健生物科技有限公司	2021-09-14
胃癌	临床2期	中国	上海诗健生物科技有限公司	2021-09-14

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临床结果

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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


NCT04892342 (Company_Website) 人工标引	临床1期	实体瘤 \| 三阴性乳腺癌 \| HR阳性/HER2阴性乳腺癌	150	OQY-3258 (ESG401) (previously untreated TNBC)	窪範膚齋範齋窪觸築鏇(簾艱遞構遞餘鑰襯艱製) = 壓製夢膚膚鏇鏇製醖衊鏇願遞鹽範願獵獵願願 (醖顧鏇顧願鑰淵範鹽築 ) 更多	积极	2025-01-29
				OQY-3258 (ESG401) (late-stage TNBC)	窪範膚齋範齋窪觸築鏇(簾艱遞構遞餘鑰襯艱製) = 築範餘獵繭築簾遞選齋鏇願遞鹽範願獵獵願願 (醖顧鏇顧願鑰淵範鹽築 ) 更多
NCT04892342 (ESMO2024) 人工标引	临床1期	三阴性乳腺癌 \| HER2阳性乳腺癌 \| HR阳性/HER2阴性乳腺癌一线 HER2 Positive \| Hormone Receptor Positive \| PR Negative \| ... 更多	117	ESG401tage HR+/HER2-BC 12 mg/kg	窪衊襯構廠襯鏇膚鬱遞(鹽獵構選蓋構壓膚繭鬱) = 築鏇鬱鬱壓壓醖憲觸齋憲繭鏇範鏇鹹鬱網餘觸 (糧醖膚鏇獵獵構簾顧艱, 64.7 ~ 87.5) 更多	积极	2024-09-16
				ESG401tage TNBC 12 mg/kg	窪衊襯構廠襯鏇膚鬱遞(鹽獵構選蓋構壓膚繭鬱) = 壓膚蓋艱鑰鏇網餘鹹廠憲繭鏇範鏇鹹鬱網餘觸 (糧醖膚鏇獵獵構簾顧艱, 44.8 ~ 77.5) 更多
NCT04892342 (ESMO2024) 人工标引	临床1期	转移性HER2阴性乳腺癌一线 HER2 Negative	16	ESG401 12 mg/kg	鏇廠網蓋壓積夢鹹糧鹽(襯範憲壓壓獵鹹積鏇醖) = 鹽遞簾壓觸膚鹽餘鏇顧構網窪網壓遞廠窪鑰鹹 (鬱網願膚範蓋構繭壓觸, 15.2 ~ 64.6) 更多	积极	2024-09-15
NCT04892342 (Literature \| Pubmed \| Cell Rep Med) 人工标引	临床1期	实体瘤	40	ESG401	蓋觸遞壓鹽齋鬱憲顧壓(齋積廠範簾糧願壓鏇獵) = 簾憲顧襯艱鏇艱窪顧鏇製蓋艱獵選鑰淵獵齋製 (齋簾憲築夢鬱簾構蓋醖 ) 更多	积极	2024-08-30
				ESG401 (TRD)	蓋觸遞壓鹽齋鬱憲顧壓(齋積廠範簾糧願壓鏇獵) = 簾壓壓範製蓋繭餘獵積製蓋艱獵選鑰淵獵齋製 (齋簾憲築夢鬱簾構蓋醖 ) 更多
NCT04892342 (ASCO_Breakthrough2024) 人工标引	临床1期	三阴性乳腺癌一线	19	ESG401	憲網鑰襯齋憲壓築憲鏇(積糧積壓鹹齋製夢餘醖) = 鏇鬱餘築淵鏇艱鬱淵簾鏇鑰製膚壓簾齋範淵願 (選餘獵構糧淵鏇壓餘網 ) 更多	积极	2024-08-09
NCT04892342 (ESG401, ASCO2024)	临床1期	三阴性乳腺癌一线 TROP2	23	ESG401 (16 mg/kg IV)	製夢夢範醖築糧獵廠鹽(範餘築網願淵選獵糧繭) = 獵鹽顧觸壓蓋壓網繭襯願獵築鏇窪膚糧鹹襯餘 (蓋願艱簾選願積壓淵顧 ) 更多	积极	2024-05-24
NCT04892342 (ESG401-101, ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	实体瘤	35	ESG401 (triple negative breast cancer)	構鏇糧鑰蓋遞淵繭糧襯(夢糧鏇網蓋襯鏇壓選願) = 艱蓋膚廠製餘蓋襯襯鏇衊選觸繭餘膚網餘淵蓋 (鏇鹹艱襯構醖積鑰醖蓋 ) 更多	积极	2023-05-26
				ESG401 (HR+/HER2- breast cancer)	構鏇糧鑰蓋遞淵繭糧襯(夢糧鏇網蓋襯鏇壓選願) = 觸網築淵齋餘積餘淵壓衊選觸繭餘膚網餘淵蓋 (鏇鹹艱襯構醖積鑰醖蓋 ) 更多
NCT04892342 (ESG401-101, NEWS) 人工标引	临床1/2期	实体瘤	-	ESG-401	膚蓋齋簾艱夢糧網齋積(艱憲襯鏇膚艱積繭衊齋) = 血液毒性（白细胞和中性粒细胞降低、贫血）和消化道毒性（严重腹泻）出现的频率和程度均大幅度降低。襯壓餘獵憲築淵窪鏇鹽 (積糧糧餘鹽鬱網獵蓋襯 )	积极	2022-09-21