更新于：2024-06-29

Zenocutuzumab

更新于：2024-06-29

概要

研发状态

概要

基本信息

药物类型

双特异性抗体

别名

HER3 x HER2 Biclonics、Immunoglobulin g1, bispecific, anti-(human epidermal growth factor receptors, her2 and her3) (humanized clone mcla-128 .gamma.1-chain), disulfide with humanized clone mcla-128 light chain, dimer、Mcla-128 (igg1 bispecific antibody with enhanced antibody-dependent cell-mediated cytotoxicity (adcc) activity targeting her2 and her3 receptors.)

+ [5]

靶点

HER2 x HER3

作用机制

HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、HER3拮抗剂(受体酪氨酸蛋白激酶erbB-3拮抗剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [3]

在研适应症

NRG1融合阳性非小细胞肺癌NRG1融合阳性胰腺癌转移性去势抵抗性前列腺癌+ [4]

非在研适应症

食管癌

原研机构

Merus NV

在研机构

Merus NV

非在研机构-

最高研发阶段申请上市

首次获批日期-

最高研发阶段(中国)无进展

特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)

序列信息

Sequence Code 43197L

来源: *****

Sequence Code 26101535H

来源: *****

Sequence Code 315583329H

来源: *****

关联

项与 Zenocutuzumab 相关的临床试验

NCT05588609 / Recruiting临床2期

A Phase 2 Study Evaluating Activity of Zenocutuzumab (MCLA-128) in Patients With or Without Molecularly Defined Cancers

This is a Phase II, open-label, 2-arm, multicenter, international study designed to evaluate the efficacy of zenocutuzumab alone or in combination in patients with the following diagnoses:
Group A: NRG1+ NSCLC Group B: mCRPC

开始日期2022-11-17

申办/合作机构

Merus NV

NCT03321981 / Completed临床2期

Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC

A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (MBC) populations, Human Epidermal Growth Factor Receptor (HER) 2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2).
Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially zenocutuzumab is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet.
The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet.
In Cohort 2 zenocutuzumab is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

开始日期2018-01-15

申办/合作机构

Merus NV

NCT04100694 / AvailableN/A

Treatment Plan of the HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor

Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128 clinical trial or have other considerations that prevent access to MCLA-128 through an existing clinical trial. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual's medical history and program eligibility criteria.

开始日期-

申办/合作机构

Merus NV

100 项与 Zenocutuzumab 相关的临床结果

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100 项与 Zenocutuzumab 相关的转化医学

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100 项与 Zenocutuzumab 相关的专利（医药）

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项与 Zenocutuzumab 相关的文献（医药）

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Reichert, Janice M ; Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2023-08-17·The journal of physical chemistry letters

Zeno and Anti-Zeno Effects in Nonadiabatic Molecular Dynamics.

Article

作者: Gumber, Shriya ; Prezhdo, Oleg V

Decoherence plays an important role in nonadiabatic (NA) molecular dynamics (MD) simulations because it provides a physical mechanism for trajectory hopping and can alter transition rates by orders of magnitude. Generally, decoherence effects slow quantum transitions, as exemplified by the quantum Zeno effect: in the limit of infinitely fast decoherence, the transitions stop. If the measurements are not sufficiently frequent, an opposite quantum anti-Zeno effect occurs, in which the transitions are accelerated with faster decoherence. Using two common NA-MD approaches, fewest switches surface hopping and decoherence-induced surface hopping, combined with analytic examination, we demonstrate that including decoherence into NA-MD slows down NA transitions; however, many realistic systems operate in the anti-Zeno regime. Therefore, it is important that NA-MD methods describe both Zeno and anti-Zeno effects. Numerical simulations of charge trapping and relaxation in graphitic carbon nitride suggest that time-dependent NA Hamiltonians encountered in realistic systems produce robust results with respect to errors in the decoherence time, a favorable feature for NA-MD simulations.

2023-08-01·ISA transactions

Reachable set estimation for switched linear systems with state-dependent switching and bumpless transfer based event-triggered control

Article

作者: Li, Jinghan ; Zhao, Jun

This article focuses on the reachable set estimation and the state-feedback controller design for switched linear systems with a state-dependent switching and event-triggered control. First, the event-triggered bumpless transfer performance is given. The reachable set of the switched system is estimated under the proposed bumpless transfer based event-triggered mechanism by using the multiple Lyapunov functions method. A co-design of the event-triggered mechanism, a switching law and the controller gain is provided. Second, Zeno behavior is avoided by showing the existence of a positive lower bound on the event triggered interexecution intervals. Third, we design a state-feedback controller which contains the system states in a preset ellipsoid. Finally, numerical examples are given to illustrate the effectiveness of the theoretical claims.

项与 Zenocutuzumab 相关的新闻（医药）

2024-06-27

·E药经理人

全球首个HER3 ADC上市卡壳！礼来、艾伯维曾陷类似窘境，什么拦住了默沙东的FIC？

生产方面的缺陷为何到了FDA审查环节才被发现？撰文| Kathy 编辑| 润屿顿河就差临门一脚！凭着优异临床数据拿到优先审批资格，翘首以盼半年，默沙东和第一三共等来的却是一纸延迟批准的CRL（完整回复函）。本该摘下全球首个HER3成药光环的默沙东与第一三共，却在PDUFA（FDA对新药申请的目标批准日期）当日，遭遇反转。 6月26日，默沙东和第一三共宣布，其HER3 ADC药物Patritumab Deruxtecan基于第三方生产原因，被FDA延迟批准用于既往至少接受过两种系统治疗的EGFR突变型局部晚期或转移性非小细胞肺癌。 FDA的完整回复函中提到，延迟审批的原因来自于第三方制造设施检查相关的调查结果。作为全球首款申报上市的HER3 ADC，Patritumab Deruxtecan既承载着“全球首个HER3成药”的希望，更担着“默沙东的第一个ADC”的“重任”。不幸之中的万幸是，CRL表示，Patritumab Deruxtecan疗效和安全性数据并未存在问题。但隐藏于这番“侥幸”之下的，是越来越多好不容易迈过“十年十亿美元”研发难关的创新药，筑起千里之堤后，倏然“卡在”了生产方面的缺陷——一个或许最不该成为掣肘的环节上。打破成药黑洞只差最后一脚 73亿美元，这大概就是10个月前默沙东打包第一三共三款在研ADC产品权益时，HER3-DXd一条管线的价值，可想这含金量。具体而言，根据双方协议，双方达成合作时，默沙东一次性支付给第一三共7.5亿美元（约合54亿元）预付款用于HER3 ADC产品。待合作12个月后，继续支付7.5亿美元。预付款合计15亿美元。 HER3的竞争虽不及HER2激烈，但靶点被发现三十余年来，始终未能成药，谁能拔得头筹？备受瞩目。原本一路领跑的默沙东与第一三共，突然卡在终点线前，不禁让人惋惜。 Patritumab Deruxtecan原本是全球研发进展最快的HER3靶点药物。去年12月时，FDA受理了该药的BLA并给予优先审评，用于治疗EGFR突变的局部晚期或转移性非小细胞肺癌（NSCLC）且在接受第三代酪氨酸激酶抑制剂（TKI）和铂类药物治疗期间或之后出现疾病进展的患者。 Patritumab Deruxtecan递交的BLA是基于HERTHENA-Lung01关键性II期试验的主要结果和IASLC 2023世界肺癌大会（#WCLC23）上公布的数据结果，这些结果同时发表在《临床肿瘤学杂志》上。 HERTHENA-Lung01研究结果显示：在EGFR TKI和铂类化疗后疾病进展的225例EGFR突变局部晚期或转移性NSCLC患者中，Patritumab Deruxtecan治疗的客观缓解率（ORR）为29.8%（95%CI：23.9-36.2），包括1例完全缓解和66例部分缓解。中位缓解持续时间为6.4个月（95%CI：4.9-7.8）。细看FDA这次发出的CRL显示，被延期的原因主要是由于第三方制造设施检查相关的调查结果。让人稍感安慰的是，FDA表示疗效和安全性数据并未存在问题。这也意味着，待解决制造问题后，HER3 DXD ADC依然有希望成为照进黑洞的第一缕光，在ADC领域砸下重金的默沙东，依然还有拿下第一名的机会。然而，也极有可能的是，Patritumab Deruxtecan的第一名宝座会被摘得竞争对手弯道超车而抢占。双抗与ADC是近年来靶向HER3治疗中最有希望成药的两大赛道。就在上月，Merus公司的HER2/HER3双抗Zenocutuzumab上市申请已获FDA受理，并被授予了优先审评资格。此前有分析指出，若一切顺利，Zenocutuzumab有可能在今年11月获批。默沙东/第一三共与Merus，分别代表了ADC与双抗，双方正在首个HER3成药的审批上“暗暗较劲”，而在他们身后，处在研发阶段的企业也在奋力冲刺、虎视眈眈。百利天恒与BMS潜在总交易额高达84亿美元的项目BL-B01D1，同样是HER3靶点ADC，为EGFR×HER3双抗ADC。值得注意的是，Patritumab Deruxtecan与BL-B01D1是唯二处于临床III期的HER3 ADC。也难怪BMS此前不惜砸下重金。从研发进展来看，百利天恒已经在国内启动三项Ⅲ期临床与多项II期临床，同时BL-B01D1的Ⅰ/Ⅱ期探索性临床正在对十余个潜在适应证进行验证。此外，BL-B01D1正在开展全球多中心I期临床研究（BL-B01D1-LUNG101），根据此前披露，BMS及百利天恒将陆续启动在肺癌、乳腺癌领域的全球注册临床。就像Patritumab Deruxtecan此前曾多次遭遇临床研究失败一样，正处在II期阶段的另一款研发进展较为靠前的宜联生物HER3 ADC在上周被FDA叫停。 BioNTech在上周披露了一份SEC公告文件，其中显示FDA已部分暂停了其合作伙伴宜联生物的HER3 ADC BNT326/YL202的多中心、开放标签、首次人体I期临床（NCT05653752）。具体来看，由于试验过程中已有三位患者因药物副作用死亡，FDA表示了担忧，即在较高剂量下，可能会使人类受试者面临不合理和重大的疾病或伤害风险。究竟谁能打破HER3靶点被发现超过30年，却至今未有成药的尴尬现实？推荐阅读 * 曾10年蝉联榜首，今400亿美元围猎ADC，默沙东能重回全球药企TOP1吗？ * 全球TOP10药物大变！K药最"短命"，罗氏砍8大项目，AZ 、辉瑞停GLP-1，默沙东研发费用300亿…… 生产缺陷“害惨”了谁被延迟批准的FIC，Patritumab Deruxtecan不是第一个。上一个与其经历类似的选手Zolbetuximab，花费了近4个月的时间重新向FDA递交BLA，PDUFA也因此推迟了10个月。与HER3的相似，成名于2016年ASCO的Zolbetuximab是全球进展最快的Claudin 18.2靶点药物，一举一动同样全球瞩目。 2023年7月时，FDA基于安斯泰来提交的Zolbetuximab的优异的临床数据，授予其用于一线治疗不可切除、局部晚期或转移性、HER2阴性、胃或胃食管交界处 (GEJ) 患者的优先审批资格，PDUFA日期为2024年1月12日。同样在万众期待之下，安斯泰来收到的也是一封延迟审批CRL。在CRL信函中，FDA指出了Zolbetuximab第三方生产工厂未解决的缺陷，因此不能在原定的PDUFA日期前批准该药上市。历史总是惊人的相似，和Patritumab Deruxtecan目前的境况一样，FDA也未对Zolbetuximab的临床数据提出任何疑问，也没有要求安斯泰来开展额外的临床试验。虽然因生产缺陷暂时折戟FDA，Zolbetuximab今年3月在日本获批上市，成为全球首款且目前唯一获批的靶向CLDN18.2阳性、不可切除、晚期或复发性胃癌患者的治疗方案。在今年5月，安斯泰来重新向FDA递交了Zolbetuximab的BLA。根据处方药用户费用法案（PDUFA），FDA将新审批日期设定为今年的11月9日。一个第三方生产工厂的缺陷，让一款FIC药物上市后独占市场的时间减少至少十个月。安斯泰来与默沙东、第一三共的遭遇并非个案。包括艾伯维、礼来、诺和诺德、再生元在内的全球巨头，抑或是Biotech公司，都倒在了生产核查环节。来自生产方面的缺陷，在FDA发出CRL并延迟审批/拒绝其NDA/BLA申请的比例越来越高，甚至有企业连续四次都无法通过FDA的检查。 FDA签发CRL中所涉及的缺陷，一般分为7大类，即一般缺陷、药效、安全性、临床药理学、非临床研究、生产制造、标签。虽然药效、安全性仍然是FDA“说不”的最主要原因，但与生产制造相关问题的比例近年来明显攀升。公开数据统计，仅2023年，FDA共发出36封CRL（包含小分子及大分子药物），存在生产方面缺陷的CRL达到18封，占比已经高达50%。与药物安全性、有效性出现缺陷相比，生产方面相关的问题或许不是致命性的，但却同样会让一款药物的上市计划被搁置，轻则股价波动、重则商业化停滞、失去市场先机。艾伯维就在近日因为第三方生产商的问题第二次被FDA拒绝，股票在当日早盘交易中小幅下跌。 6月25日，艾伯维收到FDA就ABBV-951（foslevodopa / foscarbidopa）用于晚期帕金森病运动症状波动（motor fluctuations）的新药上市申请（NDA）发出的完整回复函（CRL）。时隔一年多再次被FDA拒绝批准的原因主要在于第三方生产商。 FDA列出了在对第三方合同生产组织检查中观察到的结果，不涉及ABBV-951及设备，也未提及ABBV-951（包括该组合的皮下注射泵装置）安全性、有效性、标签相关的任何问题，且没有要求艾伯维补充额外的疗效和安全性试验。不过艾伯维依然没有放弃，表示会继续与FDA保持积极合作，尽早为帕金森病患者提供该创新疗法。 MNC或许还能快速应对，对于抗风险能力较弱的Biotech公司来说，可能带来“灭顶之灾”。 Spectrum Pharmaceuticals就曾在收到FDA关于其Rolontis用于治疗接受骨髓抑制性癌症药物的患者的中性粒细胞减少证申请的CRL后，股价应声下跌了近30%，CRL信中提到因生产制造方面的缺陷，有必要对韩国的Hanmi Bioplant公司进行重新检查。比Spectrum处境更糟糕的ImmunityBio，其膀胱癌治疗药物Anktiva因第三方合同制造商存在缺陷而收到CRL，市值蒸发60%。一封CRL还带来了更严重的“后遗症”，此后ImmunityBio宣布裁员以简化运营，专注于当前的业务战略并降低成本。或许越来越多生产制造缺陷带来的CRL与警告信，正在给药物研发公司敲个警钟：在递交上市申请前，不论是自有工厂生产或委托第三方生产，都要进行风险评估与系统检查，对产品设计、生产工艺、设施等等全流程进行更严格的核查。生产方面的缺陷到了FDA审查才被发现，是否太晚了？回复“逆商”，了解电子期刊详情精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

抗体药物偶联物优先审批临床2期引进/卖出申请上市

2024-06-21

·Insight数据库

2024 年 5 月全球新药月度报告（附下载）

Insight 数据库整理了《2024 年 5 月全球新药获批上市清单》、《2024 年 5 月全球新药申请上市清单》。据统计，5 月全球获批上市 69 款新药（其中包括 12 款生物类似药和 11 款改良新药），申请上市 47 款新药（其中包括 11 款改良新和 4 款生物类似药）。详细清单可在正文内免费下载！ 5 月份全球新药热点资讯全球首款「抗血管生成联合免疫」机制的双特异性抗体新药依沃西单抗获批上市；潜在首款治疗 NRG1 阳性肿瘤的靶向疗法 Zenocutuzumab 申请上市；科伦博泰/默沙东 TROP2 靶向 ADC 临床结果积极；默沙东聚焦眼科领域，重金并购 EyeBiotech； Dato-DXd 为非鳞 NSCLC 患者带来具有临床意义的 OS 改善。基于真实可溯源的全球医药数据，丁香园 Insight 数据库每月推出「全球新药月报」，以期帮助业内人士通盘把握每月全球范围内的新药开发情况。报告内容节选试阅

抗体药物偶联物生物类似药上市批准

2024-05-24

·FierceBiotech

ASCO: Early peek at Merus' bispecific cancer data lives up to investors' expectations

Merus has been laying out plans to kick off a phase 3 trial of the antibody in second line head and neck cancer this year. Analysts have hailed Merus’ latest data drop in head and neck cancer as meeting investors’ expectations for the bispecific antibody. The slim slice of efficacy data, which Merus presented at the 2024 American Society of Clinical Oncology, comes from just 10 evaluable patients from a phase 2 trial. But the dual American and Dutch biotech has still been able to demonstrate a 60% response rate. The study is assessing petosemtamab, a bispecific antibody for EGFR x LGR5 cancers, in combination with Keytruda as a first-line treatment for recurrent/metastatic head and neck squamous cell carcinoma. By the Nov. 6, 2023, cutoff, 26 patients had been treated, with 24 continuing with their therapy. Only 10 were evaluable for response at this point, with six of these individuals seeing a tumor response, Merus explained in its May 23 release. They included one confirmed complete response, two confirmed partial responses, and three unconfirmed partial responses. In a note following the news, analysts at William Blair said they were “highly encouraged to see this level of efficacy, including a complete responder.” “Overall, this does appear to meet the bar set by many investors going into the release of a 60% response rate,” they added. Merus’ CEO Bill Lundberg, M.D., hinted at a further improved response rate that would be revealed when the biotech shares a “more mature clinical update from a later cutoff date” on a May 28 conference call. When assessing all 26 patients who received the petosemtamab-Keytruda regimen, Merus said “no significant overlapping toxicities were observed.” While treatment-emergent adverse events were reported in all patients, “most” were grade 1 or 2 in severity. Infusion-related reactions of various levels of severity were reported in 27% of patients, of which 3.8% were grade 3, and these all occurred during the first infusion before resolving, the company said. “We believe petosemtamab continues to demonstrate potential best-in-class safety and efficacy in head and neck cancer,” Lundberg said. “We are encouraged with the well-tolerated safety profile of the combination of petosemtamab and pembrolizumab, particularly with a low rate of grade 3 or greater adverse events, and a low rate of infusion-related reactions observed.” The biotech has already been laying out plans to kick off a phase 3 trial of the antibody in second-line head and neck cancer this year. A colorectal cancer study is also penciled in for this year. Talking to Fierce Biotech at the European Society for Medical Oncology conference in Madrid in October last year, Lundberg said the development of petosemtamab would be fueled by a $150 million public offering secured earlier in 2023. Leading Merus’ pipeline is the bispecific antibody zenocutuzumab, which has been submitted to the FDA for priority approval. Should the drug, which will be branded Zeno, get the green light from the regulator, it will be the first and only targeted therapy for patients with NRG1+ non-small cell lung cancer SCLC and pancreatic cancer, the company has said. Yesterday’s sneak peek at the petosemtamab data has so far received a warmer response than a similar cancer conference readout at the end of last year. For the European Society for Medical Oncology's Asia Congress 2023, Merus' shares dipped after an interim update for a bispecific therapy called MCLA-129 revealed three deaths in the lung cancer portion of an ongoing trial.

ASCO会议临床2期上市批准加速审批临床3期

100 项与 Zenocutuzumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11991	-	-	DB15559

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
NRG1融合阳性非小细胞肺癌	申请上市	美国	Merus NV	2024-05-06
NRG1融合阳性胰腺癌	申请上市	美国	Merus NV	2024-05-06
转移性去势抵抗性前列腺癌	临床2期	美国	Merus NV	2022-11-17
食管癌	临床2期	法国	Merus NV	2019-09-24
食管癌	临床2期	意大利	Merus NV	2019-09-24
食管癌	临床2期	荷兰	Merus NV	2019-09-24
食管癌	临床2期	葡萄牙	Merus NV	2019-09-24
食管癌	临床2期	西班牙	Merus NV	2019-09-24
ER阳性HER2低表达乳腺癌	临床2期	美国	Merus NV	2018-01-15
ER阳性HER2低表达乳腺癌	临床2期	比利时	Merus NV	2018-01-15

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03321981 (CTgov)	临床2期	HER2阳性乳腺癌 \| 转移性乳腺癌 \| ER阳性HER2低表达乳腺癌	105	Zenocutuzumab+Trastuzumab (Cohort 1 Doublet)	憲齋淵憲鑰顧窪網鏇獵(壓衊餘構廠艱壓積餘廠) = 壓淵鹹窪鹽顧簾構窪餘餘選艱窪築鏇齋築壓繭 (鹽憲蓋鑰遞觸艱淵簾衊, 糧鹽壓醖願壓齋鏇窪繭 ~ 鹹願壓範簾選餘襯夢觸) 更多	-	2024-03-07
NCT03321981 (CTgov)	临床2期	HER2阳性乳腺癌 \| 转移性乳腺癌 \| ER阳性HER2低表达乳腺癌	105	Zenocutuzumab+Trastuzumab+Vinorelbine (Cohort 1 Triplet)	憲齋淵憲鑰顧窪網鏇獵(壓衊餘構廠艱壓積餘廠) = 膚淵壓願廠鏇築願獵範餘選艱窪築鏇齋築壓繭 (鹽憲蓋鑰遞觸艱淵簾衊, 積範範繭廠選製膚膚鬱 ~ 構選鬱獵鏇夢鹹網構廠) 更多	-	2024-03-07
NCT02912949 (ESMO_ASIA2023) 人工标引	临床2期	NRG1融合阳性非小细胞肺癌 NRG1 Fusion	85	Zenocutuzumab	鑰壓鹽鹽築醖鏇蓋繭膚(夢艱鬱鑰願築淵蓋艱鹹) = 鏇鹹襯糧糧選簾鑰艱鬱鹹繭築繭構壓鬱糧夢憲 (蓋鏇糧艱鏇淵繭窪築鬱, 23-47) 更多	积极	2023-12-02
NCT02912949 (eNRGy, ESMO2023) 人工标引	临床2期	NRG1融合阳性胰腺癌 NRG1 fusion positive	38	Zenocutuzumab	糧範夢艱選鑰窪製鹹築(廠網淵衊糧鹽願廠餘壓) = 窪獵遞衊簾築醖廠餘願膚淵築艱鹽遞憲夢衊構 (艱築憲餘築簾膚淵鏇蓋, 26 ~ 65) 更多	积极	2023-10-23
NCT02912949 (eNRGy, ESMO2023) 人工标引	临床2期	NRG1融合阳性非小细胞肺癌 NRG1 Fusion	85	Zenocutuzumab	範願鏇鏇蓋遞鏇製獵壓(蓋鹹鑰鑰鏇遞窪淵積製) = 糧遞膚鹹淵蓋構築製顧廠鏇繭鹹範鑰餘範齋獵 (網夢獵築網簾鬱選廠膚 ) 更多	积极	2023-10-21
NCT02912949 (eNRGy, ASCO2022)	临床2期	NRG1融合阳性实体瘤	99	Zenocutuzumab (MCLA-128)	蓋窪膚糧醖憲鏇廠艱築(窪壓願觸獵衊觸醖鏇膚) = 醖窪願顧廠簾夢鹹鹹築顧網鏇築鏇夢衊鬱積鑰 (構憲網網鑰獵鑰遞積窪, 25;44) 更多	积极	2022-06-02
NCT03321981 (Corporate Publications) 人工标引	临床2期	HER2阳性转移性乳腺癌 HER2 Positive \| HER2 Amplification	39	trastuzumab+vinorelbine+MCLA-128	襯鬱選蓋醖齋範鹹鬱簾(積簾遞衊蓋積窪鏇鏇艱) = 範簾遞顧廠齋夢鑰築餘鑰壓糧襯觸鏇鏇製壓廠 (壓壓窪淵顧鏇淵糧憲醖, 34 ~ 63) 更多	积极	2021-12-10
NCT02912949 (ASCO2021) 人工标引	临床2期	实体瘤 \| 胰腺癌 NRG1 Positive	51	zenocutuzumab 750 mg	艱糧簾醖齋艱繭鏇夢醖(夢壓憲壓鑰製齋淵齋齋) = 淵夢壓遞鬱獵艱製範鹽簾齋鏇簾廠壓築觸願鹽 (製繭遞淵淵構顧夢觸觸, 15 ~ 70) 更多	积极	2021-05-20
NCT03321981 (ASCO2020) 人工标引	临床2期	转移性乳腺癌 ER positive \| HER2 Low Expression	48	endocrine therapy+zenocutuzumab	鏇願夢積膚衊膚鹽製廠(蓋選觸顧獵築淵衊鬱廠) = 鹽艱鑰餘製獵築醖鏇獵襯鬱製範網鏇獵廠願淵 (鏇鹽餘選膚顧製膚膚壓, 32 ~ 59)	积极	2020-05-29
NCT03321981 (ASCO2020)	临床2期	转移性乳腺癌	28	MCLA-128 (750 mg, 2h IV) + trastuzumab (8 mg/kg loading, then 6 mg/kg) + vinorelbine (25 mg/m², D1 and 8), q3w	艱獵糧齋齋顧淵齋鬱廠(鹽繭夢艱襯築鹽膚窪觸) = No clinically significant LVEF decline was seen 餘鬱鏇築願鑰遞鑰製膚 (艱廠艱製糧鏇夢醖願窪 ) 更多	积极	2020-05-25
NCT02912949 (ASCO2017)	临床1/2期	HER2阳性转移性乳腺癌	28	MCLA-128	網鏇觸醖艱選簾鑰積廠(餘鬱遞範憲鹹構窪壓壓) = G1-2 diarrhea in 2 pts each (13%) 鹽醖構鏇鏇蓋鑰膚襯衊 (鬱積選壓築夢願範築襯 ) 更多	积极	2017-05-30