This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.

开始日期2025-01-01

申办/合作机构

OHSU Knight Cancer Institute

[+3]

NCT06607692 / Recruiting临床2期IIT

Single-arm Open-label Phase II Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed)

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)

开始日期2024-10-01

申办/合作机构-

NCT05687123 / Recruiting临床1期IIT

A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors

This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.

开始日期2024-08-14

申办/合作机构

National Cancer Institute

100 项与 (177镥)镥氧奥曲肽相关的临床结果

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100 项与 (177镥)镥氧奥曲肽相关的转化医学

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100 项与 (177镥)镥氧奥曲肽相关的专利（医药）

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1,057

项与 (177镥)镥氧奥曲肽相关的文献（医药）

2025-01-01·SURGERY

Surgery enhances the effectiveness of peptide receptor radionuclide therapy in metastatic gastroenteropancreatic neuroendocrine tumors

Article

作者: Gujarathi, Rushabh ; Vaghaiwalla, Tanaz ; Keutgen, Xavier M. ; Liao, Chih-Yi ; Tobias, Joseph ; Abou Azar, Sara ; Keutgen, Xavier M ; Nordgren, Rachel ; Feinberg, Nicholas ; Millis, J. Michael ; Millis, J Michael

BACKGROUND:

With the advent of peptide receptor radionuclide therapy, the timing and sequence of surgery in the treatment of metastatic gastroenteropancreatic neuroendocrine tumors merits further study. We hypothesized that surgery before peptide receptor radionuclide therapy might enhance its effectiveness in patients with metastatic gastroenteropancreatic neuroendocrine tumors.

METHODS:

Eighty-nine patients with metastatic well-differentiated gastroenteropancreatic neuroendocrine tumors treated with ¹⁷⁷Lutetium-dotatate peptide receptor radionuclide therapy between 2018 and 2023 were included. Fifty-six patients underwent surgery (primary tumor resection and/or liver debulking) before peptide receptor radionuclide therapy and 33 patients did not. Primary outcome was progression-free survival according to Response Evaluation Criteria in Solid Tumors. Pretreatment dotatate positron emission tomography/computed tomography was used to calculate tumor volumes.

RESULTS:

The surgery and no-surgery groups were well-matched. Median progression-free survival after peptide receptor radionuclide therapy was 15.6 months (interquartile range, 9.1-22.7 months) in the no-surgery group compared with 26.1 months (interquartile range, 12.7-38.1 months) in the surgery group (P = .04). On subgroup analysis, median progression-free survival was 18.1 months (interquartile range, 11.9-38.4 months) in patients who underwent primary tumor resection only compared with 26.2 months (interquartile range, 14.0-38.1 months) in patients who underwent liver debulking (P = .04). Tumor volume was lowest in patients who underwent liver debulking (median 146.07 mL³) compared with no surgery (median 626.42 mL³) (P = .001). On univariable analysis, a tumor volume <138.8 mL³ was associated with longer progression-free survival (hazard ratio, 2.03; 95% confidence interval, 0.95-4.34, P = .05), with a median progression-free survival of 38.1 months (interquartile range, 16.9-41.3 months) compared with 17.8 months (interquartile range, 10.8-28.7 months).

CONCLUSION:

Surgery may enhance the effectiveness of ¹⁷⁷Lutetium-dotatate in the treatment of metastatic well-differentiated gastroenteropancreatic neuroendocrine tumors. This positive effect may be the result of a lower tumor volume in patients after surgery. Our findings fortify the concept of using surgical debulking to improve systemic therapies such as peptide receptor radionuclide therapy.

2025-01-01·CLINICAL NUCLEAR MEDICINE

A False-Negative 123I-MIBG SPECT/CT With True-Positive 68Ga-DOTATATE PET/CT in a Patient With Neuroblastoma Following 177Lu-DOTATATE Therapy

Article

作者: Lu, Xia ; Yang, Jigang ; Wang, Wei ; Li, Siqi ; Xu, Yanfeng

Abstract:

A 10-year-old girl with high-risk neuroblastoma underwent 123I-MIBG SPECT/CT and 68Ga-DOTATE PET/CT, which both showed multiple bone metastases. However, following 177Lu-DOTATATE therapy, only 68Ga-DOTATATE PET/CT identified residual lesions with negative 123I-MIBG SPECT/CT results. The case emphasized the complementary role of 68Ga-DOTATATE PET/CT and 123I-MIBG SPECT/CT after 177Lu-DOTATATE therapy.

2024-12-01·NUCLEAR MEDICINE COMMUNICATIONS

SeHCAT retention measurements may be compromised by traces of 177Lu/177mLu more than 90 days after 177Lu-DOTATATE was administered

Article

作者: Meades, Richard ; Willson, Tamar

[75Se]tauroselcholic acid (SeHCAT) retention measurement provides a noninvasive test for bile acid diarrhea (BAD); however, it is sensitive to the presence of other radionuclides. Two SeHCAT patients at the Royal Free Hospital (RFH) had significant discrepancies between the lower photopeak (111–159 keV) and central photopeak (242–296 keV) windows, indicating contamination with a radionuclide other than 75Selenium. These patients had received lutetium-177 oxodotreotide (177Lu-DOTATATE) therapy 98 and 151 days before their SeHCAT tests. Traces of 177Lu may be retained longer than typically modeled, along with the contaminant 177mLu. This work includes a retrospective audit to examine the prevalence of SeHCAT tests being affected by 177Lu and phantom measurements to investigate the potential impact. Of 579 patients who received 177Lu-DOTATATE therapy at our center, 11 subsequently attended for a SeHCAT test. The two previously identified patients may have had compromised SeHCAT results; however, the other patients had longer intervals between their therapy and test, and their tests are believed to be valid. Spectra were acquired from a phantom containing either a SeHCAT capsule or a mixture of 177Lu/177mLu representative of a patient >90 days after their treatment. The SeHCAT spectrum was scaled to produce simulated day-7 spectra, and the SeHCAT retention that would have been calculated if 177Lu/177mLu were present was determined. All SeHCAT measurement windows are affected by the 177Lu/177mLu, producing clinically significant errors. Patients requiring SeHCAT testing should be asked whether they have ever received 177Lu-DOTATATE. Patient-specific background measurements may be useful for checking for significant levels of other radionuclides.

432

项与 (177镥)镥氧奥曲肽相关的新闻（医药）

2024-12-15

·E药经理人

2024-2030年RDC核药行业深度调研及发展战略咨询报告

随着全球核药技术的不断发展，治疗型核药快速发展全球 RDC 药物加速开发与商业化落地。目前全球已有11款RDC 药物获批上市，其中9款药物用于诊断，2款药物用于治疗，上市的RDC 药物靶点集中于前列腺特异性膜抗原(PSMA)和生长抑素受体(SSTR)。特别是 2018 年和 2022 年诺华的两款重磅 RDC 产品(Lutathera、Pluvicto)获批上市后展现的优异疗效以及快速的商业化放量，吸引全球更多的MNC将资源投入治疗用核药的开发上。2023年Pluvicto的销售额约为9.21亿美元，2024 上半年该药销售额已超过5亿美元，预计全年销售额将超过 10 亿美元。从长远来看，2026年全球核药市场规模有望超百亿美元目前诊断类核药占比近七成。自2013年起全球核药市场规模快速扩容，十年间的 CAGR 约为6%，据Nature(自然杂志)披露 2026 年全球核药市场规模有望达120 亿美元，而据Evaluate 预测，到2028 年全球治疗型放射性药物的年销售额预计将超过 60 亿美元，治疗用核药市场规模占核药整体市场比重有望快速提升。而据中国核安全局数据显示，预计2025 年，国内放射性药物市场规模将达到93 亿元人民币，到 2030年，市场规模将进一步增加至260 亿元人民币。那么，在RDC核药当前形势下，我们该如何把握和抓住RDC 核药的发展机遇和前景趋势呢? 识别二维码▼查看完整版报告《2024-2030 年 RDC 核药行业深度调研及发展战略咨询报告》正是在这一背景下应运而生，旨在通过全面、深入的分析，为业界提供一份关于 RDC 核药行业未来发展趋势的权威指南。本报告基于广泛的市场调研、专家访谈、政策解读以及技术创新追踪，力求从多角度、多层次揭示 RDC 核药行业的现状、挑战与机遇。识别二维码进群▼了解更多报告一审| 黄佳二审| 李芳晨三审| 李静芝

放射疗法上市批准

2024-12-14

·医学新视点

《自然-医学》年度预测发布！2025年，这11项研究或塑造医疗新格局

▎药明康德内容团队编辑 2024年即将过去，医学界取得了不少的突破和进展。内分泌领域的司美格鲁肽、替尔泊肽等兼具减重、降糖等多方面疗效的药物引发广泛关注；肝脏疾病方面，美国FDA批准了首个用于治疗非酒精性脂肪性肝病的药物；心血管领域，多款siRNA疗法为高血压、高血脂患者带来了新选择。迈向2025年，有哪些新的医疗技术或创新将产生，为临床医学治疗提供切实可行的解决方案？近日，《自然-医学》（Nature Medicine）发表的年度盘点系列文章，来自哈佛医学院、牛津大学、妙佑医疗等机构的全球知名科学家，预测了有望在2025年塑造医学新局面的11项重磅研究，涵盖了乳腺癌筛查、基因编辑、自闭症干预等多个疾病或医学技术领域。截图来源：Nature Medicine 1、朊病毒病的基因药物朊病毒病是由朊病毒引起的导致人类和哺乳动物中枢神经系统退化性疾病，人朊病毒病包括克-雅病、库鲁病等，动物疾病包括牛海绵状脑病（俗称“疯牛病”）、羊瘙痒症等。每6000人中就有1人因朊病毒疾病死亡，因此朊病毒病并不罕见。来自美国麻省理工学院和哈佛医学院布罗德研究所的Sonia Vallabh教授团队，发起了一项评估对朊病毒疾病鞘内注射ION-717的安全性、耐受性和药代动力学的研究。ION-717是一种反义寡核苷酸，研发目的是抑制朊病毒蛋白的产生。目前，全球已有16个临床医学中心正在开展ION-717相关试验，第一批研究数据有望在2025年披露。Sonia Vallabh教授表示：“我们正在为神经退行性疾病的早期治疗而努力，若能越早开始早期治疗，就越能保护患者的大脑功能”。 2、镰状细胞疾病的碱基编辑，有望造福广大血液病患者既往碱基编辑在离体试验和体内试验均获得了成功，因此来自哈佛大学的David Liu教授团队主导开展了“首个”针对造血干细胞的碱基编辑临床试验。若该试验能获得成功，将有望造福广大血液病患者，因为人体内所有的血细胞，包括免疫细胞，均来源于造血干细胞。这项名为BEACON的研究是一项开放标签、单臂、多中心的1/2期研究，目的是评估自体碱基编辑的CD34+造血干细胞和祖细胞（BEAM-101）在严重镰状细胞疾病患者中应用的安全性和有效性。经过碱基编辑的造血干细胞理论上将增加胎儿血红蛋白水平，并改善患儿临床症状。David Liu教授表示：“我希望临床碱基编辑能在造血干细胞中发挥作用，因为据我所知另外三项碱基编辑相关临床试验已获得了积极的临床结果”。 3、个体化筛查乳腺癌目前，临床对于乳腺癌的筛查主要基于年龄，大多数国家指南建议从50岁开始筛查乳腺癌。但这种筛查方式存在一定局限性，仅能够将乳腺癌死亡率降低20%左右，却增加了不必要的诊断和治疗。考虑到尽管每位女性都存在罹患乳腺癌的风险，风险大小与遗传、生活方式、环境暴露等息息相关，因此采用更为个体化的方式调整筛查的年龄和频率，让高风险女性接受更为频繁的筛查，低风险女性减少不必要的乳房X线检查是更为合理的。法国Gustave Roussy研究所的Suzette Delaloge教授团队领衔了MyPeBS试验，据Suzette Delaloge教授介绍，这是目前同类研究中规模最大的一项全球性试验，纳入全球6个国家的超5.3万女性，比较遵循当前标准乳腺癌筛查和基于发病风险的个体化筛查策略的女性，随访第4年后乳腺癌发病率情况。Suzette Delaloge教授表示：“如果研究结果证实个体化筛查效果与标准筛查一致，甚至优于标准筛查，那么将有望彻底改变乳腺癌预防策略。我们希望这种方式能改善乳腺癌高风险女性的临床结局，同时也能最大限度地降低对低风险女性的不必要伤害”。图片来源：123RF 4、精准营养支持食物和饮食对不同人的作用存在较大差异。既往饮食相关指南建议的制定，来源于传统饮食干预的研究结果，这些研究通常纳入的人群比较有限，因此饮食指南建议可能忽略了从饮食中获益特别大或特别小的人群。美国国立卫生研究所资助了一项精准健康营养项目，目的是尽可能地了解哪些因素造成人们对于相同食物的不同反应。来自易斯安那州立大学的Leanne Redman教授领衔了这项研究，该研究纳入了8000多例成人参与者，设定的排除标准较少，旨在扩大当前营养指南的覆盖范围，以指导更多人群。研究人员在详细记录了个体的日常饮食、遗传信息、体内微生物组、生活习惯、医疗史和健康史对个人饮食的影响后，利用机器学习和统计模型来确定与饮食选择最相关的个人特征，并预测哪些食物和饮食模式对个体更有益。这项研究的所有数据收集工作预计在2026年夏季结束，研究人员预期能够在2025年公布首批数据相关结果。 5、前列腺癌的核药自美国FDA批准Lu177-PSMA-617疗法用于治疗前列腺特异性膜抗原（PSMA）阳性转移性去势抵抗性前列腺癌成人患者（已接受雄激素受体信号通路抑制剂和紫杉烷类化疗的）以来，在前列腺癌治疗模式中探索Lu-177的作用开始为科学界所关注。事实上，使用Lu-177作为PSMA的治疗，这一想法早在15年前就被提出，但直到最近这一想法才有了比较实质性的进展，且已有几项临床研究正在进行中，如PSMAfore试验和PSMAddition试验。此前，美国妙佑医疗的Oliver Sartor教授已在2023年欧洲肿瘤学会年会上介绍了PSMAfore试验，结果显示Lu177-PSMA-617可显著改善转移性去势抵抗性前列腺癌患者的总生存期。目前Lu177-PSMA-617的扩展适应证申请已递交美国FDA，美国FDA预计将在2025年公布审批结果。PSMAddition试验则比较了Lu177-PSMA-617与标准疗法在PSMA阳性转移性前列腺癌患者中的疗效，这些患者均未经治疗或仅接受最低限度治疗。若Lu177-PSMA-617的扩展适应证能成功通过审批，将有望改变全球数十万前列腺癌患者的现在有治疗策略。 6、自闭症儿童的学习游戏自闭症儿童在社交和兴趣爱好方面能力有限。美国斯坦福大学Dennis P. Wall教授团队设计了一款游戏，适用于广泛自闭症儿童，为他们提供有效治疗，增加社交中的目光接触、动机和注意力，并减少兴趣缺失的焦虑感受。这款游戏在孩子及其照顾者中建立了社会“关系”，有望减少照顾者心理压力，同时消除患儿与社会融合不畅出现的负面影响。通过游戏过程中产生的数据，研究人员可用于搭建和训练能够理解自闭症患者的人工智能工具，并不断增加患儿的参与度。目前，这项研究正在招募年龄2~8岁的自闭症儿童。图片来源：123RF 7、聊天机器人帮助筛查宫颈癌 Farida Selmouni教授来自法国里昂国际癌症研究所，她的团队在开展一项对年龄30~65岁女性的宫颈癌筛查研究中遇到了一些困难，该研究需要这些女性自我进行人乳头瘤病毒（HPV）采样，但仅有不到20%的人愿意完成这项操作。为了解决这个问题，Farida Selmouni教授团队开发了一款聊天机器人，通过手机上APP，参与者即可获得相关宫颈癌的信息。研究人员在此之前已对参与者开展定性研究，了解他们的需求后设计了该聊天机器人。从结果来看，参与者对这款聊天机器人非常满意，因为她们的问题基本都能得到快速解答。目前，研究团队正在开展的一项评估聊天机器人对于改善基于HPV检测的宫颈癌女性筛查影响的随机对照研究，预计研究在2025年结束。 8、评估青少年心理健康的工具包正在进行的mSELY研究希望了解数字干预措施，是否有助于解决青少年心理健康问题。因此，美国纽约大学的Keng‑Yen Huang教授团队开发了可评估青少年心理健康的工具包，可以帮助青少年与同伴间建立联系，也能够评估和管理他们的心理健康需求。研究人员会将相关数据返回给青少年，让他们对自己有更清晰的认识。Keng‑Yen Huang教授表示：“我们希望为青少年及其父母提供的数字干预措施工具能强调一个事实，那就是父母需要与孩子进行开放式沟通交流”。 9、大麻二酚用于预防精神病 Philip McGuire是牛津大学精神病学教授，他主导了一项探索使用大麻二酚用于早期精神病的分层治疗研究（STEP）。STEP研究包含3项临床试验，在全球11个国家的30家医疗中心开展，计划对约1000例精神病患者使用大麻二酚治疗，利用磁共振成像等技术来阐明大麻二酚的作用，以及探索预测治疗成功的生物标记物。每项试验均涵盖不同病情阶段的精神病患者，分别为1）精神病高风险患者，目的是了解大麻二酚能否阻止患者病情进展；2）近期罹患精神病患者；3）治疗耐药患者。Philip McGuire教授表示，他们预计在2025年获得关于大麻二酚治疗精神病的首个安全性和耐受性结果。图片来源：123RF 10、冷却屋顶以预防与炎热相关的疾病德国海德堡大学的Aditi Bunker教授团队正在全球各地开展试验，以了解更多应对各种气候变化的干预措施。他们的研究之一就是使用高反射性屋顶涂层材料，通过反射太阳辐射和阻止热量传导，让屋顶变得“凉爽”，从而降低室内温度。通过这种简单的方式，就有望减少炎热相关疾病的发生和患者死亡。最近他们在西非开展的一项冷却屋顶研究刚结束，数据结果正在分析中。这项研究目的是了解冷却屋顶与改善人类健康之间是否存在因果关系、热量是如何影响人类健康的以及是否应该推广这项干预措施。 11、气候变化对营养的影响德国波恩大学的Ina Danquah教授团队正在开展ALIMUS研究，这项多中心随机对照试验的目的是希望解决气候变化对营养的影响作用。由于气候变化，以玉米、小麦和高粱为主食的国家和地区可能受到影响，因为这些农作物的铁、锌、硒和蛋白质等营养素水平可能所有下降。研究团队希望探索将家庭园艺和营养支持进行结合，通过鼓励当地居民在离家近的地方种植蔬菜和水果，来增加日常饮食的多样性，以抵消主要农作物营养素流失的影响，再通过儿童的年龄、身高评分来评估当地人营养状况。这项研究与2020年开始，目前已进入最后研究阶段，结果将于2025年中公布。点击文末“阅读原文/Read more”，即可访问Nature Medicine官网阅读完整论文。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料 [1]Webster, P., Healey, N. Eleven clinical trials that will shape medicine in 2025. Nat Med 30, 3384–3388 (2024). https://doi.org/10.1038/s41591-024-03383-y 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「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com 分享，点赞，在看，传递医学新知

寡核苷酸siRNA临床研究核酸药物

2024-12-09

·GlobeNewswire-Health Care

Nusano and GlyTherix Announce Lutetium-177 Supply Agreement

VALENCIA, Calif. and SYDNEY, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Nusano, a physics company transforming the production of radioisotopes, and GlyTherix Ltd (GlyTherix), an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumors, today announced a supply agreement for non-carrier-added lutetium-177 (Lu-177). The agreement also provides GlyTherix access to Nusano’s future actinium-225 (Ac-225) production, currently scheduled to begin in 2026, and planned future production of zirconium-89 (Zr-89), lead-212 (Pb-212) and terbium-161 (Tb-161). GlyTherix's radiotherapy approach combines Lu-177 with an antibody targeting Glypican-1, a protein found in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma, esophageal and ovarian cancer. GlyTherix plans to use 177Lu-DOTAMiltuximab® in its planned Australian Phase Ib in 2025, followed by US Phase II trials in 2026. “GlyTherix is building a global network of radioisotope suppliers to support our clinical trials and ongoing research,” said Dr. Brad Walsh, CEO of GlyTherix. “We share Nusano’s enthusiasm for the future of radiopharmaceuticals and appreciate their focus on bringing supply stability to the market so more patients can access clinical trials and treatments.” Radioisotopes are essential components in the active pharmaceutical ingredients (API) used in new and emerging cancer therapies. Existing supply chains for these treatment-enabling resources are often strained, posing a risk to patient care, clinical trials, and ongoing drug development. “Nusano is working to enable multiple industries by making radioisotopes available and abundant,” said Chris Lowe, CEO of Nusano. “Our production of lutetitum-177 begins in early 2025 and will scale rapidly to meet the growing needs of drug developers, researchers and patients. We are honored to work with GlyTherix look forward to supporting their current and future efforts.” About NusanoNusano is a privately held physics company committed to bringing stability and innovation to the rapidly emerging and critically undersupplied medical radioisotopes market. Nusano’s proprietary ion source is smaller and more efficient than existing production methods. This results in significantly greater yields and allows for the simultaneous manufacturing of multiple radioisotopes. Nusano’s technologies will supply the fight against cancer and support diagnostic and therapeutic radiopharmaceutical development. The company’s state-of-the-art production facility opens in 2025 in West Valley City, Utah. For more, please visit www.nusano.com. About GlyTherix GlyTherix Ltd is an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumors. Miltuximab® specifically targets Glypican-1, a protein found in solid tumors such as prostate, bladder, pancreatic, glioblastoma, esophageal and ovarian cancers, and is not present in healthy tissue. The company has a strong proprietary and Intellectual property position covering both Miltuximab® and the antigen Glypican-1. This provides robust and long-term protection for the commercialization of important new treatments to people with little hope. GlyTherix has completed a ‘First-in-Human’ trial of 12 patients using Miltuximab® with no drug-related adverse events. Miltuximab® will be used in a Phase Ib trial as an antibody theranostic. GlyTherix is interested in partnerships or collaborations with larger biotech and pharmaceutical partners. Contacts: Nusano Media: Scott Larrivee, Nusano, 608-345-6629, scott.larrivee@nusano.comInvestor Relations: Joyce Allaire, LifeSci Advisors, LLC, 212-915-2569, jallaire@lifesciadvisors.com GlyTherix Dr. Brad Walsh, CEO, +61 413 231 296 or brad.walsh@glytherix.com

临床1期放射疗法

100 项与 (177镥)镥氧奥曲肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	V10XX04	DB13985

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
神经内分泌肿瘤	加拿大	Advanced Accelerator Applications USA, Inc.	2019-01-09
胃肠胰神经内分泌肿瘤	美国	Advanced Accelerator Applications USA, Inc.	2018-01-26
SSTR阳性胃肠胰神经内分泌肿瘤	欧盟	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	冰岛	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	列支敦士登	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	挪威	Advanced Accelerator Applications SA	2017-09-26

未上市

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
晚期神经内分泌肿瘤	临床3期	中国	北京先通国际医药科技股份有限公司	2024-06-01
晚期胰腺神经内分泌肿瘤	临床3期	中国	江苏恒瑞医药股份有限公司	2023-07-06
大肠类癌	临床3期	美国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	比利时	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	法国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	德国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	意大利	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	葡萄牙	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	西班牙	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	英国	Advanced Accelerator Applications SA	2012-09-06

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03972488 (NETTER-2, CTgov)	临床3期	胃肠胰神经内分泌肿瘤	226	30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot)+2.5% Lys-Arg sterile amino acid solution+Lutathera (Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm))	窪醖壓範襯構積獵範鑰(襯糧餘廠淵構糧鏇簾遞) = 淵糧廠鑰積鹽選簾醖鬱餘廠衊鏇餘繭遞壓醖壓 (網願鹽淵膚範夢鏇鏇餘, 窪夢膚壓築齋艱醖製積 ~ 淵鑰淵衊積淵膚鬱壓顧) 更多	-	2024-10-10
NCT03972488 (NETTER-2, CTgov)	临床3期	胃肠胰神经内分泌肿瘤	226	High dose 60 mg octreotide long-acting repeatable (Octreotide LAR 60 mg (Control Arm))	窪醖壓範襯構積獵範鑰(襯糧餘廠淵構糧鏇簾遞) = 製獵簾願餘膚製餘構壓餘廠衊鏇餘繭遞壓醖壓 (網願鹽淵膚範夢鏇鏇餘, 艱積蓋醖衊鹹淵範膚願 ~ 蓋夢築淵齋選淵糧齋鬱) 更多	-	2024-10-10
Biospace 人工标引	临床2期	脑膜瘤	20	Lutathera	築範衊鹹鹹觸膚淵顧膚(獵窪壓製蓋鑰範膚獵顧) = 範壓窪積遞廠壓膚簾築醖築襯鹹齋鬱衊簾繭觸 (糧選簾鏇積襯構遞窪繭 ) 更多	积极	2024-09-30
NCT04086485 (EANM2024)	临床1/2期	神经内分泌肿瘤 SSTR	11	Lu-177-DOTATATE + Olaparib	憲窪築鬱鹽築夢夢鏇構(積艱糧淵鏇蓋淵衊醖鏇) = 鹹鬱觸鹽範製積衊鹹鬱獵鑰壓廠積繭蓋膚醖網 (鬱齋獵艱襯鑰壓廠構遞, 0.77 ~ 248.85)	积极	2024-09-27
EANM2024	N/A	神经母细胞瘤	23	Lu-177 DOTATATE	蓋構網艱鏇鹹齋窪憲夢(積淵鏇繭餘觸壓鏇築選) = 繭淵網鏇遞獵顧網遞選築衊繭範壓艱壓築蓋範 (遞顧鏇窪鬱獵繭獵齋鏇 ) 更多	积极	2024-09-27
EANM2024	N/A	胃肠道肿瘤	36	[177Lu]Lu-DOTA-TATE (Ileal NET)	鑰醖衊鹽積窪醖醖築鹹(鑰鑰範構鏇鏇壓鏇構蓋) = 壓糧願構餘廠蓋醖夢糧觸鹽餘選網繭製夢餘衊 (艱觸鏇製襯網蓋鹽繭獵 ) 更多	积极	2024-09-27
ESMO2024	N/A	-	-	90Y DOTA-TATE	艱鏇願觸襯餘艱憲鏇醖(糧願衊鏇壓窪願範襯築) = 簾網廠觸醖積齋築製繭範憲簾淵鹽簾窪廠廠構 (蓋構觸憲鏇構襯淵餘醖, 40 ~ 100.4) 更多	-	2024-09-16
ESMO2024	N/A	-	-	177Lu DOTA-TATE	艱鏇願觸襯餘艱憲鏇醖(糧願衊鏇壓窪願範襯築) = 夢製鏇淵獵簾繭繭鏇淵範憲簾淵鹽簾窪廠廠構 (蓋構觸憲鏇構襯淵餘醖, 40 ~ 100.4) 更多	-	2024-09-16
ESMO2024	N/A	-	-	[177Lu]Lu-DOTA-TATE + octreotide 30 mg long-acting release (LAR)	鬱餘獵顧網餘選淵襯膚(餘鹹遞鏇壓獵積製鬱願): OR = 10.43 (95% CI, 3.98 ~ 27.29), P-Value = <0.1 更多	-	2024-09-13
ESMO2024	N/A	-	-	octreotide 60 mg LAR		-	2024-09-13
ESMO_GI2024 人工标引	N/A	神经内分泌肿瘤	44	PRRT+177Lu-Dotatate	製齋願齋壓觸選窪鹽積(簾鹹構襯鏇衊構簾糧鏇) = 遞夢餘積鬱憲鑰膚網壓觸夢憲鹹夢艱艱鑰蓋製 (顧獵廠衊顧膚廠醖壓鹹, 18.7 ~ 31.3) 更多	积极	2024-06-20
SNMMI2024	N/A	-	-	Lu-177 DOTATATE (Female patients)	憲淵簾構網艱遞鬱蓋淵(淵膚遞窪積夢積範鏇積) = 糧窪膚願壓糧簾範鬱築淵鏇鬱製繭鏇鹹願夢網 (鏇顧艱襯壓鹹糧鹹鹹範, 0.8–1.8) 更多	-	2024-06-09
SNMMI2024	N/A	肿瘤 \| Somatostatin Receptor-Positive Neuroendocrine Tumor	-	177Lu-DOTATATE	鬱醖觸艱衊鹹窪鑰獵鏇(鑰製夢鹹衊餘積壓襯築) = 夢願繭齋範製夢膚艱鏇夢觸鹽襯衊糧網鏇餘鹽 (餘顧窪範醖鬱窪顧築範, 35.0 ~ 51.3)	-	2024-06-09
SNMMI2024	N/A	肿瘤 \| Somatostatin Receptor-Positive Neuroendocrine Tumor	-	Control (octreotide LAR)	鬱醖觸艱衊鹹窪鑰獵鏇(鑰製夢鹹衊餘積壓襯築) = 夢餘鏇構夢構網顧鏇鏇夢觸鹽襯衊糧網鏇餘鹽 (餘顧窪範醖鬱窪顧築範, 3.8 ~ 18.3)	-	2024-06-09