A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors

This study aims to determine the safety and the recommended phase II dose of RYZ101 (actinium-225 labelled DOTA-octreotate (225Ac-DOTATATE)) in participants with refractory and relapsing multiple myeloma (MM) that have received at least 3 prior lines of myeloma therapy. Participants will be selected based on somatostatin receptor (SSTR) positivity assessed by gallium-68 labelled DOTA-octreotate (68Ga-DOTATATE) PET/CT. The response to 225Ac-DOTATATE therapy will also be assessed in the target study population.

开始日期2024-10-01

申办/合作机构

Jules Bordet Institute

[+1]

NCT06590857 / Recruiting临床1/2期

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) Alone and in Combination with Pembrolizumab in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)

Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) alone and with pembrolizumab in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.

开始日期2024-07-19

申办/合作机构

Rayzebio, Inc.初创企业

NCT05595460 / Recruiting临床1期

Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC.

开始日期2022-10-10

申办/合作机构

Rayzebio, Inc.初创企业

100 项与 RYZ-101 相关的临床结果

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100 项与 RYZ-101 相关的转化医学

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100 项与 RYZ-101 相关的专利（医药）

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项与 RYZ-101 相关的文献（医药）

2024-07-01·RADIOLOGY

Dotatate PET/CT and ²²⁵Ac-Dotatate Therapy for Somatostatin Receptor–expressing Metastatic Breast Cancer

Article

作者: Atzen, Sarah ; VanderMolen, Louis A. ; Ulaner, Gary A. ; Li, Gary ; Ferreira, Denis

Background Somatostatin receptors, and specifically somatostatin receptor type 2 (SSTR2), have primarily been associated with neuroendocrine tumors and have revolutionized the imaging and therapy of patients with these tumors. SSTR2 is expressed on other tumors at lower prevalence. Purpose To evaluate the potential of SSTR2-targeted imaging and therapy in patients with breast cancer. Materials and Methods In a preclinical experiment, SSTR2 expression was assessed in tissue microarrays of breast cancer samples using H-score analysis. H-scores higher than 50 (0-300 scale) were considered positive. Then, a prospective phase 2 clinical trial of SSTR2-targeted tetraazacyclododecane tetraacetic acid octreotate (Dotatate) PET/CT was performed in participants with biopsy-proven estrogen receptor (ER)-positive breast cancer from January to August 2023. A positive Dotatate PET/CT scan was defined as tumors with a Krenning score of 3 (avidity greater than liver) or 4 (avidity greater than spleen). The proportion of positive scans and the 95% CI were calculated. One participant with metastatic ER-positive breast cancer and a Krenning 4 Dotatate PET/CT result underwent treatment with SSTR2-targeted actinium 225 (²²⁵Ac) Dotatate. Results Preclinical microarrays demonstrated that 63 of 123 ER-positive breast cancer tissue samples (51% [95% CI: 42, 60]) but only 22 of 121 ER-negative breast cancer tissue samples (18% [95% CI: 12, 26]) were enriched for SSTR2 (P < .001). Thirty female participants (mean age, 66 years ± 15) with metastatic ER-positive breast cancer were accrued to the phase 2 SSTR2-targeted imaging trial and underwent Dotatate PET/CT. Dotatate PET/CT demonstrated that nine of 30 participants (30% [95% CI: 15, 49]) had tumors with Krenning scores of 3 or 4, indicating strong SSTR2 expression. SSTR2-targeted therapy with alpha-emitting ²²⁵Ac-Dotatate resulted in a near complete response in a heavily pretreated participant with metastatic ER-positive breast cancer and a Krenning 4 Dotatate PET result. Conclusion Molecular imaging targeting SSTR2 and radioligand therapy with SSTR2-targeted ²²⁵Ac-Dotatate enables a new therapeutic option for patients with metastatic breast cancer. Clinical trial registration no. NCT05880394 © RSNA, 2024 See also the editorial by Lin and Choyke in this issue.

2024-05-01·European journal of hospital pharmacy : science and practice

¹⁷⁷Lu-Dotatate administration using an infusion pump or a peristaltic pump: comparison of two methods

Article

作者: Deshayes, Emmanuel ; Fersing, Cyril ; Rubira, Léa ; Donzé, Charlotte ; Santoro, Lore ; Kotzki, Pierre Olivier ; Viarasakd, Malissone

OBJECTIVES:

¹⁷⁷Lu-oxodotreotide (Lutathera) is an intravenous peptide receptor radionuclide therapy to treat unresectable metastatic digestive neuroendocrine tumours. The recommended method for Lutathera administration is gravity infusion; however, other appropriate and safe techniques are possible. This work compares two infusion methods from a medico-economic, radiation protection, efficiency and practicality point of view.

METHODS:

Two infusion methods were studied, either involving a volumetric infusion pump (method 1) or a peristaltic pump (method 2). For each method, the mean residual activity per vial and the mean injection time were compared. Occupational radiation exposure was measured. The cost of initial equipment and consumables for one administration was determined. Feedback from operators and past incidents during injections were collected through a survey.

RESULTS:

Three operators performed 219 Lutathera injections over 70 months: 60.7% (133) with method 1 and 39.3% (86) with method 2. After infusion, the mean residual activity in vial was 124.3±16.9 MBq with method 1 and 80.9±19.3 MBq with method 2 (34.9% decrease). The average administration time was 41±7.2 min with method 1 and 39±8.5 min with method 2. Occupational exposures obtained with both methods were very low and quite similar. Method 1 required an initial investment of 1165.8 US$ plus 4.0 US$ of supplies for each administration. Initial investment for method 2 was comparable (1261.4 US$) but supplies cost per administration was higher (12.5 US$). Two major incidents were recorded with method 1 and none with method 2. From operators' experience, method 2 felt safer and more suitable.

CONCLUSIONS:

Method 2 appeared to be convenient and secure, despite a higher cost per injection. It could also be applied to new radioligand therapies such as ¹⁷⁷Lu-PSMA or ²²⁵Ac-Dotatate.

2023-12-01·Molecular cancer therapeutics

RYZ101 (Ac-225 DOTATATE) Opportunity beyond Gastroenteropancreatic Neuroendocrine Tumors: Preclinical Efficacy in Small-Cell Lung Cancer

Article

作者: Han, Guangzhou ; Kim, Daniel ; Clift, Renee ; Lin, Fanching ; Guest, Matt ; Li, Gary ; Bischoff, Eric ; Moran, Susan ; Hwang, Eunmi

Abstract:

Overexpression of somatostatin receptors (SSTR), particularly SSTR2, is found in gastroenteropancreatic neuroendocrine tumors (GEP-NET), and subsets of other solid tumors such as small-cell lung cancer (SCLC). SCLC accounts for approximately 13% to 15% of lung cancer and lacks effective therapeutic options. IHC analysis indicates that up to 50% of SCLC tumors are SSTR2-positive, with a substantial subset showing high and homogenous expression. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogue, Lu-177 DOTATATE, has been approved for GEP-NETs. Different strategies aimed at improving outcomes, such as the use of alpha-emitting radioisotopes, are currently being investigated. RYZ101 (Ac-225 DOTATATE) is comprised of the alpha-emitting radioisotope actinium-225, chemical chelator DOTA, and octreotate (TATE), a somatostatin analogue. In the cell-based competitive radioligand binding assay, RAYZ-10001-La (lanthanum surrogate for RYZ101) showed high binding affinity (Ki = 0.057 nmol/L) to human SSTR2 and >600-fold selectivity against other SSTR subtypes. RAYZ-10001-La exhibited efficient internalization to SSTR2-positive cells. In multiple SSTR2-expressing SCLC xenograft models, single-dose intravenous RYZ101 3 μCi (0.111 MBq) or 4 μCi (0.148 MBq) significantly inhibited tumor growth, with deeper responses, including sustained regression, observed in the models with higher SSTR2 levels. The antitumor effect was further enhanced when RYZ101 was combined with carboplatin and etoposide at clinically relevant doses. In summary, RYZ101 is a highly potent, alpha-emitting radiopharmaceutical agent, and preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR-positive cancers.

118

项与 RYZ-101 相关的新闻（医药）

2024-12-09

·PipelineReview

MTTI 225Ac-EBTATE is Highly Effective Against Neuroendocrine Tumors

WEST CHESTER, PA, USA I December 09, 2024 I Molecular Targeting Technologies, Inc. (MTTI) published preclinical study results for their proprietary 225 Ac-EBTATE against SSTR2 NET cancers online in the European Journal of Nuclear Medicine. (“Long acting 225 Ac-EBTATE is highly efficacious against somatostatin receptor-2-positive neuroendocrine tumors” ( https://rdcu.be/d2lCG ). Professor Humphrey Fonge of the Université de Laval and lead author commented, “At just 40% of the administered dose reported for 225 Ac-DOTATATE, 225 Ac-EBTATE produces enhanced anti-tumor efficacy in Small Cell lung cancer (SCLC) and Pan-neuroendocrine tumor (NET) models as shown with complete tumor remissions. At a therapeutic dose of 2x 34 kBq, 225 Ac-EBTATE showed general safety for 28 days after blood biochemistry analysis, CBC, and histopathological examination of major organs and tissues. We demonstrated that 225 Ac-EBTATE was effective against human small-cell lung cancer (SCLC) with 80% complete remission and 100% survival in preclinical models.” MTTI has licensed commercial use rights for the patented Evans blue (EB) technology from the National Institute of Biomedical Imaging and Bioengineering (“ NIBIB ”), part of the National Institutes of Health (“ NIH ”). This platform is the basis for the best-in-class, new generation, collection of targeted radiopharmaceuticals (TRP). EB binds to serum albumin, extending in vivo circulatory half-life and tumor residence time, enhancing up to 30-fold uptake at a tumor and enabling good efficacy with significantly lower radiopharmaceutical activity and fewer dosing cycles vs. the current standard of care. Our 3-year follow up of 177 Lu-EBTATE in patients* (N=30) with metastatic neuroendocrine tumors, demonstrated good safety with no nephro- or hepatoxicity and 86% disease control rate using only 40% of the administered dose of 177 Lu-DOTATATE. Dr. Jean-Mathieu Beauregard, MD, Associate Professor of Department of Radiology of Université Laval, said, “I am encouraged to see the positive results of 225 Ac-EBTATE in treating small cell lung cancer and Pan-neuroendocrine tumor (NET) in preclinical studies. I look forward to working with MTTI and Professor Fonge to translate this into the clinic.” Dr. Chris Pak, President & CEO of MTTI commented “ 225 Ac-EBTATE effectiveness was encouraging, paralleling the clinical superiority of 177 Lu-EBTATE. We look forward to collaborating with Professors Beauregard and Fonge to drive 225 Ac-EBTATE into clinical trials in 2025.” Molecular Targeting Technologies, Inc. (MTTI) . Molecular Targeting Technologies, Inc. is a private, clinical stage biotech developing targeted radiopharmaceuticals (TRP) for rare cancers. MTTI is committed to building value by translating innovative TRP to improve human health. For more information: www.mtarget.com . *Jiang Y, Liu Q, Wang G, et al. Safety and efficacy of peptide receptor radionuclide therapy with 177 Lu-DOTA-EB-TATE in patients with metastatic neuroendocrine tumors. Theranostics. 2022;12(15):6437-6445. SOURCE: Molecular Targeting Technologies Inc

临床结果

2024-11-18

·医药魔方Pro

超7亿美元！诺华“加码”核药

11月18日，Ratio Therapeutics宣布与诺华子公司Novartis Pharma AG签订了全球独家许可和合作协议。Ratio致力于利用创新技术开发best-in-class放射性药物。此次合作主要聚焦下一代SSTR2靶向放射性药物。根据协议条款，Ratio将获得高达7.45亿美元的预付款和潜在里程碑付款，并有资格获得分级特许权使用费。Ratio将与诺华合作，推动临床前活动，以筛选靶向SSTR2的候选药物。诺华将负责所有剩余的开发、生产和商业化活动。 Ratio成立于2022年，总部位于波士顿。2024年1月，公司宣布完成5000万美元的B轮融，BMS也出现在投资者名单中。Ratio主打Trillium™和Macropa™两大技术平台。Trillium™用于调节候选分子的药代动力学（PK），提高药物可用性和肿瘤递送，同时降低副作用。Macropa™技术包含一种专有的螯合剂，其独特的化学性质使其易于制造，并提高了所得化合物的体内稳定性。Macropa™可与多种化合物一起使用，从小分子到多肽，甚至大多肽，如抗体。知识卡：靶向放射性药物（也被称为放射性配体疗法、RDC等）一般包含四部分：放射性同位素（radioisotope）、螯合剂（chelator，负责稳定或“笼化”放射性核素，以防止核素在到达目的地之前伤及无辜）、靶向配体（负责精准识别和结合肿瘤靶点）及连接子（linker，负责连接靶向配体和螯合剂）。 Ratio认为，结合Trillium™和Macropa™两大平台非常有可能开发出基于α粒子（actinium-225）的best-in-class放射性药物。目前公司在推进其首个FAP靶向放射性药物的开发，计划明年进入临床试验。而关于此次与诺华合作的靶点，医药魔方NextPharma®数据库显示，目前全球有20款左右SSTR2靶向放射性药物在研，进展最快的是BMS的RYZ101，处于III期临床。去年12月，BMS以41亿美元收购 RayzeBio获得了RYZ101等资产。诺华是核药赛道当之无愧的“王者”，目前手握Lutathera和Pluvicto两款明星产品，且有包括177Lu-FAP-2286、177Lu-NeoB、225Ac-PSMA-617在内的多款在研管线。2024年，诺华在核药赛道继续加码，5月以17.5亿美元收购了核药公司Mariana Oncology。参考资料： [1]https://ratiotx.com/2024/11/18/november-18th-2024-ratio-enters-license-and-collaboration-agreement-with-novartis-for-sstr2-targeting-radiotherapeutic-candidate/ [2]https://www.businesswire.com/news/home/20231225781528/en/%C2%A0Bristol-Myers-Squibb-Adds-Premier-Radiopharmaceutical-Platform-with-Acquisition-of-RayzeBio Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任

放射疗法临床3期引进/卖出并购临床结果

2024-11-11

·药渡

“狂飙”的核药：重磅BD不断、产能扩张、研发热情空前高涨

来源：药渡撰文：哥哈骎编辑：维他命在全球医药创新的浪潮中，放射性药物的发展正进入前所未有的高光时刻。作为精准治疗领域的利器，放射性药物凭借其强大的靶向杀伤能力迅速在癌症等疾病治疗中崭露头角。不仅仅是产能的扩充，制药公司和合同开发与生产组织（CDMO）对这一领域的投入和热情也在持续攀升。巨大的研发资金、尖端技术的突破，以及全球范围内的合作与竞争，正推动着放射性药物的开发进入全新高度。放射性药物将成为各大制药巨头竞相投资、加速推进的核心赛道。 1 放射性药物CDMO积极扩展产能 01 Nucleus RadioPharma 在首次融资两年后，CDMO组织Nucleus RadioPharma宣布将在两个地点进行扩建，将显著改善那些具有前景的放射性肿瘤学药物的市场准入情况。Nucleus在10月21日表示，即将升级亚利桑那州Mesa和宾州Springhouse的工厂，升级后的工厂将实现研发和商业生产的一站式业务，这将使Nucleus的生产能力提高200%。 Mesa的工厂占地近5000平米，而位于Springhouse的工厂占地将近4500平米。随着扩建工程的完成，Nucleus预计将在每个地点创造大约50个新工作岗位，扩建工程预计将在2026年底完成，此次升级将使更多患者能够接受放射性药物治疗。放射性药物的保质期相对较短，因此产能的增加将使此类药品短缺的情况得到显著缓解。Nucleus的CEO Charles Conroy表示，此次扩建将明显增加患者获得这些救命药物的机会，并且将加快临床试验，可能将新疗法的上市时间缩短30%。Conroy宣称，Nucleus扩建后的生产能力还将使得全美60%人口获得这些放射性药物的行程控制在四小时的车程以内。很多放射性药物需要在生产后的当天送达并使用，这是因为放射性药物中的放射性同位素具有较短的半衰期，这意味着它们的放射性会迅速衰减，从而影响药物的效力和安全性。此外，放射性药物的供应链管理也非常关键，因为这些药物对外部因素非常敏感，可能需要冷藏或在使用前短时间内准备或激活。因此，确保放射性药物在生产后迅速、安全地送达使用地点是实现其治疗潜力的关键因素。这也就决定了生产设施地缘的重要性。 02 SpectronRx 将提升放射性药物产能作为战略发展方向的CDMO远非Nucleus一家，总部位于美国印第安纳波利斯的放射药物CDMO SpectronRx也在积极拓展其海外的生产设施。SpectronRx最近与比利时核研究中心（SCK CEN）签署协议，将在比利时建设其首座欧洲放射性药物工厂，新设施预计在2025年第一季度投入运营。SpectronRx负责提供设备和制造服务，而SCK CEN将提供SpectronRx所需的资源来支持其开发和生产工作。 SpectronRx在比利时的工厂将专注于锕-225（Ac-225）放射药物。Ac-225有限的供应量一直是此类放射性药物的生产瓶颈。但基于Ac-225放射性药物的开发热情却不断增长，开发管线也持续扩张，这种现状导致了Ac-225药物的短缺。 SpectronRx表示，公司已开发出从多种源元素中生产Ac-225的方法，因此对大规模制造Ac-225标记药物的能力充满信心。除了即将开设的比利时工厂，SpectronRx还在五个地点运营着超过15万平米的放射药物制造和开发空间，服务于29个国家。该公司拥有约150名员工，并与31家制药公司合作。 2 生物制药公司扩增放射性药物生产与合作不只是CDMO在积极扩展放射性药物的生产能力，生物制药公司也亲自上阵，加速产能提升的进程。作为这个领域绝对的领袖，诺华的举动在一定程度上指引行业未来的发展方向。他们正投资2亿多美元，进一步增强其放射治疗基础设施，包括建立一座全新的设施和扩建现有地点。诺华正在美国建立其第三个放射性药物制造基地，新设施位于加州的Carlsbad。诺华现有的放射性药物生产基地分别位于新泽西的米尔本和印第安纳波利斯。新建设的加州生产基地将负责向美国西海岸的患者生产放射性肿瘤药物。此外，印第安纳波利斯的基地也正在进行重要升级。诺华已在该基地内开工建设一座新的工厂，专门生产放射性同位素。诺华在这些扩建项目上的投资超过2亿美元，新设施的资格认证和监管批准预计将在2026年前完成。印第安纳波利斯的设施将成为诺华在美国拥有的首个同位素生产来源。尽管如此，诺华仍将继续与外部同位素供应商合作，以满足国际市场的需求。值得注意的是，这是诺华在全球放射性同位素短缺的背景下进行的同位素生产设备建设。早些时候，百时美施贵宝因锕-225短缺而暂停了其RYZ101的第三阶段研究，但很快又恢复了试验招募，该候选药物是BMS41亿美元收购RayzeBio交易中的核心资产。去年12月，百时美施贵宝以41亿美元收购RayzeBio，从而正式进入放射性药物赛道，当时的收购价格是RayzeBio在三个月前IPO时的三倍多。造成医用放射性同位素短缺的原因有很多，包括几年前一家大型医学同位素生产商关闭了其在加拿大的生产基地。此外，持续的俄乌战争和日益增长的放射性同位素需求也令短缺问题雪上加霜。诺华在美建设放射性同位素生产基地的战略决定将支持其放射性前列腺癌药物Pluvicto的商业生产，诺华称其产能达到了每年25万剂的水平。除了美国的基地外，诺华还在意大利Ivrea和西班牙萨拉戈萨运营放射疗法设施。诺华已经开始在浙江省海盐县开工建设一个新设施，并计划在日本再建一个。诺华的胃肠胰神经内分泌肿瘤放射性药物Lutathera和Pluvicto，都使用发射β粒子的放射性核素镥-177。诺华目前也在开发不同的放射性核素、配体和放射性药物。他们最近以10亿美元的预付款收购了开发临床前放射疗法的生物科技公司Mariana Oncology。这家小型公司的主要候选药物是一种用于小细胞肺癌的锕放射治疗。在另一笔放射性药物开发交易中，诺华已经预付给日本PeptiDream 1.8亿美元，用于开发放射性多肽-药物偶联物（PDC，Peptide-Drug Conjugates）。在这个模态中，多肽成为负载放射性核素的配体，诺华的Lutathera从模态上来看就是一款PDC。诺华与PeptiDream的这笔交易还可能涉及27.1亿美元的里程碑支付，PeptiDream将利用其平台识别和优化新型大环肽配体。除了诺华之外，阿斯利康、百时美施贵宝和礼来也签署了价值14亿至41亿美元的放射性药物收购协议。澳大利亚Telix Pharmaceuticals最近以高达2.5亿美元的价格，收购了位于佛罗里达州的RLS Radiopharmacies。这是Telix今年的第三次收购，目的在于扩大其在放射性药物领域的业务范围，这笔交易预计将于明年第一季度完成。根据收购条款，RLS将获得2.3亿美元的预付款，并有可能获得2000万美元的里程碑付款。Telix今年3月以8200万美元的现金和股票收购了ARTMS，后者是一家加拿大公司，拥有回旋加速器的同位素生产平台。 3 放射性同位素制造商积极融资放射性同位素是放射性药物的灵魂所在，因此加强放射性同位素的生产能力决定了药物准入的水平。成立仅两年的比利时放射性同位素生产商PanTera于今年9月获得了9300万欧元（1.025亿美元）的超额认购A轮融资，领投方为EQT Life Sciences。EQT表示，这是比利时生命科学领域公司有史以来规模最大的A轮融资，表明人们对放射性药物日益高涨的兴趣。他们获得这笔融资将用来建造位于比利时的新工厂。作为Ac-225供应商，PanTera已与拜耳签约，为其提供用于临床试验的Ac-225。这是PanTera与大型制药商达成的第一笔交易。 4 放射性药物及其诊断试剂市场预测放射性药物市场的未来发展前景非常乐观，预计将显著增长。根据SkyQuest Technology的报告，全球放射性药物市场预计到2031年将达到80亿美元，复合年增长率（CAGR）为9.8%。这一增长主要受到核医学益处的日益普及和放射性药物可用性的增加所推动。在中国，放射性药物市场也在快速扩张。根据国家核安全局的报道，预计到2030年，中国的放射性药物市场规模将达到260亿元人民币。这一增长反映了中国在医疗技术和核医学领域的快速发展。此外，放射性药物市场的增长还受到对早期诊断的高需求、先进成像技术的使用增加以及核医学日益流行的推动。在全球范围内，放射性药物市场的增长还受到治疗诊断学（theranostics）领域的推动。根据一份市场报告，全球放射性药物治疗诊断学市场预计从2022年的18亿美元增长到2028年的34.4亿美元，年复合增长率为11.3%，这种增长主要得益于放射性药物在癌症和其他疾病治疗中的应用增加。总体而言，放射性药物市场的未来前景乐观，随着个性化医疗和治疗诊断学的发展，市场将迎来更多的增长机会。参考文献： 1. Kansteiner, F. CDMO SpectronRx homes in on completion of European plant to crank out key radiopharma isotope. Fierce Pharma. 17. 10. 2024. 2. Dunleavy, K. Radiopharma CDMO Nucleus lays out plan to triple manufacturing capacity, add 100 jobs. Fierce Pharma. 21. 10. 2024. 3. Taylor, N. P. Novartis pays PeptiDream $180M as radiopharma big bang continues. Fierce Biotech. 30. 04. 2024. 4. Liu, A. Novartis expands radiotherapy manufacturing network with $85M plant in China. Fierce Pharma. 01. 12. 2023. 5. Liu, A. Radiotherapy leader Novartis brings US isotope production in house, builds West Coast plant. Fierce Pharma. 04. 09. 2024. 6. Keenan, J. Telix expansion spree rolls on with $250M acquisition of RLS Radiopharmacies. Fierce Pharma. 23. 09. 2024. 7. Dunleavy, K. Next-gen radiopharmaceutical manufacturer PanTera attracts $102.5M in Series A funding. Fierce Pharma. 11. 09. 2024. 专栏作者哥哈骎南开大学本科、硕士，德国比勒菲尔德大学博士。多肽化学、多肽API GMP生产专家、欧洲制药公司首席科学家；拥有Lean Six Sigma黑带认证；著有专著《Side Reactions in Peptide Synthesis》。 *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！新药速递：FDA10月批准药物盘点传奇抗癌药物「曲妥珠单抗」：或将纳入2025版《中国药典》众药企三季度财报亮点纷呈，恒瑞医药位列净利润榜首！

放射疗法并购抗体药物偶联物

100 项与 RYZ-101 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
类癌	临床3期	美国	Rayzebio, Inc.初创企业	2022-03-24
类癌	临床3期	比利时	Rayzebio, Inc.初创企业	2022-03-24
类癌	临床3期	巴西	Rayzebio, Inc.初创企业	2022-03-24
类癌	临床3期	加拿大	Rayzebio, Inc.初创企业	2022-03-24
类癌	临床3期	法国	Rayzebio, Inc.初创企业	2022-03-24
类癌	临床3期	荷兰	Rayzebio, Inc.初创企业	2022-03-24
类癌	临床3期	西班牙	Rayzebio, Inc.初创企业	2022-03-24
功能性内分泌肿瘤	临床3期	美国	Rayzebio, Inc.初创企业	2022-03-24
功能性内分泌肿瘤	临床3期	比利时	Rayzebio, Inc.初创企业	2022-03-24
功能性内分泌肿瘤	临床3期	巴西	Rayzebio, Inc.初创企业	2022-03-24

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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


NCT05595460 (WCLC2024) 人工标引	临床1期	广泛期小细胞肺癌	10	RYZ101 carboplatinTATetoposide	餘齋遞窪衊窪網築襯顧(艱鏇憲觸膚築餘壓簾鑰) = G1 decreased appetite, G2 dehydration, G1 diarrhea, G1 fatigue, G2 influenza-like illness, G2 nausea, G2 neutrophil count decrease, G1 vomiting 廠鹹糧蓋鹹鑰窪願鑰醖 (淵遞齋觸選觸選鑰夢鹹 ) 更多	积极	2024-09-08
SNMMI2024	N/A	胃肠胰神经内分泌肿瘤	-	RYZ101 120 kBq/kg	鬱獵積廠顧糧鑰簾鬱網(遞築網衊繭獵淵範壓構) = 52.9% 鬱範網壓製築衊積淵憲 (餘齋積蓋獵觸觸鏇廠遞 ) 更多	-	2024-06-09
NCT05477576 (ACTION-1, ASCO2024) 人工标引	临床1期	SSTR阳性胃肠胰神经内分泌肿瘤 SSTR2	17	RYZ101 120 kBq/kg	糧餘齋淵鏇淵鹹廠窪憲(遞糧顧範憲鏇淵鑰顧構) = 淵鬱網醖鬱憲夢鏇憲淵蓋艱齋廠顧鹹鏇鹽鏇窪 (鬱構觸簾鑰鹽鏇膚範鏇 ) 更多	积极	2024-05-24
NCT05477576 (ACTION-1, ESMO2023) 人工标引	临床1期	胃肠胰神经内分泌肿瘤 SSTR positive	17	RYZ101 120kBq/kg	蓋築鹽繭蓋廠蓋膚簾襯(醖鬱膚蓋窪網壓構齋壓) = 糧鏇選網淵鑰積網鏇鬱繭鏇蓋範鹽觸憲網願觸 (簾淵壓鏇鏇鏇顧窪憲選 ) 更多	积极	2023-10-22
NCT05477576 (ACTION-1, ASCO2023) 人工标引	临床1期	SSTR2阳性胃肠胰神经内分泌肿瘤 SSTR2 Expression	9	RYZ101	餘鹹積鹽獵顧鬱夢築積(夢鏇膚鑰齋壓繭衊遞繭) = 廠鹽淵壓壓廠艱獵憲齋選襯鏇窪襯構築膚鏇壓 (遞築壓廠製積鏇艱壓積 ) 更多	积极	2023-05-31
SNMMI2022	N/A	胃肠胰神经内分泌肿瘤	-	225Ac-DOTATATE TAT	網簾襯鏇齋積鏇膚齋遞(蓋醖襯壓獵蓋壓鑰齋選) = Malignant ascites was noted in 14, resulting in 11 deaths 獵齋鑰糧網遞構範膚蓋 (簾鏇窪構築觸廠廠繭選 ) 更多	-	2022-08-08
SNMMI2022	N/A	胃肠胰神经内分泌肿瘤	-	177Lu-DOTATATE		-	2022-08-08
SNMMI2021	N/A	胃肠胰神经内分泌肿瘤	-	225Ac-DOTATATE	艱簾鹽遞範憲顧襯構願(夢鑰觸範遞膚餘鏇鏇鏇) = No grade 3 renal or hepatotoxicities were observed. No other unexpected longer-term adverse events were observed with 225Ac-DOTATATE therapy 膚鹽憲網壓壓鏇構顧憲 (憲淵蓋糧積醖觸淵遞艱 ) 更多	-	2021-05-18