This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC).
The name of the study drug involved in this research study is:
-177Lu-PSMA-617 (a type of radioligand therapy)

开始日期2025-11-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06783348

/ Not yet recruiting临床2期IIT

Phase II Trial Evaluating the Efficacy of 177Lutetium-PSMA-617 Treatment in Patients With Metastatic Clear Cell Renal Carcinoma Cell With Progressive Disease on First-line or Second-line Systemic Treatment

Background This study is for adults with advanced kidney cancer that has spread to other parts of the body and has continued to progress despite treatment with immunotherapy and targeted therapy. Unfortunately, treatment options at this stage of the disease are limited. The existing treatments' ability to work against cancer has not been fully looked into.
Rationale The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient 177Lutetium-PSMA and has been used as a standard treatment for advanced prostate cancer since December 2022, can also help treat advanced kidney cancer.
The drug 177Lu-PSMA-617 is being tested as an experimental treatment that targets a specific protein on cancer cells. This protein, known as prostate-specific membrane antigen (PSMA), is present on the surface of kidney cancer cells. Therefore, before the treatment begins, participants will undergo a PET (positron-emission tomography) scan to check if their kidney cancer cells express high levels of PSMA. This scan uses a small amount of radioactive material (in the form of 177Lutetium) to visualize the presence of PSMA on the cancer cells. Only participants who test positive for PSMA can take part in the study. In this approach, PSMA serves two purposes. First, it helps assess whether the cancer expresses this protein and allows 177Lu-PSMA-617 to specifically target and attach to the cancer cells. Second, 177Lu-PSMA-617 delivers a small amount of radiation directly to the tumour, which helps kill cancer cells while minimizing damage to normal cells. This type of treatment is known as a radiopharmaceutical.
Objective The primary aims are to find out if 177Lu-PSMA-617 is useful against kidney cancer and to assess its safety. Throughout the study, participants will undergo several imaging assessments to check their disease and response to treatment.
The study also includes the collection of tissue samples. Together with the information collected from the imaging assessments, this will allow further research into markers that may lead to earlier detection of tumour spread or help identify individuals who may benefit more from treatment with 177Lu-PSMA-617.
Treatment All participants will receive 177Lu-PSMA-617 through an intravenous injection at a standard dose of 7,400 MBq (megabecquerel: a measure of radioactivity). Treatments will be administered approximately every six weeks, for a maximum of six times.
Blood tests are done before and during treatment to check the participant's health and to detect any early side effects from the treatment. Different types of scans are performed before, during, and after 177Lu-PSMA-617 administration to check how well the treatment is working. After treatment ends, follow-up visits will be scheduled every six weeks during the first year. In the second year, your doctor will decide how often you need to come in for visits. These appointments are important for monitoring how the body continues to respond to the treatment. The entire study period will last approximately two years from the time of study entry.
Participants
The study will include approximately 56 participants who will be tested for PSMA expression, to obtain a minimum of 48 participants expressing PSMA entering the study. To qualify, participants must:
* Be diagnosed with advanced kidney cancer previously treated with immunotherapy and targeted therapy.
* Test positive for PSMA on a PET scan.
* Be generally healthy and able to perform daily activities.
* Be at least 18 years of age.
Benefit-risk analysis The drug 177Lu-PSMA-617 has proven to work well in treating advanced prostate cancer and could be a promising new treatment possibility for kidney cancer, although this has not yet been shown. By joining this study, participants will contribute to valuable research to better understand kidney cancer and improve treatment options for future patients. Participating in this study offers a chance to try a new treatment, which might help people with advanced kidney cancer live longer and prevent the disease from getting worse, especially for those who have limited treatment options left after immunotherapy and targeted therapy.
With all new treatments, there are possible risks and side effects associated with them. Side effects of the drug 177Lu-PSMA-617 may include feeling tired, nausea, dry mouth, loss of appetite, and changes in blood cells. While not all side effects are known yet, the study team will carefully follow participants for any side effects during and after treatment. It is important to understand that while the study is being done to provide new information, there are still some questions on the treatment's safety and how well it will work.

开始日期2025-10-30

申办/合作机构-

100 项与镥[177Lu] 特昔维匹肽相关的临床结果

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100 项与镥[177Lu] 特昔维匹肽相关的转化医学

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100 项与镥[177Lu] 特昔维匹肽相关的专利（医药）

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580

项与镥[177Lu] 特昔维匹肽相关的文献（医药）

2025-07-01·NUCLEAR MEDICINE AND BIOLOGY

Enhancing the therapeutic index of [211At]YF2 with iodo pseudo carrier: A simple strategy for reducing accumulation in kidneys, salivary and lacrimal glands

Article

作者: Feng, Yutian ; Vaidyanathan, Ganesan ; Banks, Rebecca L ; Huynh, Truc T ; Zalutsky, Michael R

INTRODUCTION:

Low-molecular-weight (LMW) PSMA-targeted agents have enjoyed success; however, their off-target toxicity in normal tissues such as kidneys, salivary gland and lacrimal gland can be dose limiting. Herein, we have evaluated the effect of co-administration of the non-radioactive iodo pseudo carrier, iodo YF2, on the normal tissue uptake of [²¹¹At]YF2 in xenografted mice. The potential implications for clinical translation of these studies were investigated by evaluating the binding of LMW PSMA-targeted agents to murine and human PSMA.

METHODS:

[²¹¹At]YF2 was synthesized following established protocols. Groups of 5 mice bearing subcutaneous PSMA+ PC3 PIP xenografts received [²¹¹At]YF2 co-injected with varying i.v. doses of iodo YF2 (0-2 nmol), and the biodistribution was evaluated at 1 h post injection (p.i.). In another study, the biodistribution of [²¹¹At]YF2 alone and [²¹¹At]YF2 co-administered with 1.5 nmol iodo YF2 was evaluated at 1 and 8 h p.i. Bead-based radioligand binding assays were conducted for [¹³¹I]YF2 and several other LMW agents to compare their binding to human and murine PSMA.

RESULTS:

At 1 h, no significant difference was seen in kidney uptake of [²¹¹At]YF2 at iodo YF2 concentrations of 0, 0.05 and 0.1 nmol (p > 0.05), but renal accumulations significantly reduced by co-administering 2.0 nmol iodo YF2 (p < 0.0001). Decreases in salivary and lacrimal gland uptake also were observed at 1 h for [²¹¹At]YF2 co-injected with 0.1 nmol iodo YF2 (p < 0.05). A follow-up study revealed a kidney uptake of 1.8 ± 0.4 % ID/g for [²¹¹At]YF2 with 1.5 nmol iodo YF2, compared to 46.5 ± 7.7 % ID/g for [²¹¹At]YF2 alone at 8 h. Tumor uptake showed no significant difference (p > 0.05) between [²¹¹At]YF2 alone (17.1 ± 8.8 % ID/g at 1 h; 13.6 ± 5.3 % ID/g at 8 h) and [²¹¹At]YF2 plus 1.5 nmol iodo YF2 (12.8 ± 2.7 % ID/g at 1 h; 14.1 ± 3.2 % ID/g at 8 h). Bead-based radioligand binding assays showed that [¹³¹I]YF2 has the highest binding fractions to both human PSMA (94.1 ± 0.1 %) and murine PSMA (92.5 ± 0.2 %) with minimal differences between the two, while [¹⁷⁷Lu]PSMA-617 had the greatest species-dependent disparity with a binding fraction of 90.5 ± 0.3 % to human PSMA and 60.9 ± 1.4 % to murine PSMA.

CONCLUSIONS:

Co-administration of iodo YF2 reduced kidney uptake of [²¹¹At]YF2 and decreased accumulation in normal tissues with no significant change in tumor uptake. In some cases, there was a significant difference in binding to human and murine PSMA among LMW PSMA-targeted agents suggesting that particularly for some agents, applying mouse data to predict human dosimetry must be done with caution.

2025-06-01·PROSTATE

Outcome of Subsequent Therapies After ¹⁷⁷Lu‐Vipivotide Tetraxetan for Metastatic Castrate‐Resistant Prostate Cancer: A Tertiary Cancer Center Experience

Article

作者: Borges, Nuno ; Liu, Mofei ; Choudhury, Atish D. ; Kavanaugh, Michael ; Jacene, Heather ; Robertson, Matthew ; Losee, Meryam ; Morgans, Alicia ; Wolanski, Andrew ; Hyun, Hyewon ; Pomerantz, Mark ; Wei, Xiao X. ; Taplin, Mary‐Ellen ; Sakellis, Christopher ; Stoltenberg, Hailey ; Ravi, Praful ; Kilbridge, Kerry L. ; Ng, Thomas ; Haberman, Veronica ; Ritzer, Jolivette ; Bhimaniya, Sudhir ; Shah, Hina

ABSTRACT:

Background:

177Lu‐vipivotide tetraxetan (177Lu‐PSMA‐617, LuPSMA) improves overall survival in patients with metastatic castration‐resistant prostate cancer (mCRPC) after at least one taxane chemotherapy and androgen receptor pathway inhibitor. There are limited data on the clinical course and outcomes of patients with mCRPC after receipt of LuPSMA.

Methods:

We queried an IRB‐approved prospectively maintained registry of all patients with mCRPC who received standard‐of‐care LuPSMA at our institution between June 2022 and January 2024. Clinical data about LuPSMA and subsequent therapies were extracted from the electronic medical record, including the type and number of subsequent systemic therapies, reason for treatment cessation, hematologic toxicity and supportive treatment, and PSA50 response to subsequent therapy (defined as a ≥ 50% decrease in PSA).

Results:

A total of 146 patients were evaluated; mean age 72 (range 52–87), observed median follow‐up 5.9 months (range 0.51–18.7). Forty‐four received systemic treatment after LuPSMA. The most common subsequent treatment after LuPSMA was chemotherapy (n = 27), primarily cabazitaxel ± carboplatin/cisplatin (n = 23), and the median number of cycles received was 4 (range 1–7). In 35/44 men with available hematologic toxicity data, 13 developed grade ≥ 3 anemia, 7 had ≥ grade 3 thrombocytopenia, and 16 received hematologic support. PSA50 to post‐LuPSMA treatment occurred in 10/36 (28%) evaluable patients. Median overall survival from subsequent systemic therapy was 7.6 months (95% CI 5.81–NR).

Conclusions:

30% of patients receiving standard‐of‐care LuPSMA received subsequent therapy, mostly cabazitaxel‐containing regimens. Post‐LuPSMA treatment appeared tolerable and was associated with a PSA50 response rate of 28%. These outcomes may be biased by limited standard‐of‐care life‐prolonging treatment options at the time of LuPSMA FDA approval, but it also highlights the continued need to develop novel therapeutic strategies for mCRPC post‐LuPSMA.

2025-06-01·JOURNAL OF NUCLEAR MEDICINE

Safety and Efficacy of 20 Cycles of [¹⁷⁷Lu]Lu-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer

Article

作者: Sandhu, Shahneen ; Buteau, James P ; Azad, Arun A ; Hofman, Michael S ; Jewell, Kerry E ; Medhurst, Elizabeth ; Kwan, Edmond M

802

项与镥[177Lu] 特昔维匹肽相关的新闻（医药）

2025-06-16

·PRNewswire

Clarivate Identifies Radioligand Therapy Innovators as Companies to Watch in the Future of Precision Oncology

New Report Highlights Emerging Leaders Advancing Next-generation Radiopharmaceuticals, Reshaping Cancer Care Through Targeted Innovation and Strategic Growth LONDON, June 16, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a leading global provider of transformative intelligence, today announced the release of a new Companies to Watch report, Radioligand Innovators Ushering in a New Era of Precision Oncology. The report spotlights pioneering companies that are redefining the drug discovery and development landscape through advancements in radioligand therapies (RLTs)—a rapidly evolving class of therapeutics that combines nuclear medicine with precision-targeted biotechnology to treat cancer with heightened specificity. Drawing on proprietary data, expert analysis and insights into therapeutic benefit, financing activity and R&D momentum, the report highlights why these organizations are considered high-impact innovators. This latest edition follows previous Companies to Watch reports focused on RNA-based technologies, artificial intelligence/ machine learning (AI/ML), next-generation gene-editing and antibody-drug conjugates (ADCs). Radioligand therapies represent one of the most promising frontiers in oncology, offering highly specific delivery of radioactive isotopes to tumor cells while minimizing damage to healthy tissue. These agents are rapidly gaining momentum as both scientific breakthroughs and strategic investments accelerate across the global pharmaceutical landscape. Michael Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, said: "Radioligand therapies are emerging as a cornerstone of precision oncology, combining decades of research in nuclear medicine with the latest innovations in biotechnology. This report identifies the innovators that are pushing the boundaries of what's possible in cancer care — and highlights the market, scientific and strategic signals that make them companies to watch." David Bejker, Chief Executive Officer, Affibody, said: "Radioligand therapies (RLTs) are transforming the promise of precision medicine into reality, enabling treatments that are finely tuned to the unique characteristics of each patient and their tumor, rather than relying on one-size-fits-all solutions. By uniting the precision of targeted drug delivery with the power of radiotherapy, RLTs use tumor-seeking molecules linked to therapeutic radioisotopes to deliver radiation directly to cancer cells, minimizing damage to healthy tissue and opening a new frontier in personalized cancer care." The report offers a detailed view of the evolving RLT landscape, highlighting the science, clinical promise and market momentum behind this precision approach. It profiles emerging innovators; explores key trends in M&A, funding and partnerships; and examines how differentiated R&D strategies and IP positioning set companies apart. The report also addresses challenges in manufacturing and regulation while assessing advances in alpha-emitting isotopes, combination therapies and the infrastructure needed to deliver next-generation radiotherapies at scale. The Radioligand Companies to Watch are: Affibody, founded by researchers at the KTH Royal Institute of Technology and Karolinska Institutet, has a mission of addressing medical needs with pioneering treatments that can improve the lives of patients with serious diseases. As a clinical stage biopharmaceutical company, it has pre-clinical and clinical development programs in oncology and immunology, with a broad product pipeline focused on developing innovative next-generation biopharmaceutical drugs based on its proprietary technology platform, Affibody® molecules. Alpha-9 Oncology is developing and advancing a pipeline of differentiated and highly targeted radiopharmaceuticals as potentially life-improving treatments for various malignancies. The company's bespoke, iterative process leverages the team's deep expertise in modifying peptides, small molecules and small biologics to inform target selection, molecule design, formulation and clinical evaluation. Ariceum Therapeutics was launched after the acquisition of the rights for its lead product, satoreotide (SSO110), from Ipsen, which has remained a shareholder in the company. Satoreotide is a proprietary peptide derivative that binds to somatostatin receptor 2 (SSTR2), which is overexpressed in neuroendocrine tumors and some aggressive cancers. The company is developing radiopharmaceutical theranostic pairs focusing on aggressive tumors such as small-cell lung cancer (SCLC) and Merkel cell carcinoma (MCC). Convergent Therapeutics is developing radioantibodies, by conjugating alpha radionuclides to antibodies that target cancer cells. Its lead candidate, CONV01-α (Ac-225 rosopatamab tetraxetan), is in phase 2 trials for prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Perspective Therapeutics, a clinical-stage, radiopharmaceutical company, has adopted a theranostic approach using its proprietary chelator technology platform that enables radiolabeling of targeting moieties against cancers with therapeutic isotopes of lead (Pb-212) or diagnostic isotopes such as Ga-68 for high-resolution imaging of uptake or Pb-203 for retention of uptake. The company has also entered into exclusive licensing and patent agreements with academic institutions to broaden its alpha-emitting radiopharmaceutical platform capabilities. PRECIRIX®, founded as a spin-off from Vrije Universiteit Brussel (VUB), is designing and developing radiopharmaceutical theranostics using camelid single-domain antibodies (sdAb) labeled with radiometals against multiple targets. The company's lead program, which targets fibroblast activation protein (FAP), could be a best-in-class alpha-emitting targeted radiotherapy against FAP and has been designed to address FAP-positive tumors. Notable developments shaping the RLT field include high-profile acquisitions — such as Bristol Myers Squibb's $4.1 billion purchase of RayzeBio and AstraZeneca's $2.4 billion acquisition of Fusion Pharmaceuticals — as well as blockbuster therapies like Novartis' PLUVICTO® and LUTATHERA®, which have paved the way for broader adoption. As the global radiopharmaceutical market is projected to surpass $13 billion within the next decade, the companies featured in this report are well-positioned to lead the next wave of therapeutic innovation. To download the full report or learn more, visit here . Methodology for the Companies to Watch Report Clarivate analysts employed a rigorous, multidimensional framework to identify the emerging innovators featured in this Companies to Watch report. Each company was assessed for its ability to address critical scientific, clinical and business challenges within the radioligand therapy space. Key considerations included demonstrated proof of concept, achievement of developmental milestones and positioning within the clinical trial landscape. The evaluation also factored in the strength of collaborations with leading academic and research institutions, the potential to address significant unmet medical needs and the overall burden of disease targeted by each therapy. Financial health was a further determinant, with analysts examining capital raised, investor partnerships, projected runway and prospects for future growth through fundraising or strategic alliances. Finally, each company's intellectual property estate was analyzed to understand the strength and breadth of its innovation pipeline. The assessment was underpinned by insights from Clarivate's trusted proprietary data sources, including Cortellis Competitive Intelligence™, Cortellis Deals Intelligence™, Cortellis Regulatory Intelligence™, Cortellis Clinical Trials Intelligence™, BioWorld™ and OFF-X™ Translational Safety Intelligence, ensuring a holistic view of the companies poised to shape the future of precision oncology. About Clarivate Clarivate is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit clarivate.com Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期并购引进/卖出

2025-06-16

·求实药社

97亿天价买下"冷门靶点"！BMS押注前列腺癌核药

2025年6月10日，Philogen 宣布，其子公司 Philochem AG 将前列腺癌放射性药物 OncoACP3 的全球权益，独家授权给百时美施贵宝（BMS）全资子公司 RayzeBio。交易总金额高达13.5亿美元（约97亿人民币），其中包括3.5亿美元首付款和最高10亿美元的里程碑付款，以及未来销售的特许权使用费。尽管这笔金额未及BMS在2023年以41亿美元收购RayzeBio时的震撼规模，但它却是BMS在整合核药平台后的第一笔重磅出手。显然，买的不是一个“火热靶点”，而是押注一种更长期、更可复制的核药开发模式。ACP3 是什么？RayzeBio 为何看上它？OncoACP3 是一种针对酸性磷酸酶 3（ACP3）的高亲和力小分子配体，用于前列腺癌的诊断与治疗核药开发。Philochem 围绕它搭建了一组核药组合，包括诊断用的 68Ga-OncoACP3 和 18F-OncoACP3，以及治疗用的 177Lu-OncoACP3 和 225Ac-OncoACP3。68Ga-OncoACP3目前正处于 I 期临床试验（NCT06840535），数据显示其在肿瘤组织中具有良好的选择性摄取和滞留能力，而健康组织蓄积极低。后者的临床试验申请（IND）正在筹备中。虽然 ACP3 并非首次发现，但它尚未进入主流核药开发管线，尤其是在PSMA表达阴性患者中的潜力，为 RayzeBio 提供了管线差异化的重要拼图。不只是靶点，BMS 其实买的是组合潜力与其说是买靶点，不如说是买打法。ACP3 本身的数据尚在早期，单独拆出来很难撑起13.5亿美元的估值。真正被看重的是 RayzeBio 构建“模块化核药平台”的能力：用标准化的核素递送架构，持续接入多种靶点，不断扩张组合边界。RayzeBio 当前已在 SSTR（RYZ101）和 GPC3（RYZ801）等方向推进α核素药物，OncoACP3 属于“边缘靶点+核心核素”的拼图逻辑。平台可以放大单个靶点的价值，而不是反过来依赖某个靶点“爆单”。对BMS来说，这是在为未来布局多靶点、多核素的“组合战”打法，尤其押注在前列腺癌中PSMA阴性人群这一未满足的亚群市场。技术看点与现实挑战：α核素虽强，门槛不低225Ac 被认为是放射配体疗法中的“王炸”，它的高能量和短射程让其对肿瘤细胞杀伤更精准，毒副作用理论上更小。但想用好它，必须跨越几个门槛。一是递送系统的稳定性。225Ac 衰变产物（如221Fr、213Bi）若在体内游离，会引发非靶向组织辐射毒性。RayzeBio 已在其SSTR项目中展示了配体稳定性优化能力，有望在ACP3项目中复用，但OncoACP3尚未发布相关数据，仍有待验证。二是供应链瓶颈。225Ac 当前的全球产量极为有限，依赖加拿大TRIUMF、美国DOE等政府级放射设施。2024年，BMS 就曾因锕-225短缺而暂停RYZ101的III期临床。供应链紧张仍是RayzeBio及整个α核素赛道的核心挑战。那么问题来了：值不值13.5亿美元？这个数字乍看之下偏高，尤其是在ACP3仍处于早期I期阶段的背景下。但放在放射性药物的整体行业逻辑下，其合理性就变得更清晰。以市场上最成功的核药之一 Pluvicto（177Lu-PSMA-617）为例，诺华2024年全年销售额高达13.92亿美元，并仍在稳步增长。这显示出核药一旦成功，具有极高的商业转化能力。若 OncoACP3 成功进入市场，并在PSMA阴性患者群中建立差异化定位，即便实现 Pluvicto 的 30–40% 销售额，也足以覆盖当前投入并带来超额回报。同时，这也要看 OncoACP3 在 RayzeBio 平台体系中的“带动效应”——它强化了RayzeBio的α核素组合打法，为后续吸纳新靶点、拓展新癌种提供了通路和模板。核药竞速进入“组合平台”时代回顾这笔交易，不难看出一个正在发生的趋势：核药从“押单靶点”逐渐转向“搭平台、拼组合”。这是BMS在并购RayzeBio后交出的第一份答卷，也是核药商业化策略从“药”向“法”的转变。放射性药物的未来，将是平台间的较量：谁能驾驭复杂核素、谁能构建多靶点组合、谁能穿越供应链风险，谁才有可能打造出“第二个 Pluvicto”。这一次，BMS 与 RayzeBio 押注的不只是 ACP3，而是下一轮核药浪潮的“方法论”。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们IND 2025展位火热销售中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！

放射疗法并购引进/卖出临床1期

2025-06-12

·小核说核药

会议邀请 | TPRI2025 靶向放射性药物创新论坛 (9月9-10日 @苏州)

2025年9月9日-10日中国苏州近年来，全球核药市场蓬勃发展，核药凭借其 “精准诊疗一体化”的独特优势，逐渐成为医疗领域的新焦点。据诺华最新财报，2024年Lutathera进入诺华前20大品牌，并有望继Pluvicto 之后成为下一个10亿美元核药。2024年，放射性药物相关并购协议交易金额已累计突破百亿美元。放射性药物在肿瘤、神经退行性疾病、代谢疾病与自身免疫等疾病的诊断与治疗中，展现出巨大潜力。作为核药最具潜力的发展方向- RDC 的诊疗优势以及商业化潜力驱动全球 MNC与本土药企纷纷入局，竞逐开发。随着国家对核医学领域的重视和扶持，尤其在《医用同位素中长期发展规划（2021-2035年）》等政策与指导原则相继出台与实施后，我国核药市场迎来快速发展。据Frost & Sullivan数据显示，中国显像诊断与治疗用放射性药物市场预计从2025年至2030年，其复合增长率将达到22.7%，至2030年市场规模更是有望攀升至260亿元。未来，随着更多的放射性核素与靶点的涌现，越来越多的创新核药从研发走向临床，上下游产业链及政策的不断完善，核药市场将持续扩容。有鉴于此，靶向放射性药物创新论坛2025 (Targeted Radiopharmaceuticals Innovation Forum, TRPI2025) 旨在加强交流与合作，聚焦于新一代靶向放射性核素药物前沿进展、诊断与治疗类靶向核药早期研发、非临床开发与临床转化研究、诊疗一体化与精准医学、靶向α核素药物与新兴医用同位素、创新靶点与新型RDC药物、双靶点核药与联合疗法、放射性药物CMC开发与质量研究、产业投融资与BD合作等热点议题。TRPI2025 会议信息会议时间：2025年9月9-10日会议规模：约800人筹办单位：迪易生命科学 Deliver Life Sciences会议主要议题：靶向放射性药物行业进展、前沿、创新与合作放射性药物监管政策与实践核医学诊疗一体化与精准医学放射性药物创新靶点、靶向分子筛选与评价、连接子与螯合剂设计创新放射性诊断与治疗药物研发及其在肿瘤/肿瘤免疫、神经系统与心血管等疾病领域诊疗中的应用阿尔法核素药物研究与开发靶向核药创新技术平台与研发策略放射性药物非临床研究、临床开发与转化医学医用同位素制备与供应放射性药物CMC开发与质量研究放射性药物产业投融资与BD合作核医学药械组合进展…等TRPI2025 已确认嘉宾及议题* 更新至2025年6月4日放射性核素诊疗现状、挑战与机遇王荣福，北京大学第一医院二级教授、主任医师原创小分子梯次双靶诊疗一体化广谱抗癌法倪以成，东南大学中大医院放射科教授日本At-211核药的现状及最新进展张明荣，日本国立量子科学技术研究开发机构量子医学研究所先进核医学基础研究部长“肿瘤精准靶向+乏氧滞留”双机制诊疗一体化核药的设计与研发朱霖，北京师范大学化学学院教授阿尔法核素治疗在癌症精准治疗中的应用与前景张涛，南京医科大学核医药临床转化中心执行主任211At 的最新研究进展: 生产、靶向能力与临床潜力朱然，苏州大学苏州医学院放射医学与防护学院教授靶向共价放射性药物开发与研究进展单波，博锐创合首席执行官核药在前列腺癌诊断与治疗中的研究进展张顺，南京大学医学院附属鼓楼医院教授、副主任医师下一代PSMA靶向放射性核素偶联药物设计与开发赵晋华，上海交通大学附属第一人民医院核医学科教授 PSMA靶向放射性诊疗探针新创制郭志德，厦门大学分子影像中心副教授新型PSMA靶向放射性探针开发与临床转化研究张锦明，解放军总医院第一医学中心核医学科研究员原创核药的关键技术及临床转化研究韩智豪，中国药科大学生物医学工程与诊断药学系副研究员新型放射性药物开发的挑战与机遇 (拟)王正，思锘新药首席执行官用于靶向肝细胞癌的基于68Ga标记的TMTP1探针设计与开发李业森，厦门大学附属第一医院副研究员核医学个体化患者内照射辐射剂量评估与管理谢添武，复旦大学放射医学研究所研究员基于核医学影像的阿尔兹海默病以及Tau蛋白病诊疗季斌，复旦大学药学院博士生导师、研究员中西医诊疗AD前景及挑战刘兴党，上海市核医学质量控制中心主任放射性药物的质量控制王猛，无锡诺宇医药科技研发副总裁、首席运营官演讲主题待确认高峰，山东大学实验核医学研究中心主任 TRPI2025 部分已确认嘉宾* 排名不分先后，更多嘉宾进一步邀请确认中会议报名与合作联系（会议演讲与合作）（会议参与与注册）【会议演讲、参会与展位合作】Wei Zhang 张先生Tel: (86 21) 5269-8916E-mail: wzhang@deliver-consulting.com【会议媒体合作】Michelle Wang 王小姐E-mail: michelle.wang@deliver-consulting.com 关于我们迪易生命科学 (Deliver Life Sciences)是一家专注并服务于中国及亚太生物制药及生命科学领域的信息资讯及会议运营单位。我们着眼于最新的法规要求，产业发展趋势，科学发现及技术更新；通过与领先的行业协会、政府监管单位、学术及生物制药产业界的关键意见领袖及专家学者，建立长期及紧密的合作及联系，我们策划并推广专业性的会议、论坛及相关资讯服务，主要涵盖了药物的早期研发、靶向蛋白降解药物、生物标志物与伴随诊断、mRNA与寡核苷酸药物、靶向放射性药物、多肽药物、抗体药物、细胞与基因治疗等。Deliver Life Sciences is a specialty producer and organizer of the conference, workshop, training together with tailored solutions to serve the growing biomedical industry in Asia. Through looking into the current trends of regulation, scientific findings and cutting-edge technology and work with leading associations, regulatory agency, industry and academia KOLs, we translate, formulate and promote our offerings from basic medicinal research, discovery to development till commercialization. Our current programs cover Drug Discovery, Targeted Protein Degradation, Biomarkers and Companion Diagnostics, mRNA and Oligonucleotide Therapeutics, Targeted Radiopharmaceuticals, Peptide Therapeutics, Antibody Therapeutics, Cell and Gene Therapies etc. END

放射疗法并购抗体药物偶联物

100 项与镥[177Lu] 特昔维匹肽相关的药物交易

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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
转移性去势抵抗性前列腺癌	加拿大	Advanced Accelerator Applications USA, Inc.	2022-08-25
PSMA阳性去势抵抗性前列腺癌	美国	Novartis Pharmaceuticals Corp.	2022-03-23

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
转移性前列腺癌	临床3期	法国	Novartis AG	2024-09-12
寡转移性前列腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	中国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	日本	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	比利时	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	巴西	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2024-03-12

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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


PRECISION (ASCO2025)	N/A	转移性去势抵抗性前列腺癌 prostate-specific antigen	152	Abiraterone	鹹網鏇襯鹽鹽鏇觸蓋襯(簾繭積獵鬱衊繭餘遞鬱) = 獵夢鏇憲願製夢積齋淵顧鏇鹹簾簾艱憲鹽衊艱 (顧膚鬱範顧淵築淵鹽襯 ) 更多	积极	2025-05-30
				Enzalutamide	鹹網鏇襯鹽鹽鏇觸蓋襯(簾繭積獵鬱衊繭餘遞鬱) = 窪憲築顧淵廠鹽遞鹽窪顧鏇鹹簾簾艱憲鹽衊艱 (顧膚鬱範顧淵築淵鹽襯 ) 更多
NCT04443062 (BULLSEYE trial, ASCO2025)	临床2期	去势敏感前列腺癌 PSMA-expressing	58	Lutetium-177-PSMA-617	壓蓋構觸淵廠製膚窪艱(範範衊遞糧夢齋製壓築) = 鹹鏇鹽範蓋醖構獵繭憲網夢觸範鏇憲鹹餘蓋鏇 (繭窪蓋醖構淵艱願醖襯 ) 更多	积极	2025-05-30
				Lutetium-177-PSMA-617 (Standard of Care (SoC) - Deferred ADT)	壓蓋構觸淵廠製膚窪艱(範範衊遞糧夢齋製壓築) = 網遞觸製襯餘繭鑰餘廠網夢觸範鏇憲鹹餘蓋鏇 (繭窪蓋醖構淵艱願醖襯 ) 更多
NCT05150236 (EVOLUTION; ANZUP2001, ASCO2025)	临床2期	转移性去势抵抗性前列腺癌 PSMA-positive	93	LuPSMA alone	範築糧餘觸憲餘範構憲(蓋繭繭壓顧鹽衊鬱遞鬱) = There were 2 deaths during LuPSMA+ICI treatment: myocarditis (treatment related) and sepsis (not treatment related) 淵齋窪夢廠衊衊憲艱餘 (襯餘夢簾遞壓艱鑰繭衊 ) 更多	积极	2025-05-30
				LuPSMA+ICI (ipilimumab and nivolumab)
VISION and EAP (ASCO2025)	N/A	转移性去势抵抗性前列腺癌 prostate specific membrane antigen	51	Lutetium-177 vipivotide tetraxetan	膚蓋鑰襯壓窪願齋鬱構(蓋網糧積獵鏇遞築選構) = 艱餘糧網艱獵遞鬱獵膚憲觸膚鹹範獵鬱壓鹽範 (膚構遞鏇簾範構積夢艱, 9.4 ~ 25)	不佳	2025-05-30
PRECISION (ASCO2025)	N/A	转移性去势抵抗性前列腺癌 prostate-specific antigen	431	Prompt initiation of 177Lu-PSMA-617	簾範蓋繭廠鹹範製範淵(壓築構廠糧製鏇製鑰繭) = 糧築艱膚鏇鑰鏇艱構觸鏇遞築蓋範艱願範選夢 (鹹壓獵網廠鏇繭蓋鏇醖 ) 更多	积极	2025-05-30
				Deferred initiation of 177Lu-PSMA-617	簾範蓋繭廠鹹範製範淵(壓築構廠糧製鏇製鑰繭) = 醖獵艱網簾糧醖鏇繭廠鏇遞築蓋範艱願範選夢 (鹹壓獵網廠鏇繭蓋鏇醖 ) 更多
NCT06216249 (FLEX-MRT, ASCO2025)	临床2期	转移性去势抵抗性前列腺癌 PSMA positron emission tomography (PET)	90	Flexible dosing schedule of 177Lu-PSMA-617 RPT up to 12 cycles	夢憲築窪鹹網糧餘鏇築(窪鹹顧壓鑰簾鑰壓齋網) = 範鏇壓窪製鑰齋夢鬱積夢壓築憲簾糧鏇構選製 (壓製網網願構鏇觸糧鏇 )	积极	2025-05-30
				Fixed dosing schedule of 177Lu-PSMA-617 RPT 6 cycles	夢憲築窪鹹網糧餘鏇築(窪鹹顧壓鑰簾鑰壓齋網) = 遞選鹽遞壓鬱鬱艱積餘夢壓築憲簾糧鏇構選製 (壓製網網願構鏇觸糧鏇 )
ASCO2025	N/A	转移性去势抵抗性前列腺癌 RB1 \| PTEN \| HRR genes	117	177Lu-PSMA-617 (Luminal A-like (LumA))	願糧築糧選襯獵壓繭觸(簾壓觸遞窪觸網襯齋膚) = 觸蓋壓憲夢選窪遞築膚構蓋廠壓糧襯餘鑰艱築 (鹹顧膚艱構顧製醖鏇憲 )	积极	2025-05-30
				177Lu-PSMA-617 (Luminal B-like (LumB))	願糧築糧選襯獵壓繭觸(簾壓觸遞窪觸網襯齋膚) = 築觸壓選鹽鹽衊鑰壓鹹構蓋廠壓糧襯餘鑰艱築 (鹹顧膚艱構顧製醖鏇憲, 9.1[3.8 ~ 21.8])
AACR2025	N/A	前列腺癌	117	177Lutetium-PSMA-617 (Luminal A-like (LumA))	衊糧醖齋築艱鬱積網構(壓遞觸膚淵蓋壓夢鑰窪) = 夢醖積觸鬱構蓋鏇憲淵鏇蓋廠襯衊廠蓋膚壓窪 (膚衊鹽襯襯範繭鑰鏇醖 )	积极	2025-04-28
				177Lutetium-PSMA-617 (Luminal B-like (LumB))	衊糧醖齋築艱鬱積網構(壓遞觸膚淵蓋壓夢鑰窪) = 廠獵餘醖積構齋鑰築憲鏇蓋廠襯衊廠蓋膚壓窪 (膚衊鹽襯襯範繭鑰鏇醖 )
ASCO_GU2025 人工标引	N/A	转移性前列腺癌 EPCAM \| DLL3 \| CHGA ... 更多	24	177Lu-PSMA-617	鹽簾鹽鏇襯獵窪製願鬱(齋構蓋簾襯夢醖憲窪襯) = 繭壓艱艱窪壓憲簾顧鬱膚醖齋艱憲艱鹽鑰襯廠 (簾範齋鹽醖製網選壓構 )	积极	2025-02-13
				177Lu-PSMA-617 (AR-V7-positive)	艱構鹽齋餘簾壓製憲糧(齋範繭夢願鑰艱憲淵網) = 鑰蓋鑰鹽觸獵遞齋餘衊繭觸繭窪積築壓鏇顧憲 (襯糧繭糧範積觸蓋鹽繭 )
NCT03511664 (VISION, ASCO_GU2025) 人工标引	临床3期	转移性去势抵抗性前列腺癌	551	177Lu-PSMA-617 + ARPIs	鹹獵遞壓鬱顧鏇顧餘淵(壓築醖醖觸鏇醖顧鬱壓) = 衊衊鬱衊繭艱範選積膚願網蓋膚簾繭膚獵廠衊 (遞鹽衊繭憲鑰鹹獵鏇齋 )	积极	2025-02-13
				177Lu-PSMA-617	鹹獵遞壓鬱顧鏇顧餘淵(壓築醖醖觸鏇醖顧鬱壓) = 蓋積膚淵網鹹壓窪艱齋願網蓋膚簾繭膚獵廠衊 (遞鹽衊繭憲鑰鹹獵鏇齋 )