A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer

This is a three-part study evaluating the safety and efficacy of a PSMA-directed radioantibody (rosopatamab tetraxetan, conjugated to either In-111 or Ac-225). Part 1 will consist of one administration of In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants then will be enrolled into either Part 2 (Dose Optimization) or Part 3 (Dose Escalation and Expansion) depending on their prior treatment history. Participants qualifying for Part 2 will be randomized to receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle (dose administration on Day 1 and Day 15) at either 45 or 60 kBq/Kg. Participants qualifying for Part 3 must have received prior Lu-177-PSMA-radioligand therapy and will receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle at 45, 55, or 60 kBq/Kg. Dose limiting toxicities (DLTs) will be monitored in Part 3 to determine the recommended phase 2 dose (RP2D), and the study may enroll additional participants to be treated with the RP2D dose level. Participants enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments.

开始日期2024-08-06

申办/合作机构

Convergent Therapeutics, Inc.

NCT05567770

/ Withdrawn临床1期IIT

ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer

The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy.

开始日期2023-12-01

申办/合作机构

Weill Medical College of Cornell University

[+1]

NCT04946370

/ Recruiting临床1/2期IIT

Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab + androgen receptor inhibitor (ARI) is more effective against prostate cancer than pembrolizumab + ARI alone.

开始日期2021-08-12

申办/合作机构

Weill Medical College of Cornell University

[+2]

100 项与 Actinium 225-J591 相关的临床结果

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100 项与 Actinium 225-J591 相关的转化医学

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100 项与 Actinium 225-J591 相关的专利（医药）

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项与 Actinium 225-J591 相关的文献（医药）

2024-03-01·JOURNAL OF CLINICAL ONCOLOGY

Prostate-Specific Membrane Antigen–Targeting Alpha Emitter via Antibody Delivery for Metastatic Castration-Resistant Prostate Cancer: A Phase I Dose-Escalation Study of ²²⁵Ac-J591

Article

作者: Vallabhajosula, Shankar ; Sternberg, Cora N. ; Nanus, David M. ; Ballman, Karla ; Bander, Neil H. ; Sartor, A. Oliver ; Stangl-Kremser, Judith ; Osborne, Joseph R. ; Sun, Michael ; Tagawa, Scott T. ; Molina, Ana ; Nauseef, Jones T. ; Castellanos, Sandra Huicochea ; Bissassar, Mahelia ; Thomas, Charlene

PURPOSE:

Novel therapies are needed to extend survival in metastatic castration-resistant prostate cancer (mCRPC). Prostate-specific membrane antigen (PSMA), a cell surface antigen overexpressed in PC, provides a validated target. This dose-escalation study investigated the safety, efficacy, maximum tolerated dose (MTD), and recommended phase II dose (RP2D) for 225Ac-J591, anti-PSMA monoclonal antibody J591 radiolabeled with the alpha emitter actinium-225.

METHODS:

Following investigational new drug-enabling preclinical studies, we enrolled patients with progressive mCRPC that was refractory to or who refused standard treatment options (including androgen receptor pathway inhibitor and had received or been deemed ineligible for taxane chemotherapy). No selection for PSMA was performed. Patients received a single dose of 225Ac-J591 at one of seven dose-escalation levels followed by expansion at the highest dose. Primary end point of dose-escalation cohort was determination of dose-limiting toxicity (DLT) and RP2D.

RESULTS:

Radiochemistry and animal studies were favorable. Thirty-two patients received 225Ac-J591 in an accelerated dose-escalation design (22 in dose escalation, 10 in expansion). One patient (1 of 22; 4.5%) experienced DLT in cohort 6 (80 KBq/kg) but none in cohort 7; MTD was not reached, and RP2D was the highest dose level (93.3 KBq/kg). The majority of high-grade adverse events (AEs) were hematologic with an apparent relationship with administered radioactivity. Nonhematologic AEs were generally of low grade. Prostate-specific antigen (PSA) declines and circulating tumor cell (CTC) control were observed: 46.9% had at least 50% PSA decline at any time (34.4% confirmed PSA response), and protocol-defined CTC count response occurred in 13 of 22 (59.1%).

CONCLUSION:

To our knowledge, this is the first-in-human phase I dose-escalation trial of a single dose of 225Ac-J591 in 32 patients with pretreated progressive mCRPC demonstrated safety and preliminary efficacy signals. Further investigation is underway.

2023-08-01·Experimental hematology & oncology

Novel agents and clinical trials in castration-resistant prostate cancer: latest updates from 2023 ASCO-GU Cancers Symposium.

Letter

作者: Jiang, Yuanhong ; Li, Zeyu ; Yu, Jiazheng ; Xu, Zhenqun ; Wu, Siyu ; Chen, Xiaonan ; Li, Shijie ; Li, Mingyang ; Xin, Kerong ; Li, Rong ; Zheng, Jianyi

Numerous novel and effective therapeutic agents and clinical trials addressing castration-resistant prostate cancer (CRPC) were reported during the 2023 American Society of Clinical Oncology-Genitourinary (ASCO-GU) Cancers Symposium. Notably, radionuclide drug conjugates (RDC), specifically 177Lu/111In-J591 and 225Ac-J591, exhibited enhanced therapeutic efficacy in treating patients with CRPC. Furthermore, promising treatment approaches for CRPC included dual anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and anti-programmed death-1 (PD-1) blockade in rare tumors (DART)-Lorigerlimab, prostate stem cell antigen (PSCA)-directed chimeric antigen receptor (CAR)-T cell immunotherapy-BPX-601, and protein kinase inhibitor (AKTi)-CAPltello-280. We have summarized the latest CRPC treatment strategies presented at the 2023 ASCO-GU Cancers Symposium, along with recent advances in CRPC clinical trials.

项与 Actinium 225-J591 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

2025-02-10

·PRNewswire

Convergent Therapeutics Announces Two Clinical Trial Updates on CONV01-α at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium 2025

- Phase I Follow-Up Data Showed an Overall Survival of 29.8 Months with the Addition of CONV01-α to 177Lu-PSMA-I&T in Advanced Prostate Cancer CAMBRIDGE, Mass., Feb. 10, 2025 /PRNewswire/ -- Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, today announced clinical trial updates for its lead asset, CONV01-α (225Ac-J591), a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to actinium-225 (225Ac). Data will be presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, which will take place February 13-15, 2025, in San Francisco, California. The first presentation, titled "Mature phase 1 follow up of alpha emitter 225Ac-J591 with 177Lu-PSMA-I&T in advanced prostate cancer," reported clinical follow-up of a Phase I dose-escalation trial exploring the addition of CONV01-α to 177Lu-PSMA-I&T, a PSMA-targeted beta emitting small molecule for the treatment of advanced prostate cancer. The study population presented included 18 patients (six at each dose level of CONV01-α) with progressive metastatic castration-resistant prostate cancer (mCRPC). Relatively low doses of CONV01-α were used. Data showed that the median overall survival was 29.8 months, with 10 patients still alive at the time of submission. Five patients were free from PSA progression at one year including one patient progression-free at 34 months on no active therapy. A decline in prostate-specific antigen (PSA) levels was seen in 94% of patients, 64% of patients achieved a PSA50 and 28% achieved a PSA90 response. Additionally, circulating tumor cell count changes were seen, with 80% of evaluable patients converting from "unfavorable" to "favorable." High grade adverse events were rare. "The impressive clinical activity is consistent with our pre-clinical data demonstrating that the antibody/ligand combination delivers a synergistic dose to tumor. Importantly, the synergistic tumor dose is achieved in the absence of additive toxicity due to the non-overlapping normal organ biodistribution of the ligand and antibody. This was also confirmed by the benign safety profile in the trial. The dosimetry and safety profile suggest the potential for additional cycles beyond the two cycles used in this trial. That the overall survival in this trial was double that of the Phase III VISION trial of 177Lu PSMA-617 further increases our enthusiasm for future trials of this combination," said Neil Bander, MD, Convergent's Co-Founder and Chief Scientific Officer and Professor Emeritus of Urology at Weill Cornell Medicine. The second presentation, titled "CONVERGE-01: Dosimetry, randomized dose optimization, dose escalation, and efficacy of Ac-225 rosopatamab tetraxetan in participants with PSMA-positive castration-resistant prostate cancer," is a "Trials in Progress" presentation of the three-part company sponsored Phase II trial evaluating the safety and efficacy of CONV01-α (225Ac-J591) monotherapy in patients with castration-resistant prostate cancer. Philip Kantoff, MD, Co-Founder and CEO said, "CONVERGE-01 is intended to confirm the high response rate and durability of CONV01-a monotherapy and solidify the path forward to our pivotal trial." About CONV01-α CONV01-α, Convergent's alpha-emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha-emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA), which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen, and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called Ac-225, which releases alpha particles that kill cancer cells through DNA double-strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful, yet precise, payload offers the ideal combination to treat many types of cancers. Convergent Therapeutics is currently enrolling into the CONVERGE-01 Phase II monotherapy trial to confirm the high response rate, durability and safety of CONV01-a pre and post radioligand beta. About Convergent Therapeutics, Inc. Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radioantibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology and its proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radioantibodies precisely target cancer cells with potent, localized radiation. For more information, please visit and follow us on X and LinkedIn. Media Relations: Bryan Blatstein Spectrum Science 917-714-2609 [email protected] SOURCE Convergent Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果ASCO会议临床1期临床2期

2025-01-12

·动脉网

诺和诺德掷金4000万，这家α粒子核药企业A轮融资达1.3亿

放射性药物疗法研究企业Convergent Therapeutics（以下简称Convergent）再添一员“猛将”。 2024年12月11日，美国生物技术公司Convergent宣布任命Barbara Duncan为其董事会成员。 Barbara Duncan女士是宾西法尼亚大学沃顿商学院工商管理硕士，拥有超过25年的财务管理经验，目前在Atea Pharmaceuticals、皮下药物递送领头羊Halozyme Therapeutics和Ovid Therapeutics三家上市生物制药公司的董事会和各个委员会任职。核药企业Fusion在去年6月被阿斯利康宣布以约24亿美元的价格收购。收购前，Barbara还担任该公司的董事长。 2023年，Convergent完成了奥博资本和RA Capital Management领投，Invus参投的9000万美元A轮融资。去年9月又获得由Novo Holdings（诺和控股）领投的A+轮融资4000万美元。至此，Convergent的A轮融资总额增加到1.3亿美元。 01 25年+开发研究，脱胎于康奈尔大学 Convergent Therapeutics Inc.成立于2020年，总部位于美国马萨诸塞州剑桥。Convergent是一家临床阶段的制药公司，专注于为前列腺癌和其他癌症开发下一代放射性药物疗法。 Philip Kantoff博士是Convergent的首席执行官兼联合创始人，同时担任哈佛Dana-Farber 癌症研究所（DFCI）实体瘤肿瘤学部的主任以及泌尿生殖系统肿瘤学中心的主任。在创办Convergent之前，Kantoff博士在世界最大的癌症研究中心纪念斯隆—凯特琳癌症中心担任了六年的医学系主任，在治疗癌症患者的同时开发生物标注物和癌症疗法。如果说Kantoff博士是Convergent的躯干，那放射抗体技术和前列腺特异性膜抗原（PSMA）领域先驱Neil Bander博士就是Convergent的核心。 Neil Bander博士是Convergent联合创始人兼首席科学官，目前就任威尔康奈尔医学院的前泌尿肿瘤学教授。过去25年间，他曾带领团队开发了第一个针对PSMA的单克隆体，并验证了PSMA作为前列腺癌和其他癌症治疗靶点的有效性。 Convergent的核心专有技术—双靶向放射性核素治疗（RNT）便是来自Bander教授的研究，目前已得到康奈尔大学授权。 02 基于α粒子，最大程度减少治疗副作用放射抗体是一种靶向治疗，其中抗体与放射性有效载荷相关联。这种放射性有效载荷具有通过从内部来破坏细胞来杀死癌细胞的能力。每种放射抗体都是通过精心选择对特定癌症靶标具有高亲和力的抗体而制备的。这使得放射抗体能够归巢并锁定在癌细胞表面。一旦附着，放射性抗体就会被吸入细胞中，将放射性有效载荷输送到细胞核附近，最终杀死癌细胞。然而，放射治疗是把双刃剑，在杀死癌细胞的同时，也会对周边的健康组织造成无法修复的损伤。经过放射性治疗后，患者可能会出现四肢乏力、恶心呕吐、皮肤变黑等症状。为此,Convergent基于其专有技术改进了当前放射疗法的局限性。与其他技术相比（包括那些依赖于β发射同位素的技术，如Lu-177），发射α的放射性抗体具有更高的精度和效力，虽然还达不到“0”副作用，但也能在最大程度上减少对其他健康组织的损害，减轻放疗副作用。 α较β粒子的优势图源:Convergent官网 Convergent公司凭借对α粒子的了解和双靶向放射性核素治疗技术的灵活运用，已经开发了其主要管线产品CONV01-α（Ac-225 rosopatamab tetraxetan）。α粒子具有强大的短程特性，射程相当于几个细胞直径（＜100μm），可最大限度地减少对健康邻近细胞和组织的辐射暴露。当与其专有抗体结合时，便会形成一种有效且精确的放射抗体，能够特异性靶向癌细胞并将放射性有效载荷直接输送到细胞中。 α核素的机制相较于传统β核素更为复杂，存在许多未知领域，其开发极具挑战。首先，这些药物必须具有极高的靶向性，以减少对正常组织的损害。其次，需要克服Actinium-225（释放α粒子的放射性核素之一，通过DNA双链断裂杀死癌细胞）衰变时可能产生的反冲效应，这可能导致药物脱靶。此外，Actinium-225的供应量稀缺也是一个主要问题，因为目前只有少数几个中心能够生产这种核素，且数量有限，无法满足全球医药常规治疗的需求。拜耳研发的镭-223药物Xofigo是目前唯一获得批准的α发射疗法。根据《靶向阿尔法疗法市场规模、药物批准、专有技术和临床试验洞察（2024）》，目前有超过20种α粒子发射性药物正在进行临床试验。2024年11月，SK Biopharmaceuticals与韩国放射医学科学研究所（KIRAMS）宣布合作，旨在发现和开发使用α粒子放射性同位素Actinium-225的放射性药物候选物。 03 同类最佳，主要候选药物已进入Ⅱ/Ⅲ期临床开发阶段根据2024年“《柳叶刀》前列腺癌重大报告”（The Lancet Commission on prostate cancer: planning for the surge in cases）的预测，全球前列腺癌病例数将从2020年的每年140万例增加到2040年的每年290万例。早在去年4月，Convergent的主要候选药物CONV01-α的IND申请就获得了FDA批准。紧接着在9月完成了II期临床首例患者给药，证实其对抵抗性前列腺癌（mCRPC）患者的安全性和有效性。 CONV01-α是一种专有的、同类最佳的Actinium-225标记放射抗体，靶向几乎所有前列腺癌细胞表面表达的蛋白质（抗原）。它结合了抗体的精确性和药代动力学特性，以及α发射型放射性核素的肿瘤杀伤潜力，在精确辐射杀死癌细胞的同时还能保留健康组织。具体来说，CONV01-α与其他抗体的区别在于能同时使用抗体和α放射性核素。在利用抗体的选择性和α放射性同位素的肿瘤破坏潜力时，Convergent的放射抗体能以有效的局部辐射精确靶向癌细胞。选择α放射性核素是研发成功的充分条件，而将其与高选择性抗体配对则是创造有效治疗癌症的疗法的必要条件。单克隆抗体对PSMA等靶标具有更大的亲和力，它能提供更好的肿瘤内化和保留效果，从而使药物的效力更强，所需剂量更少，总体辐射剂量也更低。相比之下，β或α小分子配体则没有这些优势。抗体作用机理图源：Convergent官网此外，通过将Actinium-225与肿瘤靶向抗体连接，在提高肿瘤杀伤辐射传递速度的同时还可以大大降低肿瘤外效应和每个疗程的辐射量，从而提高治疗效果和安全性。 Convergent管线图源：Convergent官网目前，Convergent正在进行一项随机、开放标签、多中心的1/2期临床试验研究，旨在评估CONV01-α在mCRPC患者中的安全性和有效性。据其对外披露，结果显示，在威尔康奈尔医学院接受CONV01-α治疗的患者中，67%的患者前列腺特异性抗原（PSA；判断前列腺癌的指标)下降了50%，27%的患者PSA下降了90%。CONVERGE-01的招募工作正在进行中，未来试验的计划仍在继续。基于对α放射性同位素的开发，Convegent或将利用现有技术开发针对实体瘤的药物。目前处于探索阶段。 Convergent管线图源：Convergent官网据动脉网不完全统计，2024年至今，包括阿斯利康、百时美施贵宝在内的多家MNC已投入上百亿美元进军这一领域。近年来，中国在靶向阿尔法粒子放疗领域也取得了显著进展。 2021年7月7日，西南医科大学附属医院完成了我国首例225Ac治疗，标志着我国在该领域的实质性突破。同年9月，我国又开展了国际首例转移性嗜铬细胞瘤225Ac-DOTATATE治疗，并取得了理想疗效。据磐美迪控股，全球范围内α核素的研究尚处于起步阶段，需要在理论与技术方面取得更多进展。 2024年10月，余飞教授团队在《Theranostics》上发表的“Targeting senescence with radioactive 223Ra/B a SAzymes enables senolytics-unlocked One‐Two punch strategy to boost anti-tumor immunotherapy”研究论文，首次从核辐射驱动的旁观者效应角度探讨了α核素的辐射生物学作用。这是我国在212Pb/212Bi应用基础研究领域的先驱性成果，为α粒子放疗的深入研究和临床应用提供了新的视角和理论支持。如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

放射疗法并购高管变更

100 项与 Actinium 225-J591 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
PSMA阳性去势抵抗性前列腺癌	临床2期	美国	Convergent Therapeutics, Inc.	2024-08-06
前列腺腺癌	临床2期	美国	Merck Sharp & Dohme Corp.	2021-08-12
转移性去势抵抗性前列腺癌	临床2期	美国	Weill Medical College of Cornell University	2020-08-18
去势敏感前列腺癌	临床1期	-	Convergent Therapeutics, Inc.	2023-12-01
转移性前列腺癌	临床1期	-	Convergent Therapeutics, Inc.	2023-12-01

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适应症

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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


NCT04886986 (ASCO_GU2025) 人工标引	临床1期	晚期前列腺癌	18	225Ac-J591 + PNT2002	糧顧壓選衊積壓襯鏇糧(蓋遞獵膚窪鹹餘鹹鑰製) = 35 KGBq/kg 顧選積壓鬱選憲壓餘鬱 (糧糧鑰廠窪淵窪製選糧 ) 更多	积极	2025-02-13
NCT04946370 (ESMO2024) 人工标引	临床1期	转移性去势抵抗性前列腺癌	12	Pembrolizumab 225Ac-J591	憲網簾製選襯壓築獵範(獵襯鬱願糧廠鏇簾鹹齋) = determined to be 80 KBq/Kg 構憲廠壓鹽糧憲齋襯網 (獵繭獵獵獵廠鹹壓艱鬱 )	积极	2024-09-15
				Pembrolizumab 225Ac-J591
NCT04886986 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	前列腺癌	18	225Ac-J591+PNT2002	製鹹齋顧鹽鹹夢壓選襯(願顧膚願襯鑰衊齋夢壓) = 2 of 6 pts with DLT at 40 KBq/Kg (Gr 2 or 3 thrombocytopenia delaying cycle 2 by >3 wk); no DLT observed in other cohorts. 醖簾觸齋蓋憲夢顧觸觸 (繭築鬱鬱鬱鏇構遞獵範 ) 更多	积极	2023-05-31
NCT03276572 (AACR2023) 人工标引	临床1期	转移性去势抵抗性前列腺癌	24	225Ac J591	網繭積齋構齋鑰廠獵獵(構壓鑰獵醖蓋鹹鏇窪餘) = No DLTs were observed in Cohort 1 (n=3) or 2 (n=6). In C3, 2/6 subjects experienced DLTs 糧艱鹹襯壓襯鬱願鹹鹹 (餘獵願鹹蓋鏇鏇積範艱 ) 更多	积极	2023-04-14
NCT04946370 (ASCO_GU2023) 人工标引	临床1/2期	去势抵抗性前列腺癌	13	pembrolizumab+225Ac-J591	憲餘鏇鹹顧壓廠範簾觸(鏇遞襯遞鑰選衊鏇齋廠) = 9 (75%) thrombocytopenia (3 with g≥3; 1 g4 with PC marrow infiltration), 7 (58%) neutropenia (none g≥3), 6 (50%) nausea, 7 (58%) g1-2 fatigue, 9 (75%) g1-2 xerostomia, 7 (58%) g1 AST 蓋廠壓遞簾膚鬱選醖鬱 (鹽蓋窪夢積願築衊網鑰 ) 更多	积极	2023-02-21
NCT03276572 (Phase I Dose-Escalation Study of <sup>225</sup>Ac-J591, CTgov)	临床1期	转移性去势抵抗性前列腺癌	32	225Ac-J591 (225Ac-J591 Cohort 1)	鹹選艱蓋膚獵憲範製構 = 築構淵範窪蓋憲觸簾艱蓋蓋窪觸艱築簾構築積 (簾壓鑰鬱範網淵繭艱廠, 蓋餘鏇獵簾齋壓衊簾積 ~ 築觸遞觸遞獵繭憲衊艱) 更多	-	2022-12-06
				225Ac-J591 (225Ac-J591 Cohort 2)	鹹選艱蓋膚獵憲範製構 = 簾淵鑰製壓膚齋鬱網繭蓋蓋窪觸艱築簾構築積 (簾壓鑰鬱範網淵繭艱廠, 鑰網鏇製蓋淵獵蓋鑰築 ~ 廠廠夢淵鹹衊構願獵獵) 更多
NCT03042468 \| NCT03276572 (ESMO2022)	临床1/2期	转移性去势抵抗性前列腺癌 AR copy number \| homologous recombination repair (HRR) gene copy number	80	177Lu-PSMA-617	獵遞獵夢顧憲衊鏇鑰製(壓鑰糧鹽構繭夢選築製): HR = 2.14 (95% CI, 1.15 ~ 4), P-Value = 0.017 更多	-	2022-09-10
				225Ac-J591
NCT04506567 (ASCO_GU2021)	临床1/2期	转移性去势抵抗性前列腺癌	-	225Ac-J591 (Fractionated-dose cohort)	齋齋鹽襯鑰衊積簾構構(艱遞顧鹹齋簾蓋鏇鏇願) = 鹹淵夢壓膚鬱鏇淵積顧齋廠願鏇積積遞鬱鬱鹹 (範襯廠壓鑰餘構衊繭憲 )	-	2021-03-02
				225Ac-J591 (Multiple-dose cohort)	齋齋鹽襯鑰衊積簾構構(艱遞顧鹹齋簾蓋鏇鏇願) = 顧範夢襯夢範襯顧憲醖齋廠願鏇積積遞鬱鬱鹹 (範襯廠壓鑰餘構衊繭憲 )
NCT03276572 (ASCO2020)	临床1期	转移性去势抵抗性前列腺癌	22	<sup>225</sup>Ac-J591	齋艱衊餘蓋廠膚構範鏇(簾鬱鹽壓簾積鬱醖壓範) = 鹽築觸網製獵觸膚夢鹽淵簾選製夢構淵鏇範蓋 (糧餘範獵艱構蓋膚願窪 ) 更多	积极	2020-05-25