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 ; Wu, Siyu ; Yu, Jiazheng ; Xu, Zhenqun ; Li, Shijie ; Chen, Xiaonan ; 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.

The Prostate

Prognostic value of neutrophil‐to‐lymphocyte ratio in patients with metastatic castration‐resistant prostate cancer receiving prostate‐specific membrane antigen targeted radionuclide therapy

Article

作者: Molina, Ana ; Osborne, Joseph R. ; Nanus, David M. ; Bander, Neil H. ; Sun, Michael ; Tagawa, Scott ; Thomas, Joseph ; Ho, Benedict ; Nauseef, Jones T. ; Stangl‐Kremser, Judith ; Sternberg, Cora N.

Abstract:

Background:

Neutrophil count:lymphocyte count ratio (NLR) may be a prognostic factor for men with advanced prostate cancer. We hypothesized that it is associated with prostate‐specific antigen (PSA) response and survival in men treated with prostate‐specific membrane antigen (PSMA)‐targeted radionuclide therapy (TRT).

Methods:

Data of 180 men with metastatic castration‐resistant prostate cancer (mCRPC) who were treated in sequential prospective radionuclide clinical trials from 2002 to 2021 (utilizing 177Lu‐J591, 90Y‐J591, 177Lu‐PSMA‐617, or 225Ac‐J591) were retrospectively analyzed. We used a logistic regression to determine the association between NLR and ≥50% PSA decline (PSA50) and a Cox proportional hazards model to investigate the association between NLR and overall survival (OS).

Results:

A total of 94 subjects (52.2%) received 177Lu‐J591, 51 (28.3%) 177Lu‐PSMA‐617, 28 (15.6%) 225Ac‐J591, and 7 (3.9%) 90Y‐J591. The median NLR of 3.75 was used as cut‐off (low vs. high NLR; n = 90, respectively). On univariate analysis, NLR was not associated with PSA50 (HR 1.08; 95% confidence interval [CI] 0.99–1.17, p = 0.067). However, it was associated with worse OS (hazard ratio [HR] 1.06, 95% CI 1.02–1.09, p = 0.002), also after controlling for circulating tumor cell count and cancer and leukemia group B risk group (HR 1.05; 95% CI 1.003–1.11, p = 0.036). Men with high NLR were at a higher hazard of death from all causes (HR 1.43, 95% CI 1.05–1.94, p = 0.024).

Conclusions:

NLR provides prognostic information in the setting of patients with mCRPC receiving treatment with PSMA‐TRT.

项与 Actinium 225-J591 相关的新闻（医药）

2026-01-15

·小触核药

通瑞生物1类治疗核药临床获批，Ac-225核药研发全球加速中

导语 Introduction 近日，通瑞生物制药（成都）有限公司（通瑞生物）研发的1类放射性治疗药物“TRC003注射液”的临床试验申请获得国家药品监督管理局药品审评中心默示许可，同意开展拟用于治疗前列腺特异性膜抗原（PSMA）阳性的转移性去势抵抗性前列腺癌（mCRPC）的成年患者的临床研究。在去年10月份的欧洲核医学大会（EANM 2025）上，由通瑞生物支持的两项关于225Ac-PSMA-CY313在转移性去势抵抗性前列腺癌（mCRPC）领域的研究，凭借其创新性与重要价值，获大会评审委员会高度认可，被评选为 “Top Rated Oral Presentation”（最受欢迎的口头报告）。因此，推测此次申报很可能为该公司首款Ac-225核素的放射性治疗药物。在Ac-225供应有望改善的预期下，全球制药巨头和创新生物技术公司早已开始争相布局基于Ac-225的靶向放射性药物。全球范围内，Ac-225核药的研发正进入一个高速发展期，据统计，截至2025年，全球已有超过70条Ac-225核药研发管线，其中超过20项已进入临床试验阶段，覆盖了从前列腺癌到血液肿瘤的多种恶性疾病，其中不乏已进入临床II/III期研究的重磅候选药物。前列腺癌：最热门的战场前列腺癌是Ac-225核药研发最为集中的领域，主要靶点是前列腺特异性膜抗原（PSMA），这是一种在绝大多数前列腺癌细胞上高表达的蛋白质。 [225Ac]Ac-PSMA-617 (Pluvicto-α)：这是诺华（Novartis）公司在其已上市的β粒子药物Pluvicto（[177Lu]Lu-PSMA-617）基础上开发的α粒子版本。理论上，Ac-225的强效杀伤力有望克服对β粒子疗法产生耐药性的肿瘤，或对恶性程度更高的肿瘤提供更优的治疗效果。目前，诺华的[225Ac]Ac-PSMA-617注射液正在全球多地开展临床试验，包括针对转移性去势抵抗性前列腺癌（mCRPC）患者的I/II期研究。其在中国的临床试验申请也已被国家药品监督管理局（NMPA）受理。这是最受关注、也最接近商业化的Ac-225药物之一。 [225Ac]Ac-J591：由Weill Cornell Medicine和Actinium Pharmaceuticals联合开发，靶向PSMA的胞外域。该药物在早期临床试验中已显示出令人鼓舞的疗效，尤其是在mCRPC患者中观察到了显著的PSA（前列腺特异性抗原）水平下降和肿瘤消退。目前正在进行更深入的临床评估。 [225Ac]Ac-PSMA-I&T：这是一种基于PSMA抑制剂的靶向配体，由慕尼黑工业大学等机构率先开展临床研究，同样在mCRPC患者中显示了高缓解率。多项学术研究和临床试验正在评估其安全性和有效性。实体瘤的广泛探索除了前列腺癌，Ac-225核药的研发也扩展到了其他多种实体瘤。神经内分泌肿瘤（NETs）：靶向生长抑素受体（SSTR）是治疗NETs的成熟策略。基于Ac-225的SSTR靶向药物，如[225Ac]Ac-DOTATATE，被认为是现有Lu-177标记的SSTR药物（如Lutathera）的有力补充或后续治疗选择，尤其适用于对β粒子疗法不敏感或复发的患者，评估其在晚期NETs患者中的应用。 [225Ac]Ac-FPI-2265：由Fusion Pharmaceuticals（已被阿斯利康收购）开发，是一款靶向神经降压素受体1型(NTR1)的Ac-225药物，用于治疗表达NTR1的实体瘤，正在进行进入II/III期临床试验。 [225Ac]Ac-FPI-2059：由Fusion Pharmaceuticals（已被阿斯利康收购）开发，靶向胰岛素样生长因子1受体（IGF-1R），正在进行针对多种实体瘤的I期临床试验。 RYZ101（[225Ac]Ac-DOTATATE）：RayzeBio（已被BMS收购）的RYZ101（[225Ac]Ac-DOTATATE）已进入III期临床，目前因同位素供应短缺被迫暂停，是进展最快的Ac-225药物之一。针对乳腺癌、非小细胞肺癌等的Ac-225核药也在临床探索中。血液系统恶性肿瘤 Ac-225同样在治疗白血病等血液肿瘤方面显示出潜力。 Lintuzumab-Ac225 (Actimab-A)：由Actinium Pharmaceuticals公司开发，Lintuzumab是一种针对CD33的单克隆抗体，与放射性同位素Ac-225结合，形成Lintuzumab-Ac-225，CD33在大多数AML细胞上表达，以增强对AML细胞的打击能力。该药物已完成多项I/II期临床试验，并正在探索与其他药物的联合治疗方案。目前，全球Ac-225核药研发领域呈现出大型制药公司（通过收购）与创新生物技术公司并驾齐驱的格局。 · 诺华（Novartis） 2024年5月初，诺华宣布收购核药生物技术公司Mariana Oncology，诺华支付10亿美元预付款，以及7.5亿美元里程碑付款。Mariana的首发管线MC-339，是用于治疗小细胞肺癌的靶向核药。该候选药物由一种肽类小分子组成，经设计可携带放射性锕（Ac）有效载荷。此外，凭借其在PSMA靶向核药领域的深厚积累，其下一代核药225Ac-PSMA-617目前处于全球Ⅰ期阶段，用于治疗前列腺癌。 · 百时美施贵宝（BMS） 2024年初，百时美施贵宝（BMS）宣布完成了对RayzeBio的收购。此次收购的交易总额约为41亿美元，每股现金价格为62.50美元。将其进展最快的Ac-225药物之一RYZ101收入囊中，强势入局。24年12月中百时美施贵宝重新取得了ABZ-706（相当于RYZ801）在大中华区开发和商业化的独家权利，该管线靶向磷脂酰肌醇蛋白聚糖3（GPC3），用于基于Ac的放射性疗法治疗肝细胞癌，目前正在进行IND研究。 · 礼来（Eli Lilly） 2023年10月礼来以14亿美元收购Point Biopharma，获得了Ac-225的泛癌FAP-α项目PNT2004及PSMA项目PNT2001。2024年5月礼来与Aktis Oncology达成了一项价值高达11亿美元的协议。Aktis Oncology是一家专注于开发新型α核素（靶向疗法的生物技术公司，该合作强化了礼来在α核素药物平台的能力。2024年6月底日，礼来与Radionetics Oncology达成战略合作，将共同推进靶向GPCR的小分子放射性药物。2025年2月礼来又与AdvanCell扩大合作，共同开发靶向α核素疗法。 · 阿斯利康（AstraZeneca） 2024年3月阿斯利康以高达24亿美元的价格收购了Fusion Pharmaceuticals，进入了放射性药物领域。Fusion是一家专注于精准核药开发的公司，利用α粒子的医学同位素，结合靶向癌细胞的抗体，精准狙击癌细胞。Fusion的管线资产包括225Ac-PSMA I&T（FPI-2265），225Ac-FPI-1434和FPI-2059等。这些项目针对前列腺癌、实体瘤等多种癌症类型，并处于不同的临床试验阶段。其中，FPI-2265为核心项目，在mCRPC患者的的治疗中显示出显著优势。此外，阿斯利康与海德堡大学和Euratom达成基于锕系元素的PSMA靶向放疗的全球独家许可协议。 · 拜耳（Bayer）早在2009年就与Algeta合作开发Xofigo，并于2013年获批上市，用于治疗晚期骨转移型去势抵抗性前列腺癌。Xofigo上市后，销售额在2017年达到峰值（4.08亿欧元），后续开始逐年下滑。2023年5月拜耳与Bicycle Therapeutics达成战略合作，Bicycle将获得4500万美元的预付款，如果达到开发和商业化的里程碑，Bicycle可能获得总计高达17亿美元的款项；拜耳可获得Bicycle的专有肽，用于开发下一代靶向放射治疗，增强肿瘤相关研发管线。目前拜耳有两款核药225Ac-macropa-pelgifatamab (BAY3546828) 和225Ac-PSMA-Trillium（BAY 3563254），两款核药采用的核素均为Ac-225。 · 强生（Johnson & Johnson） 2017年，强生JJDC（Johnson & Johnson Development Corporation）通过领投Fusion Pharmaceuticals的2500万美元A轮融资，开始入局核药。2024年，Abdera完成了一轮新的融资，该轮融资由强生JJDC和Foresite投资，金额为3000万美元。除投资外，目前强生公开的管线来看，首发核药资产是一款靶向HK2的核药JNJ-6420，采用的核素同样是Ac-225。 “ Actinium Pharmaceuticals 专注于α粒子疗法，拥有丰富的临床管线，尤其是在血液肿瘤领域。 “ Clarity Pharmaceuticals 拥有独特的“SARTATE”螯合技术，并与Terra Power等供应商建立了稳固的Ac-225供应关系。 “ Ariceum Therapeutics 主打药物225Ac-SSO110是一种锕-225标记的放射性药物，靶向SSTR2。该药物通过将Ac-225与特异性靶向肽结合，精准作用于表达SSTR2的肿瘤细胞，如广泛期小细胞肺癌（ES-SCLC）和默克尔细胞癌（MCC），旨在实现高效肿瘤杀伤同时减少对正常组织的损伤。 “ Defence Therapeutics 与加拿大核实验室（CNL）合作，将α粒子放射疗法Ac-225与Defence专有的Accum®递送技术相结合，进行临床前研究。 “ Abdera Therapeutics 依托先进的抗体工程 ROVEr™平台设计和开发用于癌症治疗的可调节精准放射性药物。Abdera的主要项目ABD-147是下一代精准放射性药物生物疗法，旨在将Ac-225递送至表达DLL3的实体瘤，用于治疗小细胞肺癌（SCLC）和大细胞神经内分泌癌（LCNEC）。 “ Ratio Therapeutics 专有研发平台Trillium™和Macropa™，使得开发具有药物动力学调制能力的适配异功能放射性药物，从而提升药物的可用性、肿瘤传递和肿瘤载荷。近日宣布，其首款核心治疗性放射药 [Ac-225]-RTX-2358 临床试验的首个队列已完成给药。该药物是一种高选择性成纤维细胞活化蛋白靶向放射治疗药物，以Ac-225为标记同位素，适用于治疗成纤维细胞活化蛋白阳性的复发或难治性软组织肉瘤患者。 “ Convergent Therapeutics 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），是一种专有的、同类最佳的Ac-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）。 “ Alpha-9 Oncology Alpha-9的平台建立在系统性的分子设计方法之上，通过优化靶向配体、连接子和螯合剂，创造出在肿瘤中具有优异摄取和滞留能力，同时能最大限度减少脱靶效应的放射性治疗药物。Alpha-9的核心管线A9-3408是一种新型靶向黑色素皮质素1受体（MC1R）的Ac-225核素药物，用于治疗经标准疗法治疗后病情进展的MC1R阳性黑色素瘤患者，已于近日完成首例患者给药。尽管与欧美发达国家相比，我国在 Ac-225 药物研发方面仍处于相对早期的阶段，但也在稳步行进中。 ○ 东诚药业控股的子公司蓝纳成（LNC）开发的[225Ac]Ac-LNC1011注射液，在2025年获得了国家药品监督管理局（NMPA）核准签发的药品临床试验批准通知书。该药物拟用于治疗PSMA阳性表达的晚期前列腺癌患者。 ○ 辐联科技是一家具有国际背景的中国公司，[225Ac]Ac-FL-020注射液已于11月10日获得临床试验默示许可，拟用于治疗mCRPC。辐联科技的另一款AC-225产品FL-091已经在2024年7月授权给SK Biopharmaceuticals，该产品用于治疗靶向神经降压素受体1型（NTSR1）阳性的癌症。此次交易的总金额高达5.72亿美元，涵盖了首付款、研发及商业里程碑付款。此外，多条管线均涉及Ac-225核素。 ○ 诺宇医药布局了多条核药管线，其中涉及Ac-225核药研发管线，根据官网，目前处于临床前研究阶段，暂未有更多消息披露。 ○ 先通医药也在使用Ac-225进行早期的药物研发，该公司在成都温江的研发生产基地已经建成了全自动放射性药物生产线，并计划生产225Ac-抗体注射液。 ○ 威智知科研发管线中的225Ac-PSMA-VG01和225Ac-FAP-VG02均采用了Ac-225作为放射性核素，针对前列腺癌、纤维肉瘤激活蛋白（FAP）表达肿瘤等进行研发。 ○ 博锐创合官网在研管线中BRP-020、BRP-030与BRP-040项目明确提及使用Ac-225作为放射性核素，适应症为晚期实体瘤。 ○ 纽瑞特医疗官网显示有Ac-225采购相关的字样。根据公开信息，纽瑞特也在积极布局Ac-225等α核素药物的研发与生产，其研发平台覆盖Ac-225标记药物的开发，并具备相应的GMP生产能力。 ○ 景嘉航布局α核素和β核素的核药研发，与西安迈斯拓扑签署225Ac供应协议以获得225Ac的优先、稳定供应，并与中核秦同签署战略合作协议，以便在研发核药用核素的供应方面得到更好的保障。 ○ 2024年6月3日，西南医科大学附属医院的陈跃教授团队在中国临床试验注册中心登记了一项关于225Ac-TBM治疗骨转移的转化研究，旨在评估225Ac-TBM治疗肿瘤骨转移的疗效和安全性，及其对正常器官和肿瘤的辐射剂量。结语） Conclusion 全球 Ac-225 核药研发已从早期探索进入了快速发展的临床验证阶段。巨头的纷纷入局，更预示着该领域巨大的商业潜力正被资本市场认可，有望在未来5-10年内迎来首批Ac-225药物的上市。虽然中国Ac-225核药产业仍面临诸多挑战，但其展现出的巨大潜力和快速发展的势头令人瞩目。在政策支持、资本助力和科研创新的共同推动下，中国有望在这一全球前沿的医疗领域中占据重要一席，为全球癌症患者带来新的希望。

2026-01-08

·汇佳生物

Convergent与 NorthStar 宣布扩大合作, 助力前者晚期 α 放射性抗体项目推进

●专属生产基地：为 Convergent 的药物商业化生产提供保障，产能可满足 CONV01-α 后期临床试验及商业化需求 ●合作升级目标：通过整合药物生产与高纯度Ac-225同位素生产环节，实现规模经济效益专注于下一代癌症治疗放射性药物研发的临床阶段生物科技公司 Convergent Therapeutics Inc.，（Convergent）与全球领先的放射性药物企业 NorthStar Medical Radioisotopes（NorthStar）近日联合宣布，双方已达成一项扩展合作协议。根据协议，Convergent 将入驻 NorthStar 位于威斯康星州Beloit 的生产基地，使用专属生产线开展药物研发及临床批次生产工作。将 Convergent 的生产环节与 NorthStar 的设施进行协同布局，为基于Ac-225 的 CONV01-α 药物产品打造了一条集成化、高可靠性的供应链。此举不仅能缓解 α 放射性疗法领域长期存在的供应限制问题，还将为 Convergent 正在开展的临床试验提供支持，并顺利衔接后续商业化生产。 Convergent 首席执行官兼联合创始人 Philip Kantoff, M.D. 表示：“与 NorthStar 的合作，让我们得以充分释放核心放射性抗体项目的潜力。我们正通过相关研究验证 α 发射体在治疗转移性去势抵抗性前列腺癌（mCRPC）方面的优势，同时也在满足患者对更安全、更有效新型疗法的迫切需求。依托稳定的Ac-225 供应、已取得的临床概念验证数据，以及候选药物潜在的同类最优疗效与耐受性，CONV01-α 具备推动转移性去势抵抗性前列腺癌治疗发展的坚实基础。我们在生产设施方面的战略投入，将为 CONV01-α 单药疗法的后期研究提供支撑，同时助力开展该药用于前列腺癌早期治疗、以及与其他疗法联合用药的额外临床试验。” CONV01-α 是 Convergent 针对转移性去势抵抗性前列腺癌开发的核心候选药物，也是其管线中多款放射性药物的代表。该药物充分发挥了 α 发射同位素的强效性与靶向精准性优势。NorthStar 近期宣布已实现治疗用 α 放射性同位素的规模化生产，而 Convergent 正是其Ac-225 产品的核心客户。稳定的Ac-225 供应进一步强化了 Convergent 开发下一代 α 放射性疗法的能力，而 CONV01-α 在既往临床试验中已展现出靶向精准、耐受性良好的特点，为后续研发奠定了基础。 NorthStar总裁兼首席执行官 Dr. Frank Scholz 表示：“我们很高兴能与 Convergent 扩大合作。这项协议充分印证了我们一体化生产基地的价值 —— 该基地能够简化生产流程，打造稳定可靠的供应链，从而为患者及时提供可用药物。” 早在 2024 年 8 月，NorthStar 就与 Convergent 达成了战略合同生产服务协议。根据彼时协议，NorthStar 将为 Convergent 提供 CONV01-α 生产所需的Ac-225，并利用其新建的先进合同研发生产组织（CDMO）设施，为 Convergent 生产用于临床试验的 CONV01-α 药物，同时开展相关研发工作。 Convergent 生产负责人 Caitlyn Harvey 表示：“将药物生产与Ac-225 供应环节都集中在 NorthStar 的生产基地，为我们的供应链带来了独特优势。借助 NorthStar 在放射性药物生产领域的深厚经验，我们能够实现更高的生产效率、更强的供应灵活性，并有效节约成本。他们在治疗用 α 发射体生产领域的领先地位，确保了我们在关键临床试验、商业化上市乃至后续阶段，都能获得稳定的生产能力与Ac-225 供应。” 关于 CONV01-α CONV01-α 是一款靶向前列腺特异性膜抗原（PSMA）的Ac-225 放射性抗体，兼具抗体的靶向精准性与 α 射线的局部杀伤效力。该药物旨在改善转移性去势抵抗性前列腺癌的治疗效果，其核心成分是一种靶向前列腺特异性膜抗原的人源化单克隆抗体。前列腺特异性膜抗原是前列腺癌中特征明确且高表达的抗原，是理想的治疗靶点。CONV01-α 的独特优势在于，能够通过这款靶向抗体将Ac-225 精准递送至肿瘤部位，利用 α 射线短射程、高能量的特性，对肿瘤细胞 DNA 造成靶向损伤，同时最大程度减少对周围正常组织的辐射暴露。在超过 120 例患者参与的早期研究中，CONV01-α 已完成临床概念验证，展现出持续稳定的抗肿瘤活性与差异化的安全性特征。这种高靶向选择性，再加上药物在肿瘤组织中滞留性强、唾液腺与肾脏摄取量低的特点，使 CONV01-α 有望成为治疗前列腺特异性膜抗原阳性癌症的一款具有显著临床价值的疗法。关于 Convergent Therapeutics, Inc. Convergent Therapeutics, Inc. 是一家临床阶段生物科技公司，专注于开发肿瘤靶向性 α 放射性抗体疗法。公司由临床诊疗、科研、药物开发及肿瘤生物学领域的国际知名专家联合创立，其核心技术平台源自康奈尔大学的专利授权。通过将抗体的靶向选择性与 α 放射性同位素的肿瘤杀伤潜力相结合，Convergent 开发的放射性抗体能够向癌细胞精准输送强效的局部辐射。关于 NorthStar Medical Radioisotopes, LLC NorthStar Medical Radioisotopes 是一家商业化阶段的放射性药物企业，致力于通过创新技术实现放射性同位素的商业化规模生产。这些同位素与靶向分子结合后，可用于癌症及其他重大疾病的诊断与治疗。凭借在高端放射性同位素制备领域的独特技术优势、经验丰富的管理团队，以及环境友好型的先进生产设施，NorthStar 在快速发展的放射性药物治疗领域持续巩固行业领先地位。NorthStar 可量产Cu-67，同时也是全球首家采用电子加速器技术实现n.c.a. Ac-225商业化规模生产的企业。公司旗下放射性药物合同研发与生产组织（CDMO）业务单元，可提供定制化服务及专业的放射性药物技术支持，助力生物制药企业加速推进药物研发与商业化进程。往期回顾 Shine致力于在美国生产用于SPECT成像的Mo-99 SPECT/CT可识别预后不良的前列腺癌患者 Shine收购Lantheus的SPECT业务汇佳生物专注于转化医学领域的前沿研究及临床转化应用技术，业务涵盖生物标志物和药物靶标技术，新型诊断试剂及治疗药物的研发，相关仪器设备的开发及临床转化技术的应用，实现了产、医、研的融合发展。媒体合作/科研宣传/产品咨询长按二维码，联系我们

放射疗法临床结果临床3期

2026-01-06

·BioSpace

Convergent Therapeutics and NorthStar Medical Radioisotopes Announce Expanded Partnership to Support Convergent’s Late-Stage Alpha-Emitting Radioantibody Program

Purpose-built facility secures Convergent’s drug product manufacturing at the scale needed to meet late-stage CONV01-α clinical studies and commercial demand Expanded partnership designed to drive economies of scale across drug-product manufacturing and high-purity Actinium-225 (Ac-225) isotope production CAMBRIDGE, Mass. & BELOIT, Wis.--(BUSINESS WIRE)--Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, and NorthStar Medical Radioisotopes (NorthStar), a leading radiopharmaceutical company, today announced an expanded agreement under which Convergent will support its drug development and clinical batch production with dedicated manufacturing suites on NorthStar’s Beloit, Wisconsin campus. Co-locating Convergent’s manufacturing at NorthStar establishes an integrated and reliable supply chain for CONV01-α drug product production with Ac-225, relieving supply constraints for alpha-based radiotherapies and supporting Convergent’s ongoing clinical trials through to commercial production. “The relationship with NorthStar enables us to fully realize the potential of our leading radioantibody program as we demonstrate the advantages of alpha emitters in addressing metastatic castration-resistant prostate cancer (mCRPC) and the significant need for new, safer, and more effective therapies for patients. With secured Ac-225 supply, clinical proof-of-concept, and potential best-in-class efficacy and tolerability, CONV01-α is well-positioned to advance mCRPC treatment,” said Convergent CEO and Co-Founder Philip Kantoff, M.D. “Our strategic investment in manufacturing will support late-stage monotherapy studies of CONV01-α, and additional trials to assess CONV01-α in earlier stages of prostate cancer and in combination with other therapeutics.” CONV01-α, Convergent’s lead program for mCRPC and other radiopharmaceuticals in its pipeline, leverage the power and precision of alpha-emitting isotopes. NorthStar recently announced it now produces alpha radioisotopes for therapeutic applications at scale, with Convergent as a key customer for Ac-225. Reliable Ac-225 supply further supports Convergent’s ability to deliver the next generation of alpha-based radiotherapies, building on the precision and tolerability advantages demonstrated in clinical trials to date with CONV01-α. “We are pleased to expand our partnership with Convergent,” said Frank Scholz, President and CEO of NorthStar Medical Radioisotopes, LLC. “This agreement underscores the value of our integrated campus designed to reduce complexity and create a robust, reliable supply chain to deliver patient-ready drugs.” In August 2024, NorthStar and Convergent announced a strategic contract manufacturing services agreement to provide Convergent with Ac-225 for use in CONV01-α and to utilize NorthStar’s new state-of-the-art contract development and manufacturing facility to manufacture CONV01-α for Convergent’s clinical trials and perform research and development activities. “Having drug product and Ac-225 supply co-located on the NorthStar campus provides a unique advantage for our supply chain, enabling greater efficiencies, flexibility, and cost savings, as we leverage NorthStar’s extensive track record in radiopharmaceutical manufacturing,” said Caitlyn Harvey, Head of Manufacturing at Convergent. “Their leadership in producing alpha emitters for radiotherapies ensures critical production capabilities and access to Ac-225 are in place for pivotal studies through commercial launch and beyond.” About CONV01-α CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of metastatic castration-resistant prostate cancer (mCRPC), uses a humanized monoclonal antibody directed at prostate-specific membrane antigen (PSMA), a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver Actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers. 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 Convergent’s 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. Visit: About NorthStar Medical Radioisotopes, LLC (NorthStar) NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is the first commercial-scale producer of non-carrier added actinium-225 (n.c.a. Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services. Visit: Contacts For Convergent Therapeutics, Inc: Jason Glashow Glashow Strategic Communications jason@glashowstrategic.com For NorthStar Medical Radioisotopes, LLC Corporate: Gauri Gupta Vice President, Chief of Staff 312-288-5431 ggupta@northstarnm.com Investor Relations: Victor Miller Chief Financial Officer 847-650-3860 vmiller@northstarnm.com

放射疗法临床研究

100 项与 Actinium 225-J591 相关的药物交易

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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
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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临床结果

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	窪觸壓膚糧鏇夢觸鑰膚(繭範廠製艱製鏇鹽遞觸) = 35 KGBq/kg 夢繭遞壓糧遞願齋淵鑰 (糧網憲製蓋積衊製淵膚 ) 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	繭範蓋鹹鹹醖淵襯蓋憲(餘艱積築鬱憲顧襯製選) = determined to be 80 KBq/Kg 壓選構艱齋艱簾蓋築窪 (壓蓋艱鹽繭鹽築襯醖顧 )	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	積簾積鹽鹹網膚糧鏇願(糧窪積醖膚選觸衊窪艱) = 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. 遞窪憲選積衊窪衊遞夢 (廠鏇糧鹽選觸膚願夢選 ) 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	窪顧製鹹淵鬱簾糧窪製(艱鏇壓壓淵蓋齋鹽顧壓) = No DLTs were observed in Cohort 1 (n=3) or 2 (n=6). In C3, 2/6 subjects experienced DLTs 簾蓋獵簾鏇鬱製簾夢淵 (衊齋憲憲鹹觸齋鑰築願 ) 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	鏇膚遞艱鏇襯構蓋簾夢(蓋蓋艱觸蓋廠衊齋襯艱) = 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 鑰範襯醖繭築網齋簾壓 (齋艱廠壓淵夢憲網衊顧 ) 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)	觸鹹鏇鬱觸願襯鑰廠艱 = 願觸夢蓋鏇夢遞網選淵憲糧鬱願簾顧齋願糧淵 (鏇鹹選艱選顧淵鏇艱衊, 積築衊製蓋鹹糧廠顧蓋 ~ 積遞鏇鏇範網窪簾窪壓) 更多	-	2022-12-06
				225Ac-J591 (225Ac-J591 Cohort 2)	觸鹹鏇鬱觸願襯鑰廠艱 = 餘窪壓鑰製淵觸鑰顧艱憲糧鬱願簾顧齋願糧淵 (鏇鹹選艱選顧淵鏇艱衊, 糧夢窪壓餘觸餘網構鹹 ~ 蓋築餘觸鹽鑰築簾範鹹) 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	簾憲憲鹽憲蓋繭鹹鹹憲(醖鹹構壓齋簾蓋壓淵鏇): 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)	遞遞艱範餘願鏇餘獵餘(壓艱鬱淵鑰積鑰鹽製鹹) = 齋築鬱鑰鹹鹹蓋構積鏇簾築製鹽壓艱淵蓋鏇膚 (積鬱餘鬱齋鬱窪蓋觸鑰 )	-	2021-03-02
				225Ac-J591 (Multiple-dose cohort)	遞遞艱範餘願鏇餘獵餘(壓艱鬱淵鑰積鑰鹽製鹹) = 糧鏇鏇憲範廠糧廠願顧簾築製鹽壓艱淵蓋鏇膚 (積鬱餘鬱齋鬱窪蓋觸鑰 )
NCT03276572 (ASCO2020)	临床1期	转移性去势抵抗性前列腺癌	22	<sup>225</sup>Ac-J591	廠襯淵鏇夢鬱觸襯蓋鏇(構夢鑰憲顧範築獵醖餘) = 範顧顧繭願夢壓築壓觸蓋鑰繭鑰鏇糧繭製鑰襯 (膚鏇構築糧積醖蓋網範 ) 更多	积极	2020-05-25