SECuRE试验更新：第二阶段队列扩展中的首位患者已接受治疗-动脉网

SECuRE trial update: First patient treated in the Phase II Cohort Expansion

CISION 等信源发布 2025-04-15 21:02

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亮点

The first of the planned 24 participants in the Cohort Expansion Phase (Phase II) of the SECuRE trial has been treated with their first dose of 8 GBq of

SECuRE试验的队列扩展阶段（第二阶段）计划中的24名参与者中的第一名已接受首次8 GBq剂量的治疗。

Cu-SAR-bisPSMA.This follows the recent recommendation by the Safety Review Committee (SRC) after the successful completion of the Dose Escalation Phase to commence enrollment for the Cohort Expansion Phase at the 8 GBq dose level, with an increase of the number of cycles from up to 4 to up to 6.

Cu-SAR-bisPSMA。这是在成功完成剂量递增阶段后，安全审查委员会（SRC）近期建议在8 GBq剂量水平开始队列扩展阶段的患者入组，并将治疗周期数从最多4个增加到最多6个。

This participant will be treated with the combination of 8 GBq of

该参与者将接受8 GBq的组合治疗

Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), as per the recent protocol amendment to include a subset of participants in the Cohort Expansion Phase to receive this combination.

根据最近的协议修正案，在队列扩展阶段中包含一部分参与者接受Cu-SAR-bisPSMA与恩杂鲁胺（雄激素受体通路抑制剂[ARPI]）的组合治疗。

Prior to the start of the Cohort Expansion Phase, Clarity rolled out its improved

在队列扩展阶段开始之前，Clarity推出了其改进版

Cu-SAR-bisPSMA product formulation. The enhanced formulation offers room temperature stability, supply and scalability, which are essential for late-stage clinical trials and streamlined commercial-scale manufacture.

Cu-SAR-bisPSMA 产品配方。该增强型配方提供了室温稳定性、供应能力和可扩展性，这对于后期临床试验和简化的商业规模生产至关重要。

SYDNEY

悉尼

，

April 15, 2025

2025年4月15日

/PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ('Clarity' or 'Company'), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce the treatment of the first participant with their first dose of 8 GBq of .

/PRNewswire/ -- Clarity Pharmaceuticals（ASX：CU6）（“Clarity”或“公司”），一家临床阶段的放射性药物公司，致力于开发改善癌症患者治疗效果的下一代产品，欣然宣布已为第一名受试者进行了首次8 GBq剂量的治疗。

Cu-SAR-bisPSMA in the Cohort Expansion Phase of the SECuRE trial (NCT04868604)

SECuRE试验（NCT04868604）的队列扩展阶段中的Cu-SAR-bisPSMA

[

。

The dosing of this participant follows the recent successful completion of the Dose Escalation Phase (Phase I) of the trial and subsequent SRC recommendation to progress to the Cohort Expansion Phase (Phase II) at the 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6.

该参与者按照试验的剂量递增阶段（第一阶段）近期成功完成后的剂量进行给药，随后SRC建议在8 GBq剂量水平下进入队列扩展阶段（第二阶段），并将总周期数从最多4个增加到最多6个。

This recommendation is based on the favourable safety profile and efficacy of .

该建议是基于良好的安全性和有效性。

Cu-SAR-bisPSMA observed to date

迄今为止观察到的Cu-SAR-bisPSMA

[

。

This participant will be receiving the combination of 8 GBq of

该参与者将接受 8 GBq 的组合治疗

Cu-SAR-bisPSMA and enzalutamide (ARPI), allowed by a recent protocol amendment. This amendment incorporated an increase in the number of participants in this cohort from 14 to 24, in which a subset of participants will receive this combination therapy. These changes are aligned with the positive results from the Enza-p trial.

Cu-SAR-bisPSMA 和恩杂鲁胺（ARPI），这是根据最近的协议修正案允许的。该修正案将该队列的参与者人数从14人增加到24人，其中一部分参与者将接受这种联合治疗。这些更改与 Enza-p 试验的积极结果相符。

[

and the ongoing discussions with and advice from key global medical experts in the field of prostate cancer, including the Company's Clinical Advisory Board members, Prof

以及来自前列腺癌领域关键的全球医学专家的持续讨论和建议，包括公司临床咨询委员会成员，教授

Louise Emmett

路易斯·埃米特

and Prof

和教授

Oliver Sartor

奥利弗·萨托尔

, as well as the SRC.

，以及SRC。

The recently amended SECuRE trial protocol will also focus on the evaluation of metastatic castration-resistant prostate cancer (mCRPC) participants in the pre-chemotherapy setting. This aligns with Clarity's strategy of bringing

最近修订的SECuRE试验方案还将侧重于在化疗前环境中评估转移性去势抵抗性前列腺癌（mCRPC）参与者。这与Clarity的战略一致。

Cu-SAR-bisPSMA to earlier stages of the disease and is based on its promising safety and efficacy data, especially in pre-chemotherapy participants treated in the SECuRE trial to date. In the Dose Escalation Phase, preliminary data showed that 92% of pre-chemotherapy participants (12/13) demonstrated prostate-specific antigen (PSA) drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants.

基于其在SECuRE试验中迄今为止治疗的化疗前参与者中的出色安全性和有效性数据，Cu-SAR-bisPSMA被应用于疾病更早阶段。在剂量递增阶段，初步数据显示，92%的化疗前参与者（12/13）前列腺特异性抗原（PSA）下降超过35%，61.5%（8/13）的参与者PSA降低超过50%，46.2%（6/13）的参与者达到了80%或更高的下降幅度。

These outstanding results were achieved despite many of the 13 pre-chemotherapy participants having considerable disease burden, being heavily pre-treated, and the majority of them only receiving a single dose of .

尽管13名术前化疗参与者中有许多人疾病负担沉重、经过多次治疗，且大多数人只接受了一剂药物，但仍然取得了这些显著的成果。

Cu-SAR-bisPSMA

[

。

In preparation for the Cohort Expansion Phase, Clarity rolled out its improved

在为队列扩展阶段做准备时，Clarity推出了其改进版

Cu-SAR-bisPSMA product formulation. The enhanced formulation allows for room temperature stability, supply and scalability, which are essential for late-stage clinical trials and streamlined commercial-scale manufacture.

Cu-SAR-bisPSMA 产品配方。改进后的配方允许在室温下保持稳定性、供应和可扩展性，这对于后期临床试验和简化的商业规模生产至关重要。

Clarity's Executive Chairperson, Dr

Alan Taylor

艾伦·泰勒

, commented, 'We are incredibly excited about the progress we've achieved in the SECuRE trial to date and look forward to continuing to generate promising data in the Cohort Expansion Phase.

，评论道：“我们对SECuRE试验迄今为止取得的进展感到无比兴奋，并期待在队列扩展阶段继续生成有希望的数据。

'With the latest protocol amendments ensuring that we are utilising the most recent advances and knowledge in the radiopharmaceutical space, we continue to be driven by the highest standards of clinical trial management and research. At Clarity, we are committed to working with various key opinion leaders in the field and incorporating the most recent findings into our study design to maximise the probability of clinical trial success and positive patient outcomes.

“通过最新的协议修正案，我们确保利用放射性药物领域的最新进展和知识，我们始终以临床试验管理和研究的最高标准为驱动力。在Clarity，我们致力于与该领域的多位关键意见领袖合作，并将最新研究成果纳入我们的研究设计中，以最大化临床试验成功和患者积极结果的概率。”

As a result, we are focused on bringing .

因此，我们专注于带来。

Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy, especially in the pre-chemotherapy setting, where we have seen very promising safety and efficacy to date. We are also investigating the benefits of combination therapy, where SECuRE participants are being treated with

将Cu-SAR-bisPSMA应用于前列腺癌治疗的更早阶段，尤其是在化疗前的环境中，迄今为止我们已经看到了非常有希望的安全性和有效性。我们还在研究联合疗法的益处，其中SECuRE试验的参与者正在接受治疗。

Cu-SAR-bisPSMA and enzalutamide based on the results from Prof Emmett's Enza-p trial and in consultation with global thought leaders in the prostate cancer space.

基于Emmett教授的Enza-p试验结果，并与全球前列腺癌领域的思想领袖协商，使用Cu-SAR-bisPSMA和恩杂鲁胺。

'We are committed to continuously improving our product and took the opportunity to advance our

“我们致力于不断改进我们的产品，并借此机会提升我们的

Cu-SAR-bisPSMA formulation prior to dosing our first patients in the Cohort Expansion Phase of the trial. The improvements also help us prepare for the large-scale manufacture in a potential Phase III trial and during commercialisation, allowing for room temperature stability with considerable advantages for supply and scalability.

在试验的队列扩展阶段为首位患者给药之前，进行Cu-SAR-bisPSMA制剂。这些改进还帮助我们为潜在的III期试验和商业化期间的大规模生产做好准备，确保室温稳定性，并为供应和可扩展性带来显著优势。

The ability to manufacture .

制造能力。

Cu-SAR-bisPSMA under room temperature reduces the likelihood of batch failures which lead to common supply issues and subsequent product shipment delays. Through the improvements in formulation, we hope that no patient is left waiting for their

Cu-SAR-bisPSMA 在室温下降低了批次失败的可能性，从而避免了常见的供应问题以及随后的产品发货延迟。通过配方的改进，我们希望不会有任何患者等待他们的

Cu-SAR-bisPSMA treatments.

Cu-SAR-bisPSMA 治疗。

'We thank our community, our team, Principal Investigators, members of the SRC, and especially the participants who have contributed to the SECuRE study so far. Armed with favourable safety and efficacy data from the Dose Escalation cohorts and with 3 US Food and Drug Administration (FDA) Fast Track Designations for the SAR-bisPSMA molecule, 1 for therapy and 2 for diagnostics, we are closer than ever to delivering on our ultimate goal of improving treatment outcomes for people with cancer.'.

“我们感谢我们的社区、团队、首席研究员、SRC的成员，特别是那些迄今为止为SECuRE研究做出贡献的参与者。凭借剂量递增队列中获得的良好安全性和有效性数据，以及SAR-bisPSMA分子获得的3项美国食品药品监督管理局（FDA）快速通道资格（1项用于治疗，2项用于诊断），我们比以往任何时候都更接近实现改善癌症患者治疗效果的最终目标。”

About the SECuRE trial

关于SECuRE试验

The SECuRE trial (NCT04868604)

SECuRE 试验 (NCT04868604)

[

is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using

是一项使用PSMA表达的mCRPC参与者进行识别和治疗的I/IIa期治疗诊断试验

Cu/

铜/

Cu-SAR-bisPSMA.

Cu-SAR-bisPSMA。

Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent

Cu-SAR-bisPSMA 用于可视化表达 PSMA 的病灶，并选择后续候选者

Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US and

Cu-SAR-bisPSMA疗法。该试验是一项多中心、单臂、剂量递增研究，并在大约54名美国参与者中进行队列扩展。

Australia

澳大利亚

. The overall aim of the trial is to determine the safety and efficacy of

试验的总体目标是确定其安全性和有效性

Cu-SAR-bisPSMA for the treatment of prostate cancer.

用于治疗前列腺癌的Cu-SAR-bisPSMA。

About SAR-bisPSMA

关于SAR-bisPSMA

SAR-bisPSMA derives its name from the word 'bis', which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body.

SAR-bisPSMA 的名称来源于“bis”一词，体现了将两个靶向 PSMA 的分子连接到 Clarity 专有的 sarcophagine（SAR）技术上的创新方法。该技术利用笼状结构（称为螯合剂）将铜同位素稳固地锁定在内部。与其他市售螯合剂不同，SAR 技术可防止铜泄漏到体内。

SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or .

SAR-bisPSMA 是一种靶向铜诊疗剂 (TCT)，可与铜-64 (Cu-64) 的同位素一起使用。

Cu) for imaging and copper-67 (Cu-67 or

用于成像的铜（Cu）和铜-67（Cu-67 或

Cu) for therapy.

铜）用于治疗。

Cu-SAR-bisPSMA and

Cu-SAR-bisPSMA 和

Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of

Cu-SAR-bisPSMA 是未注册产品。其安全性和有效性

Cu-SAR-bisPSMA and

Cu-SAR-bisPSMA 和

Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.

Cu-SAR-bisPSMA 尚未经过美国 FDA 或治疗用品管理局 (TGA) 等卫生机构的评估。无法保证这些产品会实现商业供应。

About Prostate Cancer

关于前列腺癌

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide

前列腺癌是全球男性中诊断出的第二大常见癌症，也是全球男性癌症死亡的第五大原因。

[

. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease

前列腺癌是美国男性癌症死亡的第二大原因。美国癌症研究所估计，到2025年，美国将有大约313,780例新发前列腺癌病例，约35,770人死于该疾病。

[

。

About Clarity Pharmaceuticals

关于Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers in children and adults.

Clarity是一家临床阶段的放射性药物公司，专注于严重疾病的治疗。该公司是创新放射性药物的领导者，基于其SAR技术平台开发针对儿童和成人癌症治疗的靶向铜诊疗药物。

www.claritypharmaceuticals.com

For more information, please contact:

更多信息，请联系：

Clarity Pharmaceuticals

清晰制药公司

Dr Alan Taylor

艾伦·泰勒博士

Catherine Strong

凯瑟琳·斯特朗

Executive Chairperson

执行主席

Investor/Media Relations

投资者/媒体关系

ataylor@claritypharm.com

c.strong@morrowsodali.com

+61 406 759 268

References

参考文献

ClinicalTrials.gov Identifier: NCT04868604,

ClinicalTrials.gov 注册号：NCT04868604，

https://clinicaltrials.gov/ct2/show/NCT04868604

Clarity Pharmaceuticals. SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences.

Clarity Pharmaceuticals. SECuRE试验更新：92%的化疗前参与者在所有队列中PSA水平下降超过35%。队列扩展阶段开始。

https://www.claritypharmaceuticals.com/news/secure-update/

Emmett L et al. ENZA-p Trial Investigators; Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Overall survival and quality of life with [

埃米特·L 等。ENZA-p 试验研究者；澳大利亚和新西兰泌尿生殖及前列腺癌试验组。总体生存率与生活质量 [

177

Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):291-299. doi: 10.1016/S1470-2045(25)00009-9.

Lu]Lu-PSMA-617联合恩杂鲁胺对比单独使用恩杂鲁胺治疗转移性去势抵抗性前列腺癌（ENZA-p）：来自一项多中心、开放标签、随机、二期试验的次要结局。《柳叶刀肿瘤学》2025年3月；26(3):291-299。doi: 10.1016/S1470-2045(25)00009-9。

Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries,

全球癌症统计2022：GLOBOCAN对185个国家36种癌症的全球发病率和死亡率估计

https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834

American Cancer Society: Key Statistics for Prostate Cancer.

美国癌症协会：前列腺癌的关键统计数据。

https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

This announcement has been authorised for release by the Executive Chairperson.

本公告已获执行主席授权发布。

SOURCE Clarity Pharmaceuticals

来源：Clarity Pharmaceuticals

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