A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

开始日期2025-05-30

申办/合作机构

Canadian Cancer Trials Group

[+4]

NCT06931340

/ Not yet recruiting临床3期IIT

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

开始日期2025-05-08

申办/合作机构

Alliance for Clinical Trials in Oncology

[+1]

NCT07002320

/ Recruiting临床1/2期IIT

ASpiRE: A Proof-of-mechanism and Proof-of-concept Clinical Trial Evaluating the Safety, Tolerability, Biological and Anti-tumour Activity of Apalutamide With Dual CXCR1 and CXCR2 Blockade by SX-682 for Men Suffering From Metastatic Castration-resistant Prostate Cancer (mCRPC)

ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).

开始日期2025-04-28

申办/合作机构

The Institute of Cancer Research: Royal Cancer Hospital

[+7]

100 项与阿帕他胺相关的临床结果

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100 项与阿帕他胺相关的转化医学

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100 项与阿帕他胺相关的专利（医药）

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819

项与阿帕他胺相关的文献（医药）

2025-07-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of novel tetrahydroquinoline derivatives as potent, selective, and orally Available AR antagonists

Article

作者: Qin, Yiyang ; Hou, Tingjun ; Zhang, Minkui ; Yuan, Leer ; Sheng, Rong ; Li, Dan ; Cai, Lvtao ; Liao, Jinbiao ; Liao, Jianing

Androgen receptor (AR) antagonists are the first-line medicine for the treatment of prostate cancer (PCa) in clinic. In our previous work, the tetrahydroquinoline derivative AT2 was identified as a novel scaffold AR antagonist via virtual screening and structural modifications, while its poor pharmacokinetic properties hindered further development. Herein, we report the systematic structural optimizations of AT2 and discover a novel tetrahydroquinoline derivative C2 as potent AR antagonist with an IC₅₀ value of 0.019 μM, accompanied with excellent selectivity over other nuclear receptors (PR, GR, MR). Further biological assays revealed that C2 significantly inhibited LNCaP cell proliferation, and efficiently reduced PSA protein expression. Especially, C2 showed superior efficacy against AR^F877L/T878A mutants compared to darolutamide and enzalutamide. Furthermore, C2 demonstrated excellent oral bioavailability, indicating the potential to enhance in vivo efficacy and to serve as a promising therapeutic option for PCa treatment.

2025-06-03·Expert Opinion on Drug Metabolism & Toxicology

Drug-drug interactions in metastatic hormone-sensitive prostate cancer (mHSPC): practical considerations for treating men with androgen receptor pathway inhibitors and common medications in this stage

Review

作者: Conde-Estévez, David ; Usán, Paola ; Tourís-Lores, Manuel ; Ríos, Emilio ; López-Campos, Fernando ; Montesa, Álvaro ; Moretones, Cristina ; Ibáñez, Cristina

INTRODUCTION:

New androgen receptor pathway inhibitors (ARPIs) are an essential part of the treatment strategy for patients with metastatic hormone-sensitive prostate cancer (mHSPC). Despite the good tolerability of ARPIs, after treatment is started, drug-drug interactions (DDIs) between these and other medications frequently taken by these patients may appear. DDIs may reduce the therapeutic effect of both and lead to increased adverse events. DDIs should be carefully assessed before an ARPI is started.

AREAS COVERED:

We first review the current therapeutic landscape for mHSPC, common age-related comorbidities and other comorbidities or adverse events arising from previous or current treatments for prostate cancer, and patients' symptomatology. We then analyze the potential toxicities arising from medications for these conditions and those of mHSPC: ARPIs (abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and darolutamide) and docetaxel.

EXPERT OPINION:

Before mHSPC patients are treated with an ARPI, careful assessment of patient eligibility for each treatment alternative and potential DDIs between these and treatments for current comorbidities is a fundamental component in clinical decision-making. ARPIs with low potential DDIs allow keeping current concomitant medications without significant relevant dose adjustments and help reduce the risk of toxicities and comorbidity-related decompensation.

2025-06-01·PROSTATE CANCER AND PROSTATIC DISEASES

Cardiovascular events among men with prostate cancer treated with androgen receptor signaling inhibitors: a systematic review, meta-analysis, and network meta-analysis

Review

作者: Miki, Jun ; Klemm, Jakob ; Karakiewicz, Pierre I. ; Ploussard, Guillaume ; Kimura, Shoji ; Kimura, Takahiro ; Matsukawa, Akihiro ; Briganti, Alberto ; Rajwa, Pawel ; Yanagisawa, Takafumi ; Shariat, Shahrokh F. ; Laukhtina, Ekaterina ; Mori, Keiichiro ; Parizi, Mehdi Kardoust ; Fazekas, Tamás ; Shariat, Shahrokh F ; Karakiewicz, Pierre I

Abstract:

Background:

Androgen-receptor pathway inhibitors (ARPIs) have dramatically changed the management of advanced/metastatic prostate cancer (PCa). However, their cardiovascular toxicity remains to be clarified.

Objective:

To analyze and compare the risks of cardiovascular events secondary to treatment of PCa patients with different ARPIs.

Methods:

In August 2023, we queried PubMed, Scopus, and Web of Science databases to identify randomized controlled studies (RCTs) that analyze PCa patients treated with abiraterone, apalutamide, darolutamide, and enzalutamide. The primary outcomes of interest were the incidence of cardiac disorder, heart failure, ischemic heart disease (IHD), atrial fibrillation (AF), and hypertension. Network meta-analyses (NMAs) were conducted to compare the differential outcomes of each ARPI plus androgen deprivation therapy (ADT) compared to standard of care (SOC).

Results:

Overall, 26 RCTs were included. ARPIs were associated with an increased risk of cardiac disorders (RR: 1.74, 95% CI: 1.13–2.68, p = 0.01), heart failure (RR: 2.49, 95% CI: 1.05–5.91, p = 0.04), AF (RR: 2.15, 95% CI: 1.14–4.07, p = 0.02), and hypertension (RR: 2.06, 95% CI: 1.67–2.54, p < 0.01) at grade ≥3. Based on NMAs, abiraterone increased the risk of grade ≥3 cardiac disorder (RR:2.40, 95% CI: 1.42–4.06) and hypertension (RR:2.19, 95% CI: 1.77–2.70). Enzalutamide was associated with the increase of grade ≥3 AF(RR: 3.17, 95% CI: 1.05–9.58) and hypertension (RR:2.30, 95% CI: 1.82–2.92).

Conclusions:

The addition of ARPIs to ADT increases the risk of cardiac disorders, including IHD and AF, as well as hypertension. Each ARPI exhibits a distinct cardiovascular event profile. Selecting patients carefully and vigilant monitoring for cardiovascular issues is imperative for those undergoing ARPI + ADT treatment.

314

项与阿帕他胺相关的新闻（医药）

2025-06-02

·ioncology

ASCO热评丨郑伏甫教授分享mHSPC治疗重要进展

编者按：mHSPC是前列腺癌治疗的关键窗口，及时干预可显著延缓疾病进展至预后极差的mCRPC阶段，并大幅提高患者生存率。因此国内外指南均强调早期强化治疗的重要性，通过NHT或联合方案改善生存质量，延长总生存期，降低医疗负担。在近期的ASCO大会上，泌尿系统肿瘤专场的多个口头报告聚焦于mHSPC，为这类患者的生活质量改善与长期生存带来希望。肿瘤瞭望-泌尿时讯特邀中山大学附属第一医院郑伏甫教授分享精彩内容。01PSA缓解：mHSPC预后评估与治疗的重要指标随着新型雄激素受体通路抑制剂（ARPI）的广泛应用，转移性激素敏感性前列腺癌（mHSPC）已进入强化治疗时代，患者的生存获得极大改善，目前临床亟需短期的预后指标指导临床决策，如PSA缓解水平。2025版EAU前列腺癌指南[1]再次强调了PSA≤0.2 ng/ml是mHSPC重要的预后指标：基于SWOG9346研究[2]，将接受ADT后7个月的PSA缓解至绝对水平4 ng/ml和0.2 ng/ml作为预后分层因素；CHAARTED研究[3]中，ADT联合或不联合多西他赛治疗7个月PSA≤0.2 ng/ml是患者生存的强预测因素；LATITUDE研究[4]中，6个月后达到≤0.1ng/ml的PSA水平与长期结果相关；TITAN研究[5]中，阿帕他胺+ADT治疗3个月时达到PSA≤0.2 ng/ml或PSA90的患者，OS显著更长。本次2025 ASCO大会上公布的IRONMAN大规模真实世界数据[6]，前瞻性纳入了1288例接受ADT联合ARPI±多西他赛治疗的mHSPC患者，治疗6-12个月后PSA>0.2 ng/ml的患者3年总生存率（OS）仅45.3%，而PSA<0.02 ng/ml组高达92.7%。这与既往多项研究一致，进一步提示PSA缓解具备中长期结局的预后性，应作为mHSPC的重要治疗目标。对于PSA应答不佳者，需及时调整强化方案；而持续低PSA者或可探索降阶梯策略（去强化治疗），减少长期治疗毒性。未来可结合分子标志物（如BRCA、SPOP）进一步精准分层，优化mHSPC全程管理。02基于分子特征优选多西他赛获益人群STAMPEDE研究中的最新附属研究提示[7]，PTEN失活联合Decipher评分高危可作为mHSPC患者从多西他赛强化治疗中获益的关键标志物，为ADT联合化疗的精准分层提供了重要依据。数据显示，PTEN失活且Decipher高危患者接受ADT+多西他赛后死亡风险降低45%（HR=0.55），而PTEN活性保留者无显著获益（HR=1.05）。STAMPEDE研究首次将PTEN失活与Decipher评分整合，建立“双重筛选模型”，显著提升疗效预测精度。未来需前瞻性验证该模型，并探索PTEN失活与DNA损伤修复（如ATM缺陷）的协同机制，进一步拓展精准治疗边界。03mHSPC生存与生活质量的双重获益mHSPC的治疗目标不仅是延长生存，患者生活质量（HRQoL）的改善或维持也越来越受到关注。近期公布的III期ARANOTE试验中[8]，达罗他胺联合ADT不仅显著降低46%的影像学进展或死亡风险（HR 0.54，P<0.0001），更在HRQoL及疼痛控制方面展现出独特优势，为临床决策提供了重要循证依据。研究采用FACT-P量表多维度评估患者生活质量，结果显示达罗他胺组FACT-P总分恶化中位时间较安慰剂组延长5.1个月（HR 0.76），其中社会/家庭功能（HR 0.79）、躯体功能（HR 0.78）和泌尿系症状（HR 0.78）三个子量表的改善尤为突出。这一发现提示，达罗他胺不仅能延缓疾病进展，还可通过改善患者社会参与度、日常活动能力和尿路症状，维护其生活尊严。研究同时表明，疼痛控制与PSA深度应答相关。研究采用简明疼痛量表（BPI-SF）评估疼痛程度和疼痛干扰，结果显示DARO组疼痛进展风险降低28%（HR 0.72），且任意时间达到PSA深度应答（<0.2 ng/mL）患者较PSA可测者（≥0.2 ng/mL），其疼痛进展风险和HRQoL恶化风险更低。这印证了PSA深度抑制与症状控制的正相关性，提示临床需重视早期强效PSA控制对生活质量的潜在增益。长期治疗依从性的基石；而药物引发的不良反应，可能影响患者的日常生活质量，加重病情管理的复杂性。达罗他胺的分子结构特性（低血脑屏障穿透性）可能减少疲劳、认知障碍等神经毒性相关不良事件风险。ARANOTE研究显示达罗他胺组因不良事件停药率低于PBO组（6.1% vs. 9.0%），且整体安全性谱与安慰剂相当。低停药率意味着更多患者能够持续接受有效治疗，避免因毒性导致的剂量调整或换药，从而维持疾病控制的稳定性。作为在mHSPC领域同时实现显著生存获益和HRQoL改善的雄激素受体抑制剂，达罗他胺为“以患者为中心”的治疗模式提供了新选择。希望后续临床实践中将HRQoL评估纳入疗效监测体系，结合PSA动态变化优化个体化治疗策略。04mHSPC实现长期生存2025年美国临床肿瘤学会（ASCO）年会发布ARCHES研究的5年随访OS分析结果和ENZAMET研究的98个月随访结果[9,10]，证实了恩扎卢胺联合ADT在mHSPC患者中的长期生存获益。研究设计严谨，随访时间进一步延长，结果具有重要临床意义。在ARCHES研究中，恩扎卢胺+ADT组较安慰剂组显著降低34%死亡风险（HR 0.70，P=0.0003），且各亚组获益一致。特别值得注意的是，高瘤负荷患者的中位OS改善达36个月（83.1 vs 47.6个月），既往接受多西他赛者：HR=0.67（中位OS 83.1 vs 59.5个月）。初诊转移（≤90天）：HR=0.71（中位OS 86.4 vs 58.9个月）。这一结果对临床实践具有重要指导价值。在ENZAMET研究中，恩扎卢胺组中位OS达95个月（8年），NSAA组为70个月；8年生存率50% vs 40%（HR=0.73，P<0.0001）。长期随访证实，恩扎卢胺联合睾酮抑制治疗mHSPC，在8年时仍显著延长OS；同时恩扎卢胺治疗的长期安全性、耐受性良好。尽管ARCHES研究存在交叉治疗可能稀释疗效差异，恩扎卢胺仍显示出持续生存优势，进一步强化了其作为mHSPC标准治疗的地位。ARCHES研究亚组分析中低瘤负荷和不同年龄组患者也观察到获益趋势。上述结果为恩扎卢胺在mHSPC全程管理中的应用提供了高级别循证依据，长期随访数据增强了结论的可靠性。参考文献上下滑动查看更多内容[1]. https://d56bochluxqnz.cloudfront.net/documents/full-guideline/EAU-EANM-ESTRO-ESUR-ISUP-SIOG-Guidelines-on-Prostate-Cancer-2025_2025-03-24-120144_rinw.pdf[2]. Moinpour C, Berry D L, Ely B, et al. Preliminary quality-of-life outcomes for SWOG-9346: Intermittent androgen deprivation in patients with hormone-sensitive metastatic prostate cancer (HSM1PC)—Phase III[J]. 2012.[3]. Kyriakopoulos C E, Chen Y H, Carducci M A, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED trial[J]. Journal of Clinical Oncology, 2018, 36(11): 1080-1087.[4]. Fizazi K, Tran N P, Fein L, et al. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial[J]. The Lancet Oncology, 2019, 20(5): 686-700.[5]. Chi K N, Chowdhury S, Bjartell A, et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study[J]. Journal of Clinical Oncology, 2021, 39(20): 2294-2303.[6]. Michael Ong, et al. 5002 Prognostic significance ofPSA>0.2 after 6-12 months treatment formetastatic hormone-sensitive prostate cancer (mHSPC) intensified byandrogen-receptor pathway inhibitors (ARPI): A multinational real-worldanalysis of the IRONMAN registry. ASCO 2025[7]. Emily Grist, et al. 5003 Transcriptome classification of PTEN inactivation to predict survival benefit from docetaxel at start of androgen deprivation therapy (ADT) for metastaticprostate cancer (PC): An ancillary study of the STAMPEDE trials. ASCO 2025[8]. Alicia K.Morgans, et al. 5004 Health-related quality of life (HRQoL) outcomes with darolutamide in thephase 3 ARANOTE trial. ASCO 2025[9]. Andrew J.Armstrong, et al. 5005 ARCHES: 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in patients (pts) withmetastatic hormone-sensitive prostate cancer(mHSPC). ASCO 2025[10]. Alison Yan Zhang, et al. 5090 8-year outcomes of enzalutamide (ENZA) versus a non-steroidal anti-androgen (NSAA) for metastatic, hormone-sensitive prostate cancer (ENZAMET; ANZUP 1304). ASCO 2025 郑伏甫教授主任医师，博士生导师，博士后合作导师中山大学附属第一医院泌尿外科哈佛大学麻省总医院访问学者美国泌尿外科学会（AUA）国际会员中国医疗保健国际交流促进会泌尿生殖分会委员中国科技产业化促进会精准医学专委会常务委员广东省医学会泌尿外科分会前列腺学组副组长广东省医师协会泌尿外科分会委员广东省抗癌协会泌尿生殖肿瘤专委会委员广东省中西医结合学会泌尿外科分会常务委员广东省泌尿生殖协会肿瘤分会常委委员广东省癌症中心肾癌诊疗质控专委会常务委员泌尿外科杂志（电子版）常务编委JU,WJU,中华实验外科杂志等审稿专家（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床结果临床1期

2025-06-01

·药明康德

疾病控制率达100%的抗癌ADC；复合完全缓解率达96%的组合疗法…… | 一周盘点

本期看点1. Genmab公司旗下抗体偶联药物（ADC）rinatabart sesutecan用以治疗复发性/晚期子宫内膜癌的早期临床试验结果积极，低剂量组患者的疾病控制率（DCR）达100%。2. γ9δ2 T细胞激活剂ICT01联用阿扎胞苷和维奈托克（Aza-Ven）治疗不适合强化化疗的新确诊的急性髓系白血病（AML）患者，在一项1/2期临床试验中的复合完全缓解（CRc）率达96%。3. 个体化癌症疫苗SV-102治疗转移性去势抵抗性前列腺癌（mCRPC）的1期临床试验表现亮眼，客观缓解率（ORR）达87%，完全缓解（CR）率为53%。Rinatabart sesutecan：公布1/2期临床试验数据Genmab公司日前披露旗下的候选疗法rinatabart sesutecan（Rina-S）在1/2期试验中，用以治疗复发性/晚期子宫内膜癌患者中的疗效结果。Rina-S是一种潜在“best-in-class”、叶酸受体α（FRα）靶向ADC，Genmab在去年4月收购普方生物（ProfoundBio）时获得此款疗法。截至2024年11月22日，64例接受过大量既往治疗的子宫内膜癌患者（中位3线，范围1-8）接受了100 mg/m2（n=22）或120 mg/m2（n=42）剂量的Rina-S治疗。在疗效可评估患者中，中位治疗持续时间为18.7周。分析显示，接受低（n=22）与高（n=33）剂量患者的未确认ORR分别为50%与45.5%，其中低剂量组包含2例CR。低与高剂量组患者的DCR则分别为100%和81.8%。此外，在低与高剂量组中，分别有81.8%（9/11）与80.0%（12/15）患者持续缓解。安全性方面，最常见（>25%）的治疗伴发不良事件（TEAE）在不同剂量下相似，主要是血细胞减少症和1-2级胃肠道事件（恶心、呕吐、食欲下降）。ICT01：公布1/2期联合治疗试验数据ImCheck Therapeutics公司公布了其新型γ9δ2 T细胞激活剂ICT01联用Aza-Ven治疗不适合强化化疗的新确诊AML患者的积极1/2期临床试验数据。γ9δ2 T细胞是先天免疫系统的一部分，负责对肿瘤和感染的免疫监察。ICT01是一款靶向嗜乳脂蛋白家族成员BTN3A的单克隆抗体疗法，通过与BTN3A结合，它可以选择性地激活γ9δ2 T细胞，并且促进它们迁移和浸润肿瘤，进一步激发CD8阳性T细胞和自然杀伤细胞的抗肿瘤反应。截至2025年1月20日的数据，接受推荐剂量的ICT01联合治疗的患者的CRc率为96%，CR率为74%，且各种分子亚型的患者均有缓解。值得注意的是，具有不良或中等风险突变的患者通常对Aza-Ven治疗应答较低，但接受三联疗法治疗的患者实现了高缓解率，例如TP53突变AML患者的CR和CRc率分别达到了60%和83%。此外，接受10 mg ICT01治疗的患者初步的9个月总生存率为83%。安全性方面，三联疗法在临床上具有良好的可控性。SV-102：公布1期临床试验数据Syncromune公司公布了其个体化癌症疫苗SV-102在mCRPC患者中的1期临床试验结果。数据表明，接受SV-102治疗患者的ORR为87%，53%的患者达到了CR。安全性方面，SV-102耐受性良好，观察到的TEAE多为低级别。ORIC-944：公布1b期联合治疗试验的初步数据ORIC Pharmaceuticals公司公布了其选择性PRC2别构抑制剂ORIC-944联用雄激素受体（AR）抑制剂治疗mCRPC的1b期临床试验的初步数据。截至2025年5月9日的数据，59%（10/17）的患者达到PSA50应答（即前列腺特异性抗原水平降低50%），确认的PSA50应答率为47%（1例待确认），24%（4/17）的患者达到确认的PSA90应答。在所有ORIC-944剂量水平中均观察到PSA应答，目前大多数患者仍在继续治疗，其中多名患者的治疗时间已接近一年或更长。安全性方面，ORIC-944与apalutamide或darolutamide联合使用的耐受性普遍良好，绝大多数不良事件为1/2级，与PRC2和AR抑制一致。STX-001：公布1期临床试验的初步数据Strand Therapeutics公司公布了其自我复制mRNA疗法STX-001用于治疗晚期实体瘤的1期临床试验结果。STX-001是一种脂质纳米颗粒封装的自我复制mRNA药物，可激活先天免疫系统，促进免疫原性癌细胞死亡，并表达IL-12以诱导针对肿瘤的免疫反应。在临床前模型中，STX-001表现出显著的免疫调节和抗肿瘤活性。从2024年5月29日至数据截止日期（2024年12月16日），5名完成评估的黑色素瘤患者中，有3人的非注射病灶缩小（即远隔效应），其中1例达到确认的CR，1例达到部分缓解（PR），1例靶病灶缩小100%，多个皮肤/内脏病灶出现显著的炎症反应。STX-001显示出初步良好的疗效、强烈的免疫激活作用以及可控的安全性。这些结果支持其作为单药疗法以及与免疫检查点抑制剂联合使用的进一步开发。参考资料（可上下滑动查看）[1] 오토텔릭, 'TGF-β2 ASO' 고형암 1상 "호주 IND 승인". Retrieved May 30, 2025, from https://www.biospectator.com/news/view/25209[2] Syncromune® Inc. Announces Publication of Abstract on SYNC-T® Therapy SV-102 Phase 1 Data for Metastatic Prostate Cancer at ASCO 2025 Annual Meeting. Retrieved May 30, 2025, from https://syncromune.com/2025/05/23/syncromune-inc-announces-publication-of-abstract-on-sync-t-therapy-sv-102-phase-1-data-for-metastatic-prostate-cancer-at-asco-2025-annual-meeting/[3] Autobahn Therapeutics Announces Presentation of ABX-002 Phase 1 Clinical Results at the 2025 ASCP Annual Meeting. Retrieved May 30, 2025, from https://autobahntx.com/news/autobahn-therapeutics-announces-presentation-of-abx-002-phase-1-clinical-results-at-the-2025-ascp-annual-meeting/[4] Immix Biopharma Announces Positive Results for NXC-201 at ASCO Oral Presentation, Enabling Pathway to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis. Retrieved May 30, 2025, from https://immixbio.com/immix-biopharma-announces-positive-results-for-nxc-201-at-asco-oral-presentation-enabling-pathway-to-best-in-class-therapy-for-relapsed-refractory-al-amyloidosis/[5] AbelZeta Presents New Data on C-CAR168 for the Treatment of Autoimmune Diseases at LUPUS 2025. Retrieved May 30, 2025, from https://www.prnewswire.com/news-releases/abelzeta-presents-new-data-on-c-car168-for-the-treatment-of-autoimmune-diseases-at-lupus-2025-302463558.html[6] ImCheck Reports High Remission Rates in AML Patients with ICT01 Combination Therapy at ASCO 2025. Retrieved May 30, 2025, from https://www.globenewswire.com/news-release/2025/05/22/3087173/0/en/ImCheck-Reports-High-Remission-Rates-in-AML-Patients-with-ICT01-Combination-Therapy-at-ASCO-2025.html[7] Boehringer Ingelheim to present early clinical evidence of innate immune modulation and anti-tumor activity via SIRPα blockade in two ongoing trials at ASCO 2025. Retrieved May 30, 2025, from https://www.globenewswire.com/news-release/2025/05/22/3087166/0/en/Boehringer-Ingelheim-to-present-early-clinical-evidence-of-innate-immune-modulation-and-anti-tumor-activity-via-SIRP%CE%B1-blockade-in-two-ongoing-trials-at-ASCO-2025.html[8] Auron Announces First Patient Dosed in Phase 1 Clinical Trial of AUTX-703 in Advanced Hematologic Malignancies. Retrieved May 30, 2025 from https://www.globenewswire.com/news-release/2025/05/29/3090174/0/en/Auron-Announces-First-Patient-Dosed-in-Phase-1-Clinical-Trial-of-AUTX-703-in-Advanced-Hematologic-Malignancies.html[9] Genmab to Highlight New Data Evaluating Late-Stage Oncology Portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved May 24, 2025 from https://ir.genmab.com/news-releases/news-release-details/genmab-highlight-new-data-evaluating-late-stage-oncology[10] Navigator Medicines Announces First Participants Dosed in a Phase 1b Trial of NAV-240, a Potential Best-in-Class Anti-OX40L and Anti-TNFα Bispecific Antibody Therapeutic for Autoimmune Diseases. Retrieved May 30, 2025 from https://www.businesswire.com/news/home/20250529174222/en/Navigator-Medicines-Announces-First-Participants-Dosed-in-a-Phase-1b-Trial-of-NAV-240-a-Potential-Best-in-Class-Anti-OX40L-and-Anti-TNF-Bispecific-Antibody-Therapeutic-for-Autoimmune-Diseases[11] Kura Oncology and Kyowa Kirin Announce Pivotal Monotherapy Data for Ziftomenib in Oral Presentation at the 2025 ASCO Annual Meeting. Retrieved May 23, 2025, from https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-announce-pivotal-monotherapy-data[12] Cullinan Therapeutics, Taiho Pharmaceutical, and Taiho Oncology to Present Positive Results from Pivotal Phase 2b REZILIENT1 Trial of Zipalertinib at ASCO 2025. Retrieved May 23, 2025 from https://www.globenewswire.com/news-release/2025/05/22/3087169/0/en/Cullinan-Therapeutics-Taiho-Pharmaceutical-and-Taiho-Oncology-to-Present-Positive-Results-from-Pivotal-Phase-2b-REZILIENT1-Trial-of-Zipalertinib-at-ASCO-2025.html[13] Palisade Bio Reports Positive Phase 1a Results for PALI-2108, a First-in-Class Terminal Ileum and Colon-Targeted PDE4 B/D Inhibitor for Fibrostenotic Crohn’s Disease and Ulcerative Colitis. Retrieved May 30, 2025 from https://www.globenewswire.com/news-release/2025/05/27/3088623/0/en/Palisade-Bio-Reports-Positive-Phase-1a-Results-for-PALI-2108-a-First-in-Class-Terminal-Ileum-and-Colon-Targeted-PDE4-B-D-Inhibitor-for-Fibrostenotic-Crohn-s-Disease-and-Ulcerative-.html[14] AskBio Announces Publication of Complete Results of Phase 1b Trial of AB-1005 Gene Therapy in Participants with Parkinson’s Disease in Movement Disorders. Retrieved May 30, 2025 from https://www.globenewswire.com/news-release/2025/05/27/3088653/0/en/AskBio-Announces-Publication-of-Complete-Results-of-Phase-1b-Trial-of-AB-1005-Gene-Therapy-in-Participants-with-Parkinson-s-Disease-in-Movement-Disorders.html[15] Lupin Announces Presentation of Phase 1 Data on LNP7457 (PRMT5 inhibitor) at the American Society of Clinical Oncology - Annual Meeting 2025. Retrieved May 30, 2025 from https://www.prnewswire.com/news-releases/lupin-announces-presentation-of-phase-1-data-on-lnp7457-prmt5-inhibitor-at-the-american-society-of-clinical-oncology---annual-meeting-2025-302465586.html[16] IRLAB reports positive results from the second part of a Phase I study with IRL757. Retrieved May 30, 2025 from https://irlab.se/mfn_news/irlab-reports-positive-results-from-the-second-part-of-a-phase-i-study-with-irl757/[17] Entrada Therapeutics Receives Authorization in the European Union to Initiate ELEVATE-45-201, a Phase 1/2 Multiple Ascending Dose Clinical Study of ENTR-601-45 in Patients Living with Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping. Retrieved May 30, 2025 from https://www.globenewswire.com/news-release/2025/05/28/3089307/0/en/Entrada-Therapeutics-Receives-Authorization-in-the-European-Union-to-Initiate-ELEVATE-45-201-a-Phase-1-2-Multiple-Ascending-Dose-Clinical-Study-of-ENTR-601-45-in-Patients-Living-wi.html[18] Phase I dose escalation trial of STX-001, an LNP-encapsulated self-replicating mRNA expressing IL-12, in patients (pts) with advanced solid tumors. Retrieved May 30, 2025 from https://ascopubs-org.libproxy1.nus.edu.sg/doi/10.1200/JCO.2025.43.16_suppl.9556[19] ORIC® Pharmaceuticals Announces Potentially Best-In-Class Preliminary Efficacy and Safety Data from Ongoing Phase 1b Trial of ORIC-944 in Combination with AR Inhibitors for the Treatment of Patients with mCRPC. Retrieved May 30, 2025 from https://www.globenewswire.com/news-release/2025/05/28/3089929/0/en/ORIC-Pharmaceuticals-Announces-Potentially-Best-In-Class-Preliminary-Efficacy-and-Safety-Data-from-Ongoing-Phase-1b-Trial-of-ORIC-944-in-Combination-with-AR-Inhibitors-for-the-Trea.html[20] AKTIS ONCOLOGY INITIATES PHASE 1B CLINICAL TRIAL OF ITS NECTIN-4-TARGETING RADIOPHARMACEUTICAL PRODUCT CANDIDATE, AKY-1189, ACROSS MULTIPLE TUMOR TYPES. Retrieved May 30, 2025 from https://www.prnewswire.com/news-releases/aktis-oncology-initiates-phase-1b-clinical-trial-of-its-nectin-4-targeting-radiopharmaceutical-product-candidate-aky-1189-across-multiple-tumor-types-302466453.html[21] Enveda Reports Favorable Phase 1 Safety for Novel Oral Anti-Inflammatory, Launches Phase 1b Trial in Atopic Dermatitis. Retrieved May 30, 2025 from https://www.businesswire.com/news/home/20250528125414/en/Enveda-Reports-Favorable-Phase-1-Safety-for-Novel-Oral-Anti-Inflammatory-Launches-Phase-1b-Trial-in-Atopic-Dermatitis[22] Phanes Therapeutics announces first patient dosed in clinical study of mavrostobart (PT199) in combination with chemotherapy. Retrieved May 30, 2025 from https://www.prnewswire.com/news-releases/phanes-therapeutics-announces-first-patient-dosed-in-clinical-study-of-mavrostobart-pt199-in-combination-with-chemotherapy-302464552.html[23] TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy. Retrieved May 30, 2025 from https://www.businesswire.com/news/home/20250529307401/en/TIXiMED-Announces-Successful-Completion-of-a-Phase-1-Study-of-its-Novel-Oral-Disease-Modifying-Type-1-Diabetes-Therapy免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新2

临床2期临床结果临床1期并购抗体药物偶联物

2025-05-31

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超20亿美元！罗氏加码这一赛道

分子胶技术站在了聚光灯下。近期，罗氏宣布以超20亿美元总金额与Orionis Biosciences达成第二次合作，共同开发针对肿瘤领域新颖和具有挑战性靶点的小分子单价分子胶药物。此前，双方在2023年达成协议，共同开发针对肿瘤及神经退行性疾病等难治领域中的“不可成药”靶点的创新分子胶疗法，交易总金额也超过20亿美元。值得注意的是，罗氏不是唯一一家进军分子胶赛道的MNC巨头。近年来，诺和诺德、默沙东、辉瑞等众多跨国药企纷纷押注分子胶领域。在这股市场热潮下，中国药企也找到了自己的用武之地。解锁下一代药物革命百时美施贵宝（BMS）最早入局分子胶领域，并且吃到巨大市场蛋糕。早在2019年，BMS就豪掷740亿美元收购了血液巨头Celgene（新基制药），拿下了Revlimid（来那度胺）、Pomalyst（泊马度胺）等分子胶降解剂。其中，来那度胺全球销售额在2021年达到峰值128亿美元；泊马度胺这几年的销售额保持在33亿美元左右。图片来源：国金证券研报分子胶的市场潜力如此巨大，难怪众多MNC巨头争相押注。2023年4月，默沙东以超25亿美元与Proxygen达成合作，共同确定和开发针对多种治疗靶点的分子胶降解剂；2023年10月，罗氏以超20亿美元与Monte Rosa Therapeutics达成合作，开发针对肿瘤和神经系统疾病不可成药靶点的分子胶降解剂；2024年2月，诺和诺德以超14亿美元与Neomorph达成合作，开发用于心脏代谢和罕见疾病的新型分子胶降解剂；2024年5月，武田制药以12亿美元与达歌生物达成合作，开发用于肿瘤学、神经科学和炎症领域多个靶点的新型分子胶降解剂；2024年10月，辉瑞以超15亿美元与TRIANA Biomedicines达成合作，发现用于多个疾病领域（包括肿瘤学）的针对多个靶点的新型分子胶降解剂，同时诺华斥资超22亿美元收购了Monte Rosa公司一款临床阶段分子胶MRT-6160（靶向VAV1，具有治疗免疫疾病潜力）。今年1月，艾伯维以超16亿美元与Neomorph达成合作，开发针对肿瘤和免疫学多个靶点的新型分子胶降解剂。可见，分子胶赛道已经集齐了几乎所有的全球制药巨头，从上述交易中还能看出分子胶技术“爆火”的原因：攻克“不可成药”靶点、广泛应用于多种疾病领域、商业价值巨大。分子胶是继PROTAC之后的新型蛋白降解剂，具有区别于PROTAC药物的优势。对比来看，PROTAC面临分子量大、口服生物利用度低等挑战。而分子胶降解剂简化了传统PROTAC降解剂的结构，化学机构更简单、成药性更好，且由于分子量更小、生物利用度更好，容易穿透血脑屏障，在神经退行性疾病方面显示出了巨大的潜力。另外，目前获FDA批准上市的分子胶降解剂不多，且全球已进入临床阶段的分子胶管线也较少，表明市场尚处于蓝海阶段，竞争压力小。基于此，MNC巨头纷纷抢滩入局分子胶赛道，掀起了研发热潮。开启拓荒之路分子胶技术，正在开启拓荒之路。目前全球已获批上市的分子胶降解剂，主要靶向IKZF1/3，针对血液肿瘤。IKZF1/3是血液瘤（如多发性骨髓瘤）的关键转录因子，其异常表达与疾病进展密切相关。BMS已获批上市的泊马度胺、来那度胺、沙利度胺，均通过结合E3泛素连接酶Cereblon（CRBN）诱导转录因子IKZF1/3降解，从而发挥抗肿瘤作用。三款度胺类药物的适应症，均为多发性骨髓瘤及其他血液瘤，其中来那度胺是目前多种血液瘤的一线治疗药物，由此成就了“年销售额超百亿美元”的壮举。从市场现状看，三款度胺类药物的临床效果，成功验证了IKZF1/3靶点的成药性，使得IKZF1和IKZF3成为当前分子胶研发的热门靶点。另外，分子胶设计难度高，药企倾向于选择已验证的靶点以降低风险，也是导致靶点集中的原因之一。理性设计难度是分子胶研发的核心瓶颈。这是因为E3连接酶存在局限性，E3酶与靶蛋白的互作机制不明确。目前，大多数分子胶依赖CRBN等少数E3泛素连接酶，而E3酶的底物选择性复杂，导致理性设计困难。尽管选择已验证靶点可降低研发风险，但过度集中会带来同质化竞争。这点可参考CD19和BCMA靶点在CAR-T疗法中的类似情况。基于此，BMS旗下的新基布局了新型口服Cereblon E3连接酶调节剂Iberdomide（CC-220），正在开展治疗多发性骨髓瘤、淋巴瘤和系统性红斑狼疮（SLE）的临床试验，其中针对活动性系统性红斑狼疮患者的Ⅱ期研究已取得成功。图片来源：国金证券研报除了差异化适应症，还有一些药企布局了针对新靶点的管线。例如，BMS布局了一种口服生物可利用的双靶向Cereblon E3泛素连接酶调节药物BMS-986470，可通过降解WIZ和ZBTB7A转录因子，显著提高胎儿血红蛋白（HbF）的水平，正在开展用于镰状细胞病（SCD）的Ⅰ/Ⅱ期临床试验。Monte Rosa Therapeutics开发了一种口服有效的GSPT1降解剂MRT-2359，正在开展治疗去势抵抗性前列腺癌和HR+乳腺癌患者的临床试验，预计今年下半年公布临床数据。诺华从Monte Rosa手中收购的MRT-6160，是一款潜在同类首创（First-In-Class）的强效、高选择性口服VAV1降解剂，在临床前模型中显示出具有治疗多发性硬化、类风湿性关节炎、炎症性肠病和皮肤病等多种免疫介导疾病的潜力。今年3月，Monte Rosa宣布，MRT-6160在I期临床试验中取得初步数据，后续的Ⅱ期试验将由诺华主导推进。据Monte Rosa Therapeutics预测，VAV1分子胶降解剂有望冲击现有规模达千亿级别的市场。中国药企亮剑度胺类药物销售额的爆发，吸引了众多中国药企争相布局，包括诺诚健华、恒瑞医药、正大天晴（中国生物制药子公司）、分迪药业（一品红子公司）、康朴生物、标新生物等。目前，已有不少国产分子胶管线进入临床阶段：诺诚健华ICP-490：创新口服下一代CRBN E3连接酶调节剂，诱导转录因子IKZF1和IKZF3的泛素化降解，克服了对前几代CRBN调节剂的获得性耐药，可单药治疗，也可与其他药物联用，目前正在中国针对多发性骨髓瘤（MM）和非霍奇金淋巴瘤（NHL）患者开展I/II期剂量递增和扩展研究。在联合治疗方面，ICP-490与强生的CD38单抗Darzalex（Daratumumab，达雷妥尤单抗）展现出了协同作用，可极大提高Darzalex在多发性骨髓瘤中的疗效。其中，Darzalex是强生年销售额超百亿美元的重磅大单品。对于NHL，ICP-490与BTK抑制剂奥布替尼联合使用时显示出协同杀伤肿瘤的作用，为临床联合治疗提供了科学依据。恒瑞医药HRS-3738：在来那度胺、泊马度胺等类似结构基础上增加侧链，增大与CRBN的结合表面以增加亲和力，同时较来那度胺、泊马度胺对IKZF1/IKZF3在降解速率和最大降解幅度上也大幅改善，有望克服因CRBN表达下调引起的来那度胺耐药，目前正在开展单药或联合药物治疗复发或难治性MM和NHL患者的I期临床试验。康朴生物布局了丰富的分子胶管线，包括KPG-818、KPG-121、KP-09S、gDAC-S等。其中，KPG-818正在美国进行治疗多种血液肿瘤的I期试验及治疗SLE的Ib/IIa期试验；KPG-121正在开展与雄激素受体拮抗剂（包括恩扎卢胺、醋酸阿比特龙、阿帕他胺或达罗他胺）联用治疗转移性和非转移性去势抵抗性前列腺的I期研究。康朴生物的研发管线图片来源：康朴生物官网分迪药业FD-001：国内首个进入临床阶段的GSPT1降解剂，具备治疗急性髓系白血病（AML）、MM和NHL等血液肿瘤的潜力，临床前研究显示出给药不到两周即可完全消除肿瘤，并可克服维奈克拉（Venetoclax）的不足。其中，维奈克拉是艾伯维的大药，2024年销售额达25亿美元。达歌生物DEG6498：全球首个针对First-in-Class靶点HuR靶点的分子胶降解剂，拟开发适应症包括结直肠癌、肺癌、肝癌和其他类型实体肿瘤，今年2月获FDA批准开展针对实体瘤的临床试验。标新生物GT919和GT929：正在中美两地分别开展治疗难治和复发MM、难治和复发NHL患者的Ⅰ期临床试验。格博生物GLB-001：具有FIC潜力的酪蛋白激酶1α（CK1α）口服分子胶蛋白降解剂，与来那度胺作用机制相似，已获FDA批准进入临床研究，用于治疗复发/难治性AML或复发/难治性较高危骨髓异常增生综合征（R/R HR-MDS）。结语分子胶技术正掀起小分子药物设计的范式革命，其应用领域正在突破血液瘤的单一战场。全球制药巨头围绕这一领域掀起“技术军备竞赛”，全球竞争转向“速度与差异化”的博弈。当前，中国药企的快速跟进策略初见成效，正凭借快速临床转化能力实现追赶。可见，这场竞赛的终极战场，将是技术、资本与临床价值的深度融合。参考资料：1.各家公司的财报、公告、官微2.《医药健康行业研究：靶向蛋白降解，有望弥补抑制剂耐药和难成药靶点未满足需求-241016》，国金证券研报声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

并购细胞疗法蛋白降解靶向嵌合体免疫疗法

100 项与阿帕他胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11040	阿帕他胺	L02BB05	DB11901

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
转移性前列腺癌	日本	Janssen Pharmaceutical KK	2020-05-29
转移性去势抵抗性前列腺癌	美国	Janssen Biotech, Inc.	2019-09-17
激素依赖性前列腺癌	欧盟	Janssen-Cilag International NV	2019-01-14
激素依赖性前列腺癌	冰岛	Janssen-Cilag International NV	2019-01-14
激素依赖性前列腺癌	列支敦士登	Janssen-Cilag International NV	2019-01-14
激素依赖性前列腺癌	挪威	Janssen-Cilag International NV	2019-01-14
前列腺癌	加拿大	Janssen Research & Development LLC	2018-07-27
去势敏感前列腺癌	澳大利亚	Janssen-Cilag Pty Ltd.	2018-07-05
去势抵抗性前列腺癌	美国	Janssen Biotech, Inc.	2018-02-14

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
前列腺腺癌	临床3期	中国香港	Janssen LP	2020-07-20
复发性前列腺癌	临床3期	中国香港	Janssen LP	2020-07-20
非转移性前列腺癌	临床3期	法国	Janssen Pharmaceutica NV	2020-01-09
阿尔茨海默症	临床3期	美国	西安杨森制药有限公司	2015-12-07
阿尔茨海默症	临床3期	美国	Janssen Research & Development LLC	2015-12-07
阿尔茨海默症	临床3期	美国	Aragon Pharmaceuticals, Inc.	2015-12-07
阿尔茨海默症	临床3期	日本	Aragon Pharmaceuticals, Inc.	2015-12-07
阿尔茨海默症	临床3期	日本	Janssen Research & Development LLC	2015-12-07
阿尔茨海默症	临床3期	日本	西安杨森制药有限公司	2015-12-07
阿尔茨海默症	临床3期	阿根廷	Aragon Pharmaceuticals, Inc.	2015-12-07

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临床结果

适应症

分期

评价

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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


ASCO2025	N/A	激素依赖性前列腺癌 PSA kinetics	129	Apalutamide plus ADT	繭鏇蓋膚蓋憲製築餘顧(鹽簾鏇觸壓網鹹鹽積鹽) = 構選築鑰顧網顧壓齋淵醖選憲鹽鏇觸範廠遞廠 (製網窪糧網鬱艱憲製鑰 ) 更多	积极	2025-05-30
NCT04926181 (CTgov)	临床2期	神经内分泌前列腺癌 \| 前列腺小细胞癌	2	Apalutamide+Cetrelimab	網製鏇蓋鬱鬱齋衊艱壓 = 鹽醖鬱製膚鹹範鑰廠鬱廠製衊選糧襯膚願艱廠 (窪憲壓蓋簾襯製積選膚, 艱壓膚醖衊衊蓋夢壓構 ~ 窪遞築鏇鑰餘遞鑰糧淵) 更多	-	2025-05-15
NCT04108208 (CTgov)	临床4期	去势抵抗性前列腺癌	75	Placebo (Placebo Plus Androgen-deprivation Therapy (ADT))	膚選衊廠餘簾積簾鬱鹹(鏇鹽繭願襯觸遞窪憲壓) = 憲夢廠壓範遞糧糧製醖衊憲廠壓夢壓積觸觸夢 (齋鬱觸廠築鹽夢顧鹽鹽, 積選鑰壓齋壓製選繭艱 ~ 選選積襯糧醖廠鏇製糧) 更多	-	2025-03-28
				Apalutamide (Apalutamide 240 mg Plus ADT)	膚選衊廠餘簾積簾鬱鹹(鏇鹽繭願襯觸遞窪憲壓) = 製觸顧遞範艱糧繭鹹夢衊憲廠壓夢壓積觸觸夢 (齋鬱觸廠築鹽夢顧鹽鹽, 襯壓範廠製憲鏇衊選構 ~ 網膚廠積積鏇積廠範壓) 更多
NCT04666129 (ASCO_GU2025) 人工标引	临床1期	晚期前列腺癌	24	Relugolix 120 mg + Abiraterone 1000 mg + prednisone 5 mg/methylprednisolone 4 mg (Part 1)	糧壓鏇鑰鑰願壓膚積顧(遞壓齋艱鑰構構齋遞願) = 築憲網遞憲獵積夢膚簾壓築壓積願壓遞選選顧 (構壓齋範鬱範蓋齋遞齋, 3.2) 更多	积极	2025-02-13
				Relugolix 240 mg + Apalutamide 240 mg	糧壓鏇鑰鑰願壓膚積顧(遞壓齋艱鑰構構齋遞願) = 鏇鹽顧衊鹽製構獵壓鬱壓築壓積願壓遞選選顧 (構壓齋範鬱範蓋齋遞齋, 8.0) 更多
NCT02489318 (TITAN, ASCO_GU2025) 人工标引	临床3期	去势敏感前列腺癌	524	Apalutamide + ADT (With CV/metabolic risk factors at baseline)	廠廠膚鹹網願餘窪鹽憲(壓壓顧構夢壓衊艱鑰夢): HR = 0.49 (95% CI, 0.38 ~ 0.63), P-Value = <0.0001 更多	积极	2025-02-13
				Placebo + ADT (With CV/metabolic risk factors at baseline)
NCT05717660 (PERSIAN, ASCO_GU2025) 人工标引	临床2期	激素依赖性前列腺癌	174	Apalutamide+ADT (ARM A: Control)	選觸鑰獵願鏇範簾夢鑰(觸鑰淵醖獵鬱獵鏇觸餘) = 鹽醖獵遞鑰積鬱衊簾簾築淵積顧齋淵窪願積蓋 (獵鬱願衊網鹽廠製窪構 )	积极	2025-02-13
				Apalutamide+ADT+SBRT (ARM B: Treatment)	選觸鑰獵願鏇範簾夢鑰(觸鑰淵醖獵鬱獵鏇觸餘) = 遞膚夢淵觸艱簾壓網顧築淵積顧齋淵窪願積蓋 (獵鬱願衊網鹽廠製窪構 )
ASCO_GU2025 人工标引	N/A	去势敏感前列腺癌 Prostate specific antigen	363	Apalutamide (APA)	膚願窪襯簾範壓艱繭襯(選獵鏇獵壓積醖簾鏇願) = 艱餘憲觸觸鏇遞願繭積醖餘範壓範構積觸選艱 (遞齋築繭壓鹽顧鹽餘獵 ) 更多	积极	2025-02-13
				Abiraterone acetate (ABI)	膚願窪襯簾範壓艱繭襯(選獵鏇獵壓積醖簾鏇願) = 積壓築憲製願壓襯鹽範醖餘範壓範構積觸選艱 (遞齋築繭壓鹽顧鹽餘獵 ) 更多
NCT06013475 (DEAR-EXT, ASCO_GU2025) 人工标引	未知	去势抵抗性前列腺癌	1,205	DarolutamideDarolutamide (DARO) (Black pts)	-	积极	2025-02-13
				DarolutamideDarolutamide (DARO) (White pts)
ASCO_GU2025	N/A	晚期前列腺癌 autoimmune disease \| skin disease \| eosinophil count	120	apalutamide (Black men)	願壓夢鑰願構築選鑰憲(窪遞獵憲鬱觸顧夢糧遞) = 觸顧憲窪鬱窪鑰廠鏇積醖壓繭鬱廠醖觸糧築選 (衊構憲鬱築齋醖獵憲衊 ) 更多	-	2025-02-13
				apalutamide (White men)	願壓夢鑰願構築選鑰憲(窪遞獵憲鬱觸顧夢糧遞) = 蓋淵遞鹽製壓醖餘憲蓋醖壓繭鬱廠醖觸糧築選 (衊構憲鬱築齋醖獵憲衊 ) 更多
TITAN and SPARTAN (ASCO_GU2025)	N/A	晚期前列腺癌	2,190	Statin use	-	积极	2025-02-13
				Apalutamide + Statin	觸鏇鑰遞廠願膚艱淵齋(餘齋襯獵醖願襯餘壓壓) = 網憲襯淵鑰鏇築鹹蓋鏇鏇積鑰簾夢鏇繭衊網襯 (夢蓋衊鏇範繭廠衊夢壓 )