The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.

开始日期2025-07-14

申办/合作机构

The Case Comprehensive Cancer Center

NCT06890832

/ Not yet recruiting临床2期

A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen

A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.
The study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.
Key efficacy assessments include CT scans/MRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.
Pharmacokinetic parameters will also be evaluated.

开始日期2025-05-01

申办/合作机构

Jina Pharmaceuticals, Inc.

NCT06632977

/ Recruiting临床2期IIT

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide 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. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

开始日期2025-02-06

申办/合作机构

Alliance for Clinical Trials in Oncology

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100 项与卡巴他赛相关的临床结果

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100 项与卡巴他赛相关的转化医学

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100 项与卡巴他赛相关的专利（医药）

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1,653

项与卡巴他赛相关的文献（医药）

2026-08-01·CLINICAL NUCLEAR MEDICINE

Excellent Response to Combined 223Ra-dichloride and Enzalutamide After Failure of 177Lu-PSMA Radioligand Therapy

Article

作者: Maas, Moritz ; la Fougère, Christian ; Späth, Magdalena Sophie ; Calderón, Eduardo ; Trautwein, Nils F.

We report an 81-year-old man with metastatic castration-resistant prostate cancer (mCRPC) after multiple prior therapies, including androgen deprivation therapy (ADT), the androgen receptor pathway inhibitor (ARPI) abiraterone, taxane chemotherapy with docetaxel and cabazitaxel, radiopharmaceutical therapy (RPT) with 4 cycles of [ 177 Lu]PSMA-I&T, and the PARP inhibitor olaparib in combination with abiraterone. Due to biochemical and clinical progression, [ 18 F]PSMA-1007 PET/CT was performed for restaging, revealing diffuse skeletal metastases without significant extraosseous disease. Based on this imaging pattern, treatment with the ARPI enzalutamide combined with 223 Ra-dichloride was initiated, resulting in an excellent response with a >90% PSA decline and a progression-free survival of 10 months.

2026-07-01·CLINICAL CANCER RESEARCH

Clonal Hematopoiesis after 177Lu-PSMA-617 Radioligand Therapy in Prostate Cancer

Article

作者: Koudjanian, Melissa ; Buteau, James P. ; Iravani, Amir ; Scott, Andrew M. ; Parekh, Karan ; Wyatt, Alexander W. ; Bernales, Cecily Q. ; Stockler, Martin R. ; Kwan, Edmond M. ; Williams, Scott G. ; Emmett, Louise ; Karsan, Aly ; Donnellan, Gráinne ; Davis, Ian D. ; Zhang, Alison Y. ; Joshua, Anthony M. ; Sandhu, Shahneen ; Herberts, Cameron ; Hofman, Michael S. ; Azad, Arun A. ; Munzur, Aslı D. ; Martin, Andrew J. ; Lee, Sze-Ting ; Bacon, Jack V.W. ; Francis, Roslyn J.

Abstract:

Purpose::

Clonal hematopoiesis (CH) is a precursor state linked to risk of hematologic neoplasms and may be exacerbated by radiation exposure. We aimed to compare CH prevalence after the new radioligand therapy 177Lu-PSMA-617 versus the alternative standard-of-care cabazitaxel chemotherapy in metastatic castration-resistant prostate cancer (mCRPC).

Experimental Design::

This post hoc correlative analysis used serial blood samples from TheraP (ANZUP 1603), a randomized phase II trial in docetaxel-refractory mCRPC. Cell-free DNA and leukocyte DNA underwent error-corrected deep targeted sequencing. CH mutations were called at variant allele frequency (VAF) ≥0.25%. Variants detected at progression but undetected at baseline were defined as treatment-emergent CH. A total of 178 patients had a baseline sample; 107 (60 177Lu-PSMA-617; 47 cabazitaxel) had paired baseline–progression samples (median interval, 29 vs. 27 weeks).

Results::

Baseline CH was detected in 77% (138/178) of patients, with similar prevalence and gene distribution between arms. Treatment-emergent CH occurred more often after 177Lu-PSMA-617 than cabazitaxel [62% (37/60) vs. 40% (19/47); P = 0.03], and 83% (121/146) of all emergent mutations were detected after 177Lu-PSMA-617. The DNA damage response gene PPM1D accounted for 42% (51/121) of 177Lu-PSMA-617–emergent mutations, with odds ratios of 3.2 for any treatment-emergent CH and 5.4 for PPM1D, relative to cabazitaxel. CH clones expanded more frequently and to a greater magnitude with 177Lu-PSMA-617 (proportion expanding, 70.9% vs. 29.5%; P = 7.5 × 10−5), and increases in maximal CH VAF correlated with the number of 177Lu-PSMA-617 cycles received (+2.9% per cycle; P = 0.002).

Conclusions::

177Lu-PSMA-617 strongly promotes CH, supporting integration of longitudinal monitoring for long-term hematologic sequelae as radioligand therapy is implemented earlier in prostate cancer care.See related commentary by Lückerath et al., p. 2527

2026-06-15·CLINICAL CANCER RESEARCH

Carboplatin, Cabazitaxel, and Abiraterone in High-Volume Metastatic Castration-Sensitive Prostate Cancer: The CASCARA Phase II Study

Article

作者: Proudfoot, James A. ; Lewis, Brian ; Cao, Qing ; Stadler, Walter M. ; De Souza, Andre L. ; Bryce, Alan H. ; Sartor, A. Oliver ; Jha, Gautam G. ; Ryan, Charles J. ; Carneiro, Benedito A. ; Davicioni, Elai ; Dhawan, Mallika ; VanderWeele, David J. ; Kelly, W. Kevin ; Morgans, Alicia K. ; Singh, Parminder ; Antonarakis, Emmanuel S. ; Catharine, Victoria ; Barata, Pedro C.

Abstract:

Purpose::

This multicenter, single-arm, phase II trial evaluated the safety and efficacy of cabazitaxel and carboplatin followed by abiraterone, plus androgen deprivation therapy (ADT), in patients with high-volume metastatic castration-sensitive prostate cancer (mCSPC).

Patients and Methods::

Eligible patients had high-volume mCSPC and ≤3 months of prior ADT. Patients received six 21-day cycles of cabazitaxel (20 mg/m2) and carboplatin (AUC 4) with continuous ADT, followed by maintenance abiraterone (1,000 mg daily) and prednisone (5 mg daily). The primary endpoint was the proportion of patients free of prostate-specific antigen (PSA) or radiographic progression at 12 months. Secondary endpoints included complete PSA response (≤0.2 ng/mL), objective response, progression-free survival (PFS), and safety. Overall survival (OS) was also reported.

Results::

Sixty-one participants were enrolled at eight sites. The median age was 64 years, median baseline PSA was 6.6 ng/mL (0.07–745.7 ng/mL), 73.3% had Gleason grade group 5, 69.5% had 10 or more metastases, and 19.6% had a homologous recombination repair (HRR) mutation. PSA PFS at 12 months was 84.6% [95% confidence interval (CI), 72.5%–91.7%], and OS at 12 months was 94.8% (84.7%–98.3%). Complete PSA response was 66.7%, and complete objective response was 30.7%. Contrary to our hypothesis, relative to HRR wild-type patients, HRR-mutated patients (19.6%) had numerically fewer complete PSA responses (33.3% vs. 70.3%) and inferior PFS (HR, 2.43; 95% CI, 0.93–6.39). Common side effects of this quadruplet regimen included fatigue, nausea, and diarrhea.

Conclusions::

Cabazitaxel and carboplatin followed by abiraterone, together with ADT, were feasible, safe, and efficacious in patients with high-volume mCSPC and warrant further study in larger randomized trials.

183

项与卡巴他赛相关的新闻（医药）

2026-08-05

·泓流Flood

下一代百亿靶点争夺战打响，BioNTech联手映恩生物亮剑

作者 | 周在安「泓流Flood」出品谁能够接棒TROP2成为下一代ADC（抗体偶联药物）泛肿瘤靶点？目前业内似乎已经形成了一定的共识。在前几天葛兰素史克（GSK）发布的半年报中，GSK已经开始把B7-H3 ADC研发作为GSK肿瘤管线中的核心位置。也正是在7月份，GSK完成了对肿瘤技术公司Nuvalent的收购，在官方公告中，GSK称之为“为B7-H3 ADC提供扩张的平台”。大家都知道，像GSK这种MNC肯投入大量资源，一方面已经足以说明B7-H3 ADC的市场空间巨大且具有相当的确定性，侧面印证了靶点的临床价值及泛肿瘤通用价值；另一方面也显然会进一步催动整个B7-H3赛道的成熟，直接推进中国的优质ADC 资产在全球范围内的研发与商业化进程。总体看下来，GSK没有挑明的潜台词很可能是，B7-H3正逐渐展现出成为下一代重磅ADC靶点的潜力。当然，关注B7-H3 ADC赛道MNC不能仅看GSK，还需要横向对比第一三共、BioNTech等其他玩家。8月4日，BioNTech召开Q2业绩电话会，其中披露了更多B7-H3的关键信息值得跟大家进一步分享一下。 01 根据目前国内披露的数据，B7-H3已经在国内SCLC（小细胞肺癌）三期研究上已经取得了数据突破。在抗癌药的临床试验中，SCLC的研发范式已经非常成熟，也正因为其恶性高、进展快、耐药快的特性，虽然SCLC患者人群基数并不大，但也通常被看作临床验证的“试金石”。但是更让市场关注的，其实是B7-H3的泛瘤种特性。按照BioNTech在电话会上披露的信息，公司已经在前列腺癌（Prostate）、非小细胞肺癌（NSCLC）、小细胞肺癌（SCLC）、乳腺癌（HR+ BC, TNBC）、结直肠癌（CRC）、胃癌、宫颈癌、卵巢癌、胰腺癌（PDAC）、头颈鳞癌（HNSCC）、肝癌（HCC）及黑色素瘤（Melanoma）在内的 14种适应症中展开了临床研究，B7-H3在这些瘤种中都有中高程度的表达。也就是说， B7-H3药物可能会对大量癌种均有效，一旦药物研发成功，就极有可能拿下巨大的市场份额。我们不妨先看看整个B7-H3 ADC赛道的情况，总体来说有四个大玩家：第一三共与MSD合作开发的DS-7300（Ifinatamab deruxtecan / I-DXd）、BioNTech与映恩生物合作开发的DB-1311（Elfe-D / BNT324）、GSK与翰森制药合作开发的HS-20093（Risvutatug rezetecan / Ris-Rez），以及宜联生物与罗氏合作开发的YL-201（Tambotatug pelitecan / RG-6919）。其中，第一三共/默沙东的DS-7300是这个赛道的老前辈了，目前在全球铺开多地的三期临床。按照BioNTech披露的信息，其B7-H3 ADC（DB-1311/BNT324, Elfe-D）的临床探索已经覆盖了上述14项适应症，所有适应症的全球入组患者数量已经超过1000名。更重要的是将近500例患者已经接受了PD-L1/VEGF双抗Pumitamig联用治疗，使其成为目前全球B7-H3 ADC领域最大的联合治疗临床数据库之一，其中一项联用临床研究已获得ESMO优选口头报告（Preferred Oral，摘要编号9990）接收，笔者很期待读出的数据。另外，在BioNTech积累了如此庞大的临床样本后，外界有预测其离开启全球多中心三期临床已为期不远，后续进展值得期待。图源：BioNTech《Second Quarter 2026 Earnings Presentation》在BioNTech披露的各项研发进度中，去势抵抗性前列腺癌（mCRPC）无疑是跑得最快的一个，Elfe-D在 mCRPC 上的进度目前已处于临床三期阶段，仅次于第一三共，是全球仅有的两款进入前列腺癌 III 期临床的 B7-H3 ADC 之一，国内则是最快。翰森制药HS-20093则是与GSK合作，目前成功拿到了国内SCLC三期数据以及NSCLC的POC数据，验证了B7-H3靶点的价值，同时也在瞄准CRPC和骨肉瘤方向，取得了一定进展；宜联生物的YL201使用了“微环境激活”的技术，走的是差异化的路线，在国内已经提交鼻咽癌的上市申请，目前还在推进SCLC、ESCC、NSCLC、CRPC及头颈癌等实体瘤的二期/三期研究。具体到CRPC的各项数据上，我们不妨看下表：从表中数据可以看出，映恩生物与BioNTech合作的DB-1311除了样本量更大外，它的样本患者人群选择其实也更加贴近当下CRPC治疗的真实情况，而这也有助于其未来FDA上市审批和商业化放量。对于CRPC患者来说，当下最火爆（尤其在欧美地区）、也是商业化最成功的靶向药其实是Lu-177，但很多患者在用过Lu-177后会产生耐药。由于患者构成及随访时间存在差异，不同研究结果并不构成严格头对头比较，但DB-1311在较高比例Lu-177经治患者中的表现，仍具有一定参考价值。所以，DB-1311的数据价值就在于，它有超三分之一的样本采用了Lu-177经治人群，并且也包含后线接受过卡巴他赛治疗的人群。而其他国产现有ADC数据中，要不就是未披露Lu-177经治人群比例（不排除未采用该样本的可能），要不就是比例较低。从疗效上看，DB-1311在仅随访 6.5 个月的情况下，中位 rPFS 已经达到了 11.3 个月，总生存达到了 22.5 个月。随着患者继续随访，这个疗效数据还有可能进一步变好。从安全性上看，DB-1311在样本中的严重副作用（≥G3 TRAE）仅为 20%，而其他产品却高达 50% 左右。这其中的价值在于，正因为DB-1311安全性优异，患者才可能能够耐受，一方面更适合一线患者的长期用药需求，在降低脱落率的情况下更好的发挥药物的疗效；另一方面也更能保障一线患者的生活质量；同时，优异的安全性也是适合与双抗等其他强力药联合治疗的基础。也就是说，DB-1311的CRPC单药后线数据，其实打开了BioNTech在B7-H3 ADC赛道上的更多市场空间，也放大了其冲击一线市场的可能性。在此基础上，BioNTech针对CRPC的3期临床也直接瞄准了一线mCRPC的适应症，并且未来有进一步前移到HSPC的可能性。综合目前各方公开的CRPC数据来看，DB-1311不仅建立了极具差异化的临床壁垒，也为其未来在B7-H3赛道中确立 Best-in-Class 的地位奠定了不小的基础。 02 然而，肺癌才是决定胜负的战场。 BioNTech在电话会上引用的数据显示，NSCLC一线转移性患者每年新增约40万，二线及以上转移性患者每年约23万，而SCLC的一线转移性每年约8万，二线及以上每年约3.5万。这个市场空间显然是巨大的。Elfe-D是映恩生物与BioNTech合作的B7-H3 ADC，采用的是映恩生物自研平台技术。具体来说，其分子设计的特殊之处主要在于三点：第一，肿瘤细胞中B7-H3的类型主要是4lg类型，而正常组织多为2lg类型，DB-1311对4lg类型做了专门的优化，所以可以更有效地瞄准癌细胞、避开正常器官，使靶向更精准；第二，DB-1311的抗体经过了安全处理（Fc段沉默改造设计），大大降低了误伤正常组织的风险，副作用更小；第三，DB-1311携带的药物载荷比相对更高（DAR值为6），且动物实验证明其耐受剂量极大，这意味着用较小剂量就能见效，治疗的安全范围也更宽。另外，DB-1311拥有酶切敏感的连接子，因此在血液中稳定，到了肿瘤微环境中被切割，从而释放游离毒素，而这些游离毒素还具备特殊的物理化学特性，能够穿透肿瘤细胞膜，从而向周围细胞扩散，产生所谓的“旁观者效应”。因为肿瘤细胞往往具有异质性，所以在实际情况中，一个肿瘤块可能会出现有些细胞有B7-H3靶点，有些又没有，这也是临床上的痛点所在。但药物显然不能只杀死B7-H3高表达的癌细胞，放任低表达或不表达的癌细胞，所以DB-1311通过“旁观者效应”，能够在即使靶点表达不均的情况下，也同样精准杀伤邻近癌细胞。而对于一些B7-H3表达极低的患者，通过PD-L1/VEGF双抗联合用药，则可以改善肿瘤的微环境，通过药物协同来增加肿瘤内部ADC浓度、激活T细胞、诱导靶点表达，从而大幅提升总体疗效。而肺癌（尤其是NSCLC）其实就是典型的高异质性肿瘤，靶点表达不均，所以也就特别适合B7-H3 ADC联用双抗，这也就将DB-1311的适用范围扩充到了更大的人群中。这里我们再多讲一下肺癌ADC药物的情况。肺癌ADC研发和治疗的最大痛点是肺毒性副作用，简单来说，就是ADC在血液循环中提前脱落、解离出游离毒素，或者游离毒素穿膜性过强，会导致肺部组织损伤。而在传统随机偶联的ADC中，DAR（药物抗体比）分布非常宽，比如有些抗体可能没有挂载毒素，有些抗体可能挂载了8个甚至更多毒素，而这种DAR值极高的分子本身就极不稳定，容易被免疫系统清除从而诱发炎症和肺毒性。对比下来，DB-1311一方面如前文所述，在血液中非常稳定，极大减少了药物“脱靶”情况，另一方面采用了优化的定点偶联技术，使DAR实现稳定控制，从而减少免疫炎症引发的肺毒性。在电话会上，BioNTech也公布了公司在肺癌领域的规划，大致是，采用双抗+ADC联合疗法的策略抢占肺癌前线市场，包括NSCLC和SCLC的1L和2L+，后线仍以单药疗法为辅。图源：BioNTech《Second Quarter 2026 Earnings Presentation》大家都知道，癌症治疗越靠前（一线1L），患者的用药时间也就越长，市场规模也就越大，商业价值也就越高。患者如果在一线就使用某ADC产品并产生耐药，那么后线同载荷的其他ADC产品效果就会大打折扣。所以从商业竞争的角度来看，谁能够抢占一线市场，谁就能够直接把市场份额先锁死，让其他竞争对手在后线“无药可用”。其实自从BioNTech收购拿下PD-L1 / VEGF-A 双抗，并与BMS达成合作后，其就一直不满足后线治疗，战略上采用了“猛攻一线”的做法，如今的“双抗+ADC”的联合方案实际上就是BioNTech向一线市场进军的迅速行动，而DB-1311在CRPC后线单药治疗样本数据，也很大程度上验证了可行性。从目前的进度来看，BioNTech和映恩生物应该会是第一个读出肺癌数据的“双抗+ADC”组合。 03 从GSK重金砸向B7-H3 ADC，到BioNTech电话会上关于DB-1311的各种信息来看，B7-H3未来的市场潜力恐怕才刚刚被挖掘出来。在此前的ADC时代，Immunomedics和第一三共抢到了最大的蛋糕，而在接下来的B7-H3阶段，未来大概率也会是第一三共、GSK、BioNTech、罗氏等玩家分夺市场的格局。不过需要注意的是，从商业经营、业绩兑现的层面上看，国内ADC企业可能还会出现不小的分野，而这背后的一个重要因素，在于管线的合作模式上。可以发现，GSK与翰森制药的HS-20039采用的是License-out模式，而在该模式下，虽然可以快速回款、降低临床费用，但后续卖方能拿到的销售提成比例通常相对有限，本质上是卖方将大部分销售收益让渡给MNC，以换取确定性收益和短期现金流。目前情况来看，B7-H3 ADC的市场确定性应该还算是比较强的，随着靶点价值的不断开发、市场的不断打开，GSK将会吃下大部分利润，这也是GSK投入重金的原因。但反观映恩生物，已经于2026年5月行使独家选择权，参与分摊DB-1311/BNT324在美国地区的研发成本，并共享该药物商业化运营产生的盈亏收益，随着B7-H3 ADC市场的不断做大，其收益的市场想象空间也变得足够高。当然，联合开发模式本质上是一条“高风险高收益”的路线，对企业的现金流管理、合规管理和后期的销售管理要求极高，但好在从目前BioNTech披露的各项临床数据来看，映恩生物是走对了这条路。对于BioNTech当下的一个变数，可能在于CEO的变动。公司的CEO Uğur Şahin及担任首席医学官（CMO）的妻子Özlem Türeci此前宣布计划离职创业，8月4日，BioNTech宣布任命瑞典罕见病医药巨头Sobi的CEO Guido Oelkers为新任CEO，Oelkers将会在最晚2027年2月1日接任。选择同时拥有ADC产品商业化经验和晚期管线运营经验的CEO，BioNTech已经进入“兑现肿瘤管线价值”的阶段。在接任公告中，Oelker明确表示：“BioNTech 最突出的是强大的后期肿瘤管线，目标是到2030年成为拥有多个获批产品的全球生物制药公司”, 而跟映恩合作HER2 ADC DB-1303 今年就要递交 BLA,预计是最先商业化的ADC资产，Elfe-D则有潜力成为BNTX肿瘤业务中最具商业价值的核心资产之一。新CEO的到来或许会为BioNTech带来一些新的变化，我们不妨可以继续期待一下。免责声明：本文内容仅供参考，文内信息或所表达的意见不构成任何投资建议，请读者谨慎作出投资决策。 -END-

2026-07-30

·募林

临床试验招募 | 泌尿肿瘤（肾透明细胞癌、尿路上皮癌、前列腺癌）202607

【泌尿肿瘤】肾透明细胞癌、尿路上皮癌、前列腺癌肾透明细胞癌5172842 作为PET/CT显像剂，用于对IRM中ccRCC（肾透明细胞癌）和非ccRCC的鉴别试验分期：III期研究药物：放射性核素偶联药物年龄要求：≥18岁开展区域：北京/湖北/江苏/天津/浙江局部晚期或转移性肾细胞癌6182062 含透明细胞成分的晚期（不适合根治性手术或放射治疗）或转移性RCC 试验分期：Ib/II期研究药物：PD-1/VEGF双特异性抗体年龄要求：≥18岁开展区域：北京/湖北/湖南/江苏/山东/四川/浙江/重庆肾透明细胞癌4ST415 晚期转移或不可切除透明细胞肾细胞癌，接受过VEGF/VEGFR靶向单药或联合免疫检查点抑制剂治疗，且治疗不耐受或疾病进展、复发试验分期：I期研究药物：自体CAR-T 年龄要求：≥18岁开展区域：湖北非肌层浸润性膀胱癌8472754ST581 BCG无应答的伴或不伴Ta/T1乳头状肿瘤的非肌层浸润性膀胱癌（NMIBC）伴原位癌试验分期：II期研究药物：溶瘤病毒药物年龄要求：18岁以上开展区域：北京/天津/辽宁/上海/江苏/浙江/福建/山东/湖北/湖南/重庆/四川局部晚期或转移性尿路上皮癌2132454 携带FGFR3基因变异的既往未经治疗的局部晚期或转移性尿路上皮癌试验分期：III期研究药物：FGFR3抑制剂年龄要求：18岁或以上，或达到法定同意年龄开展区域：北京/广东/广西/黑龙江/湖北/湖南/江苏/吉林/上海/四川/天津/浙江/重庆尿路上皮癌3172261 既往经治的局部晚期/转移性尿路上皮癌试验分期：III期研究药物：TROP2 ADC 年龄要求：18岁以上开展区域：北京/广东/湖北/湖南/江苏/江西/上海/四川/天津/浙江/重庆局部晚期或转移性尿路上皮癌1122162 局部晚期或转移性尿路上皮癌试验分期：Ib/II期研究药物：PD-1/VEGF双特异性抗体年龄要求：≥18岁开展区域：北京/湖南/江苏/天津/浙江乳腺癌/前列腺癌/结直肠癌6132731 在接受标准全身治疗期间或之后疾病复发或进展、对标准治疗不耐受，或无可用标准治疗；在接受晚期/不可切除或转移性疾病的最新治疗方案期间/之后记录到影像学疾病进展；转移性去势抵抗性前列腺癌，经多西他赛或卡巴他赛，经新型激素治疗（NHT），经或未经Lu177 试验分期：I/IIa期研究药物：HER3 ADC 年龄要求：≥18岁的男性或女性开展区域：安徽/北京/福建/甘肃/广西/海南/黑龙江/河南/湖北/湖南/江苏/江西/吉林/辽宁/山东/上海/山西/四川/云南/浙江/重庆转移性去势抵抗性前列腺癌2142132 转移性去势抵抗性前列腺癌，经新型内分泌治疗和多西他赛治疗后疾病进展试验分期：I期研究药物：培化磷脂酰乙醇胺包载的微管抑制剂胶束制剂年龄要求：18~82周岁（包括18及82周岁），男性；体重≥45kg 开展区域：北京/湖南/江西/山东/上海/山西转移性去势抵抗性前列腺癌2112950 既往接受过ARPI治疗和紫杉类药物化疗且在[177Lu]Lu-PSMA靶向治疗期间或之后出现进展的PSMA阳性mCRPC（转移性去势抵抗性前列腺癌）试验分期：II/III期研究药物：靶向PSMA放射性核素偶联药物（RDC）年龄要求：≥18岁开展区域：北京/福建/广东/湖北/江苏/辽宁/上海/陕西/四川/天津转移性去势抵抗性前列腺癌6102134 转移性去势抵抗性前列腺癌（mCRPC）试验分期：I期研究药物：STEAP1/CD3双特异性抗体年龄要求：≥18岁（若该国家/地区的法定成年年龄大于18岁，则需≥该法定成年年龄）开展区域：北京/广东/上海/浙江转移性去势抵抗性前列腺癌2112853 经标准治疗后进展/不耐受的转移性去势抵抗性前列腺癌（mCRPC）试验分期：I/II期研究药物：PSMA ADC 年龄要求：≥18周岁开展区域：北京/广东/河南/湖南/江苏/山东/上海/浙江前列腺癌6102154 接受放疗和雄激素剥夺治疗的携带BRCAm局部高危前列腺癌试验分期：III期研究药物：高选择性PARP1抑制剂年龄要求：≥18岁（或达到研究所在管辖范围内的法定知情同意年龄），男性开展区域：安徽/北京/福建/甘肃/广东/湖北/湖南/江苏/江西/吉林/辽宁/山东/上海/四川/天津/浙江/重庆晚期转移性去势抵抗性前列腺癌1/9462250ST519 晚期转移性去势抵抗性前列腺癌试验分期：I期和II期研究药物：CYP11A1抑制剂年龄要求：≥18岁，男性开展区域：福建/河南/湖南/江苏/辽宁/山东/上海/天津/浙江新型内分泌药物治疗失败的转移性去势抵抗性前列腺癌1/7532262Z1345 新型内分泌药物治疗失败的转移性去势抵抗性前列腺癌试验分期：Ⅲ期研究药物：B7-H3 ADC 年龄要求：男性，≥18岁开展区域：安徽/北京/福建/甘肃/广东/广西/贵州/河北/黑龙江/河南/湖北/湖南/江苏/江西/吉林/辽宁/宁夏/山东/上海/山西/陕西/四川/天津/新疆/云南/浙江/重庆前列腺癌6192854 经组织学或细胞学确认的手术无法切除的局部晚期或转移性的恶性实体瘤，经标准治疗失败，或无标准治疗，或不耐受标准治疗（优先纳入携带BRCA1/2、PALB2、RAD51C/D等HRD相关基因突变的乳腺癌、卵巢癌、前列腺癌、胰腺癌）试验分期：I期/II期研究药物：PARP1抑制剂年龄要求：≥18周岁开展区域：安徽/北京/广东/黑龙江/河南/湖北/江苏/辽宁/山东/陕西/四川/浙江前列腺特异性膜抗原（PSMA）阳性寡转移性前列腺癌（OMPC）4142343 前列腺特异性膜抗原（PSMA）阳性寡转移性前列腺癌（OMPC）试验分期：Ⅲ期研究药物：PSMA RDC 年龄要求：≥18岁开展区域：北京/广东/上海转移性去势抵抗性前列腺癌（mCRPC）5322640 既往接受过新型内分泌治疗（NHA）和紫杉烷类化疗的转移性去势抵抗性前列腺癌（mCRPC）试验分期：Ⅲ期研究药物：口服、非甾体、高选择性CYP11A1抑制剂年龄要求：至少为18岁开展区域：安徽/北京/福建/广东/湖北/湖南/江苏/江西/山东/上海/陕西/四川/天津/新疆/云南/浙江/重庆转移性去势抵抗性前列腺癌（mCRPC）7392452 转移性去势抵抗性前列腺癌（mCRPC），既往接受过1或2种ARPI治疗nmHSPC、mHSPC、nmCRPC或mCRPC，并在治疗期间或治疗至少8周后发生疾病进展试验分期：Ⅲ期研究药物：B7-H3靶向ADC 年龄要求：至少为18岁开展区域：北京/福建/广东/广西/河南/湖北/湖南/江苏/吉林/山东/上海/山西/陕西/四川/新疆/浙江/重庆【报名资料】 1.病理/免疫组化/基因检测 2.最新住院病历（入出院记录） 3.最新影像/血常规/血生化 4.根据具体项目要求临床试验参与者招募点击查看资质全国区域（肿瘤/血液/慢病/罕见病）国家药品监督管理局批准/伦理审查委员会批准患者获益：研究相关免费/权威专家/方案补贴注意事项：药物不良反应/有效性差异/其他参与流程：报名→审核→筛选→入组联系我们：13066612315（微信同号）助力新药研发，服务大众健康。专注于提供临床试验参与者招募的一站式服务。依托分学科管理与稳定的协作能力，专业医学团队解读试验方案，算法匹配+人工复核，选择适合项目，安排筛选等相关事宜。 #临床试验招募#肾透明细胞癌#尿路上皮癌#前列腺癌

2026-07-28

·BioSpace

Starget Pharma Expands Scientific Advisory Board with Appointment of Two Global Leaders in Radiopharmaceutical Therapy

Dr. Oliver Sartor brings more than 35 years advancing the clinical development and commercialization of oncology and radiopharmaceuticals Professor Michael Hofman brings more than 20 years pioneering molecular imaging and precision radiotheranostics SHREVEPORT, La., July 28, 2026 (GLOBE NEWSWIRE) -- Starget Pharma Inc. (Starget), a U.S. clinical-stage radiopharmaceutical company, today announced the appointment of Oliver Sartor, MD, and Professor Michael Hofman, MBBS, FRACP, FAANMS to its Scientific Advisory Board (SAB), further strengthening the Company's scientific leadership as it advances multiple radioligand programs toward the clinic from its AI-powered discovery platform. Dr. Sartor and Professor Hofman are internationally recognized leaders in oncology and radiopharmaceutical medicine. Their decades of experience spanning scientific innovation through clinical development have helped establish radioligand therapy as an emerging pillar of cancer treatment. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “We are honored to welcome Oliver and Michael to our Scientific Advisory Board,” said Sigal Kalmanson Cusnir, CEO and Co-Founder of Starget Pharma. “Their deep experience advancing radioligand therapies into clinical practice will help shape our development strategy as we further advance our next-generation radioligand pipeline.” Dr. Sartor added, “Starget’s platform combines artificial intelligence with advanced peptide engineering to design radioligands with the potential to improve tumor targeting and pharmacologic performance. I look forward to working with the team to help expand the reach of radioligand therapy across a broader range of cancer targets.” Professor Hofman added, “Radiotheranostics offers a unique advantage in drug development by showing where a radioligand goes before treatment. Starget’s approach using insights from imaging to inform AI-driven optimization has the potential to accelerate the development of more effective radiopharmaceuticals, and I look forward to helping advance that vision.” Oliver Sartor, MD is an internationally recognized medical oncologist and one of the world’s leading experts in prostate cancer and radiopharmaceutical therapies. He serves as Director of the Transformational Prostate Cancer Research Center at East Jefferson General Hospital Cancer Center and previously served as Director of Radiopharmaceutical Clinical Trials at Mayo Clinic. He has led numerous landmark clinical trials that resulted in the approval of transformative therapies, including Xofigo ® (radium-223), Pluvicto ® (¹⁷⁷Lu-PSMA-617), Jevtana ® (cabazitaxel), and Quadramet ® (samarium-153). Dr. Sartor has authored more than 600 peer-reviewed publications. Professor Michael Hofman, MBBS, FRACP, FAANMS, is a globally recognized nuclear medicine physician and physician-scientist and a pioneer in molecular imaging and theranostics. Serving as an independent advisor, he is based at Peter MacCallum Cancer Centre and the University of Melbourne, where he led landmark clinical trials, including proPSMA, TheraP, UpFrontPSMA and PRIMARY2, that have helped establish PSMA imaging and radioligand therapy as standards of care for prostate cancer. His research spans radiopharmaceutical discovery, clinical translation and imaging biomarkers, with publications in leading medical journals including The Lancet . About Starget Pharma Inc. Starget Pharma is a clinical-stage radiopharmaceutical company developing next-generation peptide radioligand therapies for cancer, with operations in the U.S. and Israel. The Company’s AI-powered platform integrates computational peptide design, theranostic imaging, and biological feedback to accelerate the discovery and optimization of radioligands with the potential to improve tumor targeting and pharmacologic performance. Starget Pharma is advancing a wholly owned pipeline of differentiated radioligand therapies across a broad range of cancers, including lead programs targeting SSTR3 and GRPR that are designed to address significant unmet needs with first-in-class and best-in-class potential. Learn more at . Investor Contact Chuck Padala LifeSci Advisors, LLC chuck@lifesciadvisors.com

高管变更

100 项与卡巴他赛相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09755 D10452	卡巴他赛	L01CD04	DB06772

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
前列腺癌	日本	Sanofi KK	2014-07-04
转移性去势抵抗性前列腺癌	美国	Sanofi-Aventis U.S. LLC	2010-06-17

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	法国	Sanofi	2013-12-01
局限性前列腺癌	临床3期	法国	Sanofi	2013-12-01
尿路上皮癌	临床3期	英国	Sanofi	2013-01-01
去势抵抗性前列腺癌	临床3期	美国	Aventis Pharma	2011-05-05
去势抵抗性前列腺癌	临床3期	日本	Aventis Pharma	2011-05-05
去势抵抗性前列腺癌	临床3期	丹麦	Aventis Pharma	2011-05-05
去势抵抗性前列腺癌	临床3期	芬兰	Aventis Pharma	2011-05-05
去势抵抗性前列腺癌	临床3期	秘鲁	Aventis Pharma	2011-05-05
去势抵抗性前列腺癌	临床3期	瑞典	Aventis Pharma	2011-05-05
骨病	临床2期	意大利	Sanofi Srl	2018-03-12

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03048942 (CONCEPT, CTgov)	临床2期	HER2 阴性乳腺癌	158	Cabazitaxel (Cabazitaxel)	醖襯餘艱膚餘窪繭膚壓(餘鹹製觸鹽製顧衊範選) = 築憲餘餘蓋淵壓壓夢繭鹹簾憲窪觸憲網網鹹憲 (憲鏇網顧鏇壓鹹衊構壓, 膚獵餘鬱鹽構憲餘窪鑰 ~ 範製餘築餘齋窪鬱衊憲) 更多	-	2026-07-21
				Paclitaxel (Paclitaxel)	醖襯餘艱膚餘窪繭膚壓(餘鹹製觸鹽製顧衊範選) = 積鹹顧遞膚鬱願糧鬱構鹹簾憲窪觸憲網網鹹憲 (憲鏇網顧鏇壓鹹衊構壓, 夢製淵鏇窪網壓鑰夢鏇 ~ 鹹衊構顧網齋遞壓糧窪) 更多
ASCO2026	N/A	转移性去势抵抗性前列腺癌	1,618	Cabazitaxel plus carboplatin	鬱願網築醖繭鹹醖願壓(憲願壓築範範廠膚積鹽) = 淵餘獵繭願糧淵艱膚衊選網築廠選糧廠夢網艱 (鹹繭遞積憲願鹽蓋鬱憲 ) 更多	不佳	2026-05-29
				Cabazitaxel alone	鬱願網築醖繭鹹醖願壓(憲願壓築範範廠膚積鹽) = 網積築鹽壓齋鏇觸鏇獵選網築廠選糧廠夢網艱 (鹹繭遞積憲願鹽蓋鬱憲 ) 更多
NCT03934840 (CASCARA, CTgov)	临床2期	转移性去势敏感性前列腺癌	61	Cabazitaxel+Carboplatin+prednisone+Abiraterone	鹹襯廠鹽鹹製蓋糧觸鑰 = 鑰廠醖構構觸簾糧衊積鹽廠願憲製鹽願餘壓構 (簾衊選觸範餘窪範願鑰, 憲壓餘製遞襯蓋鬱獵鏇 ~ 簾網鬱範積顧觸遞餘觸) 更多	-	2026-05-26
NCT01308580 \| NCT02485691 \| NCT02961257 (CABASTY, Pubmed \| Eur Urol Oncol)	临床3期	转移性去势抵抗性前列腺癌	194	Cabazitaxel	蓋衊糧衊築糧繭衊淵構(窪獵齋醖蓋鏇築鹹艱鹹) = 獵廠鏇遞夢鏇鹽網鑰糧壓廠選鏇遞願淵鹽膚簾 (餘鏇壓積積鏇膚簾觸選 )	积极	2026-04-01
				ARPI	蓋衊糧衊築糧繭衊淵構(窪獵齋醖蓋鏇築鹹艱鹹) = 鑰鏇憲遞鹹糧齋構糧構壓廠選鏇遞願淵鹽膚簾 (餘鏇壓積積鏇膚簾觸選 )
NCT01616875 (The Bristol Bladder trial, CTgov)	临床2期	膀胱尿路上皮癌	28	Cabazitaxel+Cisplatin chemotherapy	鏇齋窪膚憲製遞願蓋艱 = 憲襯衊淵鬱構餘夢願廠襯艱衊積齋憲簾獵選鹹 (簾積醖鏇餘醖襯製製積, 蓋築獵鬱簾醖窪醖繭鹹 ~ 餘艱鹽製構願網窪壓鬱) 更多	-	2026-03-06
NCT01952223 (PEACE-2, ASCO_GU2026)	临床3期	局限性前列腺癌	761	ADT + Radiotherapy + Cabazitaxel ± Pelvic Radiotherapy	製壓壓簾鹹膚範窪鹹糧(夢鹽鹽網膚鹹獵淵繭餘) = 網積襯糧繭夢壓夢願齋繭遞窪餘廠範鑰壓鹽簾 (壓艱壓願遞觸網膚壓夢 ) 更多	不佳	2026-02-26
				ADT + Radiotherapy ± Pelvic Radiotherapy	製壓壓簾鹹膚範窪鹹糧(夢鹽鹽網膚鹹獵淵繭餘) = 網獵憲窪窪廠襯顧壓觸繭遞窪餘廠範鑰壓鹽簾 (壓艱壓願遞觸網膚壓夢 ) 更多
ASCO_GU2026	N/A	转移性去势抵抗性前列腺癌	28	cabazitaxel	製願構構鏇鏇鹹艱壓淵(鬱遞築夢範糧範範網製) = 選窪餘築築蓋範築顧壓壓製網鬱鏇繭齋網壓艱 (窪艱艱蓋範網繭積鏇築, 3.0 ~ 13.4) 更多	积极	2026-02-26
				cabazitaxel (PSA 50 responders to LuPSMA)	製願構構鏇鏇鹹艱壓淵(鬱遞築夢範糧範範網製) = 鹹範壓製壓鏇鬱鏇顧獵壓製網鬱鏇繭齋網壓艱 (窪艱艱蓋範網繭積鏇築, 4.0 ~ NR) 更多
NCT03419234 (CHAARTED2, CTgov)	临床2期	转移性去势抵抗性前列腺癌	223	Androgen deprivation therapy+Cabazitaxel+prednisone+Abiraterone Acetate (Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel))	夢齋積齋鏇襯觸範廠醖(築襯構鏇積廠齋醖憲衊) = 顧製蓋憲鏇餘鹹窪齋壓顧範積鑰壓鏇廠繭糧憲 (襯蓋鏇膚鹽淵積艱夢襯, 遞鹹範淵鏇顧鹹顧鏇糧 ~ 憲憲齋簾廠憲遞膚製簾) 更多	-	2026-01-08
				Androgen deprivation therapy+prednisone+Abiraterone Acetate (Arm B (Abiraterone Acetate, Prednisone))	夢齋積齋鏇襯觸範廠醖(築襯構鏇積廠齋醖憲衊) = 鏇憲簾積築齋製齋鏇網顧範積鑰壓鏇廠繭糧憲 (襯蓋鏇膚鹽淵積艱夢襯, 範築鹹願醖繭遞鏇鏇願 ~ 窪範衊遞鏇艱夢鹹餘齋) 更多
NCT02485691 (CARD, Pubmed \| JCI Insight)	临床3期	转移性去势抵抗性前列腺癌 chromosomal instability in circulating tumor cells	600	cabazitaxel	憲願選憲壓艱築齋獵衊(積簾壓膚簾觸鬱鑰衊壓) = 淵簾遞積鬱築製觸壓衊願築鹽糧醖襯窪襯築蓋 (範窪齋簾築願鏇壓夢鬱 )	积极	2025-12-22
				alternative ARPI	憲願選憲壓艱築齋獵衊(積簾壓膚簾觸鬱鑰衊壓) = 繭簾衊艱淵窪蓋窪廠蓋願築鹽糧醖襯窪襯築蓋 (範窪齋簾築願鏇壓夢鬱 )
ESMO2025	N/A	转移性去势抵抗性前列腺癌	38,315	Docetaxel	膚艱艱簾憲願襯淵鹽窪(膚觸憲築範觸襯膚齋繭) = 蓋鹽鏇鑰製襯窪繭願顧獵築齋窪選簾獵範鏇艱 (築遞襯繭願衊膚範遞願 )	积极	2025-10-17
				Docetaxel	膚艱艱簾憲願襯淵鹽窪(膚觸憲築範觸襯膚齋繭) = 淵蓋觸顧窪餘壓鏇鏇積獵築齋窪選簾獵範鏇艱 (築遞襯繭願衊膚範遞願 )