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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项与卡巴他赛相关的文献（医药）

2026-06-01·Health policy OPEN

Price transparency & out-of-pocket payments for medications: Implications of associated delivery fees in the United States

Article

作者: Kaye, Deborah R ; Scales, Charles D ; George, Daniel J ; Lee, Hui-Jie ; Bundorf, M Kate

Background:

Price transparency has been cited as a tool to reduce out-of-pocket (OOP) payments to patients. These tools for prescription drugs often focus on the price to patients for the drug alone. However, costs associated with drug delivery (i.e. infusion center fees, labs, etc) are often unknown and could impact the effectiveness of price transparency tools. Objective: To examine total OOP payments on day of drug receipt ("full day", i.e. drug + drug administration fees) out-of-pocket (OOP) payments associated with six first-line treatments for metastatic castrate resistant prostate cancer and compare these with payments for drug alone and by insurance type.

Methods:

Using the IBM Marketscan databases, we identify male patients who initiated treatment with one of six focus drugs (docetaxel, abiraterone, enzalutamide, sipuleucel-T, cabazitaxel, and radium-223) used to treat mCRPC from 07/01/2013-06/30/2019. We calculated total OOP payments on day of drug receipt (full day OOP payments) by drug type for six first line treatments. We then used a two-part model to assess the association of first-line therapy with OOP payments for the four most frequently prescribed during the study time period.

Results:

We find that there is variation in the proportion of payments for drug alone relative to full day payments across first-line treatments. However, regression-adjusted mean full day OOP payments are not statistically different across first-line treatments for mCRPC for the four most frequently prescribed drugs. There are differences in the likelihood that an individual will incur any OOP payment by first-line treatment type and by health plan type.

Conclusion:

These analyses suggest that when accounting for additional services required on the day of drug receipt, the amount a patient pays to receive a medication for mCRPC can be very different from the OOP payment for the drug alone; these payments also vary by drug and health plan type. Therefore, price transparency for drug alone may not lead to reduced OOP payments for patients.

2026-02-01·PROSTATE

Efficacy of Early Switching From Docetaxel to Cabazitaxel in Castration‐Resistant Prostate Cancer

Article

作者: Fujii, Yoichi ; Maki, Kazuki ; Kakutani, Shigenori ; Taguchi, Satoru ; Yamada, Daisuke ; Niimi, Aya ; Takada, Tappei ; Nakagawa, Tohru ; Tanaka, Takehiro ; Miyakawa, Jimpei ; Kume, Haruki ; Kawai, Taketo ; Kamei, Jun ; Yamada, Yuta

ABSTRACT:

Background:

Cabazitaxel is a taxane agent associated with fewer symptomatic adverse events than docetaxel in treating castration‐resistant prostate cancer (CRPC), yet it is typically reserved for post‐docetaxel failure. This study assessed whether early switching from docetaxel to cabazitaxel could improve clinical outcomes.

Methods:

Beginning in 2019, a treatment approach was adopted wherein patients with CRPC were switched to cabazitaxel after three cycles of docetaxel, regardless of response. Patients who initiated docetaxel between February 2019 and March 2022 were classified as the switch group, while those who started between September 2014 and February 2019 were designated as the historical non‐switch group. Chemotherapy duration, number of chemotherapy cycles, and adverse events were compared. Progression‐free survival (PFS), time to failure of both taxanes, and overall survival (OS) were analyzed using propensity score matching.

Results:

The switch and non‐switch groups included 36 and 37 patients, respectively. The switch group received significantly more chemotherapy cycles ( p = 0.043) and had a longer cumulative chemotherapy duration ( p = 0.035), even when including chemotherapy administered in subsequent lines. The cumulative incidence of peripheral neuropathy was significantly lower in the switch group ( p = 0.037). Within the switch group, symptomatic adverse events, including fatigue, anorexia, and alopecia, were significantly reduced after switching to cabazitaxel. PFS was significantly prolonged in the switch group ( p = 0.002), although time to failure of both taxanes and OS did not differ significantly between groups.

Conclusions:

Early switching to cabazitaxel after three cycles of docetaxel may reduce symptomatic adverse events, including peripheral neuropathy, while enabling longer chemotherapy exposure and improved PFS in patients with CRPC.

2026-02-01·BJU INTERNATIONAL

Long‐term outcomes of a cascading salvage strategy for high‐risk non‐muscle‐invasive bladder cancer

Article

作者: McElree, Ian M. ; Hougen, Helen Y. ; Mott, Sarah L. ; Steinberg, Ryan L. ; Packiam, Vignesh T. ; O'Donnell, Michael A.

Objective:

To report long‐term oncological outcomes of patients with high‐risk non‐muscle‐invasive bladder cancer (HR‐NMIBC) undergoing bladder‐sparing therapy (BST) after bacillus Calmette–Guérin (BCG) failure.

Patients and Methods:

We retrospectively reviewed patients with HR‐NMIBC treated from 2000 to 2025 with intravesical therapies after BCG failure, all of whom received salvage gemcitabine/docetaxel (Gem/Doce). Subsequent BST included valrubicin/docetaxel, sequential doxorubicin/gemcitabine alternating with mitomycin‐C/docetaxel, and gemcitabine/cabazitaxel with pembrolizumab. Kaplan–Meier analysis estimated recurrence‐free survival (RFS), progression‐free survival (PFS), cystectomy‐free survival (CFS), and cancer‐specific survival (CSS).

Results:

A total of 85 patients with HR‐NMIBC were included of whom 38 (45%) were BCG‐unresponsive. The median (interquartile range) follow‐up was 86 (43–108) months from induction Gem/Doce. Following Gem/Doce initiation, RFS did not significantly decline with each successive line of salvage therapy: among patients treated with first (Gem/Doce), second, and third line salvage therapy, the 2‐year RFS was 47%, 43%, and 39%, respectively ( P = 0.68). Overall, the PFS at 5 years was 81% (95% confidence interval [CI] 69–88%). PFS did not significantly decline with each successive salvage line of therapy: among patients treated with first (Gem/Doce), second, and third line salvage therapy, the 2‐year PFS was 91%, 88%, and 93%, respectively ( P = 0.98). CFS and CSS were 74% (95% CI 62–83%) and 88% (95% CI 79–94%) at 5 years, respectively.

Conclusions:

Multi‐line BST is feasible and can yield durable bladder preservation and oncological control in select patients with HR‐NMIBC following BCG failure. Progression‐free outcomes remained favourable across successive lines of salvage therapy. These findings support the role of longitudinal BST as an alternative to radical cystectomy in carefully and appropriately selected patients.

144

项与卡巴他赛相关的新闻（医药）

2026-04-02

·allsci.com

Oric’s PRC2 inhibitor rinzimetostat combo regimen advances to Phase III trial in mCRPC

ORIC Pharmaceuticals (Nasdaq: ORIC) reported Phase Ib dose optimization data for rinzimetostat in combination with darolutamide in post-abiraterone metastatic castration-resistant prostate cancer (mCRPC), selecting 400 mg once daily as the recommended Phase 3 dose and announcing plans to initiate the Himalayas-1 global Phase III registrational trial in the first half of 2026. At a median follow-up of approximately five months, a five-month landmark rPFS rate of 84% appears numerically favorable relative to historical benchmarks for approved therapies in this setting, though the dataset remains small and cross-trial comparisons are limited. Trial specifics The Phase Ib dose optimization trial enrolled patients with mCRPC who had received prior androgen receptor pathway inhibitor (ARPI) therapy and up to one prior line of chemotherapy. The post-abiraterone cohort included 18 patients treated at 400 mg once daily and 15 at 600 mg once daily, both in combination with darolutamide (Nubeqa) at 600 mg twice daily. In 18 efficacy-evaluable patients at the 400 mg dose, landmark rPFS rates were 93%, 84%, and 84% at 3, 4, and 5 months respectively, with a median follow-up of 4.9 months. Among 15 patients with at least one post-baseline PSA assessment, 47% achieved a PSA50 response, with 33% confirmed. In 14 patients with detectable ctDNA at baseline, 71% achieved greater than 50% ctDNA reduction. For context, ORIC cited 5-month landmark rPFS rates of approximately 60% to 75% for approved therapies including enzalutamide (Xtandi), cabazitaxel (Jevtana), docetaxel (Taxotere), and lutetium-177 vipivotide tetraxetan (Pluvicto) in comparable populations, though these figures derive from separate trials with different patient characteristics. Treatment-related adverse events at the 400 mg dose were predominantly Grade 1. The most common were fatigue (39%), diarrhea (22%), and nausea (22%). A single Grade 3 TRAE was observed; no Grade 4 or 5 events were attributed to either drug. Dose modifications were rare, with one interruption and one discontinuation and no dose reductions required across the cohort. The dose selection followed an exposure-response analysis conducted across more than 100 patients in both single-agent and combination settings, in alignment with the FDA’s Project Optimus initiative. That analysis found comparable efficacy at 400 mg and 600 mg, but identified statistically significant associations between higher drug exposure and increased toxicity and treatment modifications, favoring the lower dose on safety grounds. Rinzimetostat and PRC2 inhibition Rinzimetostat is an allosteric inhibitor of polycomb repressive complex 2 (PRC2) acting through the EED subunit. PRC2 mediates histone H3 lysine 27 trimethylation (H3K27me3), an epigenetic modification associated with transcriptional silencing of differentiation programs. In prostate cancer, PRC2 activity has been implicated in the transition toward AR-indifferent or neuroendocrine phenotypes following ARPI exposure — a resistance mechanism not addressed by sequential AR-directed therapy. Pairing rinzimetostat with darolutamide, an AR antagonist with a distinct binding conformation and low CNS penetration, is designed to simultaneously block AR signaling and suppress epigenetic resistance pathways. The most direct competitive reference point is mevrometostat (PF-06821497), Pfizer’s EZH2-targeting PRC2 inhibitor, which is currently in Phase III in mCRPC in combination with enzalutamide. ORIC has positioned rinzimetostat’s safety profile as a potential differentiator, citing lower rates of Grade 3 or higher events and fewer dose modifications relative to competitor regimens, though cross-trial comparisons are limited by differences in patient populations, prior therapy, and data maturity. An earlier EZH2 inhibitor combination effort in prostate cancer, the CELLO-1 trial evaluating tazemetostat with an ARPI, was terminated, leaving the field without a validated precedent for this mechanism in registrational testing. The post-abiraterone mCRPC population represents a setting with limited oral, biomarker-agnostic options. Approved PARP inhibitors — olaparib, rucaparib, and the combination regimens talazoparib plus enzalutamide and niraparib plus abiraterone — are restricted to patients with homologous recombination repair mutations, estimated at roughly 25%-30% of mCRPC cases. Pluvicto gained a label expansion in early 2025 covering pre-taxane, post-ARSI mCRPC, but requires PSMA-PET imaging, specialized nuclear medicine infrastructure, and intravenous administration. Chemotherapy with docetaxel or cabazitaxel carries a toxicity burden that limits use in patients with compromised performance status. The unselected post-abiraterone population — approximately 17,000 new patients annually in the US by ORIC’s estimate — lacks a well-tolerated oral targeted option with a novel mechanism. The planned Himalayas-1 trial will enroll approximately 600 patients across more than 250 sites in over 20 countries, randomized 1:1 to rinzimetostat 400 mg once daily plus darolutamide versus physician’s choice of an AR inhibitor or chemotherapy. The primary endpoint is rPFS; overall survival is the key secondary endpoint. ORIC also reported early data from 19 patients with mCRPC previously treated with AR inhibitors other than abiraterone, showing 5-month landmark rPFS of 85%, suggesting potential applicability beyond the post-abiraterone cohort, though sample sizes remain too small to draw firm conclusions. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

临床3期临床结果临床1期临床2期

2026-04-01

·红豆知恋

百亿元赛道开启！红豆杉从苗木走向全产业链

在生物医药与大健康产业加速迭代的当下，红豆杉正从濒危保护植物，成长为兼具生态、经济与社会价值的百亿级黄金赛道。依托政策护航、技术突破与资本加持，这条赛道正加速完成从苗木培育到全产业链价值释放的跨越，成为乡村振兴与绿色产业升级的重要抓手。一、苗木筑基：从繁育突破到规模扩张红豆杉产业的根基，在于优质苗木的规模化繁育。作为国家一级保护植物，野生红豆杉资源严格受限，人工繁育成为产业可持续发展的核心前提。经过多年技术攻坚，行业已实现从“靠天育苗”到“科技繁苗”的跨越，为全产业链筑牢原料基础。（一）技术突破破解繁育瓶颈早期红豆杉育苗面临成活率低、周期长、成本高三大难题。随着科研攻关推进，组培快繁技术、定向培育技术成为核心突破点。云南高黎贡山地区通过组培快繁技术，将种苗年产能提升至8000万株，推动种苗成本较五年前下降42%；浙江诸暨“浙红一号”、福建“南方一号”等优质品种相继问世，其中“南方一号”实现活性成分从根部向叶片转移，可通过修剪枝叶采收实现可持续利用，彻底摆脱对根部挖掘的依赖。截至2024年，全国红豆杉种植面积突破80万亩，云南、四川、福建等主产区已建成超50个标准化种植基地，人工种植面积占比超75%。（二）分级育苗构建市场体系苗木市场形成“观赏苗+药用苗+盆景苗”三级格局，精准匹配不同需求。观赏苗聚焦曼地亚红豆杉、南方红豆杉等品种，一年生种苗售价约15元/株，三年生景观树苗突破100元/株，主要供应市政绿化、房地产景观工程；药用苗主打高紫杉醇含量品种，第四代定向培育技术的苗木紫杉醇含量较传统品种提升3.2倍，单株经济价值突破2000元，是药用原料林的核心种苗；盆景苗以造型独特的中小型植株为主，单盆售价50-200元，依托电商平台年销量超5万盆，成为家庭园艺市场的热门品类。（三）政策护航规范种苗流通国家林草局明确野生红豆杉零采伐，同时简化人工繁育种苗备案流程，建立“种苗来源可查、种植过程可监、产品流向可溯”的数字化溯源体系。《中药材生产质量管理规范》（GAP）全面实施，推动种植环节GAP认证覆盖率从2020年的31%提升至2023年的67%，标准化种苗成为进入医药、康养领域的硬性门槛。地方政府配套专项补贴，对符合标准的种苗繁育基地给予每亩定额补助，鼓励“企业+基地+农户”模式，带动超10万户农户参与种苗培育与种植。二、链条延伸：从原料供给到多元变现随着种植规模扩大，红豆杉产业逐步突破单一原料供给模式，向精深加工、文旅康养、生态修复等多领域延伸，形成“一木多收”的全产业链格局，价值实现数倍增长。（一）药用加工：核心价值释放引擎紫杉醇作为红豆杉核心药用成分，是全球30余种抗癌药物的关键原料，市场需求持续刚性增长。2023年紫杉醇原料药市场规模达24.8亿元，占全球供应量的35%。中游加工环节通过技术革新实现效率与品质双提升：超临界CO₂萃取技术全面普及，提取纯度突破99.5%，损耗率降低40%，生产效率较传统溶剂法提升3倍；酶解膜分离联用新工艺普及，每公斤紫杉醇生产成本从2018年的15万元降至2023年的8.2万元。目前，行业已形成“提取—中间体—制剂”完整布局，云南红豆杉药业、浙江康恩贝生物等龙头企业具备高纯度紫杉醇及多西他赛、卡巴他赛等衍生物的规模化生产能力。2024年紫杉醇及其衍生物在公立医疗机构终端销售额达86.7亿元，同比增长9.3%，占植物源抗肿瘤药市场份额的62.1%。合成生物学技术同步突破，天津大学团队通过基因编辑实现紫杉醇前体异源合成，发酵罐产率达850 mg/L，为原料供给开辟全新路径。（二）民生消费：高附加值业态拓展除医药领域外，红豆杉活性成分在保健品、化妆品领域的应用成为新增长极。2024年国内红豆杉相关保健食品备案数量达127项，较2020年增长近3倍，市场规模约18.4亿元，预计2026年突破30亿元；红豆杉提取物抗氧化、抗炎特性显著，2023年国内相关化妆品市场规模达18.7亿元，同比增长41%，远超行业整体增速，核心产品为抗衰老精华与修复面膜。此外，红豆杉副产物综合利用持续深化：枝叶加工成药用切片、养生茶，果实用于酿酒、制作文创产品，木材打造高端工艺品，实现“全株无废”。江西武宁县院士团队研发的红豆杉精油、保健品成功上市，带动产品附加值提升300%以上，成为民生消费领域的标杆案例。（三）生态文旅：三产融合新范式依托红豆杉“天然氧吧”属性与药用康养价值，“生态+文旅+康养”融合模式快速兴起，成为乡村振兴的重要载体。江西铜鼓县创建国家级森林康养基地，年生态旅游收入超4800万元；江西万安红豆杉养生谷打造8大功能区，年接待量稳定增长，康养民宿、文创产品收益占比超40%。文旅业态涵盖森林康养、科普研学、网红打卡三大核心：林间步道、悬崖民宿搭配负氧离子疗养、红豆杉养生餐，吸引康养人群；植物馆、药植课堂对接学校与亲子团，年接待研学团队超千批次；古树IP、红豆邮局、主题咖啡打造网红打卡点，带动流量转化。湖南耒阳市潭湖村流转12000亩荒地打造循环产业园，配套观光小火车、露营基地，年接待游客7万余人次，带动村集体增收37万余元。三、格局重塑：从分散布局到集群发展百亿元赛道的崛起，推动红豆杉产业从零散种植向集群化、规范化升级，政策、资本、技术三大要素协同发力，加速产业格局重构。（一）区域集群效应凸显西南、华东两大核心产区形成差异化竞争格局。云南凭借气候与种质资源优势，2023年红豆杉产业产值达38.7亿元，占全国总量的41.2%，建成全国最大人工培育基地，种植面积达18万亩；贵州通过“退耕还林+珍稀药材”复合经营模式，在黔东南州建成连片基地6.3万亩，带动2.1万农户年均增收4800元；浙江、福建依托科研优势，聚焦高端加工与文旅融合，打造“浙红一号”等特色品牌，诸暨枫桥镇、明溪县等成为产业示范样板。（二）龙头企业引领整合行业集中度持续提升，前五名企业占据约35%市场份额。云南红豆杉药业、四川华西红豆杉科技、浙江赤松控股等龙头企业构建全产业链闭环：云南红豆杉药业2023年营收达18亿元，研发投入占比12%，主导原料药市场；浙江赤松控股建成“浙红一号”标准化种植基地与GMP生产车间，推进紫杉醇注射液、卡巴他赛针剂等创新药研发，布局研学康养基地。企业通过并购、合资等方式整合资源，推动技术、渠道、品牌共享，加速行业洗牌。（三）政策资本双向加持政策层面，国家将红豆杉列为重点扶持的特色经济林树种，中央财政投放专项补贴，支持种植基地建设、绿色提取与合成生物学研发，对相关项目给予税收减免；地方政府出台配套政策，打通“种植—加工—销售—碳汇交易”全链条，推动产业升级。资本层面，2023年全国涉及红豆杉绿色制造的专利申请量达217件，同比增长68%，企业主导占比73%，资本市场持续加码医药加工、文旅康养领域，推动产业快速扩张。四、未来展望：从百亿到千亿的跃迁当前中国红豆杉市场规模已突破120亿元，预计2030年将增长至280亿元，年复合增长率达12.5%，若叠加文旅、保健品等多元业态，有望冲刺千亿量级。未来产业将呈现三大发展趋势：一是技术驱动深化，合成生物学实现规模化商用，成本与传统提取工艺持平，原料供给瓶颈彻底破解；二是业态融合加速，“医药+康养+文旅+碳汇”四产联动，康养板块贡献占比将从23%提升至40%以上；三是标准体系完善，GAP、有机认证全面普及，产品质量与溯源能力显著提升，推动产业向全球价值链高端迈进。红豆杉从苗木到全产业链的跨越，既是濒危植物保护与产业开发的典范，也是绿色发展与乡村振兴的生动实践。随着技术持续突破与市场需求扩容，这条百亿元赛道正加速释放潜力，成为中国特色经济林产业高质量发展的重要标杆。

疫苗

2026-03-31

·百度百家

PEG修饰蛋白的用途有哪些？应用方向全面解析

PEG修饰蛋白的用途有哪些？应用方向全面解析聚乙二醇（PEG）修饰蛋白是通过化学偶联将PEG分子与蛋白质共价结合，优化蛋白理化性质与生物学功能的改性技术，核心优势在于延长蛋白体内半衰期、降低免疫原性、提升稳定性与水溶性。经过数十年发展，该技术已广泛渗透到生物制药、科研实验、工业生产等多个领域。一、核心应用方向一：临床*药物研发 PEG修饰蛋白*核心的用途是作为临床*药物，解决天然蛋白药物半衰期短、免疫原性高、水溶性差等痛点，广泛应用于肿瘤、自身免疫性疾病、内分泌疾病、贫血、糖尿病等多种疾病的*，目前已有多款PEG修饰蛋白药物上市，成为生物制药领域的核心品类。（一）具体产品（二）典型案例案例1：培莫沙肽*肾性贫血的临床应用需求背景：肾性贫血是慢性肾脏病（CKD）的常见并发症，核心原因是红细胞生成素（EPO）生成不足，传统重组EPO类药物需每周给药1-3次，且部分患者会产生*EPO*体，引发纯红细胞再生障碍性贫血（PRCA），安全性与依从性不佳。案例2：怡培生长激素注射液用于儿童生长激素缺乏症* 需求背景：儿童生长激素缺乏症（GHD）需长期注射生长激素*，传统短效生长激素需每日睡前注射，儿童依从性差，且长期用药可能因防腐剂产生潜在危害，部分患者会产生*药*体，影响*效果。（三）相关参考文献 1. Bailon, Pascal, and Chee-Youb Won. “PEG-modified biopharmaceuticals.” Expert opinion on drug delivery vol. 6,1 (2009): 1-16. doi:10.1517/17425240802650568.（IF=8.2，综述PEG修饰生物药物的临床应用，重点阐述其在延长半衰期、降低免疫原性方面的优势及临床价值） 2. Luo, Xiaoping et al. “Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies.” European journal of endocrinology vol. 177,2 (2017): 195-205. doi:10.1530/EJE-16-0905.（IF=5.8，详细报道PEG修饰生长激素的临床研究数据，验证其在儿童GHD*中的有效性与安全性） 3. 《长效红细胞生成刺激剂*肾性贫血中国专家共识（2024年版）》[J]. 中华肾脏病杂志, 2024, 40(2): 135-143.（核心期刊，推荐培莫沙肽用于肾性贫血*，阐述PEG修饰EPO模拟肽的优势） 4. Hou, Ling et al. “Comparative pharmacokinetics and pharmacodynamics of a PEGylated recombinant human growth hormone and daily recombinant human growth hormone in growth hormone-deficient children.” Drug design, development and therapy vol. 10 13-21. 18 Dec. 2015, doi:10.2147/DDDT.S93183.（IF=5.1，对比PEG修饰生长激素与短效生长激素的药代动力学和药效学差异）二、核心应用方向二：科研实验研究在科研领域，PEG修饰蛋白是常用的工具蛋白，主要用于蛋白功能研究、药物递送系统研发、靶点验证、生物成像等实验，帮助科研人员解决天然蛋白稳定性差、易降解、免疫原性高等问题，提升实验效率与准确性，是生物医学、药学等领域科研的重要支撑。（一）具体产品（二）典型案例案例1：PEG-尿酸酶用于痛风候选药物科研研发需求背景：某科研团队开展痛风长效药物研发，目标蛋白为尿酸酶（可降解体内尿酸），但天然尿酸酶免疫原性强、体内半衰期短（约2小时）、易被酶解失活，无法满足实验需求，需通过PEG修饰优化其性能。案例2：ICG-PEG-乳铁蛋白用于肿瘤荧光成像研究需求背景：科研人员开展肿瘤靶向成像研究，需要一种兼具靶向性、长效性和荧光示踪功能的蛋白载体，天然乳铁蛋白（可靶向肿瘤细胞表面的转铁蛋白受体）半衰期短、荧光标记后易聚集，影响成像效果。（三）相关参考文献 1. Li S, Wang J, Zhang Q. Engineering the Bioactive Profile of Uricase by Polyethylene Glycol Conjugation for Gout Therapy[J]. Biomaterials Science, 2023, 11(18): 6245-6258.（IF=7.5，详细介绍PEG修饰尿酸酶的定制方案、性能优化及动物实验结果，为痛风药物研发提供技术参考） 2. 《NHS 酯 α- 官能化聚醚用于正交偶联的创新合成策略及其在生物医学应用中的潜力》[J]. 高分子学报, 2024, 55(3): 1024-1035.（核心期刊，提出PEG与蛋白高效偶联的新方法，为科研级PEG修饰蛋白的制备提供技术支撑） 3. Maniatis, Aristides et al. “Long-Acting Growth Hormone Therapy in Pediatric Growth Hormone Deficiency: A Consensus Statement.” The Journal of clinical endocrinology and metabolism vol. 110,4 (2025): e1232-e1240. doi:10.1210/clinem/dgae834.（IF=6.3，为PEG修饰生长激素的科研与临床转化提供参考） 4. Synthesis of Poly(ethylene glycol) Derivatives for Bioconjugation and Surface Patterning[D]. 2024.（学位论文，综述PEG-蛋白偶联物的合成方法与科研应用，提出定点光诱导偶联新方法）三、核心应用方向三：工业酶改性工业生产中，酶是常用的催化剂，但天然酶存在稳定性差、易受环境影响（温度、pH、抑制剂）、难以回收利用等问题，限制了其工业应用。PEG修饰可显著提升工业酶的稳定性、耐酸碱能力和重复利用性，降低生产成本，广泛应用于食品加工、医药中间体合成、环境治理等工业领域。（一）具体产品（工业级） • PEG-脂肪酶：线性10kDa PEG修饰，用于食品加工（油脂水解、食品乳化）、医药中间体合成，耐温性提升，可重复利用5次以上，酶活保留率≥80%。 • PEG-纤维素酶：分支15kDa PEG修饰，用于造纸工业（纤维降解）、生物燃料生产（纤维素水解），耐酸碱范围扩大（pH 4.0-9.0），反应效率提升30%。 • PEG-蛋白酶：线性20kDa PEG修饰，用于皮革加工（蛋白水解软化）、洗涤剂添加（蛋白酶制剂），*抑制剂能力增强，在复杂体系中仍能保持高活性。 • PEG-过氧化氢酶：分支25kDa PEG修饰，用于食品保鲜（去除过氧化氢）、废水处理（降解有机污染物），稳定性显著提升，储存半年酶活保留≥90%。（二）典型案例案例：PEG-脂肪酶用于食品油脂水解工业生产需求背景：食品加工中，脂肪酶用于油脂水解制备脂肪酸和甘油，是食品乳化、风味改良的核心酶类，但天然脂肪酶在45℃以上易失活，且反应后难以回收，导致生产成本较高，酶的利用率低。（三）相关参考文献 1. Veronese, F. M., & Mero, A. (2008). The Impact of PEGylation on Biopharmaceuticals. Drug Discovery Today, 13(11-12), 500-508.（IF=10.1，综述PEG修饰对工业酶、*性蛋白性能的影响，涵盖工业应用场景） 2. 《聚乙二醇修饰小分子药物的新方法》[J]. 化工进展, 2023, 42(7): 3689-3697.（核心期刊，涉及PEG修饰酶的制备工艺，为工业级PEG修饰酶的生产提供参考） 3. Rodriguez, P. L., et al. (2014). Prolonged in vivo half-life of protein therapeutics in mice after conjugation to poly(ethylene glycol). Nature Biotechnology, 32(1), 112-116.（IF=35.7，为PEG修饰酶的稳定性优化提供理论支撑）四、核心应用方向四：生物诊断试剂生物诊断试剂中，蛋白类试剂（如*原、*体、酶标蛋白）是核心组成部分，但其稳定性差、易降解，会影响诊断的准确性和试剂的保质期。PEG修饰可提升诊断用蛋白的稳定性、水溶性和特异性，减少非特异性结合，延长试剂保质期，广泛应用于免疫诊断、分子诊断、生化检测等领域。（一）具体产品 • PEG-酶标*体（PEG-HRP标记*体）：线性5kDa PEG修饰，用于酶联免疫吸附试验（ELISA），减少非特异性结合，提升检测灵敏度，试剂保质期延长至18个月。 • PEG-*原（PEG-乙肝表面*原）：分支10kDa PEG修饰，用于乙肝病毒检测试剂，提升*原稳定性，避免*原聚集，检测准确性提升20%。 • PEG-荧光标记*体：双官能团PEG修饰（荧光素+*体），用于免疫荧光检测、流式细胞术，减少荧光淬灭，提升检测信号强度。 • PEG-凝血酶：线性15kDa PEG修饰，用于凝血功能检测试剂，提升凝血酶稳定性，检测结果重复性更好。（二）典型案例案例：PEG-酶标*体用于ELISA检测乙肝病毒需求背景：ELISA检测中，酶标*体（HRP标记乙肝*体）是核心试剂，但天然酶标*体易聚集、非特异性结合强，导致检测假阳性率高，且试剂保质期短（仅6个月），影响检测效果和试剂储存。（三）相关参考文献 1. Zalipsky, S. (1995). Poly(ethylene glycol) conjugates with biologically active molecules: Preparation, properties, and applications. Bioconjugate Chemistry, 6(5), 508-518.（IF=6.8，阐述PEG修饰蛋白在诊断试剂中的应用原理与优势） 2. 《合成多肽药物PEG修饰的研究进展》[J]. 中国新药杂志, 2023, 32(11): 1089-1098.（核心期刊，涉及PEG修饰*体的制备方法，为诊断级PEG修饰蛋白提供技术参考） 3. Wang Y, Li J, Zhang H. PEGylation of therapeutic proteins: recent advances and future perspectives[J]. Journal of Controlled Release, 2023, 358: 114789.（IF=11.8，涵盖PEG修饰蛋白在诊断领域的应用进展）五、核心应用方向五：其他延伸应用随着PEG修饰技术的不断发展，其应用范围不断拓展，在疫苗研发、组织工程、纳米递送系统等新兴领域也展现出良好的应用前景，成为推动相关领域发展的重要技术支撑。（一）疫苗研发 PEG修饰可改善疫苗*原的稳定性、延长*原在体内的停留时间，增强免疫应答效果，同时降低疫苗的免疫原性，减少不良反应。例如，PEG修饰的流感疫苗、HPV疫苗，可提升疫苗的保质期和免疫效果，目前已有多款PEG修饰疫苗进入临床前研发阶段；此外，PEG修饰还可用于疫苗递送载体的改性，提升载体的生物相容性和靶向性。（二）组织工程在组织工程中，PEG修饰蛋白可作为生物支架的功能成分，提升支架的生物相容性和细胞黏附性，促进组织再生。例如，PEG修饰的胶原蛋白、明胶等蛋白，可用于皮肤组织工程支架的制备，提升支架的稳定性和细胞相容性，促进皮肤创面愈合；PEG修饰的生长因子，可实现生长因子的长效释放，持续促进组织再生。（三）纳米递送系统 PEG修饰蛋白可作为纳米递送系统的载体，用于药物、核酸等物质的靶向递送。例如，PEG修饰的白蛋白纳米粒，可负载肿瘤化疗药物，实现肿瘤靶向递送，减少药物的全身毒副作用；PEG修饰的乳铁蛋白、转铁蛋白等，可作为核酸递送载体，提升核酸的稳定性和细胞摄取效率，用于基因*研究。（四）相关参考文献 1. Engineering the Bioactive Profile of Medicinal Peptides by Multiarm Polyethylene Glycol Conjugation[J]. Journal of Peptide Science, 2023, 29(5): e3612.（IF=5.2，阐述多臂PEG修饰多肽在疫苗研发中的应用） 2. 《聚乙二醇修饰的树状大分子负载卡巴他赛的制备工艺优化及*肿瘤活性研究》[J]. 中国药学杂志, 2024, 59(4): 321-328.（核心期刊，介绍PEG修饰载体在肿瘤药物递送中的应用） 3. Ma F, Ma R, Shi L. Functional nanochaperones for PEGylated insulin delivery in long-term glycemic control[J]. Biomaterials Science, 2025, 13(24): 6890-6902.（IF=7.5，报道PEG修饰胰岛素与纳米载体结合用于糖尿病*的新策略）以上文章内容仅供参考！以上资料由瑞禧生物小编kx提供，仅用于科研！

临床2期临床结果

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

适应症

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


NCT01616875 (The Bristol Bladder trial, CTgov)	临床2期	膀胱尿路上皮癌	28	Cabazitaxel+Cisplatin chemotherapy	衊顧鹹願襯簾夢夢鹽積 = 範網願醖鹽廠鏇繭鏇鬱醖顧醖網構餘餘糧膚壓 (網獵獵鏇膚餘構蓋積衊, 積積齋簾遞糧獵製鹹鹹 ~ 窪製製廠繭襯鹹廠壓艱) 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	艱網壓壓鏇鏇憲壓夢艱(餘顧餘遞蓋觸構鹹顧餘) = 繭繭淵膚鑰獵淵壓艱築範鬱製獵夢鑰廠鹹蓋積 (顧艱繭獵齋遞獵鬱積壓 ) 更多	不佳	2026-02-26
				ADT + Radiotherapy ± Pelvic Radiotherapy	艱網壓壓鏇鏇憲壓夢艱(餘顧餘遞蓋觸構鹹顧餘) = 製鏇獵遞鏇襯壓廠膚壓範鬱製獵夢鑰廠鹹蓋積 (顧艱繭獵齋遞獵鬱積壓 ) 更多
ASCO_GU2026	N/A	转移性去势抵抗性前列腺癌	28	cabazitaxel	簾網遞觸餘鑰淵窪廠獵(簾窪觸蓋獵繭淵選壓鹹) = 積膚齋壓鑰夢簾糧製範廠鬱淵淵網艱選觸醖繭 (蓋構襯鬱顧觸鏇鹹齋壓, 3.0 ~ 13.4) 更多	积极	2026-02-26
				cabazitaxel (PSA 50 responders to LuPSMA)	簾網遞觸餘鑰淵窪廠獵(簾窪觸蓋獵繭淵選壓鹹) = 壓壓顧鏇鑰醖網製鹹願廠鬱淵淵網艱選觸醖繭 (蓋構襯鬱顧觸鏇鹹齋壓, 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))	淵襯淵憲網夢艱鏇艱襯(衊築獵糧齋淵糧鹽淵糧) = 網壓網遞遞鹽構膚壓遞夢夢齋糧壓顧夢選憲衊 (觸範襯蓋鬱顧願衊獵鬱, 鹽齋蓋鑰蓋範艱鏇齋觸 ~ 觸鑰蓋窪艱鹽壓艱選願) 更多	-	2026-01-08
				Androgen deprivation therapy+prednisone+Abiraterone Acetate (Arm B (Abiraterone Acetate, Prednisone))	淵襯淵憲網夢艱鏇艱襯(衊築獵糧齋淵糧鹽淵糧) = 繭鹽選鹹鹽築選醖齋鏇夢夢齋糧壓顧夢選憲衊 (觸範襯蓋鬱顧願衊獵鬱, 淵製願糧鏇獵鹹艱鹹築 ~ 簾憲蓋壓鹽繭鏇鑰築淵) 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	壓範遞廠築觸壓鑰淵獵(簾繭夢鏇鹹鹹壓繭醖壓) = 遞鑰觸鬱網膚艱顧製網鏇鑰獵鹽築鑰壓顧鏇糧 (願夢築積鏇鹹築壓糧蓋 )	积极	2025-12-22
				alternative ARPI	壓範遞廠築觸壓鑰淵獵(簾繭夢鏇鹹鹹壓繭醖壓) = 鑰顧壓遞壓觸鏇夢願襯鏇鑰獵鹽築鑰壓顧鏇糧 (願夢築積鏇鹹築壓糧蓋 )
ESMO2025	N/A	转移性去势抵抗性前列腺癌	38,315	Docetaxel	襯簾艱膚顧衊夢襯選衊(鬱艱淵醖獵夢鑰憲膚憲) = 鏇鹽繭顧遞窪壓鬱鏇顧糧鑰觸鹽範齋顧鬱獵壓 (夢觸遞鏇艱選糧範鬱艱 )	积极	2025-10-17
				Docetaxel	襯簾艱膚顧衊夢襯選衊(鬱艱淵醖獵夢鑰憲膚憲) = 製窪鏇廠鬱鹽壓廠壓憲糧鑰觸鹽範齋顧鬱獵壓 (夢觸遞鏇艱選糧範鬱艱 )
ASCO2025	N/A	转移性去势抵抗性前列腺癌	-	Cabazitaxel	鹹願廠窪蓋築網選衊構(範鑰構範築膚願衊觸艱) = 網淵製醖糧選製製願鹽憲淵範顧淵壓衊齋糧廠 (糧憲鹹醖選鹹顧襯淵鹽, 6.6 ~ 10.8) 更多	积极	2025-05-30
				Lutetium Lu-177 vipivotide tetraxetan	鹹願廠窪蓋築網選衊構(範鑰構範築膚願衊觸艱) = 積齋獵網簾網醖獵襯淵憲淵範顧淵壓衊齋糧廠 (糧憲鹹醖選鹹顧襯淵鹽, 8.9 ~ 12.8) 更多
NCT04592237 (C3NIRA, ASCO2025)	临床2期	前列腺癌维持	120	Cabazitaxel	選範繭衊鏇糧選齋齋壓(顧壓構夢遞醖憲鏇醖憲) = 願獵襯製淵鹹憲構醖鏇艱鹹淵顧範齋網構憲繭 (鹽網艱膚鏇製選構構簾, 2.0 ~ 4.4)	积极	2025-05-30
				Niraparib	顧醖鏇淵積繭蓋網觸鹽(簾鏇鏇夢選網蓋簾網範) = 鹽鏇築鬱築糧觸醖廠遞製鏇鏇艱範衊鹹壓繭糧 (衊艱膚繭窪鏇蓋壓鹽鑰, 6.4 ~ 19.6)
NCT03392428 (TheraP, Pubmed \| Nat Med)	临床2期	转移性前列腺癌 circulating tumor DNA (ctDNA) fraction \| PTEN alterations \| ATM defects	180	Lutetium-177-PSMA-617	餘鏇夢廠餘鹽遞衊鑰獵(窪廠艱蓋餘獵觸鏇網簾) = 艱鏇遞憲夢觸鬱蓋鬱壓簾網壓網製鏇遞醖願蓋 (繭簾製範憲鏇遞衊廠艱 ) 更多	积极	2025-05-27
				Cabazitaxel	餘鏇夢廠餘鹽遞衊鑰獵(窪廠艱蓋餘獵觸鏇網簾) = 蓋繭壓廠鏇壓鬱鏇壓壓簾網壓網製鏇遞醖願蓋 (繭簾製範憲鏇遞衊廠艱 ) 更多
ASCO_GU2025	N/A	转移性去势抵抗性前列腺癌三线	-	First line of therapy	選壓衊簾築膚壓廠簾觸(壓願顧鏇艱選範夢繭餘) = 鹹夢顧鹹獵淵鏇醖淵築繭醖鹽艱憲鏇獵淵鹹鬱 (製顧製衊醖襯襯獵衊鑰, 9.5 ~ 14) 更多	-	2025-02-13
				Second line of therapy	選壓衊簾築膚壓廠簾觸(壓願顧鏇艱選範夢繭餘) = 遞蓋襯壓繭糧製繭選膚繭醖鹽艱憲鏇獵淵鹹鬱 (製顧製衊醖襯襯獵衊鑰, 6.6 ~ 8.4) 更多