优替德隆(Utidelone) - 药物靶点：Tubulin_在研适应症：复发性乳腺癌，转移性乳腺癌，局部晚期非小细胞肺癌_专利_临床

This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study.

开始日期2025-09-01

申办/合作机构

北京华昊中天生物医药股份有限公司

NCT06764940

/ Recruiting临床2期

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases

This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine.
The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.

开始日期2025-07-14

申办/合作机构

陕西奥星制药有限公司

NCT06973421

/ Not yet recruiting临床2期IIT

Preliminary Phase II Clinical Study on the Efficacy and Safety of the Combination of Utidelone Capsules and Fruquintinib Capsules in the Treatment of Platinum Resistant Recurrent Ovarian Cancer

This study is a Prospective, Single-arm, Phase 2 clinical trial. The purpose of this study is to find out if taking Utidelone Capsules together with Fruquintinib Capsules is safe and works well for people with platinum-resistant ovarian cancer . Researchers will look at the Objective Response Rate, Progression-Free Survival, Overall Survival, safety, and any side effects.

开始日期2025-07-01

申办/合作机构

复旦大学

100 项与优替德隆相关的临床结果

登录后查看更多信息

100 项与优替德隆相关的转化医学

登录后查看更多信息

100 项与优替德隆相关的专利（医药）

登录后查看更多信息

272

项与优替德隆相关的文献（医药）

2025-08-23·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[Utidelone induces apoptosis and autophagy in small cell lung cancer cells through the ROS/AMPK signaling pathway].

Article

作者: Mu, X Q ; Wu, H B ; Hu, X F ; Yu, C N ; Zhao, Y Q

Objective: To investigate the effects and underlying molecular mechanisms of Utidelone (UTD1) in small cell lung cancer (SCLC). Methods: The study utilized small cell lung cancer H446 and H1048 cell lines along with animal models. Cell proliferation, cell cycle progression, apoptosis, autophagy, and related activities following UTD1 treatment were assessed using Cell Counting Kit-8 (CCK-8), flow cytometry, immunofluorescence staining, reactive oxygen species (ROS) generation assay, and Western blot analysis. The involvement of the ROS/adenosine monophosphate-activated protein kinase (AMPK) signaling pathway was also examined. Data analysis was performed using GraphPad Prism version 8 software. Results: UTD1 inhibited the viability of H446 and H1048 cells in a dose- and time-dependent manner. The half inhibitory concentrations (IC₅₀) of UTD1 for H446 and H1048 cells were 0.675 and 0.439 μg/ml, respectively. The proportion of cells in the G₂/M phase for H446 and H1048 cells in the UTD1 group at 6 h, 12 h, and 24 h was [(53.86±4.54)%, (68.59±5.49)%, (60.89±3.26)%] and [(46.83±2.20)%, (60.67±3.44)%, (57.88±5.11)%], which were significantly higher than that in the control group, except for the proportion of H1048 cells at 6 h [(38.99±2.60)% vs. (40.73±2.50)%, P＜0.05]. The apoptosis rates were [(23.57±0.12)%, (35.79±1.59)%, and (46.15±4.57)%] for H446 cells and [(23.05±2.70)%, (37.73±2.97)%, and (43.39±3.31)% for H1048 cells], all of which were significantly higher than those in the control group [(6.44±0.96)%, (6.31±0.75)%, respectively; all P＜0.05]. The number of LC3 fluorescent spots was [(56±11), (69±8), and (66±8)] for H446 cells and [(39±7), (56±12), and (50±11)] for H1048 cells, both significantly higher than those in the control group [(13±6) and (12±5), respectively; both P＜0.05]. The relative fluorescence intensity of ROS was 2.54±0.48, 2.85±0.68, and 5.03±0.72 for H446 cells and 2.26±0.51, 4.17±0.35, and 4.66±0.51 for H1048 cells, which were also significantly higher than those in the control group (P＜0.05). The expression levels of cyclin B1, cyclin A2, and P21 of H446 cells in the three time points were [(0.63±0.07, 0.33±0.05, 0.23±0.04), (0.68±0.08, 0.46±0.03, 0.27±0.06), and (0.64±0.03, 0.32±0.05, 0.22±0.03), respectively], all significantly lower compared to the control group (P＜0.05). The apoptosis rates of H446 and H1048 cells in the UTD1+Z-VAD-FMK group were (19.97±3.19)% and (17.68±3.14)%, both lower than those in the UTD1 group [(40.73±3.35)% and (39.82±2.45)%, respectively; all P＜0.05]. The absorbance values of H446 and H1048 cells in the UTD1+3-MA group were significantly higher than those in the UTD1 group at 6h, 12h, and 24h (all P＜0.05). The levels of p-AMPKα/AMPKα, LC3-II expression, and the percentage of apoptotic cells in the H446 and H1048 cells of the UTD1+NAC group were [(1.33±0.09, 1.33±0.11), (1.49±0.16, 1.55±0.05), (17.24±2.15)%, and (19.40±4.28)%], all of which were lower than those observed in the UTD1 group [(1.98±0.17, 2.23±0.23), (2.81±0.19, 2.49±0.38), (38.07±3.53)%, and (41.20±1.87)%, all P＜0.05]. The number of LC3 fluorescence points and the percentage of apoptotic cells in the H446 and H1048 cells of the UTD1+si-AMPKα group [(24±5, 23±3), (18.35±1.15)%, and (19.15±3.46)%] were all lower than those in the UTD1+si-NC group [(46±6, 36±6), (39.34±1.77)%, and (39.50±2.15)%, all P＜0.05]. The tumor inhibition rates in small cell lung cancer tumor-bearing nude mice for the 2.5 mg/kg UTD1 group and the 5 mg/kg UTD1 group were 46.43% and 58.33%, respectively. Furthermore, the proportions of apoptosis-positive cells and p-AMPKα-positive cells in the UTD1 group were significantly higher compared to the control group, while the levels of Ki-67 positivity were significantly reduced. Conclusion: UTD1 inhibits SCLC cell proliferation, induces G₂/M phase arrest, and promotes cell apoptosis and autophagy through the activation of the ROS/AMPK signaling pathway.

2025-08-01·Therapeutic Advances in Medical Oncology

Efficacy and safety of utidelone in pretreated patients with metastatic breast cancer in China: a multicenter, real-world study

Article

作者: Ouyang, Quchang ; Zhao, Yannan ; Gong, Chengcheng ; Xu, Fei ; Xie, Ning ; Hu, Shihui ; Wang, Hong ; Wang, Biyun ; Chao, Tengfei

Background::

Utidelone (UTD1), a genetically engineered epothilone derivative, has been approved in China for use in combination with capecitabine in treating metastatic breast cancer (MBC) patients previously treated with anthracyclines or taxanes.

Objectives::

To evaluate the real-world efficacy and safety of UTD1 in Chinese patients with MBC and to explore potential predictors of therapeutic effectiveness.

Design::

A multicenter, retrospective, real-world study.

Methods::

MBC patients who received UTD1 between March 2021 and August 2023 were identified using an electronic database. Outcome variables included progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), objective response rate (ORR), clinical benefit rate (CBR), and adverse events (AEs).

Results::

A total of 270 MBC patients were included, with 81.1% presenting with visceral metastasis and 23.7% with brain metastasis. The median number of treatment lines for UTD1 was 3. UTD1 showed a median PFS of 3.97 months (95% confidence interval (CI) 3.33–4.61) and a median OS of 20.63 months (95% CI 16.72–24.54). Among the patients, 17.4% received UTD1 monotherapy, and 82.6% received UTD1-based combination therapy. The median TTF was 2.80 months (95% CI 2.31–3.29). The ORR was 8.4%, and the CBR was 33.5%. The most common AE was peripheral neuropathy (PN, 55.2%). Patients with unresolved PN from previous therapy or receiving UTD1 through intravenous infusion on days 1–5 were more likely to develop ⩾grade 3 PN.

Conclusion::

UTD1 is a new option for patients who have previously received taxanes and anthracyclines, with its clinical toxicity controllable.

2025-08-01·Molecular Pain

Utidelone induces mechanical and cold allodynia in mice via TRPA1 activation

Article

作者: Gao, Wenwen ; Zhang, Yusong ; Dai, Liya ; Tao, Jialong ; Su, Cunjin

Objective::

Utidelone (UTD1), a recently approved epothilones analog in China for metastatic breast cancer, is endorsed in combination with capecitabine for metastatic breast cancer patients who have encountered first-line therapy failures. Despite its clinically verified therapeutic efficacy, it is concurrently associated with peripheral neuropathic pain, particularly affecting extremities. However, the etiology of UTD1-induced peripheral neuropathic pain remains unclear.

Methods::

The present investigation built a mouse pain model induced by UTD1, resulting in marked mechanical and cold allodynia.

Results::

Examination of the dorsal root ganglia unveiled a notable upregulation of TRPA1, accompanied by noteworthy alterations in oxidative stress-related markers, including ATF4, SOD2, CAT, and Cyt-C. The TRPA1 antagonist HC-030031, resulted in the alleviation of mechanical and cold allodynia in the UTD1-induced pain model, as well as two antioxidants, including Mito-tempo and edaravone.

Interpretation::

The present study will provide new strategies for pain relieving induced by UTD1.

111

项与优替德隆相关的新闻（医药）

2025-09-25

·华昊中天

优替德隆又双叒叕获FDA孤儿药资格认定丨华昊中天破局胰腺癌

中国北京，2025年9月25日，北京华昊中天生物医药股份有限公司（下称“华昊中天”，股票代码：2563.HK），一家依托于合成生物学研发平台专注于开发具有自主知识产权抗癌新药的生物医药公司，今日宣布，其核心产品优替德隆再次被美国食品药品监督管理局（以下简称“FDA”）授予孤儿药资格认定，适应症为胰腺癌。这是继乳腺癌脑转移和胃癌之后，优替德隆被FDA授予的第三项孤儿药资格。胰腺癌是一种高度恶性的肿瘤，因其早期症状隐匿、诊断困难、进展迅速、侵袭性强及预后不良等特点而被称为“癌症之王”，五年生存率仅为10%左右，远低于其他常见癌症，在所有恶性肿瘤中生存率最低。目前尚无明确有效的胰腺癌治疗方案。基于吉西他滨的联合方案仍是最主要的临床治疗手段，但因胰腺癌细胞对吉西他滨易产生耐药性，治疗效果并不理想。优替德隆治疗胰腺癌的潜力在非临床和临床试验中均得以充分证实[1]：临床前数据显示优替德隆能够显著抑制胰腺癌细胞的增殖和集落形成能力，对胰腺癌模型具有良好的抗肿瘤活性。与吉西他滨联用时，优替德隆能够显著降低吉西他滨的IC50值，而不会削弱对肿瘤细胞的杀伤效果，且二者联合的抗肿瘤活性优于传统的紫杉醇联合吉西他滨。2024年CSCO大会上，华昊中天公布了优替德隆联合吉西他滨用于不可切除晚期胰腺癌一线治疗的多中心、单臂II期临床研究的初步数据：截至报告时共入组20例不可手术切除且不适合局部治疗的晚期胰腺癌患者，11例完成首次疗效评估。其中，疾病部分缓解（PR）3例，疾病稳定（SD）5例；客观缓解率（ORR）为27.27%，疾病控制率（DCR）达72.72%，中位总生存期（mOS）为9.57个月。优替德隆有望能为晚期胰腺癌患者带来良好的生存获益及疾病控制率，改善胰腺癌治疗荒漠的状态，成为胰腺癌新的治疗选择。关于“孤儿药” “孤儿药”是指用于预防和治疗罕见病的药品。在美国，罕见病是指患病人群小于20万的疾病。由于这类疾病市场规模较小，导致药企研发回报率较低。为让患者有药可医，美国在1983推出了孤儿药法案，从多个层面激励孤儿药的研发。获得FDA授予的孤儿药资格认定后，在美国的后续研发及商业化将会享受多方面政策支持，包括临床试验费用税收减免、免除新药申请费用、获得研发资助、加快审批等，特别是该药物的该适应症批准上市后可获得美国市场7年独占权。参考文献 [1] Zhou JY, et al. Utidelone combined with gemcitabine regimen inhibits pancreatic cancer cell proliferation in vitro and tumor formation in vivo by promoting early apoptosis. 2023 CCHIO. 往期回顾华昊中天合成生物学基因工程菌关键技术获美国PCT专利授权又一重磅适应症加持丨优替德隆胶囊一线治疗晚期胃癌全球临床首例患者给药优替德隆胶囊首个全球研究启动丨治疗晚期卵巢癌II/III期临床患者给药优替德隆胶囊用于三阴性乳腺癌辅助治疗临床III期完成首例患者入组 100%临床获益率丨优替德隆一线治疗晚期胃癌/食管癌II期临床数据亮相2025 ASCO 68% CNS-ORR丨优替德隆治疗乳腺癌脑转移Ⅱ期临床数据亮相2025 ASCO 单药82%临床获益丨优替德隆胶囊治疗晚期实体瘤美国Ⅰ期临床数据亮相2025 ASCO 新适应症再获国际多中心临床批准丨优替德隆胶囊治疗铂耐药卵巢癌II/III期华昊中天荣登2025年度生物制造·未来智药TOP10 斩获ASCO 2025口头报告丨华昊中天优替德隆多项临床研究成果齐亮相 FDA批准华昊中天优替德隆胶囊一线治疗晚期胃癌II/III期国际多中心临床一图回顾华昊中天2024年度进展 Biostar 2024 Annual Review 华昊中天荣获“年度卓越创新力IPO”奖强强联合，携手共赢丨华昊中天与百洋医药达成战略合作华昊中天成功登陆香港联交所主板，合成生物学引领创新药研发新时代本资讯仅供医学专业人士参考，不构成任何诊疗建议

孤儿药CSCO会议快速通道

2025-09-19

·华昊中天

华昊中天合成生物学基因工程菌关键技术获美国PCT专利授权

中国北京，2025年9月19日，北京华昊中天生物医药股份有限公司（下称“华昊中天”，股票代码：2563.HK），一家依托于合成生物学研发平台专注于开发具有自主知识产权抗癌新药的生物医药公司，今日宣布：其自主研发的一项合成生物学关键技术获美国专利与商标局授予发明专利权。该专利涉及一种优质且高效的基因工程菌，以及使用该基因工程菌发酵生产优替德隆的方法，为优替德隆知识产权保护体系中的核心专利，保护期至2041年。该专利是通过PCT国际申请途径获得授权，同族专利亦已在中国、日本等国家和地区授权。优替德隆化合物分子结构复杂，难以通过化学全合成或半合成方法实现高效生产和产业化，且化学合成产物与通过基因工程菌微生物发酵生产的产品在质量标准、药物性质、生产成本、临床安全性等方面存在差距。该专利所保护的基因工程菌为华昊中天依托独特的合成生物学技术平台开发，并实现依托该基因工程菌通过发酵工艺产业化生产优替德隆。由于该基因工程菌为优替德隆生产的前提条件和核心物料，故其专利的授权会极大提高产品的仿制壁垒，使得2041年专利到期前仿制优替德隆几无可能。华昊中天极为重视知识产权在公司商业战略中所发挥的至关重要的作用。公司全球专利组合涵盖管线产品所有关键技术领域，除基因工程菌外，同时还拥有化合物晶型、适应症、化合物结构、多种给药剂型等多方面的全球授权专利，建立了全方位、多层次的知识产权保护体系。往期回顾又一重磅适应症加持丨优替德隆胶囊一线治疗晚期胃癌全球临床首例患者给药优替德隆胶囊首个全球研究启动丨治疗晚期卵巢癌II/III期临床患者给药优替德隆胶囊用于三阴性乳腺癌辅助治疗临床III期完成首例患者入组 100%临床获益率丨优替德隆一线治疗晚期胃癌/食管癌II期临床数据亮相2025 ASCO 68% CNS-ORR丨优替德隆治疗乳腺癌脑转移Ⅱ期临床数据亮相2025 ASCO 单药82%临床获益丨优替德隆胶囊治疗晚期实体瘤美国Ⅰ期临床数据亮相2025 ASCO 新适应症再获国际多中心临床批准丨优替德隆胶囊治疗铂耐药卵巢癌II/III期华昊中天荣登2025年度生物制造·未来智药TOP10 斩获ASCO 2025口头报告丨华昊中天优替德隆多项临床研究成果齐亮相 FDA批准华昊中天优替德隆胶囊一线治疗晚期胃癌II/III期国际多中心临床一图回顾华昊中天2024年度进展 Biostar 2024 Annual Review 华昊中天荣获“年度卓越创新力IPO”奖强强联合，携手共赢丨华昊中天与百洋医药达成战略合作华昊中天成功登陆香港联交所主板，合成生物学引领创新药研发新时代本资讯仅供医学专业人士参考，不构成任何诊疗建议

ASCO会议专利到期临床3期

2025-09-15

·PRNewswire

Biostar Pharma Successively Achieved First Patient Dosing for Two Phase II/III Multiregional Clinical Trials of Utidelone Capsule (UTD2)

SAN FRANCISCO, Sept. 15, 2025 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar", Stock Code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that the first patients have been dosed for two phase II/III multiregional clinical trials (MRCT) of "Utidelone Capsule (UTD2) first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma" (NCT06841679) and "UTD2 treatment for platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer" (NCT07044349) on September 11, 2025 and September 12, 2025, respectively. Utidelone has demonstrated excellent clinical data in gastric cancer: in a completed Phase II study of Utidelone Injection (UTD1) combined with PD-1 inhibitor and oxaliplatin for the first-line treatment of unresectable locally advanced or recurrent/metastatic HER2-negative gastric cancer, 23 patients had completed efficacy evaluation. Among them, 15 achieved partial response (PR) and 8 achieved stable disease (SD), resulting in a 65.2% objective response rate (ORR) and 100% clinical benefit rate (CBR). The median progression-free survival (mPFS) was 6.1 months. The combination regimen was generally well-tolerated. Most treatment-related adverse events (TRAEs) were Grade 1-2, reversible, and manageable. The longest treatment duration received by a patient was 22 cycles [1]. Consequently, Utidelone was granted an Orphan Drug Designation by the U.S. FDA for the treatment of advanced gastric cancer. Besides gastric cancer, Utidelone has also shown considerable potential for treating ovarian cancer in previous clinical studies. A US Phase I clinical study of UTD2 as a monotherapy for advanced solid tumors had 12 evaluable patients, including one ovarian cancer patient with a complete response (CR) and another with PR, who had previously undergone 7 and 9 lines of therapy, respectively [2]. A Phase II clinical study of UTD1 as monotherapy for the treatment of advanced solid tumors had 10 evaluable patients in advanced ovarian cancer cohort, among them there were 1 PR and 3 SD. Compared to taxanes, which are difficult for oral formulation development, Utidelone is not susceptible to P-glycoprotein thus cannot be pumped out of the cancer cell by P-glycoprotein and has the advantage for higher oral bioavailability and lower risk of developing cross-resistance. By utilizing its technology platform, Biostar developed Utidelone Capsule, and its efficacy and safety have been confirmed in both US and China's studies. Utidelone Capsule will significantly improve the convenience of administration, compliance of patients, decrease in treatment cost and ease of combination therapy with other oral anti-cancer drugs, and more suitable for adjuvant or maintenance therapy. Beyond gastric and ovarian cancers, Biostar is actively planning and advancing multiple clinical studies to expand UTD2's indications, including breast cancer adjuvant intensification therapy, pancreatic cancer, esophageal cancer, colorectal cancer, and so on. About NCT06841679 Study This study is a multi-national, open-label, randomized phase II/III clinical study of UTD2 combined with standard of care to evaluate the efficacy and safety in first-line patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, untreated with systemic treatment in the advanced setting. For the Phase II part, 78 subjects are planned to be enrolled in China, US, Europe and Japan. Its primary objectives are to evaluate the safety, efficacy, and pharmacokinetic profile of UTD2 in combination therapy. The Phase III part plans to enroll 700 subjects across multiple countries/regions. The primary endpoint is overall survival (OS), with secondary endpoints including PFS, ORR, and safety. About NCT07044349 Study This study is a multi-national, open-label, randomized Phase II/III clinical trial of UTD2 for the treatment of patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Phase II part plans to enroll approximately 84 subjects. Its primary objective is to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of UTD2 under different dosing regimens in the target patient population and to recommend a dose for Phase III. The Phase III part plans to enroll 480 subjects and is planned to be conducted in multiple countries and regions worldwide. Its primary objective is to evaluate the efficacy and safety of UTD2 compared to the investigator's choice of standard treatment in the target patient population. The primary endpoint is PFS, with secondary endpoints including OS, ORR, and others. About Utidelone Utidelone is a new-generation genetically engineered microtubule inhibitor, and has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors, less prone to developing drug resistance, capability of crossing the blood-brain barrier to prevent and treat brain tumors, and high oral bioavailability. Biostar has developed two formulations of Utidelone: injection (UTD1) and capsule (UTD2). UTD1 has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC), who have progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase III study data showed that UTD1 plus capecitabine achieved both PFS and OS benefits versus capecitabine for heavily pretreated MBC patients, and the results were orally presented twice at ASCO annual meetings and published in prestigious journals [3-4]. About Biostar Biostar is an integrated biopharma company focusing on the development of innovative anti-cancer drugs utilizing its synthetic biology R&D platform. The company is listed on the Hong Kong Stock Exchange (HK 2563) in 2024. We are actively selecting reliable global partners through out-licensing or co-development of Utidelone assets. We believe that our strong capabilities of R&D and manufacturing, coupled with our enriched commercial expertise, make us the preferred partner for global biopharmaceutical companies who share our goal of bringing innovative anti-cancer products to patients around the world. For additional information on partnering with Biostar, please contact our business development team at [email protected]. Reference [1] 2025 ASCO Abstract #: 4040 [2] 2025 ASCO Abstract #: 3030 [3] B. Xu, T. Sun, Q. Zhang, et al. Annals of Oncology, 2021, 32(2): 218-228 [4] Pin Zhang, Tao Sun, Qingyuan Zhang, et al. Lancet Oncol 2017; 18: 371-83 SOURCE Biostar Pharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床1期临床2期临床3期孤儿药

100 项与优替德隆相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB01873

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
复发性乳腺癌	中国	成都华昊中天药业有限公司	2021-03-11
转移性乳腺癌	中国	成都华昊中天药业有限公司	2021-03-11

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
胃食管交界处癌	临床3期	中国	北京华昊中天生物医药股份有限公司	2025-07-16
胃食管交界处腺癌	临床3期	-	北京华昊中天生物医药股份有限公司	2025-05-01
胃腺癌	临床3期	-	北京华昊中天生物医药股份有限公司	2025-05-01
局部晚期非小细胞肺癌	临床3期	中国	北京华昊中天生物医药股份有限公司	2023-05-12
转移性非小细胞肺癌	临床3期	中国	北京华昊中天生物医药股份有限公司	2023-05-12
HER2 阴性乳腺癌	临床3期	中国	中山大学	2022-03-01
局部晚期乳腺癌	临床3期	中国	成都华昊中天药业有限公司	2022-03-01
局部晚期乳腺癌	临床3期	中国	中山大学	2022-03-01
复发性铂耐药性卵巢癌	临床2期	-	北京华昊中天生物医药股份有限公司	2025-09-01
输卵管癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2025-07-09

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05357417 (U-BOMB, Pubmed \| JAMA Oncol) 人工标引	临床2期	转移性HER2阴性乳腺癌 HER2/Neu Negative	47	Utidelone +Bevacizumab	築願夢鏇構顧遞遞遞齋(鹽衊選壓獵醖襯鬱蓋夢) = 窪簾網壓壓壓夢範鏇簾鹽顧選鹽壓繭餘餘鬱醖 (築顧夢窪鹹鏇遞憲衊願, 28.3 ~ 57.8) 更多	积极	2025-08-01
NCT05700084 (Phase I/II study of utidelone capsule, ASCO2025)	临床1/2期	晚期恶性实体瘤	31	Utidelone capsule (UTD2) 50 mg/m^2/d-5day	製齋簾餘選蓋構鹽窪蓋(製製襯簾膚憲齋糧襯構) = the most common ≥ Grade 3 AE was diarrhea appeared at 75 mg/m^2/d-7day, but recovered within 24 hours after supportive treatment 醖淵鑰選簾觸醖選簾齋 (艱鑰簾遞壓簾壓製餘齋 ) 更多	积极	2025-05-30
	临床1/2期	晚期恶性实体瘤	31	Utidelone capsule (UTD2) 75 mg/m^2/d-5day		积极	2025-05-30
NCT04911907 (ASCO2025)	临床2期	食管癌 \| 胃癌一线 HER2 negative	47	Utidelone + Sintilimab + Oxaliplatin	範願鑰鑰觸積夢鹽選鹽(膚觸夢蓋憲醖選繭窪夢) = 鏇範糧壓蓋襯鹽鬱繭繭艱鏇簾選積遞構糧壓積 (壓艱齋憲衊遞顧鹹餘蓋 ) 更多	积极	2025-05-30
NCT04911907 (ASCO2025)	临床2期	食管癌 \| 胃癌一线 HER2 negative	47	Utidelone + Tislelizumab + Capecitabine	範願鑰鑰觸積夢鹽選鹽(膚觸夢蓋憲醖選繭窪夢) = 廠選鹽願鏇衊範築遞廠艱鏇簾選積遞構糧壓積 (壓艱齋憲衊遞顧鹹餘蓋 ) 更多	积极	2025-05-30
NCT06125080 (UTILIZABLE, ESMO_BC2025)	临床2期	晚期三阴性乳腺癌	25	Utidelone + Bevacizumab + Tislelizumab	窪鑰膚憲膚壓醖顧遞獵(獵鬱夢鹹衊構觸範窪憲) = 廠製齋憲餘積醖蓋選壓願廠鹽醖齋構築衊壓醖 (齋艱遞襯窪遞餘獵蓋鹹 ) 更多	积极	2025-05-14
NCT05795920 (NEWS)	临床2期	转移性胰腺癌一线	20	优替德隆+吉西他滨	襯鏇網範鑰憲糧憲齋廠(糧艱網夢艱鏇繭製範鹽) = 網製蓋憲淵顧壓範鹽簾顧願窪願襯顧製製醖範 (鑰廠築淵糧鬱繭鹽構憲 ) 更多	积极	2024-09-30
NCT05700084 (ASCO2024)	临床1期	晚期乳腺癌	5	Utidelone Capsule 50 mg/m2/d-5day	窪遞構製窪醖糧範顧鏇(窪糧顧窪鬱壓餘淵衊構) = 簾獵鏇鏇鏇廠衊廠積艱鏇選蓋獵鹽壓觸齋積壓 (築衊糧鹹觸繭壓憲醖衊 )	积极	2024-05-24
NCT05700084 (ASCO2024)	临床1期	晚期乳腺癌	5	Utidelone Capsule 75 mg/m2/d-5day	窪遞構製窪醖糧範顧鏇(窪糧顧窪鬱壓餘淵衊構) = 憲簾餘廠獵積構壓膚鬱鏇選蓋獵鹽壓觸齋積壓 (築衊糧鹹觸繭壓憲醖衊 ) 更多	积极	2024-05-24
NCT05357417 (U-BOMB, ASCO2024)	临床2期	脑转移瘤 HER2-negative	46	Utidelone plus bevacizumab	網餘憲願網鏇遞構醖鏇(觸築餘艱襯衊築鏇鬱繭) = 構築觸願觸築網鹽鹽簾遞廠齋廠艱觸廠膚艱鹹 (鏇獵壓壓構鹽鏇壓鏇餘, 28.9% ~ 58.9) 更多	积极	2024-05-24
NCT04911907 (ASCO2024)	临床2期	晚期恶性实体瘤 \| 晚期胃癌一线 HER2 negative	79	Utidelone plus sintilimab and oxaliplatin	襯獵範鏇鏇醖鹹窪淵築(蓋膚積繭夢獵遞夢遞遞) = Grade 3/4 TRAEs occurred in 27.8% of pts in stage I, and included anemia (13.9%), peripheral neuropathy (11.4%) and neutropenia (7.6%). No treatment-related deaths occurred. Gastric cancer was chosen as the expansion cohort indication. As of February 1st2024, 14 eligible pts with GC with a median age of 57 years (range, 41-69) were enrolled. The median follow-up was 5.5 months (range, 1.0-9.7) and the longest duration of response was 8.0 months. A total of 8 PRs and 3 SDs were achieved in the 11 pts evaluable for efficacy, and 6 pts including the 3 with SD were still receiving treatment. Grade 3/4 TRAEs occurred in 28.6% of pts including diarrhea (14.3%), fatigue (14.3%), neutropenia (14.3%), and vomiting (7.1%). Other AEs were all Grade 1 or 2, with no treatment-related deaths. 選淵製鹽鹽膚範鏇衊網 (膚顧壓鏇積鹽遞繭鑰膚 ) 更多	积极	2024-05-24
NCT03693547 (BG01-1801, Pubmed) 人工标引	临床2期	转移性非小细胞肺癌 \| 局部晚期非小细胞肺癌	26	Utideloneutidelone	窪製鏇艱齋艱壓繭遞憲(壓餘製觸築範遞鏇壓製) = 構築齋齋夢選窪鑰齋鹽淵繭鏇鹹餘鏇選製壓餘 (構窪鬱糧範範廠遞壓淵, 4.4 ~ 34.9) 更多	积极	2024-04-01
NCT03693547 (BG01-1801, Pubmed) 人工标引	临床2期	转移性非小细胞肺癌 \| 局部晚期非小细胞肺癌	26	at least two cycles of utidelone (PP cohort)utidelone (PP cohort)	窪製鏇艱齋艱壓繭遞憲(壓餘製觸築範遞鏇壓製) = 醖淵遞壓簾選窪窪積遞淵繭鏇鹹餘鏇選製壓餘 (構窪鬱糧範範廠遞壓淵, 5.4 ~ 41.9) 更多	积极	2024-04-01
ESMO_ASIA2023	N/A	转移性实体瘤	50	Utidelone	壓鬱願鹽淵鏇糧夢窪製(糧鹽顧築壓夢構鏇醖遞) = 鏇壓網遞齋窪鏇壓選繭窪蓋鏇構齋構獵鑰觸蓋 (膚製鹽鑰範糧遞選網繭 ) 更多	积极	2023-12-02