| utidelone IV (UTD1) / Beijing Biostar Technologies |
| Completed | 4 | 21 | | 25 mg/m2 of Depoxythilone ;50 mg/m2 of Depoxythilone ;85 mg/m2 of Depoxythilone ;125 mg/m2 of Depoxythilone ;170 mg/m2 of Depoxythilone ;225 mg/m2 of Depoxythilone | Cancer Hospital, Chinese Academy of Medical Sciences; Level of the institution：, Beijing Biostar Technologies., Ltd. | Advanced malignant tumors including, but not limited to, breast cancer, colorectal cancer, liver cancer, gastric cancer, non-small cell lung cancer, etc. | | | | |
ChiCTR2300071458: Phase II clinical trial of utidelone in patients with advanced gastric or gastroesophageal conjunctive adenocarcinoma after first-line chemotherapy |
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| Recruiting | 4 | 60 | | Utidelone injection | Affiliated Hospital of Jiangnan University; Affiliated Hospital of Jiangnan University, Self-raised | Advanced gastric or gastroesophageal conjunctive adenocarcinoma | | | | |
ChiCTR2300069145: Utidelone plus capecitabine for inoperable local advanced HER2 negative breast cancer with no response to neoadjuvant anthracycline and taxane treatment: a multi-center, single-arm exploratory study |
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| Recruiting | 4 | 30 | | utiderone plus capecitabine | Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Provincial Hospital of Traditional Chinese Medicine, Chengdu Huahao Zhongtian Biological Co., Ltd. | breast cancer | | | | |
ChiCTR-TRC-14005100: Phase III Clinical Study of UTD1 Injection in Combination with Capecitabine in Patients With Advanced and Metastatic Breast Cancer |
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| Completed | 3 | 390 | | 30mg UTD1+2000mg Capecitabine ;2500mg Capecitabine | Cancer Hospital, Chinese Academy of Medical Sciences; Level of the institution：, Beijing Biostar Technologies, Ltd. | Advanced and Metastatic Breast Cancer | | | | |
NCT05430399: Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer |
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| Recruiting | 3 | 349 | RoW | utidelone, docetaxel | Sun Yat-sen University, Beijing Biostar Pharmaceuticals Co., Ltd., Hunan Cancer Hospital | Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer | 06/25 | 06/27 | | |
NCT05673590: Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
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| Recruiting | 3 | 612 | RoW | Utidelone Injection, Docetaxel Injection | Beijing Biostar Pharmaceuticals Co., Ltd. | Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 06/25 | 12/25 | | |
NCT05673629: Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer |
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| Recruiting | 3 | 552 | RoW | Utidelone Injection in combination with AC, Docetaxel Injection in combination with AC | Beijing Biostar Pharmaceuticals Co., Ltd. | Breast Cancer | 06/25 | 12/25 | | |
NCT05172518: Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer |
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| Not yet recruiting | 3 | 512 | RoW | Taxane plus Intermittent Capecitabine, Utidelone plus Intermittent Capecitabine, Taxane plus Metronomic Capecitabine, Utidelone plus Metronomic Capecitabine | Sun Yat-sen University, Chengdu Biostar | Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer | 03/27 | 03/30 | | |
ChiCTR-TRC-13004205: Phase II Clinical Study of UTD1 in Combination with Capecitabine or UTD1 Alone in Patients with Metastatic and Locally Advanced Breast Cancer |
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| Completed | 2 | 90 | | 30mg/m2/day UTD1 (administered for consecutive 5 days)+2000mg Capecitabine (administered for consecutive 14 days). Dosing is repeated every 21 days. ;40mg/m2/day UTD1(administered for consecutive 5 days). Dosing is repeated every 21 days. | Cancer Hospital, Chinese Academy of Medical Sciences; Level of the institution：, Beijing Biostar Technologies, Ltd. | Metastatic or Locally Advanced Breast Cancer | | | | |
NCT04681287: Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone. |
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| Active, not recruiting | 2 | 46 | RoW | inetetamab and PD-1 inhibitor combined with chemotherapy. | Henan Cancer Hospital | HER2 Positive Metastatic Breast Cancer | 11/21 | 12/24 | | |
NCT05299255: Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer |
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| Recruiting | 2 | 40 | RoW | Utidelone, Placebo | Henan Cancer Hospital | SCLC, Extensive Stage | 09/22 | 09/23 | | |
NCT05403333: Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer |
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| Not yet recruiting | 2 | 61 | NA | utidelone, Singel arm | Fudan University | Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer | 03/23 | 03/25 | | |
NCT04911907: Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors |
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| Recruiting | 2 | 120 | RoW | utidelone injection | Beijing Biostar Pharmaceuticals Co., Ltd., Chengdu Biostar Pharmaceuticals | Solid Tumor | 03/24 | 12/24 | | |
NCT06385990: Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy |
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| Recruiting | 2 | 53 | RoW | UTD1, capecitabine | Hunan Cancer Hospital | Triple Negative Breast Neoplasms | 03/25 | 03/27 | | |
ChiCTR2200058568: Phase II clinical study of Utidelone UTD1 in metastatic castration-resistant prostate cancer (mCRPC) after standard treatment failure |
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| Recruiting | 2 | 43 | | Utidelone | Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center, Sun Yat-sen University Cancer Center | prostatic cancer | | | | |
NCT05866510: Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer |
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| Recruiting | 2 | 47 | RoW | Utidelone and anlotinib | Peking University, Beijing Biostar Pharmaceuticals Co., Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Esophageal Cancer | 04/24 | 04/24 | | |
| Recruiting | 2 | 100 | RoW | utidelone, Bevacizumab | Henan Cancer Hospital | Breast Cancer | 05/24 | 05/24 | | |
NCT06458413: Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer |
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| Recruiting | 2 | 40 | RoW | Utidelone Capsule Plus Capecitabine | Min Yan, MD, Beijing Biostar Pharmaceuticals Co., Ltd. | Breast Cancer Recurrent | 06/25 | 12/25 | | |
NCT05795920: Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer |
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| Recruiting | 2 | 92 | RoW | Utidelone injection in combination with gemcitabine, UTD1 | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Pancreatic Neoplasms | 07/24 | 09/25 | | |
NCT05398861: Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer |
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| Not yet recruiting | 2 | 71 | NA | Utidelone Combined with Bevacizumab, UTD1 | Henan Cancer Hospital, Qilu Pharmaceutical Co., Ltd., Beijing Biostar Technologies, Ltd | HER-2 Negative Breast Cancer | 12/24 | 12/24 | | |
ChiCTR2200061635: Phase II clinical study of Utidelone UTD1 in metastatic castration-resistant prostate cancer (mCRPC) after standard treatment failure |
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| Recruiting | 2 | 43 | | Utidelone | Cancer Center, Sun Yat-sen University; Cancer Center, Sun Yat-sen University, Cancer Center, Sun Yat-sen University | prostatic cancer | | | | |
NCT05895864: Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma |
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| Recruiting | 2 | 34 | RoW | utidelone injection, UTD1 injection | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Metastatic Urothelial Carcinoma | 12/24 | 12/25 | | |
ChiCTR2200062161: Safety and Efficacy of Utidelone in Patients with Refractory Advanced Soft-Tissue Sarcoma: A Prospective Single-arm Phase II Study |
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| Not yet recruiting | 2 | 27 | | Utidelone treatment | West China Hospital, Sichuan University; West China Hospital, Sichuan University, No | Soft-Tissue Sarcoma | | | | |
UTILIZABLE, NCT06125080: The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer () ：Single-arm, Prospective, Open Clinical Study |
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| Recruiting | 2 | 78 | RoW | Utidelone, UTD1, Tirelizumab, Bevacizumab | Huihua Xiong | TNBC - Triple-Negative Breast Cancer | 10/25 | 10/26 | | |
NCT05983094: Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer |
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| Not yet recruiting | 2 | 181 | RoW | Utidelone, Carboplatin, Epirubicin, Trastuzumab, Pertuzumab | Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences Cancer Hospital，Shanxi Center, Chinese Academy of Medical Sciences Cancer Hospital，Shenzhen Center, First Affiliated Hospital of China Medical University | Breast Cancer, Neoadjuvant Therapy | 09/26 | 09/27 | | |
ChiCTR2200056534: A single-arm, multicentre, phase II clinical study to evaluate the efficacy and safety of Utidelone Injection in the treatment of recurrent/metastatic HER-2 negative breast cancer |
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| Not yet recruiting | 2 | 150 | | Utidelone | Shandong Cancer Hospital and Institute; Shandong Cancer Hospital and Institute, Chengdu Biostar Pharmaceuticals Co., Ltd. | Breast cancer | | | | |
| Recruiting | 2 | 252 | RoW | Organoid-guided treatment, Taxane, Abraxane, Lipusu, Capecitabine, Xeloda, Gemcitabine, Gemzar, Vinorelbine, Navelbine, Eribulin, Halaven, Anthracycline, Doxil, Lipodox, Carboplatin, Paraplatin, Utidelone, UTD1, Trastuzumab deruxtecan, Enhertu, Sacituzumab govitecan, Trodelvy | Guangdong Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Shantou Central Hospital | HER2-negative Breast Cancer, Advanced Breast Cancer | 06/27 | 06/28 | | |
NCT05700084: Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors |
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| Recruiting | 1 | 84 | RoW | Utidelone Capsule (Part 1), Drug A Utidelone Capsule (Part 2: Group A-B), Drug A Utidelone Capsule (Part 2: Group B-A), Drug B Utidelone Injection (Part 2: Group A-B), Drug B Utidelone Injection (Part 2: Group B-A), Capecitabine, Utidelone Capsule (Part 3) | Beijing Biostar Pharmaceuticals Co., Ltd. | Advanced Solid Tumor | 03/25 | 04/25 | | |
NCT05681000: Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors |
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| Recruiting | 1 | 28 | US | Utidelone Capsule | Biostar Pharma, Inc. | Advanced Solid Tumor | 04/24 | 12/24 | | |
ChiCTR2200055254: Exploratory study on the efficacy of utidelone combined with capecitabine and bevacizumab in the treatment of brain metastasis of HER2 negative breast cancer |
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| Recruiting | N/A | 29 | | utidelone combined with capecitabine and bevacizumab | Huashan Hospital Affiliated to Fudan University; Huashan Hospital Affiliated to Fudan University, Beijing Heath Medical Oncology Research Foundation | breast cancer | | | | |
ChiCTR2300070095: Clinical study of Wen Tong acupoint on the prevention and treatment of peripheral neuropathy related to Utidelone |
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| Not yet recruiting | N/A | 66 | | Wen Tong acupoint + vitamin B1 tablets, mecobalamine tablets ;vitamin B1 tablets, mecobalamine tablets | China-Japan Friendship Hospital; China-Japan Friendship Hospital, Cancer Prevention and Treatment Research Foundation of Beijing Cancer Prevention and Control Society | breast cancer | | | | |
