| Zepzelca (lurbinectedin) / PharmaMar, Jazz |
IDeate-Lung02, NCT06203210: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer |
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| Recruiting | 3 | 468 | Europe, Canada, Japan, US, RoW | Ifinatamab deruxtecan, I-DXd, Topotecan, Amrubicin, Lurbinectedin | Daiichi Sankyo, Merck Sharp & Dohme LLC | Small Cell Lung Cancer | 04/27 | 02/29 | | |
NCT06496048: Lurbinectedin or in Combination With Irinotecan Versus Topotecan in Patients With Relapsed SCLC |
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| Not yet recruiting | 3 | 180 | NA | Lurbinectedin, PM01183, Irinotecan, Topotecan | Luye Pharma Group Ltd. | Relapsed Small Cell Lung Cancer | 12/27 | 06/28 | | |
| Active, not recruiting | 3 | 509 | Europe, Canada, Japan, US, RoW | Tarlatamab, AMG 757, Lurbinectedin, Topotecan, Amrubicin | Amgen | Small Cell Lung Cancer (SCLC) | 07/27 | 07/27 | | |
IMforte, NCT05091567 / 2021-001930-20: A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer |
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| Active, not recruiting | 3 | 690 | Europe, US, RoW | Atezolizumab, Tecentriq, RO5541267, Lurbinectedin, PM01183/JZP712, Carboplatin, Etoposide | Hoffmann-La Roche, Jazz Pharmaceuticals | Small-Cell Lung Cancer | 04/25 | 03/26 | | |
LAGOON, NCT05153239 / 2021-004471-13: Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer |
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| Recruiting | 3 | 705 | Europe, Canada, Japan, US, RoW | Irinotecan, Lurbinectedin, PM01183, Topotecan | PharmaMar, Pharma Mar, S.A. | Relapsed Small Cell Lung Cancer | 04/26 | 04/26 | | |
NCT06088290: Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma |
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| Recruiting | 2/3 | 360 | Europe, US | Lurbinectedin, Doxorubicin | PharmaMar | Leiomyosarcoma | 11/26 | 11/26 | | |
| Completed | 2 | 47 | US | Lurbinectedin | Jazz Pharmaceuticals | Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Cancer, Poorly Differentiated Neuroendocrine Carcinomas, Homologous Recombination Deficient-Positive Malignancies Agnostic | 12/23 | 12/23 | | |
LASER, NCT06228066: Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder |
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| Recruiting | 2 | 35 | US | Lurbinectedin, Avelumab | National Cancer Institute (NCI) | Small Cell Carcinoma of the Bladder, High Grade Neuroendocrine Tumors of the Urinary Tract | 09/27 | 09/28 | | |
NCT06501976: An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy |
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| Not yet recruiting | 2 | 9 | NA | Lurbinectedin, PM01183, Zepzelca, Radiation Therapy | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Small Cell Lung Carcinoma | 03/25 | 12/25 | | |
| Recruiting | 2 | 30 | US | Trilaciclib, Lurbinectedin | UNC Lineberger Comprehensive Cancer Center, G1 Therapeutics, Inc. | Lung Cancer, Small-cell Lung Cancer | 12/25 | 12/27 | | |
| Not yet recruiting | 2 | 30 | NA | Serplulimab, Lurbinectedin, PM01183, Carboplatin, Etoposide | Guangzhou Institute of Respiratory Disease | Extensive-Stage Small Cell Lung Cancer | 06/25 | 12/25 | | |
| Withdrawn | 2 | 82 | Europe | Association of lurbinectedin and durvalumab, Association of carboplatin and etoposide | Institut Bergonié, AstraZeneca, PharmaMar | Small Cell Lung Cancer, Platinum-Sensitive Lung Small Cell Carcinoma, Extensive-stage Small-cell Lung Cancer | 05/24 | 05/24 | | |
NCT04607954: Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer |
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| Recruiting | 2 | 106 | US | Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, Lurbinectedin, PM01183, Zepzelca | Mayo Clinic, National Cancer Institute (NCI) | Platinum-Resistant Lung Small Cell Carcinoma, Platinum-Sensitive Lung Small Cell Carcinoma, Recurrent Extensive Stage Lung Small Cell Carcinoma, Refractory Extensive Stage Lung Small Cell Carcinoma | 11/24 | 11/25 | | |
NCT05229588: Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations |
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| Recruiting | 2 | 19 | US | Lurbinectedin 4 MG Injection [Zepzelca], PM01183 | HonorHealth Research Institute, Jazz Pharmaceuticals | Gastrointestinal Malignancies | 08/25 | 08/26 | | |
ChiCTR2400084825: Lurbinectedin and doxorubicin plus regorafenib and PD-1 inhibitor as first-line treatment of locally advanced nonresectable or metastatic Soft Tissue Sarcoma: a prospective phase Ⅱ trial |
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| Not yet recruiting | 2 | 38 | | Lurbinectedin combined with doxorubicin plus PD-1 inhibitor and regorafenib | Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences, Lurbinectedin used in this trial will be provided by Hong Kong Cancer Prevention and Treatment Foundation(HKCPT) for free | Soft Tissue Sarcoma | | | | |
NCT05574504: Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy |
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| Withdrawn | 2 | 36 | US | avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin | AdventHealth, Jazz Pharmaceuticals | Metastatic Cancer, Urothelial Carcinoma | 11/26 | 11/28 | | |
NCT05800587: Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer |
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| Recruiting | 2 | 280 | US | Carboplatin, Pemetrexed, Paclitaxel, Nab paclitaxel, Docetaxel, Gemcitabine, Etoposide, Irinotecan, Topotecan, Lurbinectedin | Fox Chase Cancer Center | Lung Cancer, Small-cell Lung Cancer, Non Small Cell Lung Cancer | 08/28 | 08/29 | | |
2019-001553-12: Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients with Advanced Small Cell Lung Cancer that Progressed Following Prior Therapy with Platinum-Based Chemotherapy Estudio de fase I-II para evaluar la seguridad, tolerabilidad y eficacia de PM01183 y atezolizumab en pacientes con cáncer de pulmón de células pequeñas avanzado que hayan progresado tras una quimioterapia previa de platino |
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| Not yet recruiting | 1/2 | 25 | Europe | PM01183, Concentrate for solution for infusion, Lyophilisate for solution for infusion, Tecentriq | Fundacion ONCOSUR, Fundación ONCOSUR | Histologically or cytologically confirmed diagnosis of extensive or limited SCLC.Progression to first-line platinum-based chemotherapy.Measurable disease according to RECIST v.1.1. Diagnóstico confirmado histológica o citológicamente de SCLC extenso o limitado.Progresión a la quimioterapia de primera línea a base de platino.Progresión documentada de la enfermedad según RECIST v1.1, diagnosis of small cell lung cancer,progression after treatment with other drugs diagnostico de cáncer de pulmón de células pequeñas,progresión tras tratamiento con otros medicamentos, Diseases [C] - Cancer [C04] | | | | |
2SMALL, NCT04253145: Study to Assess Safety,Tolerability,Efficacy of PM01183 and Atezolizumab in Patients w/ Advanced Small Cell Lung Cancer. |
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| Recruiting | 1/2 | 184 | Europe | PM 01183, Lurbinectidin, Atezolizumab, Tecentriq | Fundacion Oncosur | Carcinoma, Small Cell Lung | 05/25 | 05/25 | | |
2015-003602-16: Clinical and Pharmacokinetic Study of Lurbinectedin in Combination with Irinotecan in Patients with Advanced Solid Tumors Studio clinico e farmacocinetico di Lurbinectedina in combinazione con Irinotecan in pazienti con tumori solidi avanzati |
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| Not yet recruiting | 1/2 | 320 | Europe | Lurbinectedina, Irinotecan, [PM01183], [NA], Powder for concentrate for solution for infusion, Concentrate for solution for injection/infusion | PHARMA MAR, S.A. SOCIEDAD UNIPERSONAL, Pharma Mar S.A., Pharma Mar S.A. | Selected Advanced Solid Tumors Tumori solidi avanzati selezionati, Advanced Solid Tumors Tumori solidi avanzati, Diseases [C] - Cancer [C04] | | | | |
| Active, not recruiting | 1/2 | 28 | Europe | Lurbinectedin, PM01183, Zepsyre, Pembrolizumab, Keytruda | Antonio Calles Blanco, MedSIR, PharmaMar, Merck Sharp & Dohme LLC | Small Cell Lung Carcinoma | 09/23 | 03/25 | | |
| Recruiting | 1/2 | 320 | Europe, US | Lurbinectedin, PM01183, Irinotecan | PharmaMar | Advanced Solid Tumors, Glioblastoma, Soft Tissue Sarcoma (Excluding GIST), Endometrial Carcinoma, Epithelial Ovarian Carcinoma, Mesothelioma, Gastroenteropancreatic Neuroendocrine Tumor, SCLC, Gastric Carcinoma, Pancreatic Adenocarcinoma, Colorectal Carcinoma, Neuroendocrine Tumors | 03/26 | 03/26 | | |
LiDer, NCT06385548: Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - |
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| Not yet recruiting | 1/2 | 15 | NA | Lurbinectedin, Dostarlimab | Vall d'Hebron Institute of Oncology | Endometrial Cancer | 05/24 | 04/26 | | |
| Recruiting | 1/2 | 62 | US | Lurbinectedin, Zepzelca, Doxorubicin, Adriamycin | Massachusetts General Hospital, Jazz Pharmaceuticals | Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma, Advanced Leiomyosarcoma, Leiomyosarcoma Metastatic | 07/24 | 07/25 | | |
NCT06217536: Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas |
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| Not yet recruiting | 1/2 | 70 | US | Lurbinectedin, Zepzelca, Radiotherapy, Radiation therapy, Non-investigational surgery | University of California, San Francisco, Jazz Pharmaceuticals | Locally Advanced Soft Tissue Sarcoma | 05/26 | 10/27 | | |
NCT04802174: Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers |
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| Recruiting | 1/2 | 120 | US | Lurbinectedin, Berzosertib | National Cancer Institute (NCI) | SCLC, Small Cell Cancer, Advanced Solid Tumor, High Grade Neuroendocrine Cancers | 08/26 | 12/27 | | |
| Recruiting | 1/2 | 40 | US | Lurbinectedin, Ipilimumab, Nivolumab | ERLINDA M GORDON | Advanced Soft-tissue Sarcoma | 06/26 | 09/26 | | |
| Recruiting | 1/2 | 56 | US | Lurbinectedin | Children's Hospital of Philadelphia, Jazz Pharmaceuticals, Stand Up To Cancer | Ewing Sarcoma, Desmoplastic Small Round Cell Tumor, Pediatric Cancer, Undifferentiated Sarcoma | 07/26 | 07/28 | | |
EMERGE 101, NCT05734066: Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma |
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| Recruiting | 1/2 | 60 | Canada, US | Lurbinectedin, JZP712 | Jazz Pharmaceuticals | Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma | 12/26 | 06/27 | | |
NCT05072106: Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors |
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| Recruiting | 1 | 8 | Europe | Lurbinectedin, PM01183, Bosentan | PharmaMar | Advanced Solid Tumor | 10/22 | 11/22 | | |
NCT05063318: Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors |
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| Recruiting | 1 | 11 | Europe | Lurbinectedin alone, Lurbinectedin+Itraconazole co-administration | PharmaMar | Advanced Solid Tumors | 11/22 | 12/22 | | |
NCT04610658: Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC |
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| Terminated | 1 | 9 | US | Nivolumab, Opdivo, Ipilimumab, Yervoy, Lurbinectedin | H. Lee Moffitt Cancer Center and Research Institute, Bristol-Myers Squibb, Jazz Pharmaceuticals | Small-cell Lung Cancer, Relapsed Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer | 03/23 | 03/23 | | |
NCT05636111: Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer |
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| Recruiting | 1 | 34 | US | Paclitaxel, Taxol, Bevacizumab, Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Lurbinectedin | M.D. Anderson Cancer Center, Jazz Pharmaceuticals | Ovarian Cancer | 07/24 | 07/26 | | |
NCT04638491: Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients |
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| Completed | 1 | 32 | RoW | Lurbinectedin for injection, PM01183 | Luye Pharma Group Ltd. | Advanced Solid Tumor | 11/23 | 11/23 | | |
NCT05244239: Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer |
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| Recruiting | 1 | 22 | US | Lurbinectedin, PM01183, Zepzelca, Palliative Radiation Therapy, Palliative Radiotherapy | Emory University, National Cancer Institute (NCI), Jazz Pharmaceuticals | Extensive Stage Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8 | 01/25 | 01/25 | | |
NCT05101265: Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment |
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| Recruiting | 1 | 24 | Europe | Lurbinectedin, PM1183 | PharmaMar | Advanced Solid Tumor, Hepatic Impairment | 06/25 | 06/25 | | |
NCT06021483: Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection |
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| Recruiting | N/A | 300 | RoW | | Boryung Pharmaceutical Co., Ltd | SCLC | 09/25 | 09/25 | | |
EMERGE 402, NCT04894591: To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC) |
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| Recruiting | N/A | 300 | Canada, US | Zepzelca, lurbinectedin | Jazz Pharmaceuticals | Extensive-stage Small-cell Lung Cancer | 06/30 | 06/30 | | |
| Pozenveo (poziotinib) / Assertio |
NCT05045404: Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer |
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| Withdrawn | 2 | 36 | NA | Poziotinib Hydrochloride, 1429757-68-5, HM781-36B, NOV-1201 Hydrochloride, NOV120101 Hydrochloride, Poziotinib HCl, POZIOTINIB HYDROCHLORIDE | M.D. Anderson Cancer Center | Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8 | 02/23 | 02/23 | | |
| Terminated | 2 | 648 | Europe, Canada, US, RoW | Poziotinib | Spectrum Pharmaceuticals, Inc | NSCLC | 04/23 | 04/23 | | |
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| Terminated | 2 | 7 | US | Poziotinib | Spectrum Pharmaceuticals, Inc | NSCLC, Breast Cancer | 03/23 | 03/23 | | |
| Active, not recruiting | 2 | 93 | US | Poziotinib, HM781-36B, NOV120101 | M.D. Anderson Cancer Center, National Cancer Institute (NCI), Spectrum Pharmaceuticals, Inc | EGFR Exon 20 Mutation, ERBB2 Gene Mutation, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Non-Small Cell Lung Cancer AJCC v7 | 12/25 | 12/25 | | |
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NCT04402008: Study of Poziotinib in Japanese Patients With NSCLC |
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| Terminated | 1/2 | 42 | Japan | Poziotinib Once Daily Dosing, Poziotinib Twice Daily Dosing, Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1 | Spectrum Pharmaceuticals, Inc | NSCLC | 02/23 | 02/23 | | |
| rotigotine XR microspheres (LY03003) / Luye Group |
ChiCTR1900027183: Evaluation of the efficacy and safety of injection of rotigotine sustained-release microspheres in the treatment of patients with early-stage primary Parkinson's disease: a multicenter, randomized, double-blind, placebo-controlled study |
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| Not yet recruiting | 3 | 294 | | LY03003 ;placebo | Xuanwu Hospital Capital Medical University; Shandong Luye Pharmaceutical Co., Ltd, Sponsor Supplied | Early primary Parkinson's disease | | | | |
NCT04571164: A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD |
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| Completed | 3 | 294 | RoW | LY03003(Rotigotine,extended-release microspheres), Placebo,extended-release microspheres | Luye Pharma Group Ltd., Parexel | Parkinson Disease | 03/22 | 09/22 | | |
NCT04630860: A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PD |
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| Completed | 1 | 30 | RoW | LY03003 | Luye Pharma Group Ltd. | Parkinson Disease | 05/21 | 01/22 | | |
| 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 | | |
HNCH-MBC15-BM06, NCT06598046: A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of TNBC |
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| Recruiting | 2 | 48 | RoW | Utidelone and capecitabine | Henan Cancer Hospital | Metastatic Breast Cancer | 06/26 | 08/26 | | |
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 | | |
NeoURANIA, NCT06510465: Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer |
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| Not yet recruiting | 2 | 143 | RoW | utidelone, UTD1, Cisplatin, DDP, Trastuzumab, Pertuzumab | RenJi Hospital | Breast Cancer | 03/27 | 03/32 | | |
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 | | |
ChiCTR2400083699: The Efficacy and Safety of Utidelone combined with Tirelizumab for recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC):A single-arm, phase II study |
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| Not yet recruiting | 2 | 34 | | Utidelone plus Tirelizumab | Zhongnan Hospital Affiliated to Wuhan University; Zhongnan Hospital Affiliated to Wuhan University, Chengdu Biostar Technologies, Ltd | recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC) | | | | |
ChiCTR2400088235: A single-arm, prospective phase Ⅱ clinical study of Utidelone combined with capecitabine in the treatment of active brain metastasis of triple-negative advanced breast cancer. |
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| Not yet recruiting | 2 | 48 | | Utidelone combined with capecitabine | Henan Cancer Hospital; Henan Cancer Hospital, None | Active brain metastasis of triple-negative advanced breast cancer | | | | |
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 | | | | |
ChiCTR2400085074: Single-arm, Phase II Clinical Trial of Utidelone Capsule Plus Capecitabine (CAP) in Patients with Metastatic Breast Cancer |
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| Not yet recruiting | 2 | 40 | | Patients with recurrent or metastatic HER2 negative breast cancer who have previously received chemotherapy containing paclitaxel and/or anthracycline will receive combined treatment with utidelone capsule and capecitabine. Utidelone Capsule: 60mg/m2/d, once daily, oral on an empty stomach, continuously administered for 1-5 days; Capecitabine tablets: 1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals, and continuously administered for 14 days from day 1 to day 14. Every 21 days is a cycle until disease progression, intolerable adverse events occur, subjects voluntarily withdraw, or the researcher determines that medication must be terminated. | Henan Cancer hospital; Henan Cancer hospital, self-funded | Breast cancer | | | | |
ChiCTR2400084686: Neoadjuvant weekly utidelone combined with cisplatin in breast cancer: a prospective, multi-center study (URANIA) |
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| Not yet recruiting | 2 | 143 | | utidelone, cisplatin with tratuzumab pertuzumab; utidelone, cisplatin | Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, self-funding | 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 | | |
ChiCTR2300077853: Phase II clinical study of utidelone injection combined with gemcitabine for first-line treatment of metastatic pancreatic adenocarcinoma |
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| Recruiting | 2 | 30 | | Utidelone Injection combined with gemcitabine | Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, self-funded | pancreatic cancer | | | | |
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 | | | | |
| Ruoxinlin (toludesvenlafaxine extended release) / Luye Group |
NCT05849272: Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression |
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| Not yet recruiting | 4 | 60 | RoW | toludesvenlafaxine hydrochloride sustained-release tablets | Shanghai Mental Health Center | Somatic Symptom | 12/23 | 05/24 | | |
NCT06026917: Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) |
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| Recruiting | 4 | 15 | RoW | Toludesvenlafaxine hydrochloride sustained-release tablets | Shanghai Mental Health Center, Yantai University | Major Depressive Disorder | 01/24 | 03/24 | | |
NCT06426485: To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets |
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| Not yet recruiting | 4 | 736 | NA | Toludesvenlafaxine Hydrochloride Sustained-release Tablets, placebo | Luye Pharma Group Ltd. | Major Depressive Disorder | 02/27 | 06/27 | | |
ChiCTR2400080665: The efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in the treatment of treatment-resistant depression |
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| Not yet recruiting | 4 | 30 | | Toludesvenlafaxine Hydrochloride Sustained-release Tablets | Shandong Mental Health Center; Shandong Mental Health Center, Horizontal project | treatment-resistant depression | | | | |
ChiCTR2400080359: A study on the efficacy and safety of switching to Toludesvenlafaxine Hydrochloride Sustained-release Tablets for depression patients who are currently ineffective or partially effective in treatment |
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| Not yet recruiting | 4 | 60 | | Toludesvenlafaxine Hydrochloride Sustained-release Tablets | Beijing Huilongguan Hospital; Beijing Huilongguan Hospital, Raise independently | depression | | | | |
ChiCTR2300070331: Efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in depression with anhedonia: a single-arm, multi-center clinical study |
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| Recruiting | 4 | 120 | | oral drug administration | Peking University Sixth Hospital; Peking University Sixth Hospital, Corporate Sponsorship | Depression | | | | |
NCT05970510: A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder. |
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| Recruiting | 3 | 555 | RoW | Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg, Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg, placebo | Luye Pharma Group Ltd. | Generalized Anxiety Disorder | 04/26 | 04/26 | | |
NCT06270433: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder |
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| Recruiting | N/A | 80 | RoW | Toludesvenlafaxine hydrochloride sustained-release tablets, Desvenlafaxine succinate sustained-release tablets | Jiangsu Province Nanjing Brain Hospital | Anhedonia | 12/24 | 12/24 | | |
NCT06278038: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder |
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| Recruiting | N/A | 80 | RoW | Toludesvenlafaxine hydrochloride sustained-release tablets, Venlafaxine hydrochloride sustained-release tablets | First Affiliated Hospital of Zhejiang University | Major Depression Disorder | 12/24 | 12/24 | | |
| Rykindo (risperidone extended release microspheres) / Luye Group |
ChiCTR2200066865: The strategy of use, efficacy and safety of Rykindo in the treatment of schizophrenia spectrum disorders：a prospective, single-arm, multicenter real-world study |
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| Recruiting | 4 | 300 | | Long-acting injectable risperidone | Beijing Huilongguan Hospital; Beijing Huilongguan Hospital, Corporate Grants | Schizophrenia spectrum disorders | | | | |
| Ongoing | 3 | 250 | RoW | LY03004, RISPERDAL® CONSTA®, TEST, REFERENCE, Powder and solvent for prolonged-release suspension for injection, EU Risperdal® Consta® | Nanjing Luye Pharmaceutical Co., Ltd., Nanjing Luye Pharmaceutical Co., Ltd., Luye Pharma Group, Ltd. | schizophrenia, schizophrenia, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
| Lipusu (liposomal paclitaxel) / Luye Group |
ALTER-GO-010, NCT04807166: Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer |
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| Active, not recruiting | 2 | 56 | RoW | Drug: Anlotinib, FOCUS V, Drug: Carboplatin/Paclitaxel, bobei， Lipusu | Wenjun Cheng | Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms by Site, Genital Neoplasms, Female, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Carcinoma, Ovarian Epithelial, Ovarian Diseases, Genital Diseases, Female, Endocrine System Diseases, Carcinoma, Anlotinib, Angiogenesis, Antineoplastic Agents, Tyrosine Kinase Inhibitor | 09/25 | 12/27 | | |
| paliperidone palmitate ER (LY03010) / Luye Group |
NCT04922593: Relative Bioavailability of LY03010 Compared to Listed Drug |
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| Completed | 1 | 281 | US | LY03010; paliperidone palmitate, INVEGA SUSTENNA | Luye Pharma Group Ltd. | Schizophrenia, Psychotic Disorders, Mood Disorders, Schizophrenia Spectrum, Mental Disorders, Antipsychotic Agents, Tranquilizing Agents, Central Nervous System Depressants, Physiological Effects of Drugs, Psychotropic Drugs, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action | 03/22 | 04/22 | | |
NCT05321602: Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder |
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| Completed | 1 | 89 | US | LY03010 156 mg treatment group, deltoid, paliperidone palmitate, LY03010 156 mg treatment group, gluteal, LY03010 351 mg treatment group, deltoid, LY03010 351 mg treatment group, gluteal | Luye Pharma Group Ltd. | Schizophrenia, Psychotic Disorders, Mood Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Antipsychotic Agents, Tranquilizing Agents, Central Nervous System Depression, Physiological Effects of Drugs, Psychotropic Drugs, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action | 09/22 | 10/22 | | |
| Baituowei (goserelin acetate sustained-release microspheres for injection) / Luye Group |
| Not yet recruiting | 4 | 100 | | VISANNE 2MG Tablet once daily ;subcutaneous Goserelin acetate injections (3.6 mg/4 weeks, GoserelinAcetateSustained-ReleaseDepot) | Qilu Hospital of Shandong University; Qilu Hospital of Shandong University, no | adenomyosis | | | | |
ChiCTR2200059548: Comparison of clinical efficacy and incidence of uterine bleeding with different doses of GnRH-a in the treatment of adenomyosis in different periods of the menstrual cycle |
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| Recruiting | 4 | 180 | | A 10.8 mg goserelin acetate sustained-release implant is subcutaneously injected every 12 weeks, and a total of 1-2 injections are given according to the patient's condition ;A 3.6 mg goserelin acetate sustained-release implant is subcutaneously injected every 4 weeks, and a total of 3-6 injections are given according to the patient's condition | Qilu Hospital of Shandong University; Qilu Hospital of Shandong University, None | Adenomyosis | | | | |
