| Orserdu (elacestrant) / Menarini |
| Completed | 3 | 478 | Europe, Canada, US, RoW | Elacestrant, RAD1901, Standard of Care, Faslodex, Arimidex, Femara, Aromasin | Stemline Therapeutics, Inc. | Breast Cancer | 08/21 | 08/24 | | |
ADELA, NCT06382948: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. |
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| Not yet recruiting | 3 | 240 | NA | Everolimus, Zortress, Votubia, RAD001, Certican, Afinitor, Elacestrant, ER-306323, RAD1901, Selective estrogen receptor degrader/selective estrogen receptor modulator (SERD/SERM) RAD1901, Placebo, Auxiliary Medicinal Product - Dexamethasone, Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues | MedSIR, Stemline Therapeutics, Inc. | Advanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation | 09/27 | 04/28 | | |
ELEGANT, NCT06492616: A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence |
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| Recruiting | 3 | 4220 | US | Elacestrant, Anastrozole, Letrozole, Exemestane, Tamoxifen | Stemline Therapeutics, Inc. | Breast Cancer | 08/29 | 10/32 | | |
| Recruiting | 3 | 220 | Europe | Elacestrant, Tamoxifen, Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25 MG | European Organisation for Research and Treatment of Cancer - EORTC, Breast International Group, Menarini Group | ER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer | 07/28 | 05/30 | | |
ELCIN, NCT05596409: ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study |
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| Recruiting | 2 | 60 | Europe, US, RoW | Elacestrant | Stemline Therapeutics, Inc. | Metastatic Breast Cancer | 02/25 | 08/25 | | |
NCT06062498: Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer |
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| Not yet recruiting | 2 | 174 | US | elacestrant, palbociclib, abemaciclib, ribociclib | Northwestern University, National Cancer Institute (NCI) | Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer | 07/24 | 07/25 | | |
| Recruiting | 2 | 48 | Europe | Elacestrant, Orserdu, Triptorelin | SOLTI Breast Cancer Research Group | Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Premenopausal Breast Cancer | 10/24 | 01/25 | | |
ELEMENT, NCT06201234: Evaluating the Addition of Elacestrant (oral SERD) to Olaparib (PARP-inhibitor) in Patients with Advanced/metastatic HR+/HER2- Breast Cancer |
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| Recruiting | 2 | 176 | Europe | Olaparib + Elacestrant, Olaparib | German Breast Group, Stemline Therapeutics, Inc. | Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation | 12/28 | 12/28 | | |
NCT05826964: Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer |
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| Recruiting | 2 | 500 | US | AI+CDK4/6i, Aromatase Inhibitor (AI) + Cyclin dependent kinase 4 and 6 inhibitor (CDK4/6i), Anastrozole, Letrozole, Exemestane, Palbociclib, Ribociclib, Abemaciclib, SERD+CDK4/6i, Selective Estrogen Receptor Degrader (SERD) + CDK4/6i, Fulvestrant, mTOR inhibitor + AI, Mammalian target of rapamycin (mTOR) inhibitor + Aromatase Inhibitor (AI), Everolimus, mTOR inhibitor + SERD, mTOR inhibitor + Selective estrogen receptor modulator, Tamoxifen, PI3K inhibitor + SERD, Phosphoinositide 3-kinase (PI3K) inhibitor + SERD, Alpelisib, PI3K inhibitor + AI, Chemotherapy, Taxane, Eribulin, Capecitabine, Vinorelbine, Oral SERD, Elacestrant | University of Miami | Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer | 07/26 | 07/29 | | |
RECAST-DCIS, NCT06075953: DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment |
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| Recruiting | 2 | 400 | US | Tamoxifen, Exemestane, Letrozole, Anastrazole, Testosterone + Anastrazole, T+Ai, Elacestrant, Z-endoxifen | QuantumLeap Healthcare Collaborative | Ductal Carcinoma in Situ | 11/28 | 11/33 | | |
2022-001087-10: This study has 2 phases: a Phase 1b evaluation of elacestrant in combination with abemaciclib followed by a randomized Phase 2 evaluation of elacestrant alone or in combination with abemaciclib in women and men with brain metastases from ER positive, HER-2 negative breast cancer. Este estudio tiene 2 fases: una evaluación de Fase 1b de elacestrant en combinación con abemaciclib seguida de una evaluación randomizada de Fase 2 de elacestrant solo o en combinación con abemaciclib en mujeres y hombres con metástasis cerebrales causadas por un cáncer de mama con receptores de estrógeno y HER-2 negativo. |
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| Not yet recruiting | 1/2 | 106 | Europe | Elacestrant, Abemaciclib, LY2835219, Film-coated tablet, Verzenios® | Stemline Therapeutics, Inc, Stemline Therapeutics Inc., Stemline Therapeutics, Inc | Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer Metástasis cerebrales causadas por un cáncer de mama con receptores de estrógeno y negativo para HER-2, Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer Metástasis cerebrales causadas por un cáncer de mama con receptores de estrógeno y negativo para HER-2, Diseases [C] - Cancer [C04] | | | | |
| Recruiting | 1/2 | 44 | US | Abemaciclib, Verzenio, Elacestrant | Criterium, Inc. | Breast Cancer | 12/24 | 01/25 | | |
SUMIT-ELA, NCT05963997: A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer |
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| Active, not recruiting | 1/2 | 49 | Europe, US | Samuraciclib, Elacestrant Dihydrochloride, ORSERDU | Carrick Therapeutics Limited, Berlin-Chemie AG Menarini Group | Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer | 12/24 | 06/25 | | |
ELEVATE, NCT05563220: Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer |
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| Recruiting | 1/2 | 400 | Europe, US, RoW | Elacestrant, Alpelisib, Piqray, Everolimus, Afinitor, Ribociclib, Kisqali, Palbociclib, Ibrance, Capivasertib, Truqap, Abemaciclib, Verzenio | Stemline Therapeutics, Inc. | Breast Cancer, Metastatic Breast Cancer | 12/24 | 08/26 | | |
ELECTRA, NCT05386108: Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer |
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| Recruiting | 1/2 | 68 | Europe, US, RoW | Elacestrant, Elacestrant dihydrochloride, RAD-1901, ER-306323, Orserdu, Abemaciclib, Verzenio | Stemline Therapeutics, Inc. | Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Central Nervous System Neoplasms, Brain Diseases, Central Nervous System Diseases | 12/25 | 12/25 | | |
ELONA, NCT05618613: Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer |
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| Active, not recruiting | 1b | 67 | US | Elacestrant, RAD1901, Onapristone | Context Therapeutics Inc. | Breast Cancer | 12/24 | 04/26 | | |
NCT06126575: A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function |
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| Recruiting | 1 | 16 | US | Elacestrant dihydrochloride | Stemline Therapeutics, Inc. | Hepatic Impairment | 11/24 | 12/24 | | |
NCT06638307: A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer |
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| Recruiting | 1 | 124 | Europe, US, RoW | MEN2312, Elacestrant | Stemline Therapeutics, Inc. | Advanced Breast Cancer | 10/25 | 10/26 | | |
NCT06691035: Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer |
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| Not yet recruiting | 1 | 18 | US | Elacestrant, Oserdu, DC1 native/mutated ESR1 | H. Lee Moffitt Cancer Center and Research Institute, The V Foundation for Cancer Research | Breast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer | 11/26 | 11/27 | | |
NCT06544577: Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC |
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| Recruiting | N/A | 350 | RoW | ELacestrant | SciClone Pharmaceuticals | ESR1 Gene Mutation, Advanced Breast Cancer, Safety | 08/25 | 08/26 | | |
| Zadaxin (thymalfasin) / SciClone |
ChiCTR-TRC-11001199: The efficacy of postoperative combination therapy with Thymosin alpha 1 and capecitabine for patients with hepatocellular carcinoma |
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| Completed | 4 | 120 | | Thymosin Ta1 1.6mgS taken by ubcutaneous injection twice weekly for 6 months ;Capecitabine 0.5g , orally taken twice daily for 18months | West China Hospital, West China School of Medicine, Sichuan University; Ministry of National Science and Technology, National Science and Technology Major Project of China (2008ZX10002-025) | hepatocellular carcinoma | | | | |
ChiCTR-TRC-09000588: The Protective Effect of Thymosin Alpha 1 (Zadaxin) for Small Hepatocellular Carcinoma from Recurrence/Metastasis Following Radical Resection: A Randomised Controlled Prospective Study |
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| Completed | 4 | 220 | | Thymosin Alpha 1 (Zadaxin) 1.6mg injection subcutaneously, qd for two days before surgery, tiw for twelve weeks after surgery. ;None | Liver Cancer Institute and Zhongshan Hospital, Fudan University; Sciclone Pharmaceuticals (China) LTD-Shanghai Branch Office, Sciclone Pharmaceuticals (China) LTD-Shanghai Branch Office | Hepatocellular carcinoma | | | | |
NCT04524169: Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain |
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| Not yet recruiting | 4 | 100 | RoW | Thymosin Alpha1 | RenJi Hospital | Osteoporotic Pain | 12/21 | 12/21 | | |
ChiCTR1900024098: A real world study for postoperative antiviral therapy in patients with hepatitis B related hepatocellular carcinoma |
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| Not yet recruiting | 4 | 600 | | entecavir ;tenofovir ;entecavir+thymopentin ;tenofovir+thymopentin ;entecavir+thymalfasin ;tenofovir+thymalfasin | Chinese People's Liberation Army (PLA) General Hospital; Chinese People's Liberation Army (PLA) General Hospital, Self-funding | Liver cancer | | | | |
ChiCTR2000030244: A multicenter, exploratory study about Effects of two new thymus administration schemes on immune status of patients with lung adenocarcinoma after phase IIB adjuvant chemotherapy. |
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| Not yet recruiting | 4 | 60 | | After randomization, patients received thymalfasin therapy with a dose of 1.6mg/ time, subcutaneous injection, twice a week, until the patient developed disease progression or intolerance or 24 weeks of treatment. ;After randomization, patients were treated with thymalfasin therapy at a dose of 1.6mg/ time, subcutaneous injection, and once every other day until the occurrence of disease recurrence or intolerance or the end of 24 weeks of treatment. | Shanghai Changhai Hospital; Shanghai Pharmaceutical Association, 1.194 million yuan | Lung adenocarcinoma IIB | | | | |
| Recruiting | 4 | 40 | RoW | Thymosin Alpha1, thymalfasin, Immunosuppressant, Prednisone, Cortisone, Mycophenolate Mofetil, Tacrolimus | Jun Wang | IrAE | 11/24 | 04/25 | | |
ChiCTR1800014409: Enhanced Immunotherapy for the Prevention of Postoperative Recurrence of Hepatocellular Carcinoma:A Prospective Multicenter Randomized Controlled Trial |
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| Recruiting | 4 | 438 | | Thymosin Alpha 1 (Zadaxin) 1.6mg injection subcutaneously, biw for twenty-four weeks after surgery ;none | West China Hospital of Sichuan University; West China Hospital of Sichuan University, National Science and Technology Key Projects (2017ZX10203207- 003-002); Sciclone Pharmaceuticals (China) LTD | HBV-related Hepatocellular carcinoma | | | | |
ChiCTR2200055819: Effect of Perioperative Immune Status and Long-term Prognosis of Thymosin Alpha-1 for Injection(Zadaxin) in Treatment of Patients with Colorectal Cancer: A Prospective, Randomized Controlled Trial |
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| Recruiting | 4 | 400 | | Thymosin Alpha-1 subcutaneous injection ;without Thymosin alpha-1 | The Fourth Hospital of Hebei Medical University; The Fourth Hospital of Hebei Medical University, SciClone Pharmaceuticals (Holdings) Limited; Sisco-Sciclone Cancer Research Fund Project (2020) Y-2020Sciclone/QN-0064 | colorectal cancer | | | | |
NCT05086614: Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer |
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| Recruiting | 3 | 2500 | RoW | Thymosin Alpha1, Thymalfasin | Fudan University | Stage II Colorectal Cancer, Stage III Colorectal Cancer | 03/27 | 03/27 | | |
| Completed | 2 | 55 | NA | Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T), Refnot, Tumor necrosis factor-thymosin alfa 1 recombinant, Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy, and Dacarbazine, Lomustine, Cisplatin | Refnot-Pharm Ltd | Solid Tumor | 11/11 | 11/11 | | |
2004-001927-39: A PHASE II, MULTICENTER, UNCONTROLLED, OPEN STUDY IN PATIENTS WITH CHRONIC HEPATITIS C WHO ARE INTOLERANT TO INTERFERONS THERAPYTO EVALUATE THE SAFETY AND EFFICACY OF A TREATMENT WITH THYMOSIN ALPHA 1 PLUS RIBAVIRIN. |
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| Ongoing | 2 | | Europe | NA, NA, ZADAXIN*INIETT. 1FL 1,6MG+1F, ZADAXIN*INIETT. 1FL 1,6MG+1F | SIGMA-TAU | TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C WHO ARE INTOLERANT TO INTERFERONS THERAPY | | | | |
ChiCTR-IIR-17013316: A randomized, open, multicenter phase II study for efficacy and safety of Thymalfasin Alpha-1 combined with raltitrexed in patienr with advanced colorectal cancer |
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| Recruiting | 2 | 60 | | Thymalfasin Alpha-1 and raltitrexed ;raltitrexed | Shanghai EAST Hospital; No 1800 Yuntai Rd, Shanghai, IIS | colorectal cancer | | | | |
2019-001441-40: Study of the use of the drug Thymosin alpha 1 in adults patients with Cystic Fibrosis. Studio dell'utilizzo del farmaco Timosina alfa-1 in pazienti adulti affetti da fibrosi cistica (FC). |
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| Not yet recruiting | 2 | 24 | Europe | Zadaxin, [Ta1], Lyophilisate for solution for injection | SciClone Pharmaceuticals Limited Ltd | Cystic Fibrosis Fibrosi Cistica, Cystic Fibrosis Fibrosi Cistica, Diseases [C] - Respiratory Tract Diseases [C08] | | | | |
2021-003327-15: Thymosin-α1 in immunodeficiency associated mood disorders Thymosine-α1 in immuundeficientie-geassocieerde stemmingsstoornissen |
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| Ongoing | 2 | 20 | Europe | Thymafalsin, Powder and solution for solution for injection, Thymalfasin | Erasmus MC, SciClone | Primary immunodeficiency Primaire immuundeficientie, Primary immunodeficiency Primaire immuundeficientie, Diseases [C] - Immune System Diseases [C20] | | | | |
NCT04428008: Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients |
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| Active, not recruiting | 2 | 262 | US | Thymalfasin, Thymosin alpha 1, Ta1, ZADAXIN | William B. Ershler, MD, Davita Clinical Research, Clinical Research Consultants, LLC | COVID-19 | 10/22 | 02/23 | | |
NCT04487444: Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection |
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| Terminated | 2 | 56 | US | Thymalfasin, Thymosin alpha 1, ZADAXIN (brand name), Ta1 (abbreviation) | Rhode Island Hospital | Covid19 | 02/23 | 02/23 | | |
GASTO-1098, NCT06139419: The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC |
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| Recruiting | 2 | 114 | RoW | definitive radiotherapy, induction chemo-immunotherapy, albumin-bound paclitaxel, cisplatin, tislelizumab, concurrent chemotherapy, Immunotheapy consolidation, Thymosin Alpha1, thymalfasin | Sun Yat-sen University | Non-small Cell Lung Cancer | 08/25 | 08/26 | | |
GASTO-1042, NCT03663764: Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor |
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| Active, not recruiting | 2 | 57 | RoW | Thymosin a1, hypofractionated radiotherapy, concurrent chemoradiotherapy | Sun Yat-sen University | Thymoma and Thymic Carcinoma | 08/23 | 08/23 | | |
NCT06056804: Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer |
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| Not yet recruiting | 2 | 20 | RoW | capecitabine, tislelizumab, thymalfasin, long-term radiotherapy | Beijing Friendship Hospital, Peking Union Medical College Hospital | Locally Advanced Rectal Cancer | 07/24 | 07/27 | | |
NCT06573398: Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC |
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| Not yet recruiting | 2 | 20 | NA | SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin | Ruijin Hospital | Carcinoma, Pancreatic Ductal | 09/25 | 09/27 | | |
NCT06584006: Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors |
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| Recruiting | 2 | 50 | RoW | Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections, Combination Therapy Group, Recombinant Human Interleukin-2 Injections, Monotherapy Group | The First Affiliated Hospital of Xiamen University | Hematological Malignancy, Lymphocytopenia | 11/27 | 02/28 | | |
| Recruiting | 2 | 60 | RoW | Thymalfasin, Thymosin alpha-1, Radiotherapy, PD-1/PD-L1 inhibitor, PD-1/PD-L1 antibody, GM-CSF, :Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor for Injection | Second Affiliated Hospital of Soochow University, SciClone Pharmaceuticals | Advanced Solid Tumor, Refractory Tumor | 05/25 | 12/25 | | |
ChiCTR2300076873: The synergistic and attenuated mechanism of Xihuang pill in dual immunotherapy after stenting for advanced cholangiocarcinoma (PTIBS) |
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| Not yet recruiting | 1 | 90 | | Tumor Dual Immunotherapy Regimen (Tirilizumab Injection + Thymofaxine Injection). Tirilizumab Injection is administered by intravenous infusion at a recommended dose of 200 mg by intravenous infusion every 3 weeks until disease progression or intolerable toxicity occurs. Thymofaxine for Injection is administered at a dose of 1.6 mg subcutaneously twice weekly, 3 to 4 days apart. The course of treatment should last 4 weeks (8 injections total).; Only the tumor immunosuppressant (Tirilizumab injection) was administered. Tirilizumab Injection is administered by intravenous infusion at a recommended dose of 200 mg by intravenous infusion every 3 weeks until disease progression or intolerable toxicity occurs.; Xihuang Pills combined with tumor double immunization (Tirelizumab Injection + Thymalfasin Injection); Xihuang Pills (Tongrentang Pharmaceuticals, Lot No. 20130619), 3g /times, 2 times/d, the course of treatment is 2 months. Xihuang Pills Usage and Dosage: Oral. 3g once, twice a day. Tirilizumab Injection is administered by intravenous infusion, and the recommended dose for intravenous infusion is 200 mg every 3 weeks until disease progression or intolerable toxicity occurs. Thymofaxine for Injection is administered at a dose of 1.6 mg subcutaneously twice weekly, 3 to 4 days apart. The course of treatment should last 4 weeks (8 injections total). | Affiliated Hospital of Jiangnan University; Affiliated Hospital of Jiangnan University, Wuxi Traditional Chinese Medicine Administration Science and Technology Project Plan | Cholangiocarcinoma | | | | |
ChiCTR2000033765: Impact of thymosin alpha1 as an immunomodulatory treatment on long-term survival of postoperative non-small cell lung cancer patients: a medical records based propensity score-matched analysis from a high-volume center in China |
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| Not yet recruiting | N/A | 6500 | | postoperative adjuvant thymosin α1 therapy ;without thymosin α1 therapy | West China Hospital of Sichuan University; West China Hospital of Sichuan University, the Grants from National Natural Science Foundation of China, Science Foundation of Sichuan Province | Non-smll cell lung cancer | | | | |
ChiCTR1900025367: Efficacy and safety of Thymosin alpha 1 combined with anti-PD-1 and Apatinib in advanced gastric cancer patients failed to second line treatment |
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| Not yet recruiting | N/A | 30 | | Thymosin alpha 1 combined with PD-1 antibody and Apatinib ;PD-1 and Apatinib | Shanghai Dongfang Hospital; Shanghai Dongfang Hospital, Funded by Hangzhou Oriental Oncology Center | Advanced Gastric Cancer | | | | |
NCT05487469: Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass |
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| Recruiting | N/A | 200 | RoW | Thymosin Alpha1, Blank Control | Nanjing Medical University | Rheumatic Heart Disease, Cardiopulmonary Bypass, Immunotherapy | 12/23 | 12/23 | | |
NCT05339529: Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (Panda II) |
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| Recruiting | N/A | 300 | RoW | Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-, Blank control | Nanjing Medical University, Beijing Anzhen Hospital, Second Affiliated Hospital of Nanchang University, Qilu Hospital of Shandong University, The First Affiliated Hospital of Guangzhou Medical University, Northern Jiangsu People's Hospital, Guangdong Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University, Nanjing First Hospital, Nanjing Medical University, Shanghai East Hospital,Tongji University School of Medicine, The Seventh Affiliated Hospital of Xinjiang Medical University, Teda International Cardiovascular Hospital, Tianjin, China, First Affiliated Hospital Bengbu Medical College, West China Hospital Affiliated with Sichuan University | Acute Aortic Syndrome, Aortic Dissection Type A | 12/24 | 12/24 | | |
NCT06024356: Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer |
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| Not yet recruiting | N/A | 26 | RoW | Thymalfasin | Beijing Friendship Hospital | Colorectal Neoplasms | 12/23 | 03/24 | | |
| Recruiting | N/A | 40 | RoW | Thymosin Alpha1, Tα1, Thymalfasin | Yousheng Mao | Non Small Cell Lung Cancer | 09/25 | 12/25 | | |
NCT06607926: Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC |
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| Not yet recruiting | N/A | 40 | RoW | Thymosin Alpha 1, thymalfasin, Tislelizumab, Platinum-doublet chemotherapy | Xuanwu Hospital, Beijing | Resectable Non-Small-Cell Lung Cancer | 06/25 | 12/25 | | |
NCT04901104: Long-term Prognosis of Patients With Sepsis After Immunotherapy |
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| Not yet recruiting | N/A | 900 | NA | Thymosin Alpha1 | Sun Yat-sen University | Long-term Effects of Thymosin Alpha 1 Treatment | 12/26 | 03/27 | | |
| imifoplatin (PT-112) / Promontory Therap |
NCT02266745: A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts |
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| Active, not recruiting | 2 | 109 | Europe, US | PT-112 Injection, PT-112 | Promontory Therapeutics Inc. | Advanced Solid Tumors, CRPC, mCRPC, Metastatic Castrate-resistant Prostate Cancer, PT-112, Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site | 08/24 | 04/25 | | |
NCT05104736: PT-112 in Subjects With Thymoma and Thymic Carcinoma |
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| Recruiting | 2 | 53 | US | PT-112 | National Cancer Institute (NCI) | Thymic Epithelial Tumor, Recurrent Thymoma, Thymic Cancer | 06/25 | 06/25 | | |
PAVE-1, NCT03409458: A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab |
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| Completed | 1/2 | 68 | Europe, US | PT-112, avelumab | Promontory Therapeutics Inc., Pfizer, EMD Serono | Non-Small Cell Lung Cancer (NSCLC) | 06/22 | 08/22 | | |
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NCT05357196: PT-112 (Phosplatin's Platinum) Combine With Gemcitabine Injection for Advanced Solid Tumors |
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| Recruiting | 1/2 | 68 | RoW | PT-112, Gemcitabine | SciClone Pharmaceuticals | Biliary Tract Cancer | 08/22 | 04/23 | | |
| Recruiting | 1 | 84 | US | PT-112, Phone Call | M.D. Anderson Cancer Center, Phosplatin Therapeutics | Solid Tumors | 07/20 | | | |
| nibrozetone (RRx-001) / EpicentRx |
REPLATINUM, NCT05566041: A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer |
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| Active, not recruiting | 3 | 292 | US | RRx-001 + eLOOP Device, Cisplatin/carboplatin plus etoposide | EpicentRx, Inc., Sciclone Pharmaceuticals (China) Co., Ltd. | Carcinoma, Small Cell Lung | 12/25 | 12/25 | | |
KEVLARx, NCT05966194: RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer |
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| Recruiting | 2 | 216 | US | RRx-001, Intensity Modulated Radiation Therapy (IMRT), Cisplatin for injection 100 mg/m2 | EpicentRx, Inc. | Oral Mucositis | 07/25 | 10/25 | | |
PIRATE, NCT04525014: RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors |
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| Terminated | 1 | 2 | US | RRx-001, Temozolomide, Irinotecan | EpicentRx, Inc., Texas Children's Cancer Center | Brain Tumor, Recurrent, Brain Tumor, Pediatric, Central Nervous System Neoplasms, Unspecified Childhood Solid Tumor, Protocol Specific | 07/24 | 07/24 | | |
| locnartecan (PEN-866) / Tarveda Therap, National Cancer Institute - Bethesda |
NCT03221400: PEN-866 in Patients With Advanced Solid Malignancies |
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| Recruiting | 1/2 | 340 | US | PEN-866 Sodium, fluorouracil, 5-Fluorouracil, 5-FU, Folinic acid, Leucovorin, Niraparib, Zejula | Tarveda Therapeutics | Carcinoma, Endometrial Adenocarcinoma, Neoplasms, Squamous Cell Carcinoma of the Anus, Adenocarcinoma of the Pancreas, Advanced Cancer, Solid Tumor, Solid Carcinoma, Squamous Cell Carcinoma of the Cervix, Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Vulva, Squamous Cell Carcinoma of the Penis, Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Small-cell Lung Cancer, Small Cell Lung Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma | 01/23 | 06/23 | | |
NCT04890093: Vincristine and Temozolomide in Combination With PEN-866 for Adolescents and Young Adults With Relapsed or Refractory Solid Tumors |
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| Recruiting | 1/2 | 64 | US | PEN-866, Vincristine, Temozolomide | National Cancer Institute (NCI) | Sarcoma, Ewing, Rhabdomyosarcoma | 02/26 | 12/26 | | |
| Danyelza (naxitamab-gqgk) / Y-mAbs Therap |
NCT06047535: Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response. |
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| Not yet recruiting | 4 | 62 | NA | Naxitamab, GM-CSF, isotretinoin | SciClone Pharmaceuticals | Neuroblastoma | 06/27 | 08/27 | | |
NICE, NCT06438614: A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma |
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| Completed | 2 | 47 | Europe | HITS, Naxitamab + GM-CSF cycles, NICE | Fundació Sant Joan de Déu | Refractory Neuroblastoma, Soft Tissue Cancer | 07/23 | 10/23 | | |
2022-003812-98: To evaluate the efficacy and safety of naxitamab in patients with refractory Ewing's sarcoma. Ocena skuteczności i bezpieczeństwa zastosowania naksytamabu u pacjentów z opornym na leczenie mięsakiem Ewinga. |
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| Not yet recruiting | 2 | 24 | Europe | Concentrate for solution for infusion, DANYELZA | Institute of Mother and Child, Medical Research Agency | Ewing's sarcoma, Ewing's sarcoma, Diseases [C] - Cancer [C04] | | | | |
NCT03033303: A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma |
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| Active, not recruiting | 2 | 59 | US | Hu3F8, GM-CSF, Isotretinoin | Memorial Sloan Kettering Cancer Center, Y-mAbs Therapeutics | Neuroblastoma | 06/25 | 06/25 | | |
NCT06528496: N10: a Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children with Neuroblastoma |
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| Recruiting | 2 | 45 | US | DANYELZA, Naxitamab, Sargramostim, granulocyte-macrophage colony-stimulating factor, GM-CSF, Cytoxan, Cyclophosphamide, Topotecan, Vincristine, Oncovin, Doxorubicin, Adriamycin, Ifosfamide, Isophosphamide, Etoposide, VePesid, Etopophos, VP-16, Carboplatin, Paraplatin, Irinotecan, Camptosar, Temozolomide, Temodar | Memorial Sloan Kettering Cancer Center | High-risk Neuroblastoma, Neuroblastoma, Childhood Neuroblastoma | 07/29 | 07/29 | | |
NCT06540963: Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma |
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| Not yet recruiting | 2 | 98 | US | Tipifarnib, R115777, Naxitamab, Danyelza | Giselle Sholler | Neuroblastoma Recurrent | 08/30 | 08/35 | | |
| Recruiting | 2 | 29 | RoW | Natural killer cell, NK cell, Dinutuximab beta, Ch14.18, Interleukin-2, Aldesleukin, Granulocyte-Macrophage Colony-Stimulating Factor, Sargramostim, Spironolactone, Aldactone, Naxitamab, hu3F8 | Hong Kong Children's Hospital, The University of Hong Kong | Neuroblastoma Recurrent | 12/24 | 12/25 | | |
NCT06013618: Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma |
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| Recruiting | 2 | 30 | RoW | Naxitamab monotherapy, hu3F8, GM-CSF, Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor, Irinotecan, DNA topoisomerase I inhibitor, Temozolomide, Temozolomide for Injection, Naxitamab in combination therapy, GM-CSF with combination regimen, Sintilimab, PD-1 antibody | Sun Yat-sen University, Hainan General Hospital | Neuroblastoma | 12/24 | 12/24 | | |
| Recruiting | 2 | 122 | Europe, Canada, US, RoW | GM-CSF + Naxitamab | Y-mAbs Therapeutics | Neuroblastoma | 04/26 | 04/28 | | |
NCT02502786: Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma |
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| Active, not recruiting | 2 | 46 | US | humanized anti-GD2 antibody, hu3F8, GM-CSF | Memorial Sloan Kettering Cancer Center, Children's Hospital Los Angeles, M.D. Anderson Cancer Center, Y-mAbs Therapeutics | Recurrent Osteosarcoma | 07/25 | 07/25 | | |
NCT05489887: Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma |
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| Recruiting | 2 | 76 | Canada, US | Naxitamab, Danyelza, Ceritinib | Giselle Sholler, Y-mAbs | High-risk Neuroblastoma | 09/26 | 09/33 | | |
NCT05968768: To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly) |
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| Recruiting | 2 | 24 | Europe | Naxitamab, danyelza | Anna Raciborska, Wroclaw Medical University | Ewing Sarcoma | 05/27 | 07/28 | | |
NCT01757626: Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma |
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| Active, not recruiting | 1/2 | 186 | US | Hu3F8 With GM-CSF | Memorial Sloan Kettering Cancer Center, Y-mAbs Therapeutics | Neuroblastoma | 12/25 | 12/25 | | |
NCT06026657: Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer |
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| Recruiting | 1/2 | 42 | US | Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Gemcitabine, dFdC, dFdCyd, Difluorodeoxycytidine, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, Naxitamab, Anti-Gd2 IGG3 Monoclonal Antibody 3f8 Humanized, Danyelza, Hu3F8, Humanized Anti-GD2 Antibody 3F8, Humanized Monoclonal Antibody Hu3f8-IGG1, Universal Donor Expanded TGF-beta-imprinted NK Cells, Allogeneic TGFBi Expanded NK Cells, UD TGF-betai NK Cells, Universal Donor TGF-beta Imprinted Expanded NK Cells | Margaret Gatti-Mays | Anatomic Stage IV Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma | 12/24 | 12/24 | | |
NCT01419834: Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors |
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| Completed | 1 | 68 | US | Humanized 3F8 Monoclonal Antibody (Hu3F8) | Memorial Sloan Kettering Cancer Center, Band of Parents, Y-mAbs Therapeutics | Neuroblastoma | 08/23 | 08/23 | | |
NCT02650648: Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma |
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| Active, not recruiting | 1 | 85 | US | cyclophosphamide, Cytoxan®, NK cells, hu3F8, rIL-2 | Memorial Sloan Kettering Cancer Center, Y-mAbs Therapeutics | Neuroblastoma, High-Risk | 01/25 | 01/25 | | |
NCT03189706: Study of Chemoimmunotherapy for High-Risk Neuroblastoma |
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| Active, not recruiting | 1 | 48 | US | Irinotecan, temozolomide, Hu3F8, GM-CSF | Memorial Sloan Kettering Cancer Center, Y-mAbs Therapeutics | Neuroblastoma (NB) | 06/25 | 06/25 | | |
NCT04501757: Naxitamab and GM-CSF in People With Neuroblastoma |
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| No Longer Available | N/A | | US | Naxitamab/GM-CSF | Memorial Sloan Kettering Cancer Center | High-Risk Neuroblastoma | | | | |
NCT02307630: PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study |
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| Active, not recruiting | N/A | 7 | US | 124I-Humanized 3F8 | Memorial Sloan Kettering Cancer Center, Y-mAbs Therapeutics | Melanoma, Neuroblastoma, Sarcoma | 11/24 | 11/24 | | |
NCT06574698: Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma |
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| Recruiting | N/A | 64 | RoW | Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy | Guangzhou Women and Children's Medical Center | Neuroblastoma, GD2 Antibody (Naxitamab) | 12/29 | 12/32 | | |
| ibrilatazar (ABTL0812) / Ability Pharma |
| Not yet recruiting | 1/2 | 46 | NA | sodium 2-hydroxylinoleate | Ability Pharmaceuticals SL | Pancreatic Cancer | 07/19 | 07/21 | | |
2020-002791-13: A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer |
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| Not yet recruiting | 1/2 | 144 | Europe | ABTL0812, ABTL0812, Oral solution | Ability Pharmaceuticals, SL, Ability Pharmaceuticals, SL | Metastatic pancreatic cancer, Pancreatic cancer, Diseases [C] - Cancer [C04] | | | | |
| Suspended | 1/2 | 60 | Europe | ABTL0812, Gemcitabine and nab-paclitaxel | Ability Pharmaceuticals SL, The Cleveland Clinic | Pancreatic Cancer | 04/23 | 12/24 | | |
PanC-ASAP, NCT04431258: ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study |
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| Completed | 1/2 | 150 | Europe, US, RoW | ABTL0812, Folfirinox, Chemotherapy, Placebo | Ability Pharmaceuticals SL | Pancreatic Cancer | 01/24 | 01/24 | | |
| ZN-e4 / Zentalis Pharma |
| No trials found |
