[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epithelioid-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epithelioid-sarcoma":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,59,82,99,130,160,184],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":42,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100564132","phase-1-alphabeta-t-and-b-cell-depletion-with-zoledronic-acid-for-solid-tumors-100564132",false,"NCT06625190","Alpha\u002FBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors","Allogeneic Stem Cell Transplantation Utilizing Alpha\u002FBeta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Patients 6 months to ≤ 25 years old\n* Relapsed\u002FRefractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \\>20% chance of cure with the following diseases:\n\n  1. neuroblastoma (high risk with relapsed or refractory disease),\n  2. relapsed\u002Frefractory rhabdomyosarcoma,\n  3. relapsed\u002Frefractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),\n  4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,\n  5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor\n  6. relapsed\u002Frefractory bone tumors: osteosarcoma and Ewing sarcoma\u002FPNET, or\n  7. Wilm's tumor or other high-risk solid tumors with \\\u003C10% expected survival with conventional treatment.\n* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included.)\n* Haplo-identical related donor (at least one full haplotype must be matched).\n* Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age\n* Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\n  1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n  2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n  3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.\n* Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.\n\nExclusion Criteria:\n\n* Patients with documented uncontrolled infection at the time of study entry are not eligible.\n\n  a. Uncontrolled infection is patient without treatment antimicrobials and\u002For demonstrating progression despite antimicrobials\n* Patients with progressive solid tumor disease after relapsed\u002Frefractory treatment.\n* Demonstrated lack of compliance with medical care, as determined by the treating physician.\n* Patients who have received an allogeneic HSCT within 6 months.\n* Patients who do not have an eligible allogeneic donor available.\n* Patients with a life expectancy \\\u003C3 months\n* Patients not meeting inclusion criteria for organ function.\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.\n* Females who are known to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","ALL","6 Months","25 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.\n\nWhile solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.\n\nBy utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed\u002Frefractory solid tumors and promote an improved event-free survival and overall survival.\n\nThis study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Neuroblastoma","Rhabdomyosarcoma","Synovial Sarcoma","Peripheral Nerve Sheath Tumors","Clear Cell Sarcoma","Alveolar Soft Part Sarcoma","Desmoplastic Small Round Cell Tumor","Chordoma","Rhabdoid Tumor","Epithelioid Sarcoma","Myoepithelial Tumor","Osteosarcoma","Ewing Sarcoma","Wilms Tumor",[43,44,45],"pediatric solid tumors","stem cell transplantation","graft manipulation","RECRUITING","2026-06-25",{"date":49,"type":50},"2026-06-30","ACTUAL",{"date":52,"type":50},"2026-02-11",{"date":54,"type":21},"2030-02",{"name":56,"class":57},"University of Florida","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":58},"100550269","phase-2-phase-ii-trial-of-ubamatamab-alone-or-in-combination-with-cemiplimab-in-muc16-expressing-smarcb1-deficient-malignancies-100550269","NCT06444880","Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies","Inclusion Criteria:\n\n1. Participants with locally advanced or metastatic RMC (RMC cohort) or ES (ES cohort) histologically confirmed by expert pathology review and loss of SMARCB1 staining by IHC. Participants with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare SMARCB1 negative RMC variant occurring in individuals without sickle hemoglobinopathies) are also eligible for the RMC cohort.\n2. Eligible participants should either demonstrate serum CA-125 levels ≥ 70 units\u002Fml during screening or positive H score of \\>25 for MUC16 (CA-125) by IHC in tumor tissues collected within 12 months from screening as noted in participant EMR:\n\n   1. The H score is calculated using the standard formula commonly used in IHC: H score = \\[(0 x % negative cells) + (1 x % weak positive cells) + (2 x % moderate positive cells) + (3 x % strong positive cells). For instance, if 50% of tumor cells show weak staining, 30% of tumor cells show moderate staining, and 20% of cells show strong staining, the H-score would be: (50×1)+(30×2)+(20×3)=50+60+60=170.\n   2. If serum CA-125 ≥ 70 units\u002Fml then participants will be enrolled without delay. IHC for MUC16 will be used as a correlative biomarker but not for trial eligibility.\n   3. If serum CA-125 \\\u003C 70 units\u002Fml then for trial eligibility, MUC16 expression should be checked by IHC in tumor tissues collected within 12 months from screening:\n\n   i. If H score is \\\u003C 25 then the patient will not be eligible for the trial ii. If H score ≥ 25 then the patient will be eligible for the trial\n3. Participants will be eligible in the RMC cohort regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ.\n4. Participants must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures ≥ 15 mm with conventional techniques or ≥ 10 mm with more sensitive techniques such as MRI or CT scan. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.\n5. Participants must have progressed on at least one line of prior therapy.\n6. There must be evidence of progression on or after last treatment regimen received.\n7. ECOG performance status 0-1\n\n   a. NOTE: If participant is unable to walk due to paralysis, but is mobile in a wheelchair, participant is considered to be ambulatory for the purpose of assessing their performance status.\n8. Age (at the time of consent\u002Fassent): ≥ 18 years\n\n   a. RMC is the third most common renal cell carcinoma in children and young adults in the United States21 and while we will initially enroll participants aged ≥18 years old, we will in coordination with Regeneron consider allowing pediatric participants ≥12 years old if no trial limiting toxicities (TOX), as defined in Section 9.1.2., after the interim analysis of the first 10 participants enrolled and based on the accumulated pharmacokinetic \u002F pharmacodynamic data of ubamatamab in this population at that time. If these criteria are fulfilled, then adolescent participants age 12 years and older will be allowed with signed assent and parental consent according to institutional guidelines and requirements, as long as their weight is \\>40 kg given that this is the lower weight limit for which safety following ubamatamab with or without cemiplimab exposure has been ascertained.\n9. Consent to MD Anderson companion laboratory protocol 2014-0938\n10. Participants must have adequate organ and marrow function as defined below:\n\n    Hemoglobina ≥ 9 g\u002Fdl (treatment allowed) Absolute neutrophil countb ≥ 1,000\u002FµL Platelets ≥ 75,000\u002FµL Total bilirubin ≤ 1.5 mg\u002Fdl AST(SGOT) or ALT (SGPT) ≤ 2.5 X institutional ULN, except in known hepatic metastasis, wherein may be ≤ 5 x ULN Serum Creatininec ≤ 1.5 x ULN by gender (as long as patient does not require dialysis)\n\n    a May receive transfusion within the screening period b Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days c If creatinine is not \\\u003C1.5×ULN, then calculate by Cockcroft-Gault methods or local institutional standard and CrCl must be \\>30 mL\u002Fkg\u002F1.73 m2\n11. Participants with controlled brain metastases are allowed on protocol if the brain metastases were surgically resected or treated with radiosurgery or Gamma knife, without recurrence or edema for 1 month (4 weeks). Participants actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible.\n12. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of the study drug.\n13. Women must not be breastfeeding.\n14. WOCBP must agree to follow instructions for method(s) of contraception from the time of registration for treatment for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion. Men must agree to effective contraception from the time of registration for treatment to 7 months post last protocol treatment.\n\n    Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male participants who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of \\\u003C 1% per year when used consistently and correctly.\n\n    Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Patient\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n    Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of ubamatamab\u002Fcemiplimab administration.\n\n    The effects of ubamatamab\u002Fcemiplimab on the developing human fetus are unknown. For this reason and because immunotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early stage prostate adenocarcinoma with negligible risk of metastasis or death\n2. Participants previously treated with T-cell-redirecting bispecific antibodies or MUC16-targeted therapies (including vaccines) are excluded. Participants who received CAR-T therapies within 30 days of first dose of study drug are also excluded. However, participants previously treated with immune checkpoint therapies such as anti-PD1, anti-PD-L1, anti-CTLA-4, or anti-LAG-3 immune checkpoint inhibitors are eligible, as long as they have been off these therapies for at least 60 days (\\~3 half-lives) prior to initiation of study treatment with ubamatamab.\n3. Participants currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapies such as tazemetostat) within 2 weeks (14 days) prior to study Day 1 are excluded. Participants who have completed palliative radiation therapy more than 14 days prior to the first dose of the combination immunotherapy are eligible.\n4. Participants with persistent grade ≥2 adverse events from prior systemic therapies that would confound timely detection of immune-related adverse events due to ubamatamab and\u002For cemiplimab or otherwise hinder patient participation in the clinical trial.\n5. Participants, who have had a major surgery or significant traumatic injury (injury requiring \\> 4 weeks (28 days) to heal) within 4 weeks (28 days) of start of study drug, participants who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).\n6. Participants who have organ allografts.\n7. Known or suspected autoimmune disease. Participants with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], Systemic Lupus Erythematosus or autoimmune vasculitis \\[e.g., Wegener's Granulomatosis\\] are excluded from this study. Participants with a history of Hashimoto's thyroiditis only requiring hormone replacement, Type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate.\n8. Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency.\n\n   1. Participants with HIV who have controlled infection (undetectable viral load with the exception of clinically insignificant blips and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.\n   2. Participants with hepatitis B surface antigen positive (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are permitted.\n   3. Participants with HBsAg negative but total HBV core antibody positive (HBc Ab+) are permitted with the following requirements: Serum HBV DNA PCR should be tested and if it is above the limit of detection at screening then antiviral therapy for HBV must be initiated prior to study entry. If serum HBV DNA PCR is below the limit of detection periodic monitoring of HBsAg must be performed every 12 months +\u002F- 3 months.\n   4. Participants who are Hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n9. Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting. Patients with active COVID-19 disease as indicated by a positive polymerase reaction (PCR) test are excluded. Participants with previous COVID-19 disease are allowed if ≥30 days from last positive test, and COVID-19 symptoms have resolved and\u002For PCR test is now negative.\n10. Participants must not be scheduled to receive another experimental drug while on this study.\n11. Participants who are on high dose steroid (e.g., \\> 10mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g., infliximab). Topical, inhaled, intra-articular, ocular, or intranasal corticosteroids (with minimal systemic absorption) are allowed. A brief course (\\\u003C48 hours) of systemic corticosteroids for prophylaxis (eg, from contrast dye allergy) is permitted. Physiological corticosteroid replacement therapy for adrenal insufficiency (up to hydrocortisone 30 mg \u002F daily or equivalent) is also permitted.\n12. Left ventricular ejection fraction (LVEF) assessment with documented LVEF \\\u003C 50% by transthoracic echocardiogram (TTE) within 6 months prior to start of study treatment. In cases of LVEF 45-50% in absence of clinical symptoms, after review and clearance by cardiologist, the patient may be enrolled.\n13. Active myocarditis, regardless of etiology.\n14. Moderate to large pericardial effusion (eg, \\> approximately 100 mL) as measured by echocardiogram at baseline. Multigated acquisition (MUGA) is not sufficient for evaluating pericardial effusion.\n15. Has a history of any clinically significant arrhythmia including atrial fibrillation or implantation of a pacemaker or defibrillator.\n16. Participants who have any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\n\n    1. Symptomatic congestive heart failure of New York heart Association Class III or IV\n    2. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\n    3. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment.\n    4. Participants with a history of major psychiatric illness judged unable to fully understand the investigational nature of the study and the risks associated with the therapy.\n17. Participants must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ubamatamab or cemiplimab or that might affect the interpretation of the results of the study or render the participant at high risk from treatment complications.\n18. Participants should not receive immunization with attenuated live vaccines within 30 days of planned start of study medication.\n\n    a. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n19. Female participants who are pregnant or breast feeding, or adults of reproductive potential who are not willing to use effective birth control methods as defined above.\n20. Any participants who cannot be compliant with the appointments required in this protocol must not be enrolled in this study.\n21. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ubamatamab or cemiplimab.\n22. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","12 Years",{"count":67,"type":21},40,[25],"To find out if ubamatamab, given by itself or in combination with cemiplimab, can help to control the disease in participants with renal medullary carcinoma (RMC) and epithelioid sarcoma (ES).",[71,37,72],"SMARCB1-Deficient Malignancies","Renal Medullary Carcinoma","2026-06-16",{"date":75,"type":50},"2026-06-18",{"date":77,"type":50},"2024-10-09",{"date":79,"type":21},"2028-07-31",{"name":81,"class":57},"M.D. Anderson Cancer Center",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":4,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":96,"locationsCount":4},"100631594","compassionate-use-of-ubamatamab-100631594","NCT07502716","Compassionate Use of Ubamatamab","Eligibility will be determined during the application review process.","EXPANDED_ACCESS","Provide Compassionate Use of Ubamatamab",[91,37],"Renal Medullary Carcinoma (RMC)","AVAILABLE","2026-03-24",{"date":95,"type":50},"2026-03-31",{"name":97,"class":98},"Regeneron Pharmaceuticals","INDUSTRY",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":119,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100360033","multimodal-immune-characterization-of-rare-soft-tissue-sarcoma---miras-project-from-sarra-sarcome-rare-project-of-the-french-sarcoma-group-100360033","NCT03967834","Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group","MIRAS","Inclusion Criteria:\n\n1. Age ≥18 years at the time of study entry.\n2. Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:\n\n   * Clear Cell Sarcoma (CCS)\n   * Epithelioid Sarcoma (ES)\n   * Perivascular Epithelioid Cell neoplasm (PEComa)\n   * Desmoplastic Small Round Cell Tumours (DSRCT)\n   * Malignant Solitary Fibrous Tumours (mSFT)\n   * Alveolar Soft Part Sarcoma (ASPS)\n   * Epithelioid Hemangioendothelioma (EH)\n   * Low-Grade Fibromyxoid Sarcoma (LGFS)\n   * Sclerosing Epithelioid Fibrosarcoma (SEF).\n3. Localized\u002Flocally advanced or metastatic disease.\n4. In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).\n5. In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.\n6. Patient followed in the center within a standard of care procedure or clinical trial.\n7. Archived tumor specimen at initial diagnosis available (before treatment initiation).\n8. Evaluable disease (measurable as per RECIST 1.1) or not.\n9. ECOG Performance status 0-3.\n10. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.\n11. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Diagnosis of all other histotypes of soft tissue sarcoma.\n2. Any condition contraindicated with procedures required by the protocol.\n3. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n5. Pregnant or breast-feeding woman.\n6. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.","18 Years",{"count":108,"type":21},400,[110],"NA","This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.\n\n400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.\n\nRetrospective cases of patients (100 cases in total) will be identified in all centers through the GSF\u002FGETO clinical databases already setted up (including the clinical base Conticabase).",[113,32,37,114,34,115,33,116,117,118],"Soft Tissue Sarcoma","Perivascular Epithelioid Cell Neoplasms","Malignant Solitary Fibrous Tumors","Epithelioid Hemangioendothelioma","Low Grade Fibromyxoid Sarcoma","Sclerosing Epithelioid Fibrosarcoma",[113,32,37,114,34,115,33,116,117,118],"2026-02-09",{"date":122,"type":50},"2026-02-10",{"date":124,"type":50},"2021-04-26",{"date":126,"type":21},"2031-04",{"name":128,"class":57},"Institut Claudius Regaud",20,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100392493","phase-1-evaluate-the-safety-and-clinical-activity-of-hh2853-100392493","NCT04390737","Evaluate the Safety and Clinical Activity of HH2853","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed\u002FRefractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors","Inclusion criteria:\n\n1. Provided signed written informed consent prior to initiation of any study-related procedures;\n2. Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age);\n3. Tumor type criteria:\n\nThe specific requirements for specific subtypes of recurrent\u002Frefractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows:\n\nHistologically confirmed follicular lymphoma (FL) that has been treated with at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies) according to GELF criteria or as determined by researchers (Grade 1-3a); Relapsed\u002Frefractory diffuse large B-cell lymphoma - non-specific (DLBCL NOS, 2016 World Health Organization Lymphoma Classification) that has received at least two treatment regimens in the past (at least one with CD20 monoclonal antibody as the main treatment, with a maximum number of treatment lines\\\u003C5), and is not a candidate for salvage treatment or autologous\u002Fallogeneic stem cell transplantation.\n\nRelapsed\u002Frefractory clinicopathologically documented PTCL with at least 1 line of prior systemic treatment (maximum \\\u003C5 lines). Solid tumors that meet the following criteria:\n\n1. Histologically or cytologically documented advanced recurrent or metastatic solid tumor.\n2. Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been treated with radiotherapy or other local treatment are generally considered unmeasurable unless there is definite progression of the lesion.)\n3. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. One of the following criteria should be met.\n\nPatients must experience at least one prior standard therapy. Disease progression occurred on or after last line of therapy, or intolerant to last line of therapy (maximum ≤3 lines, Patients without treatment options available known to provide clinical benefit are also eligible upon agreement from investigator and sponsor) There is no approved therapy, or for which standard therapy is unsuitable or refused by patients after being fully informed.\n\nFor epithelioid sarcoma in Phase I and Phase II cohort 2:\n\n1. Confirmed by local histology or cytology\n2. Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity).\n\nFor solid tumors in Phase I and Phase II queue 3:\n\n1. Confirmed by local pathology as advanced recurrent or metastatic solid tumor.\n2. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1; 5. Availability of archival tissue within three years 6. Relapsed\u002FRefractory FL, Epithelioid sarcoma, relapsed\u002Frefractory PTCL, other relapsed\u002Frefractory non-Hodgkin's lymphomas with EZH2 mutation, and advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or\u002Fand SMARCA4 mutation 7. Predicted life expectancy of ≥ 3 months; 8. Patient must meet the following laboratory values: 1.Serum total Bilirubin ≤ 1.5 x ULN or ≤ 3.0 mg\u002FdL for patients with Gilbert's syndrome 2.AST\u002FSGOT and ALT\u002FSGPT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present 3.24-hour creatinine clearance (calculated\\* or measured value\\*\\*)≥ 50 mL\u002Fmin 4.Platelets ≥ 1 x LLN (no Platelet transfusion for 7 days prior to screening) 5.Hemoglobin (Hgb) ≥ 9 g\u002FdL 6.Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\\^9\u002FL 7.Adequate coagulation function: International normalized ratio (INR) \\\u003C1.3 (or \\\u003C3.0 on anticoagulants) 9. Measurable lesion\n\nExclusion Criteria:\n\n1. Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five half-lives; Local radiotherapy within 14 days of first dose.\n2. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.\n3. Patients with prior transplant are excluded;\n4. Major surgery within 4 weeks prior to first dose;\n5. A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose;\n6. HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥ 10\\^3 copies or ≥ 200 IU\u002FmL; HCV antibody test results are positive, and HCV (hepatitis C virus) RNA PCR test results are positive).\n7. Concomitant malignancies or previous malignancies\n8. Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited except low molecular weight heparin and direct oral anticoagulants.\n9. Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1\n10. There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet\u002Fantithrombotic drugs.\n11. Gastrointestinal condition which could impair absorption of study medication;\n12. Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol;\n13. Cardiac exclusion criteria:\n\n1.History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 3 months prior to first dose of study drug; 2.Fridericia's corrected QT interval (QTcF) \\> 450 ms (for male) and \\> 470 ms (for female) on ECG conducted during screening; 3.Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death; 4.History or current evidence of serious uncontrolled ventricular arrhythmias; 5.Symptomatic congestive heart failure (Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system) within the previous 3 months; 6.Left ventricular ejection fraction (LVEF) \\\u003C 50%; 14. Any evidence of serious active infections requiring antibiotics; 15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or their excipients; 16. Pregnant or breast-feeding female; 17. Contraception: 18. Other serious illness or medical conditions at the Investigator's discretion, that may influence study results 19. Previously received treatment with EZH2 or EZH1\u002F2 inhibitors. 20. Grade 3b FL or evidence of transformation to invasive lymphoma",{"count":138,"type":21},254,[24,25],"This is an open-label, multicenter, first-in-human phase I\u002FII study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.",[142,37,143,144],"FL Lymphoma","Peripheral T Cell Lymphoma","Advanced Solid Tumor",[146,147,148,149],"Phase I\u002FII","HH2853","PRC2","EZH 1\u002F2 inhibitor","2026-01-28",{"date":152,"type":50},"2026-01-30",{"date":154,"type":50},"2020-09-08",{"date":156,"type":21},"2028-12-31",{"name":158,"class":98},"Haihe Biopharma Co., Ltd.",25,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":183},"100293424","an-observational-study-on-epithelioid-sarcoma-100293424","NCT03099681","An Observational Study on Epithelioid Sarcoma","Epithelioid Sarcoma. An Observational Study","EPISObs","Inclusion criteria\n\n1. Histological diagnosis of epithelioid sarcoma according to 2014 World Health Organization (WHO) classification, performed on biopsy or surgical specimen\n2. Signed informed consent\n3. Adequate patient compliance to treatment or follow up\n4. No age limit\n\nExclusion criteria\n\n1. Other malignancies within past 5 years, with exception of carcinoma in situ of the cervix and basocellular skin cancers treated with eradicating intent\n2. Impossibility to ensure adequate compliance",{"count":169,"type":21},100,"OBSERVATIONAL","Prospective Italian study aimed to provide a description of the population affected by Epithelioid Sarcoma (ES)",[37],"2025-11-17",{"date":175,"type":50},"2025-11-18",{"date":177,"type":50},"2017-08-22",{"date":179,"type":21},"2030-03-31",{"name":181,"class":182},"Italian Sarcoma Group","NETWORK",11,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":58},"100537386","phase-2-masct-i-combined-with-doxorubicin-and-ifosfamide-for-first-line-treatment-of-advanced-soft-tissue-sarcoma-100537386","NCT06277154","MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma","A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age≥18 years and≤70 years;\n2. According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.\n3. No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.\n4. At least one measurable and assessable lesion defined by RECIST 1.1;\n5. ECOG performance status of 0-1;\n6. Estimated life expectancy≥6 months;\n7. Pulmonary function is basically normal;\n8. Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g\u002FL; b) Leukocyte≥3.5x10\\^9\u002FL; c) The absolute neutrophil count (ANC)\\>1.5x10\\^9\u002FL; d) Platelet≥100x10\\^9\u002FL; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \\[mainly unconjugated bilirubin\\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g\u002FL; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);\n9. Obtain the written informed consent of the patient\u002Flegal representative;\n10. Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.\n\nExclusion Criteria:\n\n1. Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.\n2. Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma\u002Fhemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.\n3. Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg\u002Fm2 doxorubicin.\n4. Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.\n5. Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg\u002Fday prednisone or its equivalent) and were still using them within 2 weeks before randomization.\n6. Use of immunomodulators and were still using them within 2 weeks before randomization.\n7. Allergic to sodium citrate or human albumin.\n8. Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.\n9. Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg\u002Fday prednisone or its equivalent).\n10. Have any active autoimmune disease or history of autoimmune disease.\n11. Subjects with active tuberculosis.\n12. Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.\n13. Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT\u002FQTc interval at baseline (male\\>450ms, female \\>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150\u002F95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.\n14. Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;\n15. Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;\n16. Known history of organ transplantation or ready to receive an organ transplantation;\n17. Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;\n18. Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.\n19. Surgery for soft tissue sarcoma is planned during the study.\n20. Subjects have participated in another investigational trial within 4 weeks before randomization.\n21. Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.","70 Years",{"count":193,"type":21},148,[25],"This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.",[197,198,30,199,200,37,201,202,203,204,34],"Leiomyosarcoma","Liposarcoma","Angiosarcoma","Undifferentiated Pleomorphic Sarcoma","Malignant Peripheral Nerve Sheath Tumors","Fibrosarcoma","Pleomorphic Rhabdomyosarcoma","Endometrial Stromal Sarcoma","2025-07-20",{"date":207,"type":50},"2025-07-24",{"date":209,"type":50},"2024-02-21",{"date":211,"type":21},"2027-02",{"name":213,"class":98},"HRYZ Biotech Co."]