[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"synovial-sarcomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:synovial-sarcomas":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,118,145,172,207,231],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100560022","phase-2-xl092-zanzalintinib-for-the-treatment-of-patients-with-metastatic-or-unresectable-leiomyosarcoma-bone-sarcoma-or-translocation-associated-soft-tissue-sarcoma-100560022",false,"NCT06571734","XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma","A Non-Randomized, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma","Inclusion Criteria For Cohort 1 - Leiomyosarcoma:\n\n* Patients must have histologically confirmed leiomyosarcoma that has been clinically determined to be metastatic or unresectable. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone at least 2 or more lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria For Cohort 2 - Bone Sarcoma:\n\n* Patients must have histologically confirmed diagnosis of metastatic or unresectable bone sarcoma. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone at least 1 line of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria For Cohort 3 - Translocation-associated Soft Tissue Sarcoma:\n\n* Patients must have histologically confirmed diagnosis of metastatic or unresectable translocation-associated soft tissue sarcoma (TAS). Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone greater than 2 lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria for All Cohorts\u002FSarcoma Types\n\n* Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.\n* Patients must be aged ≥ 18 years on day of signing any informed consent documents.\n* Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or \\> 70% on the Karnofsky Scale.\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (without granulocyte colony-stimulating factor support within 21 days of screening sample collection)\n* Hemoglobin (Hgb) ≥ 9 g\u002FdL without transfusion within 21 days of screening laboratory sample collection\n* Platelets (PLT) ≥ 100,000\u002Fmm\\^3 (\\> 100 GI\u002FL) without transfusion within 21 days of screening laboratory sample collection\n* International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal ULN; for patients with Gilbert's disease, total bilirubin ≤ 3 x ULN\n* Alanine aminotransferase (AST) ≤ 3 x institutional ULN\n* Aspartate aminotransferase (ALT) ≤ 3 x institutional ULN\n* Alkaline phosphatase (ALP) ≤ 3 x institutional ULN; for patients with documented bone metastasis, ALP ≤ 5 x ULN\n* Serum creatinine ≤ 1.5 x institutional ULN OR calculated creatinine clearance ≥ 40 mL\u002Fmin ( ≥ 0.67 mL\u002Fsec) using the Cockcroft-Gault equation\n* Creatinine clearance ≥ 40mL\u002Fmin\n* Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg ( ≤ 113.12 mg\u002Fmmol)\n* Patient of child-bearing potential (POCBP) and any of their partners with sperm-producing reproductive capability must agree to use a highly effective method of contraception throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method, such as a barrier method (e.g., condom) is also required\n* Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), with partners of childbearing potential from time of informed consent, for the duration of study participation, and for 96 days following completion of therapy\n* Patients must have ejection fraction \\> 50% by either MUGA scan or echocardiogram.\n* Patients must be capable of understanding and complying with the protocol requirements.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who have received previous treatment with XL092.\n* Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study day 1 treatment.\n* Patients who have received \\> 2 prior tyrosine kinase inhibitor therapies as anticancer treatments.\n* Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to start of study treatment unless they have recovered from their prior therapy (toxicity and\u002For complications) such that they now meet all other eligibility criteria\n* Patients who have received radiation therapy for bone metastasis within 14 days prior to registration\n* Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment\n* Patients with clinically relevant complications from prior radiation therapy requiring ongoing therapy, per the opinion of the treating investigator enrolling the patient.\n* Patients with a known prior or concurrent malignancy that is progressing or requires active treatment within 2 years of first dose of study treatment. Note: The following exceptions may be made:\n\n  * For patients with malignancies like basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; or superficial skin cancers, localized low-grade tumors deemed cured and not treated with systemic therapy, and incidentally diagnosed prostate cancer if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n  * For patients 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.\n* Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed. Note: Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.\n* Patients who are on concomitant anticoagulation therapy with oral anticoagulants (e.g., warfarin or direct thrombin and factor Xa inhibitors) and platelet inhibitors (e.g., clopidogrel). Note: Allowed anticoagulants are low-dose aspirin for cardioprotection (per local applicable guidelines) and low molecular weight heparins (LMWH). Therapeutic doses of LMWH are not permitted in patients with brain metastases. Note: Patients must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first study treatment, whichever is longer.\n* Patients who are taking any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks (14 days) prior to start of treatment. Note: taking complementary medications to treat symptoms of the cancer is allowed.\n* The patient has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes)\n    * Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic of \\> 90 mm Hg diastolic despite optimal antihypertensive treatment\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant ischemic events within 12 months prior to first dose of study treatment. Note: Patients who did not require prior anticoagulant therapy may be eligible must be discussed and approved by the principal investigator (PI)\n    * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-cerebrovascular accident (CVA)\u002FTIA arterial thromboembolic events within 6 months before to first dose of study treatment.\n    * Prior history of myocarditis\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    * Tumors invading the GI tract from external viscera\n    * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n    * Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess must be confirmed prior to first dose of study treatment\n    * Known gastric or esophageal varices\n    * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause of obstruction is definitively managed and subject is asymptomatic\n* Patients with clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 84 days prior to registration.\n* Symptomatic cavitating pulmonary lesions or endobronchial disease (asymptomatic or radiated lesions allowed).\n* Lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta.\n\nNote: Patients with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior vena cava) may be eligible following PI approval\n\n* Patients who are capable of donating eggs for the purpose of reproduction must not do so throughout the course of the study and for 186 days after the last dose of treatment\n* Patients who are capable of donating sperm for the purpose of reproduction must not do so throughout the course of the study and for 96 days after the last dose of treatment\n* Other clinically significant disorders that would preclude safe study participation, including, but not limited to:\n\n  * Active infection requiring systemic treatment. Note: This criterion applies only at enrollment; if a patient develops an infection while on study treatment, they may continue to receive study treatment. Note: prophylactic antibiotic treatment is allowed\n  * Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness\n  * Known positive test for or suspected infection with SARS-CoV-2 within one month prior to enrollment. Note: Demonstration that the patient has fully recovered from the infection is required to be eligible for enrollment\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if they are due to tumor-associated skin lesions\n  * Malabsorption syndrome\n  * Pharmacologically uncompensated, symptomatic hypothyroidism\n  * Moderate to severe hepatic impairment (Child-Pugh B or C)\n  * Requirement for hemodialysis or peritoneal dialysis\n  * History of solid organ or allogenic stem cell transplant\n* Recent surgery within the following parameters:\n\n  * Major surgery (e.g., GI surgery or removal\u002Fbiopsy of brain metastasis) within 8 weeks prior to study treatment\n  * Minor surgery (e.g., simple excision, tooth extraction) within 5 days prior to first dose of study treatment. Note: if a patient has had a recent surgery outside of the proscribed interval, complete wound healing from said surgery must have occurred prior to first dose of study treatment. Note: Fresh tumor biopsies should be performed at least 5 days prior to registration. Patients with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility\n* Patients with any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) grade \\> 1 at baseline from a previous anticancer therapy, with the following exceptions:\n\n  * Alopecia, vitiligo, and the laboratory values\n  * Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with XL092 may be included only after consultation with the principal investigator\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to XL092\n* Patients who are pregnant (positive serum or urine test within 72 hours prior to enrollment) or nursing. Pregnant people are excluded from this study because XL092 is a next-generation tyrosine kinase inhibitor with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing parent with XL092, breastfeeding should be discontinued if the nursing parent is treated with XL092. Note: If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, per the opinion of the treating investigator\n* XL092 is administrated orally; patients who are unable to swallow, retain, and\u002For absorb pills are not eligible for this study\n* Patients who are currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of treatment\n* Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study","ALL","18 Years",{"count":19,"type":20},73,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma. The trial has now been expanded to treat additional sarcoma types that are sensitive to tyrosine kinase inhibitors (TKIs) such as translocation-associated soft tissue sarcoma (such as synovial sarcoma), and bone sarcoma (including osteosarcoma and Ewing sarcoma).",[26,27,28,29,30,31,32,33,34,35],"Metastatic Leiomyosarcoma","Unresectable Leiomyosarcoma","Bone Sarcoma","Translocation-associated Soft Tissue Sarcoma","Synovial Sarcomas","Osteosarcoma Metastatic","Ewing Sarcoma","Ewing Sarcoma Metastatic","Sarcoma Metastatic","Sarcoma of Bone","RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":40},"2024-09-19",{"date":44,"type":20},"2033-07-01",{"name":46,"class":47},"Northwestern University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":85,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":48},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786","NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.","3 Years",{"count":59,"type":20},25,[61,23],"PHASE1","Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[64,65,66,67,68,69,70,71,72,73,74,75,76,77,30,78,79,80,81,82,83,84],"Solid Tumor Cancer","Medulloblastoma","High Risk Neuroblastoma","High Grade Gliomas","Meningioma","Paraganglioma","Pheochromocytoma","Neuroendocrine Tumours (NET)","Adrenal Tumours","DIPG","Glioblastoma","Glioblastoma (GBM)","Osteosarcoma Recurrent","Carcinoma Adrenal","Esthesioneuroblastoma","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[86,87,88,89,90,91,92,93,94,95,96,97,98,73,99,100,101,102,103,104,105,106,107,83,108],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","2026-06-02",{"date":111,"type":40},"2026-06-04",{"date":113,"type":40},"2024-09-20",{"date":115,"type":20},"2029-12",{"name":117,"class":47},"Fundación de investigación HM",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":144},"100638013","phase-1-a-study-to-test-the-safety-tolerability-and-effect-of-zi-ma4-1-for-patients-with-locally-advanced-or-metastatic-solid-malignancies-100638013","NCT07613723","A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies","A Phase 1, Dose-Escalation, Open-Label Study, Evaluating the Safety and Tolerability of ZI-MA4-1, a TCR-NK Cell Therapy, in HLA-A*02:01 Positive Patients With Inoperable, Locally Advanced, or Metastatic MAGE-A4 Expressing Solid Malignancies","Inclusion Criteria:\n\n* HLA-A\\*02:01 positive\n* Tumour(s) show expression of the MAGE-A4 protein above a defined threshold\n* Histopathological or cytological diagnosis of inoperable Locally Advanced or Metastatic malignant disease: ovarian cancer, squamous non-small cell lung cancer (NSCLC), synovial sarcoma or head and neck cancer.\n* No approved therapy with demonstrated clinical benefit is indicated or available to treat the patient, or the patient is intolerant of or has refused standard of care therapy.\n* Documented imaging confirmed disease progression while on or within 6 months after the end of the most recent therapy.\n* Participant must have received ≥2 prior lines of cancer therapy except for patient with synovial sarcoma for whom ≥1 prior lines of cancer therapy.\n* Measurable disease according to RECIST v1.1 criteria.\n* ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks, and an anticipated life expectancy of \\>3 months\n* Female participants are eligible to participate if they are not pregnant or breastfeeding. Woman of childbearing potential must have negative pregnancy test and agree to use an effective contraceptive method.\n\nOther protocol defined inclusion criteria could apply.\n\nExclusion Criteria:\n\n* Patients have received any prior cellular or gene therapy.\n* Receiving experimental investigational products within 4 weeks of lymphodepletion.\n* Recent therapies (within up to 4 weeks prior to lymphodepletion) including biologic agents (such as monoclonal antibodies), anti-cancer immunotherapy (such as monoclonal antibodies against PD-1 receptor or ligand).\n* Residual toxicities ≥2 CTCAE grade due to prior therapy, that in the opinion of the investigator may interfere with study conduct.\n* Any other active malignancy besides the tumour under study within 3 years prior to screening except for in situ removal of basal cell carcinoma or adequately treated cervix carcinoma in-situ.\n* Active or documented history of autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy. Physiological replacement, topical, and inhaled steroids are permitted.\n* Significant CNS disorders.\n* Myocardial infarction, cardiac angioplasty or stenting, cardiac arrhythmia requiring medication, unstable angina, New York Heart Association Class II or greater congestive heart failure, cardiac atrial or ventricular lymphoma involvement, or other clinically significant cardiac disease within 6 months of enrolment.\n* Active fungal, bacterial viral, or other infection requiring intravenous antibiotic, antifungal, or antiviral medication within 7 days prior to lymphodepletion.\n* Received or planned to receive a live vaccine ≤6 weeks before the planned start date of lymphodepletion.\n* Severe or uncontrolled medical condition (e.g., severe chronic obstructive pulmonary disease, interstitial lung disease , severe Parkinson's disease, active inflammatory bowel disease) or psychiatric condition, which in the opinion of the investigator would interfere with study activities.\n* Active bleeding diatheses, including but not limited to therapeutic anticoagulation, and treatment with major surgery within 28 days before lymphodepletion (minor surgical procedures such as lymph node biopsy\u002Fexcision or catheter placement are permitted).\n* Patients have significant immunosuppression\n* Known significant hepatic or biliary abnormalities. Active infection with hepatitis B, hepatitis C.\n* Any medical, psychological, or social condition, drug or alcohol abuse that would make it difficult for the patient to participate in the study and comply with the study procedures, restrictions, and requirements.\n* History of allergic reactions to compounds chemically or biologically similar to cyclophosphamide, fludarabine or other agents used in the study\n* QTc \\> 450 msec for male participants or \\> 470 msec for female participants\n* Medical conditions, such as anti-coagulation, which is not suitable for reversal which, at the opinion of the investigator, preclude or make the patient a poor candidate for biopsy.\n* Personal history of allergies or intolerance to local anaesthetic.\n* Recent treatment with immunosuppressive agents\n* Residual toxicities ≥2 Common Terminology Criteria for Adverse Events (CTCAE) grade due to prior therapy, that in the opinion of the investigator may interfere with study conduct Other protocol defined exclusion criteria could apply.","75 Years",{"count":127,"type":20},9,[61],"This study will recruit patients with the following cancer indications: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, with inoperable locally advanced or metastatic solid tumours. Currently, these patients have a poor prognosis and a relatively short overall survival. There is a lack of meaningful, effective therapies available that improve the outcome for these patients. The treatment being investigated in this study is ZIMA4-1, an allogeneic cell therapy product. This is the first time ZI-MA4-1 will be administered to humans. The study is planned to consist of two parts (A and B). Part A includes up to four dose escalation cohorts and aims to identify the maximum tolerated dose of ZI-MA4-1 and give insight into the recommended Phase 2 dose (RP2D). Part B consists of an expansion cohort and is designed to further evaluate the RP2D identified in Part A across one or more indications. The study procedures and eligibility criteria will be the same for participants in Parts A and B, except for the dose level of ZI-MA4-1.",[131,132,30,133],"Ovarian Cancer","Squamous Non-Small Cell Lung Cancer (NSCLC)","Head and Neck Cancer","2026-05-21",{"date":136,"type":40},"2026-05-29",{"date":138,"type":20},"2026-05",{"date":140,"type":20},"2032-12",{"name":142,"class":143},"Zelluna Immunotherapy AS","INDUSTRY",2,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":144},"100606351","phase-3-multi-center-study-of-tbi-1301-inn-mipetresgene-autoleucel-mip-cel-in-patients-with-ny-eso-1-positive-synovial-sarcoma-100606351","NCT07174427","Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Histologically confirmed synovial sarcoma\n3. Surgically unresectable tumor\n4. Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracycline\n5. HLA-A\\*02:01 or HLA-A\\*02:06 positive\n6. Tumor that express NY-ESO-1 by immunohistochemistry\n7. Measurable lesions that are evaluable by the RECIST ver1.1\n8. ECOG Performance Status of 0, 1 or 2\n9. No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing\n10. Life expectancy ≥ 16 weeks after consent\n11. No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST(GOT), ALT(GPT) \\\u003C 3.0 x ULN; Creatinine \\\u003C 1.5 x ULN; 2,500\u002FμL \\\u003C WBC ≤ULN; Hemoglobin ≥ 8.0g\u002FdL; Platelets ≥ 75,000\u002FμL\n12. Patients must be able to understand the study contents and to give a written consent at his\u002Fher free will.\n\nExclusion Criteria:\n\n1. Patients with the following conditions are excluded from the study; Unstable angina, cardiac infarction, or heart failure; Uncontrolled diabetes or hypertension; Active infection; Obvious interstitial pneumonia or lung fibrosis by chest X-ray; Active autoimmune disease requiring steroids or immunosuppressive therapy.\n2. Active metastatic tumor cell invasion into CNS\n3. Active multiple cancer\n4. Positive for HBs antigen or HBV-DNA observed in serum\n5. Positive for HCV antibody and HCV-RNA observed in serum\n6. Positive for antibodies against HIV or HTLV-1\n7. History of serious hypersensitivity reactions to bovine or murine derived substances.\n8. History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study\n9. History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study.\n10. History of treatment with cell therapy or gene therapy\n11. Alcohol or drug dependence that may interfere with study participation\n12. Pregnant females, lactating females (except when they cease and do not resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent to 6 months after infusion of the investigational drug.\n13. Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.",{"count":152,"type":20},5,[154],"PHASE3","The purpose of this study is to verify the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide\u002Ffludarabine pre-treatment.",[30],[158,159,160,161,162],"adoptive cell transfer","NY-ESO-1","T cell receptor","ex vivo gene therapy","synovial sarcoma","2026-02-16",{"date":165,"type":40},"2026-02-18",{"date":167,"type":40},"2026-01-05",{"date":169,"type":20},"2032-03",{"name":171,"class":143},"Takara Bio Inc.",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":193,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100605961","phase-2-hypofractionated-3-week-preoperative-proton-or-x-ray-radiotherapy-for-patients-with-localized-soft-tissue-sarcoma-100605961","NCT07169344","Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma","PROSARC-1. Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-1","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible.\n3. Primary tumor localized in head, neck, extremity, girdle and\u002For trunk wall.\n4. Measurable disease according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for PBT.\n\nExclusion Criteria:\n\n1. Locoregional or distant metastasis as assessed by CT and\u002For MRI at time of diagnosis. Patients with lung nodules \\\u003C10 mm of uncertain etiology may be included.\n2. Prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n3. Previous radiotherapy to the primary tumor region.\n4. Patients with pacemakers and\u002For implanted defibrillators.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.\n6. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.",{"count":181,"type":20},110,[23],"The purpose of the study is to investigate whether a personalized selection of patients with localized soft tissue sarcoma for preoperative proton radiation therapy can reduce long-term radiation side effects without increasing surgical complications or reducing the effectiveness of the treatment. Two radiation plans will be created for each patient-one for protons and one for photons-and through a national meeting, we will determine which type of radiation therapy each patient will receive. The radiation dose will be the same for both photons and protons.\n\nThe primary endpoint is surgical complications 120 days after surgery. Secondary endpoints include overall survival, local recurrence-free survival, disease-free survival, side effects, and quality of life. Furthermore, the study will investigate biomarkers that may predict response to radiation therapy, including changes in the tumor's genetic material (DNA), measurement of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe study will be conducted in Norway, with a planned inclusion of 110 patients.",[185,186,187,30,188,189,190,191,192],"Soft Tissue Sarcoma (Excluding GIST)","Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma of the Trunk and Extremities","Leiomyosarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Myxofibrosarcoma (MFS)","Liposarcoma","Pleomorphic Rhabdomyosarcoma",[194,195,196,197],"Soft tissue sarcoma","proton radiotherapy","x-ray radiotherapy","surgical complications","2026-01-26",{"date":200,"type":40},"2026-01-28",{"date":198,"type":40},{"date":203,"type":20},"2035-11-01",{"name":205,"class":47},"Oslo University Hospital",4,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":224,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":230,"locationsCount":144},"100606316","phase-2-dose-escalated-hypofractionated-definitive-proton-radiotherapy-for-patients-with-inoperable-soft-tissue-sarcoma-100606316","NCT07173972","Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.","PROSARC-2. Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-2","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).\n3. Measurable disease according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. For patients with metastatic disease a life-expectancy greater than 2 years should be expected.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for Proton Beam radiotherapy.\n\nExclusion Criteria:\n\n1. Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n2. Previous radiotherapy to the tumor site.\n3. Patients with pacemakers and\u002For implanted defibrillators.\n4. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.",{"count":216,"type":20},40,[23],"The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects.\n\nThe planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction).\n\nAt the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life.\n\nThe study will be conducted in Norway, with a planned inclusion of 40 patients.",[220,186,187,30,189,221,222,223,192,191],"Soft Tissue Sarcoma (STS)","Myxofibrosarcoma","Leiomyosarcoma (LMS)","Pleomorphic Liposarcoma",[225,195,226],"soft tissue sarcoma","inoperable soft tissue sarcoma",{"date":200,"type":40},{"date":198,"type":40},{"date":203,"type":20},{"name":205,"class":47},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":144},"100456725","phase-1-aoh1996-for-the-treatment-of-refractory-solid-tumors-100456725","NCT05227326","AOH1996 for the Treatment of Refractory Solid Tumors","First in Human Phase 1 Study of AOH1996 in Patients With Refractory Solid Tumors","Inclusion Criteria:\n\nInformed Consent and Willingness to Participate\n\n* 1\\. Documented informed consent by the participant\n* 2\\. Willingness to permit study team to obtain and use archival tissue, if already existing\n\nAge Criteria, Performance Status and Life Expectancy\n\n* 3\\. Age: ≥ 18 years\n* 4\\. ECOG performance status ≤ 2\n* 5\\. Life expectancy of \\> 3 months\n\nNature of Illness and Treatment History \\_\\_6. Patients with solid tumors failing standard therapies or patients refusing standard treatments (exception: Part B NSCLC combination (EGFR TKI + AOH1996) cohort: patients with stable disease or better on EGFR TKI for at least 2 months)\n\nContraception\n\n\\_\\_7. Agreement by females and males of childbearing potential\\* to use an adequate method of birth control (hormonal contraception is inadequate) or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study medication. See Appendix B for guidelines.\n\n\\- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nLaboratory Criteria (to be performed within 14 days prior to Day 1)\n\n* 8\\. ANC ≥ 1,500\u002Fmm3\n* 9\\. Platelets ≥ 100,000\u002Fmm3 :\n* 10\\. Total serum bilirubin ≤ 1.5 x ULN\n* 11\\. AST =\\\u003C 1.5 x ULN or =\\\u003C 3 x ULN with liver metastases\n* 12\\. ALT =\\\u003C 1.5 x ULN or =\\\u003C 3 x ULN with liver metastases\n* 13\\. Creatinine clearance of ≥ 60 mL\u002Fmin per 24 hour urine or the Cockcroft-Gault\n* 14\\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\nExclusion Criteria\n\nConcomitant Medications\u002FTherapies \\_\\_1. Dietary\u002Fherbal supplements\n\n* 2\\. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed.\n* 3\\. Warfarin\n* 4\\. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers\n* 5\\. Strong inhibitors or inducers of CYP2C9\n* 6\\. Strong inhibitors or inducers of CYP3A\n\nOther Illnesses and Conditions\n\n* 7\\. Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).\n* 8\\. Women who are or are planning to become pregnant or breastfeed\n* 9\\. Known allergy to any of the components within the study agents and\u002For their excipients.\n* 10\\. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.\n* 11\\. Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution\u002Frecovery is deemed adequate by the investigator (e.g. recovery from major surgery, completion of treatment for severe infection).\n\nNoncompliance\n\n\\_\\_12. Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n\n\\*\\*Eligibility should be confirmed per institutional policies.",{"count":239,"type":20},92,[61],"This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.",[243,244,245,30,131,246,247],"Refractory Malignant Solid Neoplasm","Osteosarcoma","Leiomyosarcomas","Non-Small Cell Lung Cancer","Pancreatic Cancer","2025-09-12",{"date":250,"type":40},"2025-09-18",{"date":252,"type":40},"2022-08-12",{"date":254,"type":20},"2029-09-13",{"name":256,"class":47},"City of Hope Medical Center"]