[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mesothelioma-malignant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mesothelioma-malignant":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,65,114,171,205,233,261,299,322,354],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100482949","phase-1-synkir-110-for-mesothelin-expressing-ovarian-cancer-cholangiocarcinoma-or-mesothelioma-100482949",false,"NCT05568680","SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma","A Phase 1 Study of SynKIR-110, Autologous T Cells Transduced With Mesothelin KIR-CAR, in Subjects With Mesothelin-Expressing Advanced Ovarian Cancer, Cholangiocarcinoma, or Mesothelioma","Inclusion Criteria:\n\n* Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease\n* Adult 18 years of age or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma.\n* Satisfactory Blood coagulation parameters\n* Satisfactory organ and bone marrow function\n\nExclusion Criteria:\n\n* Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years.\n* History of T or B cell malignancies or previous gene-engineered T cell therapies.\n* Sarcomatoid\u002Fbiphasic mesothelioma.\n* Pulmonary exclusions\n* Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease\n* Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening\n* Active autoimmune disease","ALL","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma.",[26,27,28],"Ovarian Cancer","Cholangiocarcinoma Recurrent","Mesothelioma, Malignant","RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-24","ACTUAL",{"date":35,"type":33},"2023-03-30",{"date":37,"type":20},"2027-12",{"name":39,"class":40},"Verismo Therapeutics","INDUSTRY",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100535398","phase-1-sw-682-in-advanced-solid-tumors-100535398","NCT06251310","SW-682 in Advanced Solid Tumors","A Phase 1a\u002F1b Dose Escalation, Dose Expansion Study of SW-682 in Participants With Advanced Solid Tumors Enriched for Those With Hippo Pathway Mutations","Key Inclusion Criteria:\n\n* Histologically confirmed, metastatic, or unresectable solid cancer that has either not responded to or progressed during or after appropriate prior systemic anticancer therapy including chemotherapy, immunotherapy, radiation therapy, or appropriate targeted therapy, or for which there is no treatment available or prior SOC therapy was not tolerated and for which there is no further SOC treatment available\n* Part 1: must have one of the following:\n\n  * Mesothelioma with or without NF2 mutations\n  * Advanced solid tumors with NF2 mutations\n  * Advanced solid tumors with other Hippo pathway mutations or fusions (e.g., FAT1, LATS1\u002F2, YAP fusions; WWTR1-CAMTA1 in EHE).\n* Part 2: must have the tumor histology and oncogenic mutation or genomic aberration specific to each dose expansion cohort defined below:\n\n  * Cohort 1: Participants with mesothelioma with or without NF2 mutations\n  * Cohort 2: Participants with advanced solid tumors with NF2 mutations\n  * Cohort 3: Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation\n  * Cohort 4: SW-682 with appropriate combination therapy.\n* In both parts, participants should have known oncogenic mutation identified by Next Generation Sequencing or local assay\n* Must have archival tumor tissue or agree to a fresh tumor biopsy at screening\n* Measurable disease per RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1\n* Adequate bone marrow, kidney, hepatic, and coagulation function\n\nKey Exclusion Criteria:\n\n* Evidence of symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression\n* Clinically significant cardiac disease or abnormal cardiac parameters\n* Preexistence or inheritance of a familial renal syndrome\n* Concomitant non-anti-arrhythmic medications that are known to prolong the QTc interval\n* Concomitant medicines that are known strong\u002Fmoderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and\u002For CYP1A2 within 14 days or 5 half-lives before the first dose of study treatment\n* Concomitant medicines that are known sensitive substrates of CYP3A4, CYP2C19, CYP2D6, CYP1A2, and\u002For CYP2B6 within 14 days or 5 half-lives before the first dose of study treatment\n* Concomitant medicines that are known sensitive substrates of PGP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1, MATE2-K, OCT2\n* Clinically significant active infection (bacterial, fungal, or viral)",{"count":50,"type":20},186,[23],"This is a first-in-human (FIH), Phase 1a\u002F1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior systemic anticancer therapy, including chemotherapy, immunotherapy, radiation therapy or targeted therapy, or for which no treatment is available, or prior standard of care (SOC) therapy was not tolerated and for which there is no further SOC treatment available. The study includes a Part 1 (Phase 1a) dose escalation phase and a Part 2 (Phase 1b) dose expansion to optimize the dose to be used for further development. All participants will self-administer SW-682 by mouth in 28-day cycles.",[54,28],"Advanced Solid Tumor","2026-06-17",{"date":57,"type":33},"2026-06-22",{"date":59,"type":33},"2024-07-31",{"date":61,"type":20},"2027-01-18",{"name":63,"class":40},"SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany",8,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":84,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100370548","phase-1-a-study-of-tulmimetostat-dzr123-cpi-0209-in-patients-with-advanced-solid-tumors-and-lymphomas-100370548","NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease",{"count":73,"type":20},275,[23,75],"PHASE2","The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[54,78,79,28,80,81,82,83],"Diffuse Large B Cell Lymphoma","Lymphoma, T-Cell","Prostatic Neoplasms, Castration-Resistant","Endometrial Cancer","Ovarian Clear Cell Carcinoma","Metastatic Castration-resistant Prostate Cancer",[85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,81,82,102,103,104,105],"Tulmimetostat","DZR123","Lymphoma, Large B-Cell, Diffuse","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)",{"date":57,"type":33},{"date":108,"type":33},"2019-09-18",{"date":110,"type":20},"2030-02-27",{"name":112,"class":40},"Novartis Pharmaceuticals",81,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":145,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100520064","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-mesothelin-targeting-logic-gated-car-t-in-participants-with-solid-tumors-that-express-msln-and-have-lost-hla-a02-expression-100520064","NCT06051695","A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","EVEREST-2","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion",{"count":123,"type":20},474,[23,75],"The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose",[127,128,129,130,131,132,133,134,135,136,137,138,139,26,140,141,28,142,143,144],"Solid Tumor, Adult","Colorectal Cancer","NSCLC","Non Small Cell Lung Cancer","NSCLC, Recurrent","Non-Small Cell Squamous Lung Cancer","Pancreas Cancer","Pancreatic Neoplasm","Colorectal Adenocarcinoma","CRC","Colon Cancer","Rectal Cancer","Cancer","Ovarian Neoplasms","Mesothelioma","Ovary Cancer","Lung Cancer","MESOM",[146,147,148,149,150,151,152,153,154,155,156,157,139,158,136,128,143,129,159,144,26,141,160],"CAR T Cell","Solid Tumors","Autologous","T Cell","Mesothelin","MSLN","HLA-A2","Solid Tumors expressing MSLN","Pancreatic","Cell Therapy","Gene Therapy","blocker","PANC","OVCA","Logic-gate","2026-06-10",{"date":163,"type":33},"2026-06-12",{"date":165,"type":33},"2024-04-03",{"date":167,"type":20},"2029-06",{"name":169,"class":40},"A2 Biotherapeutics Inc.",12,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":181,"phases":4,"briefSummary":182,"conditions":183,"keywords":190,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"100437810","solid-tumor-analysis-for-hla-loss-of-heterozygosity-loh-and-apheresis-for-car-t--cell-manufacturing-100437810","NCT04981119","Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing","An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing","BASECAMP-1","Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria\n\n1\\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n\nPart 1: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n\nPart 2 : Key Inclusion Criteria\n\n1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n2. Participants are germline HLA-A\\*02 heterozygous confirmed by HLA typing.\n3. Primary tumor tissue showing LOH of HLA-A\\*02 by NGS testing.\n4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.\n\nPart 2: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.\n5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).\n6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.\n7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.",{"count":180,"type":20},200,"OBSERVATIONAL","Objective:\n\nTo collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.\n\nDesign:\n\nThis is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.",[127,128,130,184,136,129,133,141,26,140,185,28,186,139,187,188,189],"Pancreatic Cancer","Ovarian Carcinoma","Mesothelioma; Lung","Triple Negative Breast Cancer (TNBC)","Renal Cell Carcinoma (Kidney Cancer)","Head and Neck Squamous Cell Carcinoma HNSCC",[191,192,193,194,195],"CAR T Cell Therapy","Next Generation Sequencing","Leukapheresis","Apheresis","Immunotherapy","2026-05-29",{"date":198,"type":33},"2026-06-02",{"date":200,"type":33},"2021-10-29",{"date":202,"type":20},"2029-04",{"name":169,"class":40},16,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":232},"100602668","partial-pleurectomy-surgery-for-unresectable-pleural-mesothelioma-100602668","NCT07126509","Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma","A Pilot Study of Partial Pleurectomy in Borderline and Unresectable Pleural Mesothelioma","Inclusion Criteria\n\n* Patients must have histologically confirmed epithelioid subtype pleural mesothelioma, as determined by surgical (i.e. VATS) biopsy.\n* Disease confined to the unilateral hemithorax.\n* Disease that is classified as unresectable or borderline resectable:\n* Unresectable disease is defined by cross sectional imaging (CT or MRI) demonstrating invasion of unresectable mediastinal structures (heart, great vessels, esophagus) or spine, unresectable invasion of the chest wall (multifocal chest wall invasion or apical chest wall invasion), or disease outside intended resection field.\n* Borderline resectable disease is defined by cross sectional imaging (CT or MRI) demonstrating extensive pulmonary parenchymal invasion (anticipated need for anatomic resection or complex wedge resection to clear disease) or extensive\u002Fbulky disease of (1) the diaphragm or sulci (anticipated need for diaphragm resection and reconstruction to clear disease), or (2) the chest wall (anticipated need for chest wall resection and reconstruction to clear disease). Disease with pathologically proven hilar or mediastinal lymph node involvement.\n* Successful completion of at least 6 weeks of systemic induction therapy (regimen according to treating physician choice, including the below) with no unresolved adverse event that would preclude surgery:\n* Platinum agent, pemetrexed, +\u002F- bevacizumab\n* Platinum agent, pemetrexed, pembrolizumab\n* Ipilimumab\u002Fnivolumab\n* Age ≥18 years.\n* ECOG performance status ≤1.\n* Patients must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * PT\u002FINR \\>1.5\n  * PTT \\>Upper limit of normal\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal\n  * creatinine within normal institutional limits OR\n  * creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification21. To be eligible for this trial, patients should be class 2B or better.\n* Review by multidisciplinary treatment conference consisting of mesothelioma surgeons, radiologists, pathologists, medical oncologists, and palliative care physicians. Date of review will be documented in on the patient's elgibility checklist\n* Prior or concurrent enrollment to UChicago's Mesothelioma Biobank (IRB15-0443).\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Patients with biphasic or sarcomatoid pleural mesothelioma.\n* Patients with metastatic disease or disease which extends to the abdominal cavity or subdiaphragm as identified on post-induction therapy cross sectional imaging (CT, MRI, or PET).\n* Patients who demonstrate disease progression during or following induction therapy.\n* FEV1 \\\u003C 50% and\u002For postoperative predicted DLCO \\\u003C 50%.\n* Patients who are receiving any other investigational agents.\n* Patients with uncontrolled intercurrent illness.\n* Prior malignancy active 2 years prior to registration except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast, or papillary thyroid.",{"count":213,"type":20},30,[215],"NA","Purpose of the study: The main purpose of this research study is to see if a surgery procedure (limited partial pleurectomy and decortication) helps symptoms in people who have cancer that is unresectable that might not be able to be removed completely. This is called unresectable cancer. This study will also help the research team learn more about the types of symptoms and quality of life for people who have undergone this surgery, the number of complications following , and the time from surgery to starting other therapy. Th e study team also wants to see see the overall survival of people who have had this procedure as part of their care.\n\nWhat will be done as part of research on this study:\n\n* Surgery (Partial Pleurectomy - surgery to remove lining of lungs)\n* The research team will also ask study participants questions about their symptoms through questionnaires at certain times after surgery.\n\nHow long this study will last:\n\nParticipation in this research (pre-surgery, surgery and follow-up) will last for about 2 years.\n\nConfidentiality: All personal information will be kept confidential, and data will be used only for research purposes.\n\nContact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu",[141,186,218,219,28],"Mesotheliomas Pleural","Mesothelioma Malignant Advanced",[221],"PLEURECTOMY","2026-02-13",{"date":224,"type":33},"2026-02-17",{"date":226,"type":33},"2025-12-02",{"date":228,"type":20},"2028-12-01",{"name":230,"class":231},"University of Chicago","OTHER",1,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":248,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100520543","phase-2-a-study-of-additional-chemotherapy-after-surgery-for-people-with-malignant-peritoneal-mesothelioma-100520543","NCT06057935","A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma","ICARuS II (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multicenter, Randomized Phase II Trial of Normothermic Intraperitoneal Chemotherapy and Intravenous Chemotherapy After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Malignant Peritoneal Mesothelioma","Inclusion Criteria:\n\n* Patient age 18 years or older, both sexes.\n* Clinical diagnosis of MPM at enrolling institution.\n* Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution.\n* Complete or near-complete CRS achieved.\n* Patient must be planning to undergo complete cytoreduction of all peritoneal disease.\n* ECOG performance status ≤ 1.\n* Hematology: ANC ≥ 1,500\u002Fµl.\n* Platelets \\> 75,000\u002Fµl.\n* Adequate renal function: creatinine \\\u003C 1.5× the upper limit of normal (ULN) or calculated creatinine clearance of ≥50 ml\u002Fmin.\n* Adequate hepatic function: bilirubin \\\u003C 1.5 mg\u002Fdl (except in patients with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL).\n* Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.\n* A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study\n* Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.\n\nExclusion Criteria:\n\n* Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy for peritoneal mesothelioma.\n* Subjects who have previously received platinum-containing chemotherapy regimens.\n* Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.\n* Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option.\n* High suspicion for extra-abdominal metastases.\n* Women who are pregnant or lactating.\n* Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk.\n* Uncontrolled hypertension defined as \\>140\u002F90 and not cleared for surgery at the time of consent.\n* New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.\n* History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.\n* Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable risk for participation in the study.\n* Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy.\n* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.\n* Any condition that would preclude the ability to deliver appropriate IP therapy.\n* Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator.\n* Life expectancy \\\u003C 12 weeks.",{"count":241,"type":20},64,[75],"The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.",[245,246,141,28,247],"Malignant Peritoneal Mesothelioma","Peritoneal Mesothelioma","Malignant Mesothelioma",[245,246,141,28,247,249,250,251],"ICARuS II","Memorial Sloan Kettering Cancer Center","23-145","2025-07-17",{"date":254,"type":33},"2025-07-22",{"date":256,"type":33},"2023-09-21",{"date":258,"type":20},"2028-09-21",{"name":250,"class":231},13,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":271,"conditions":272,"keywords":284,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":41},"100511807","phase-1-htl0039732-in-participants-with-advanced-solid-tumours-100511807","NCT05944237","HTL0039732 in Participants With Advanced Solid Tumours","A Cancer Research UK Phase I\u002FIIa Trial of HTL0039732, Given Orally as Monotherapy and in Combination With Immunotherapy or Other Approved Therapies in Participants With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product administration and follow-up.\n2. Phase 1, dose escalation phase\n\n   Part A (HTL0039732 monotherapy):\n   * Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the potential participant.\n   * At least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy, or at least one assessable lesion e.g. pleural or peritoneal thickening that does not fulfil RECIST v1.1 criteria for measurable disease.\n\n     a. Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression.\n   * Consent to access and analysis of any available archival tissue or a fresh tumour sample at baseline, if archival tissue is unavailable.\n   * Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression.\n\n   Phase 1 Part B:\n\n   \\- Histologically proven advanced solid tumour where PGE2\u002FEP4 signalling is believed to be more prevalent or significant (such as microsatellite stable colorectal cancer (MSS CRC), gastro-esophageal cancer, head and neck squamous cell carcinoma (HNSCC), mCRPC, pancreatic cancer, lung cancer, bladder cancer, mesothelioma, cervical cancer, renal cancer, sarcoma, pheochromocytoma and cancers with PI3K\u002FAKT\u002FmTOR pathway activating mutations using a clinically-validated assay).\n\n   Phase 2a:\n\n   \\- Histologically proven advanced solid tumour, in line with indications listed below, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the potential participant:\n   1. MSS CRC with PIK3CA or HER2 mutation, and\u002For other driver mutation as agreed with the Sponsor (genomic alteration to have been previously identified using a validated next-generation sequencing method performed on either tumour tissue or circulating tumour DNA \\[ctDNA\\]);\n   2. Gastric or gastroesophageal junction (GOJ) adenocarcinoma;\n   3. Clear cell renal cell carcinoma;\n   4. mCRPC\n\n   Phase 1 Part B and Phase 2a:\n   * Consent to access and analysis of any available archival tissue.\n   * Consent for fresh tumour biopsy samples at baseline and on treatment. However, the following exceptions will be permitted if archival tissue is available at the recruiting site:\n\n     1. Patients with mCRPC: biopsies are not required for those whose only safely accessible lesions are bone metastases that lack an accessible soft tissue component.\n     2. For the first 12 participants in each indication: the on-trial biopsy is optional; and the baseline biopsy is mandatory if there is a safely accessible lesion but may be omitted for patients who have no safely accessible lesion, to permit their inclusion in the study. This will continually be assessed through the study.\n   * Disease refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the participant.\n   * Except for mCRPC, at least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy. Potential participants with mCRPC may instead have had PD according to PCWG3 criteria.\n\n     1. Previously irradiated lesions cannot be counted as target lesions unless clearly progressed after the radiotherapy.\n     2. Lesions that are intended to be biopsied should not be counted as target lesions (those undergoing biopsy must have at least one target lesion that is not intended to be biopsied).\n   * For indications where anti-PD-1\u002FPD-L1 therapy is standard of care (such as clear cell renal cell carcinoma, or gastric or GOJ adenocarcinoma with elevated PD-L1 expression), patients must have received that therapy and must be considered to have had progressive disease by the Investigator either on, or within 6 months after, that treatment.\n3. Life expectancy of at least 12 weeks.\n4. Eastern Cooperative Oncology Group performance status of 0 or 1.\n5. Haematological and biochemical indices within the protocol specified ranges.\n6. Stable thyroid function tests. Stable doses of thyroxine replacement are permitted.\n7. Aged 18 years or over at the time consent is given.\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative reasons), chemotherapy, non chemotherapy systemic anti-cancer therapy (apart from life-long hormone suppression such as luteinising hormone-releasing agents in participants with mCRPC) or investigational medicinal products during the 4 weeks prior to enrolment; or first dose of an immunotherapy during the previous 12 weeks before first dose of HTL0039732.\n2. Ongoing toxic manifestations of previous treatments that are Grade \\>1 per CTCAE v5.0.\n3. Any central nervous system metastases (unless potential participants have had local therapy and are asymptomatic, radiologically stable and have been off steroids for ≥4 weeks prior to enrolment).\n4. Women of child-bearing potential (or who are already pregnant or lactating). Exceptions apply.\n5. Men with partners of childbearing potential. Exceptions apply.\n6. Major thoracic or abdominal surgery from which the potential participant has not yet recovered.\n7. At high medical risk because of non-malignant systemic disease, including active uncontrolled infection.\n8. Known history of current or latent tuberculosis, HIV or Hepatitis B or C infection.\n9. Prior treatment with EP4 inhibitor.\n10. Treatment with selective cyclooxygenase-2 inhibitor in the 8 weeks prior to enrolment.\n11. Known hypersensitivity or intolerance to hydroxypropyl methylcellulose.\n12. Use of systemic immunosuppressive agent in the 2 weeks prior to enrolment. Exceptions apply.\n13. Significant cardiovascular disease.\n14. Known active peptic ulcer disease, or symptoms of gastritis, dyspepsia or gastro-esophageal reflux disease (one or more episodes per week).\n15. Current or planned participation in another interventional clinical trial, whilst taking part in this trial of HTL0039732.\n16. Limited ability to swallow or absorb oral medications.\n17. Any other condition that, in the Investigator's opinion, would mean that the trial is not in the best interests of the potential participant.\n\n    Phase 1 Part B and Phase 2a:\n18. Any live vaccines in the 4 weeks prior to enrolment.\n19. Diagnosis of immunodeficiency.\n20. Active autoimmune disease requiring systemic treatment in the 2 years prior to enrolment.\n21. History or clinical suspicion of interstitial lung disease, history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.\n22. Hypersensitivity to atezolizumab or any of its excipients.\n23. Prior adverse reaction to cancer immunotherapy that required steroid or other immunosuppressive treatment or led to discontinuation of that treatment.",{"count":269,"type":20},150,[23,75],"The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.",[94,80,273,274,275,276,277,278,279,28,280,281,282,283],"Stomach Neoplasms","Esophageal Neoplasms","Head and Neck Neoplasms","Colorectal Neoplasms","Pancreatic Neoplasms","Lung Neoplasms","Urinary Bladder Neoplasms","Uterine Cervical Neoplasms","Kidney Neoplasms","Sarcoma","Pheochromocytomas",[285,286,287,288,289],"EP4 antagonist","Anti-PD-1\u002FPD-L1 agents","PGE2","EP4","COX inhibitor","2025-06-05",{"date":292,"type":33},"2025-06-08",{"date":294,"type":33},"2023-07-13",{"date":296,"type":20},"2027-06",{"name":298,"class":231},"Cancer Research UK",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":21,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":321},"100453770","phase-2-first-line-sintilimab-combined-with-anlotinib-and-platinum-doublet-chemotherapy-in-malignant-pleural-mesothelioma-100453770","NCT05188859","First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma","Study of Sintilimab Combined With Anlotinib and Platinum-Containing Dual-Agent Chemotherapy as First Line Therapy in Malignant Pleural Mesothelioma: A Single Arm, Open-label, Prospective Phase II Trial","Inclusion Criteria:\n\n* Sign written informed consent before implementing any trial-related procedures;\n* Age ≥ 18 years old.\n* Histologically confirmed, unresectable or inoperable or locally advanced (IIIB stage), recurrent or metastatic (IV stage) malignant pleural mesothelioma.\n* According to the modified version of the evaluation criteria for the efficacy of solid tumor (mRECIST1.1 ), patients have at least one imaging lesion can be measured;\n* Patients have not received any systemic anti-tumor therapy for advanced\u002Fmetastatic diseases in the past. Patients who have previously received platinum-containing adjuvant \u002F neoadjuvant chemotherapy, or radical radiotherapy and chemotherapy for advanced diseases, such as the interval between disease progression or recurrence and the end of the last chemotherapeutic drug treatment at least 6 months, are allowed to be enrolled in this study.\n* Patients with brain metastasis who are asymptomatic or stable after local treatment are allowed to be included in this study, as long as they meet the following conditions:\n\n  1. There are measurable lesions outside the central nervous system.\n  2. No central nervous system symptoms or no aggravation within at least 2 weeks.\n  3. Those who do not need glucocorticoid therapy or stop glucocorticoid therapy within 7 days before the first study drug administration.\n* Patients are allowed to receive palliative radiotherapy, but the end of radiotherapy is within 7 days before the administration of the first study drug.\n* ECOG score 0-1 points;\n* The expected survival time was \\> 3 months,\n* For adequate organ function, the patients need to meet the following laboratory indexes:\n\n  1. the absolute value of neutrophils (ANC) ≥ 1.5x109\u002FL without granulocyte colony stimulating factor in the past 14 days.\n  2. in the last 14 days without blood transfusion, the platelet count was ≥ 100x109\u002FL.\n  3. in the absence of blood transfusion or the use of erythropoietin in the past 14 days, hemoglobin \\> 9g\u002FdL;\n  4. Total bilirubin ≤ 1.5 × normal upper limit (ULN); for example,if total bilirubin \\> 1.5 × ULN but direct bilirubin ≤ ULN is also allowed to enter the group\n  5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (patients with liver metastasis allow ALT or AST ≤ 5 × ULN).\n  6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60ml;\n  7. Coagulation function is good, defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;\n  8. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled.\n  9. Myocardial enzyme spectrum is within the normal range (if the researchers comprehensively judge that there is no clinical significance of simple laboratory abnormalities can also be included in the group); (optional)\n* For female patients at childbearing age, they should undergo a urine or serum pregnancy test within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the results be negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Women of non-childbearing age are defined as at least 1 year after menopause or have undergone surgical sterilization or hysterectomy.\n* If there is a risk of pregnancy, all patient (male or female) are required to use contraception with an annual failure rate of less than 1% during the entire treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).\n\nExclusion Criteria:\n\n* Diagnosis of malignant diseases other than malignant pleural mesothelioma (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and \u002F or radical resection of carcinoma in situ) within 5 years before the first administration\n* Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;\n* Previous usage of the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;\n* Within 2 weeks before the first administration, they received systemic systemic therapy with anti-tumor indications of proprietary Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for controlling local use of pleural effusion)\n* Active autoimmune diseases requiring systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.\n* The patients are received systemic glucocorticoid therapy (excluding nasal, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration.\n\nNote: The use of physiological doses of glucocorticoids (≤10 mg\u002Fday prednisone or equivalent drugs) is allowed;\n\n* There are clinically uncontrollable pleural effusion \u002F ascites (patients who do not need drainage or stop drainage for 3 days without a significant increase in effusion can be enrolled in the group)\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Those who are known to be allergic to the active ingredients or excipients of Sintilimab in this study.\n* Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)\n* Symptomatic or uncontrolled brain metastasis;\n* Active hemoptysis (at least 2.5ml or 1\u002F2 teaspoon of blood was spit out at a time) 3 months before the first study drug administration;\n* Imaging showed that there were tumors invading \u002F infiltrating large blood vessels or bleeding tendency assessed by researchers or radiologists;\n* Received major surgery (except for surgery for the purpose of biopsy) within 4 weeks before the first study drug administration, or is expected to undergo major surgery during the study period;\n* Severe unhealed wound ulcers or fractures;\n* Minor surgery was performed within 48 hours before first receiving the study drug (outpatient \u002F inpatient surgery requiring local anesthesia, including central venous catheterization);\n* Use aspirin (\\>325 mg\u002Fday) or other non-steroidal anti-inflammatory drugs that are known to inhibit platelet function for 10 consecutive days (within 10 days before receiving the first dose of study drug) at present or in the near future;\n* Current or recent treatment with full-dose oral or parenteral anticoagulants or thrombolytic agents for 10 consecutive days (within 10 days before receiving the first study drug) Note: Prophylactic use of low-dose anticoagulants is permitted: low-dose warfarin (≤ 1mg\u002Fd) is allowed for preventive purposes on the premise that the international standardized ratio of prothrombin time (INR) ≤ 1.5. Low-dose heparin (≤ 12000 U\u002Fe d) or low-dose aspirin (≤ 100mg\u002Fd).\n* Hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis;\n* Did not fully recover from toxicity and \u002F or complications caused by any intervention (i.e., ≤ level 1 or reached baseline, excluding fatigue or hair loss) before starting treatment;\n* Known human immunodeficiency virus (HIV) infection history (i.e. HIV 1\u002F2 antibody positive)\n* Untreated active hepatitis B (defined as HBsAg positive and the number of HBV-DNA copies detected is greater than the upper limit of the normal value of the laboratory in the research center).\n\nNote: hepatitis B subjects who meet the following criteria can also be enrolled in the group:\n\n1. Before the first administration, the HBV viral load is less than 1000 copies\u002Fml (200 IU\u002Fml), and the patients should receive anti-HBV treatment during the entire study drug treatment period to avoid viral reactivation;\n2. For patients with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), there is no need to receive preventive anti-HBV therapy. However, the virus needs to be closely monitored for reactivation\n\n   * Active HCV infection subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection)\n   * Live vaccine is given within 30 days before the first administration (cycle 1, day 1).\n\nNote: It is allowed to receive inactivated virus vaccine for seasonal influenza within 30 days before the first administration; however, it is not allowed to receive live attenuated influenza vaccine for intranasal administration..\n\n* Pregnant or lactating women;\n* There are any serious or uncontrollable systemic diseases, such as\n\n  1. significant abnormalities in rhythm, conduction, or morphology of resting electrocardiogram and serious and uncontrollable symptoms, such as complete left bundle branch block, second-degree cardiac block, ventricular arrhythmia or atrial fibrillation.\n  2. unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) grade ≥ 2;\n  3. any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;\n  4. Blood pressure control is not satisfactory (systolic blood pressure \\> 140mmHg, diastolic blood pressure \\> 90mmHg).\n  5. within 1 year before the first administration, there is a history of non-infectious pneumonia requiring glucocorticoid treatment, or currently there is clinically active interstitial lung disease;\n  6. active pulmonary tuberculosis;\n  7. active or uncontrolled infections requiring systemic treatment;\n  8. clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction.\n  9. liver diseases such as liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. poorly controlled diabetes (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n  11. patients with urinary protein ≥ + + and confirmed 24-hour urinary protein quantity \\> 1.0g;\n  12. patients with mental disorders and unable to cooperate with treatment\n* At the discretion of the investigator, there are patients with serious concomitant disease that compromises patient safety or affects the patient's completion of the study; The investigator believes that there are other potential risks and is not suitable for participation this research.",{"count":307,"type":20},29,[75],"This study is a single-arm, open-lable, single-center phase II clinical trial for patients with advanced or metastatic pleural mesothelioma. The aim of this study was to observe and evaluate the efficacy and safety of Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy as first-line therapy in malignant pleural mesothelioma.",[28,311,219],"Mesothelioma, Malignant Pleural","2025-05-27",{"date":314,"type":33},"2025-05-31",{"date":316,"type":33},"2024-09-01",{"date":318,"type":20},"2027-09",{"name":320,"class":231},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",2,{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":21,"phases":333,"briefSummary":334,"conditions":335,"keywords":339,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":232},"100588829","first-local-anaesthesia-thoracoscopy-for-pleural-effusion-diagnosis-100588829","NCT06946498","First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.","Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.","FLAT","Inclusion Criteria:\n\n* Undiagnosed pleural effusion with the character of a lymphocytic exudate\n\nExclusion Criteria:\n\n* Empyema\n* Transudate pleural effusion.\n* Central airway obstruction by tumor.\n* Existence of extensive adhesions that do not allow the development of iatrogenic pneumothorax and the safe entry of the thoracoscope.\n* Uncontrollable cough.\n* Acute respiratory failure and\u002For Hypercapnia.\n* Performance Status: 5","90 Years",{"count":332,"type":20},100,[215],"Non randomized study with two groups. The study group includes patients with suspected malignant pleural effusion, in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT).\n\nThe Control Group includes patients who come to the same hospital and are treated with the Standard of Care (SOC) strategies were used. Efficacy of LAT, Sensitivity, Hospitalization, time to diagnosis and general safety and comfort of the groups' subjects will be assessed.",[336,337,338,28],"Suspected Malignant Lung Neoplasm","Pleural Effusion","Pleural Effusion, Malignant",[340,341,342,343,141,344],"Malignant Pleural Effusion","Local Anesthesia Thoracoscopy","Medical Thoracoscopy","Lung cancer","Lymphocytic Exudate","2025-04-20",{"date":347,"type":33},"2025-04-27",{"date":349,"type":33},"2023-05-23",{"date":351,"type":20},"2026-12-31",{"name":353,"class":231},"National and Kapodistrian University of Athens",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":21,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":372,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":4},"100492906","phase-1-clinical-study-to-evaluate-safety-and-dosing-of-ca9hu-1-in-patients-with-advanced-solid-tumours-100492906","NCT05698238","Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours","Phase Ib\u002Fll Clinical Study to Evaluate Safety and Dosing of Humanised Monoclonal Antibody CA9hu-1 to Human Carbonic Anhydrase IX in Patients With Advanced Solid Tumours","CAMP1","Inclusion Criteria:\n\n* Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up\n* Histologically proven solid tumors (Clear Cell Renal Cell Carcinoma Metastatic, Triple-Negative Breast Cancer, Head and Neck Cancer, Non-small-cell Lung Carcinoma, Malignant Mesothelioma) refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient\n* Life expectancy of at least 12 weeks\n* World Health Organization (WHO) performance status of 0 or 1\n* Hematological and biochemical indices within the ranges (hemoglobin ≥9.0 g\u002FdL, absolute neutrophil count ≥1.5 x 109\u002FL, platelet count ≥100 x 109\u002FL, bilirubin ≤1.5 x upper limit of normal, alanine amino-transferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x upper limit of normal. These measurements must be performed within one week (Day -7 to Day -1) before the patient receives their first infusion of CA9hi-1.\n* Calculated creatinine clearance or isotope clearance measurement ≥ 50 mL\u002Fmin\n* PT\u002FAPTT ≤1.5 upper limit of normal\n\nExclusion Criteria:\n\n* Ongoing toxic manifestations of previous treatments (Grade 2 or greater according to NCI-CTCAE v4.02) with the exception of alopecia or certain Grade 2 toxicities, which in the opinion of the investigator and CDD should not exclude the patient - these should be discussed on a case by case basis\n* Symptomatic brain metastases or spinal cord compression\n* Patients who have received prior radiotherapy to their lungs will not be eligible for this trial.\n* Female patients who are able to become pregnant (or already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral; injected or implanted hormonal contraception and condom; have an intra-uterine device and condom; diaphragm with spermicidal gel and condom) effective at the first administration of CA9hu-1, throughout the trial and for six months afterwards are considered eligible. Breast feeding should be discontinued if the mother is treated with CA9hu-1.\n* Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception \\[condom plus spermicide\\] effective at the first administration of hu-CA91, throughout the trial and for six months afterwards). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example: condom plus spermicidal gel) to prevent exposure to the foetus or neonate.\n* Any major surgical procedure within 4 weeks prior to patients scheduled Cycle 1 Day 1, any major thoracic or abdominal surgery from which the patient has not yet recovered.\n* A serious or non-healing active wound, ulcer, or bone fracture.\n* At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n* Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) or who have an active, ongoing infection or an active, known or suspected autoimmune disease or on systemic steroids.\n* Concurrent congestive heart failure, prior history of class III\u002F IV cardiac disease (New York Heart Association \\[NYHA\\]), prior history of cardiac ischemia or prior history of cardiac arrhythmia.\n* Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study of CA9hu-1. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable.\n* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.","80 Years",{"count":364,"type":20},50,[23],"Carbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers. High expression is often associated with high grade or metastatic disease and poor prognosis. CA IX is not expressed in normal tissue, potentially providing a cancer-associated target that would not likely result in significant interruption of normal biologic function in organs not affected by cancer. A humanized monoclonal antibody CA9hu-1 has shown robust activity in a variety of tumour models including models of ovarian, prostate, breast, pancreatic, colon and lung where tumour growth and metastasis are inhibited when CA9hu-1 is used as a monotherapy. Enhancement of chemotherapy has also been demonstrated in several models in combination with CA9hu-1. CA IX is also expressed by tumour-associated cells (angiogenic endothelium, tumour-associated macrophages), which also drive cancer progression. Thus, targeting CA IX with CA9hu-1 in cancer patients is expected to affect multiple pathways and multiple tumour compartments that are important to tumour progression. Taken together, there is strong rationale for developing hu-CA91 for the treatment of advanced cancer. The present study was designed to establish safety and toxicity profile and maximum tolerated dose of CA9hu-1, evaluate pharmacokinetics, investigate the presence of anti-drug antibody, to document anti-tumour activity at a clinically relevant dose, and to document the use of \\[18F\\]FLT-PET as a biomarker for detection of early tumour response at a clinically relevant dose.",[368,369,370,371,28],"Clear Cell Renal Cell Carcinoma Metastatic","TNBC - Triple-Negative Breast Cancer","Head and Neck Cancer","Non-small-cell Lung Carcinoma","NOT_YET_RECRUITING","2023-03-14",{"date":375,"type":33},"2023-03-15",{"date":377,"type":20},"2024-01",{"date":379,"type":20},"2027-01",{"name":381,"class":40},"Mabpro, a.s."]