[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pleural-mesothelioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pleural-mesothelioma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,39,92,130,173,204,228,314,342,354,384,409],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100053514","tracking-thoracic-cancer-evolution-through-therapy-rx-evo-100053514",false,"NCT05628376","TRAcking Thoracic Cancer Evolution Through Therapy (Rx) EVO","Inclusion Criteria:\n\n* Cohort A, B and C :\n\n  * Written Informed consent\n  * Agreement to be followed up (including on-study assessments and sample collection) every 3 months in the first 2 years and then 6 monthly.\n  * Agreement to be followed up at a TRACERx EVO site\n\nCohort A:\n\n* Participants ≥18 years of age, with early stage I-IIIB NSCLC disease who are eligible for primary surgery\n* Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g., diagnosis determined from frozen section in theatre)\n* Primary surgery in keeping with NICE guidelines (lobectomy, either open or thoracoscopic), lung parenchymal-sparing operations (segmentectomy or wedge resection) if a complete resection can be achieved, extensive surgery (bronchoangioplastic surgery, bilobectomy, pneumonectomy) if necessary to obtain clear margins, hilar and mediastinal lymph node sampling or en bloc resection)\n* For participants proceeding with upfront primary surgery (i.e. no neoadjuvant therapy), a minimum tumour diameter of at least 15mm on imaging to allow for tissue sampling of at least two tumour regions; this can either be two fresh tissue samples or one fresh tissue sample plus one representative diagnostic FFPE block (to be requested at a later date according to trial specific procedures)\n* Participants undergoing neoadjuvant treatment must have at least 1 region of fresh frozen or FFPE surgical or diagnostic biopsy tissue.\n* Considered sufficiently fit for upfront standard of care primary surgery or neoadjuvant therapy if indicated\n* Performance status 0 to 2\n\nCohort B:\n\n* Participants ≥18 years of age, with late-stage unresectable stage IIIB and above NSCLC disease (TNM 8th edition) or presenting with stage IV de novo metastatic disease.\n* Sufficient tissue (at least 1 region\u002Fbiopsy), either FFPE or fresh frozen\n* Deemed to be fit for anti-cancer treatment\n* Performance status 0 to 2 Participants who were initially consented into Cohort A who are found to have more advanced disease pre- or immediately post operatively (e.g. locally advanced\u002Finoperable or stage IV disease) could be included in Cohort B.\n\nCohort C:\n\n* Participants ≥18 years of age, with any stage SCLC or pleural mesothelioma.\n* Sufficient tissue (at least 1 region\u002Fbiopsy), either FFPE or fresh frozen\n* Deemed to be fit for anti-cancer treatment\n* Performance status 0 to 2\n\nExclusion Criteria:\n\n* Cohort A, B and C:\n\n  * Any other active or current malignancy and\u002For systemic treatment (excluding hormone therapy) for that malignancy in the last 12 months (i.e., participant must be cancer free for the last 12 months, and if on therapy it can only be hormone therapy).\n\n    * Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer, or for Cohort C, cases of NSCLC that have transformed to SCLC, or for Cohort A another synchronous lung cancer.\n  * Psychological condition that would preclude informed consent\n  * Diagnosis other than NSCLC, SCLC or pleural mesothelioma confirmed following surgery or biopsy\n  * Confirmed diagnosis of known high-risk infections (e.g., Human Immunodeficiency Virus) (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection, tuberculosis and Creutzfeldt-Jacob disease) unless participant case is of a particular scientific interest and agreed in advance with research staff, local mortuary staff and pathologist.\n  * Contra-indicated severe co-morbid conditions\n\nCohort A:\n\n* Positive margins, incomplete resection or insufficient nodal sampling\n* Insufficient tissue, i.e., for participants having upfront surgery and not having neoadjuvant therapy, a minimum of two tumour regions unlikely to be obtained for the study based on pre-operative imaging, or for participants having neoadjuvant therapy at least one tissue biopsy unable to be obtained prior to neoadjuvant therapy (Fresh Frozen or FFPE).\n* Participant found to have pre-invasive lesions rather than invasive cancer following surgery, such as adenocarcinoma in situ or minimally invasive lesions will be withdrawn. However, the surgical tissue and baseline blood already collected will be sent to the central laboratory. These participants will not be followed-up in the study or required to provide any further blood samples. If these participants subsequently develop invasive cancer, the date of diagnosis and the tumour histology will be reported on the electronic data capture system.\n\nCohort B\u002FC:\n\n• Insufficient tissue, i.e., at least one tissue biopsy unable to be obtained (Fresh Frozen or FFPE)","ALL","18 Years",{"count":18,"type":19},600,"ESTIMATED","OBSERVATIONAL","TRACERx EVO is a programme of work using a prospective observational cohort study of participants with early- and late-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and pleural mesothelioma.",[23,24,25],"Lung Cancer, Non-small Cell","Small Cell Lung Cancer","Pleural Mesothelioma","RECRUITING","2026-07-10",{"date":29,"type":30},"2026-07-13","ACTUAL",{"date":32,"type":30},"2023-10-20",{"date":34,"type":19},"2034-06",{"name":36,"class":37},"University College, London","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":65,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100614270","phase-1-a-study-of-ide892-as-monotherapy-and-combination-in-mtap-deleted-advanced-solid-tumors-100614270","NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease",{"count":47,"type":19},260,"INTERVENTIONAL",[50],"PHASE1","This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[53,54,55,56,57,58,59,60,25,61,62,63,64],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastric Adenocarcinoma","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Urothelial Carcinoma (UC)","Bladder Cancer","Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Pancreatic Cancer","Biliary Tract Carcinoma",[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA","2026-06-19",{"date":83,"type":30},"2026-06-23",{"date":85,"type":30},"2026-03-04",{"date":87,"type":19},"2028-04-30",{"name":89,"class":90},"IDEAYA Biosciences","INDUSTRY",14,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":48,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":38},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778","NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",true,{"count":101,"type":19},70,[103],"NA","Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[106,107,108,109,25,110,111,112,113,114,115,116,117,118,119,120],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Hodgkin's Lymphoma","Chronic Lymphocytic Leukemia","Follicular Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Colorectal Cancer","Esophageal Squamous Cell Carcinoma","Heart Cancer","Cholangiocarcinoma","Colorectal Adenocarcinoma","2026-06-17",{"date":123,"type":30},"2026-06-18",{"date":121,"type":30},{"date":126,"type":19},"2028-07",{"name":128,"class":129},"University Hospital, Angers","OTHER_GOV",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":48,"phases":139,"briefSummary":141,"conditions":142,"keywords":159,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100543937","phase-1-a-study-of-oral-7hp349-alintegimod-in-combination-with-ipilimumab-followed-by-nivolumab-monotherapy-100543937","NCT06362369","A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy","A Phase 1b\u002F2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies","Inclusion and Exclusion Criteria for Phase 1b\n\nInclusion Criteria\n\n1. Adult patients (age 18 or older)\n2. Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1\u002FPD-L1.\n3. ANC ≥ 1000\u002FµL without use of G-CSF, Hgb ≥ 9 g\u002FdL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000\u002FµL without transfusions for at least 5 days prior to pretreatment baseline.\n4. ECOG performance status of 0 or 1.\n5. Has a life expectancy of \\> 12 weeks.\n6. Renal and hepatic function requirements:\n\n   * a. Renal function with either an eCrCL ≥ 60 mL\u002Fmin (modified Cockcroft-Gault) or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (using MDRD or CKD-EPI or similar equations).\n   * b. Hepatic function with ALT\u002FAST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST\u002FALT≤ 5 x ULN will be allowed.\n7. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n8. All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).\n9. All patients must have measurable disease by applicable RECIST criteria.\n10. Willing to allow blood samples to be used for research.\n\nExclusion Criteria:\n\n1. Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed. For small molecules (MW \\\u003C 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.\n2. Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at least 2 weeks prior to first dose of study drug.\n3. Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator will not compromise the patients' safety on the trial. Patients with stable endocrinological AEs (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus) are allowed.\n4. Persistent toxicity of NCI CTCAE version 5 Grade \\> 1 severity that is related to prior therapy.\n\n   Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior treatments that are controlled with medication (e.g., diabetes or hypertension) are permitted.\n5. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3A (CYP3A) within 2 weeks before study intervention. Alintegimod may increase exposure to CYP3A4 substrates; consider a dose reduction of such substrates and monitor for signs of toxicities of co-administered sensitive CYP3A substrates (see listing of strong inhibitors and inducer drugs in FDA tables). An alternative is to replace such agents with drugs that are not CYP3A4 metabolized if at all feasible.\n6. The patient has cardiac conditions as follows:\n\n   * a) myocarditis;\n   * b) uncontrolled hypertension (blood pressure \\> 160\u002F100) despite optimal therapy;\n   * c) uncontrolled angina; ventricular arrhythmias; congestive heart failure (New York Heart Association Class II or above);\n   * d) prior or current cardiomyopathy;\n   * e) uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm); unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly);\n   * f) concomitant medication with drugs known to cause Torsades de Pointes;87\n   * g) QT interval correction for heart rate using Fridericia's formula (QTcF) ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead electrocardiogram \\[ECG\\]) at screening.\n7. Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA).\n8. Concurrent malignancies are permitted if they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or with agreement from the Principal Investigator (PI), patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n9. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WOCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WOCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n10. The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n11. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of administration of Alintegimod with the following exceptions:\n\n    * a) Topical, intranasal, inhaled, ocular, intra-articular corticosteroids;\n    * b) Physiological doses of replacement corticosteroids (e.g., for adrenal insufficiency) are not to exceed 10 mg\u002Fday of prednisone or equivalent.\n    * c) Corticosteroid premedication for infusion and\u002For hypersensitivity reactions.\n    * d) Patients may be treated with a short (\\\u003C24h) pulse course of corticosteroids to mitigate infusion or hypersensitivity reactions to radiocontrast agents.\n12. Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod.\n13. Serious autoimmune disease at the discretion of the treating Investigator: patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's Granulomatosis) are excluded from participation in this study\n14. Active or history of pneumonitis (drug-induced), idiopathic pulmonary fibrosis, Interstitial Lung Disease (ILD), or lung disease that may interfere with assessment of pneumonitis. History of radiation pneumonitis in a previous radiation field is permitted.\n15. Previous participation in a study of any investigational agent within 21 days of enrollment or within 5 half-lives of the study treatment, whichever is the least.\n16. Use of mechanical ventilation or having a resting O2 saturation \\\u003C 90% (on room air) by pulse-oximetry, require renal dialysis, require vasopressors, and\u002For severe hepatic sinusoidal obstruction syndrome.\n17. Proven or suspected ongoing systemic infection requiring IV antibiotics.\n18. Women who are pregnant or lactating.\n\n    Note: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment. Non-childbearing potential is defined as 1 of the following:\n    * a) Postmenopausal with \\> 1 year since last menses and:\n    * 1\\. If ≥ 65 years old, follicle-stimulating hormone (FSH) \\> 40 mIU\u002FmL.\n    * 2\\. If ≥ 65 years old and not on hormone replacement therapy (HRT), FSH \\> 30 mIU\u002FmL.\n    * 3\\. If ≥ 65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥ 6 months prior to dosing of study drug(s).\n    * b) Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥ 6 months prior to dosing study drug(s).\n\n    Note: Tubal ligation is not considered a form of permanent sterilization.\n19. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events or have compromised ability to provide written informed consent.\n20. Patients who have had allogeneic tissue or solid organ transplantation. Prior T cell therapy is allowed\n21. Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg (NIH-ODS 2022; Section 5.9.2.1).\n\n    Note: Patients who switch from a high dose to a dose of ≤30 µg\u002Fday are eligible for study entry.\n22. Any condition that is in the opinion of the investigator may compromise patient's participation in the trial.\n23. Active peptic ulcer disease or gastritis, active diverticulitis, or other serious gastrointestinal disease associated with diarrhea within the past 2 years before the start of therapy or GI disease which affects oral drug absorption.\n24. Patients with known soy allergy.",{"count":138,"type":19},126,[50,140],"PHASE2","This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.\n\nCurrently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b",[143,144,145,146,25,147,148,149,116,150,151,152,153,154,155,156,157,158],"Advanced Cancer","Advanced Solid Tumor","Melanoma","Metastasis","Renal Cell Carcinoma","MSI-High","Mismatch Repair Deficiency","Hepatocellular Carcinoma","Hepatocellular Cancer","Renal Cell Cancer","Kidney Cancer","Skin Cancer","Non Small Cell Lung Cancer","NSCLC","Anaplastic Lymphoma Kinase Genomic Tumor Aberrations","ALK Genomic Tumor Aberrations",[160,161,162],"Phase 1","Phase 1b","7 Hills Pharma","2026-04-07",{"date":165,"type":30},"2026-04-13",{"date":167,"type":30},"2024-08-23",{"date":169,"type":19},"2028-12-31",{"name":171,"class":90},"7 Hills Pharma, LLC",5,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":180,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":48,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100623976","integrative-multi-omics-and-functional-platform-for-the-complete-diagnostic-characterization-of-tumors-the-italian-tumor-chemogenomic-profiler-it-tcp-100623976","NCT07403630","INTEGRATIVE \"MULTI-OMICS\" AND FUNCTIONAL PLATFORM FOR THE COMPLETE DIAGNOSTIC CHARACTERIZATION OF TUMORS: THE ITALIAN TUMOR CHEMOGENOMIC PROFILER (IT-TCP)","IT-TCP POS","Inclusion criteria:\n\n* Patients aged one year and over who are referred to the centres involved in the protocol (Azienda Ospedaliero-Universitaria di Parma, University of Parma, University of Perugia and Azienda Ospedali Riuniti Villa Sofia-Cervello of Palermo).\n* Patients with an established diagnosis of haematological or solid organ malignancy, including haematological or solid malignancies characteristic of the paediatric age group.\n* Patients diagnosed with relapsed, refractory and\u002For metastatic haematological or solid malignancy. Patients may be enrolled regardless of the extent and type of previous therapy. Patients may also be enrolled if they are undergoing active treatment at the time of evaluation.\n* Patients must have the capacity to understand the investigative nature of the study and provide informed consent in writing. For patients under the age of 12 years, consent will be provided by the parent\u002Flegal guardian according to international guidelines. For patients aged 12 to 17 years, consent will be provided by the patient and the parent\u002Flegal guardian according to the mature minor principle.\n\nExclusion criteria:\n\n* Patients younger than 1 year old\n* Patients with active, uncontrolled infections","1 Year",{"count":182,"type":19},300,[103],"This is a multicenter, experimental preclinical study conducted on primary samples from patients diagnosed with hematological or solid neoplasms defined as high risk. The study will be prospective, based on the consecutive enrollment of eligible patients at each participating institution.",[186,187,188,25,63,59,189,145,190,191,192,193],"Acute Leukemia","Multiple Myeloma","Squamous Cell Carcinoma","Ovarian Cancer","Pediatric Acute Lymphoblastic Leukemia","Chronic Leukemia","Myeloproliferative Disorders","Myelodysplastic Disorders","2026-02-13",{"date":196,"type":30},"2026-02-17",{"date":198,"type":30},"2023-05-31",{"date":200,"type":19},"2028-02-12",{"name":202,"class":37},"Azienda Ospedaliero-Universitaria di Parma",2,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100480655","ttfields-in-general-routine-clinical-care-in-patients-with-pleural-mesothelioma-study-100480655","NCT05538806","TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study","TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study","TIGER Meso","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Histologically confirmed pleural mesothelioma without any option of curative resection\n* Planned treatment with NovoTTF-200T System according to IFU and medical guidelines\n* Life expectancy more than 3 months at day of enrollment\n* Signed informed consent for use and processing of data\n\nExclusion Criteria:\n\n• Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment",{"count":213,"type":19},198,"The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.",[25],[25,217],"TTFields","2025-08-18",{"date":220,"type":30},"2025-08-22",{"date":222,"type":30},"2023-08-01",{"date":224,"type":19},"2028-06",{"name":226,"class":90},"NovoCure Ltd.",23,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":48,"phases":238,"briefSummary":239,"conditions":240,"keywords":273,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":313},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":237,"type":19},115,[50,140],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[144,241,242,243,244,245,246,247,248,249,59,250,251,252,25,253,254,255,256,257,258,259,260,261,262,263,264,265,266,189,267,268,269,154,270,271,272],"Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Gastric Cancer","Cervical Cancer","Basal Cell Carcinoma","Merkel Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Cutaneous Squamous Cell Carcinoma","Esophageal Cancer","Endometrial Carcinoma","Solid Tumor","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","Mucosal Melanoma","Cutaneous Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Viral Cancer","Cervical Cancers","Endometrial Cancer",[274,275,276,277,278,279,280,156,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","immunotherapy","anti-PD-1","BCC","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":306,"type":30},"2025-07-09",{"date":308,"type":30},"2021-08-27",{"date":310,"type":19},"2026-12-30",{"name":312,"class":90},"Medicenna Therapeutics, Inc.",27,{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":48,"phases":323,"briefSummary":324,"conditions":325,"keywords":330,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":38},"100576806","phase-2-the-diagnostic-accuracy-and-clinical-value-of-fapi-pet-in-pleural-mesothelioma-100576806","NCT06790082","The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma","FAPI PET in Pleural Mesothelioma: The Diagnostic Accuracy and Clinical Value of FAPI PET at Diagnosis, Primary Staging, and the Feasibility of FAPI PET for Response Evaluation","FAPI-PM","Inclusion Criteria:\n\n* Patients with pleural lesions suspicious of pleural mesothelioma and referred to pleural biopsy.\n* Undergone\u002Fundergoing FDG PET\u002FCT as part of the diagnostic workup of a suspicious PM lesion.\n* Considered physically and mentally able to participate in the research project.\n* Understands the study subject information and able to consent to project participation.\n* 18-years or older\n\nExclusion Criteria:\n\n* Patients with an imminent need for surgery or in an emergency\n* Known concurrent other malignancy with active treatment within the last 1 year; non-melanoma skin cancer and cervical cancer in situ are exempt.\n* Pregnant or breastfeeding women.\n* Fertile women (women of childbearing potential) who could - theoretically - be pregnant (i.e., unknown pregnancy status).\n\nFertile women will be tested for pregnancy (by urine humane choriogonadotropin (HCG) or serum HCG) within 48h before FAPI PET\u002FCTs, both at primary staging and restaging. Study subjects can participate in the study if the pregnancy test is negative (i.e., not pregnant).\n\n* Subjects unable to undergo PET\u002FCT: e.g., weighing more than 180 kg (weight limit scanner), unable to fit within the imaging gantry, inability to remain still for the duration of the examination, or with known severe claustrophobia unresponsive to oral anxiolytics or severe fear of needles.\n* Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.\n* History of allergic reactions \u002F hypersensitivity attributed to \\[18F\\]FDG or FAPI-tracers.",{"count":101,"type":19},[140],"Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET\u002FCT at primary staging.\n\nThe FAPI PET\u002FCT results will be compared to conventional imaging (including FDG PET\u002FCT). The diagnostic accuracy will be determined with histopathology as reference standard.\n\nFor patients undergoing anticancer treatment (chemotherapy, immunotherapy, other treatment), an additional FAPI PET\u002FCT and an additional FDG PET\u002FCT will be conducted after the study subjects have completed 2-3 series of anticancer treatment. The feasabilitiy of FAPI PET\u002FCT in response evaluation will be investigated.\n\nAll study specific analyzes will be blinded and will not influence the patient management \u002F treatment.",[25,326,327,328,329],"Pleural Diseases","Cancer","FAPI","Fibroblast Activation Protein Inhibitor",[328,331,332,25,333],"68Ga-FAPI-46","PET\u002FCT","FDG PET\u002FCT","2025-07-01",{"date":304,"type":30},{"date":337,"type":30},"2025-01-29",{"date":339,"type":19},"2037-04-30",{"name":341,"class":37},"Aalborg University Hospital",{"id":343,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":346,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":353,"locationsCount":38},"100487537","Inclusion Criteria:\n\n* Cohort A, B and C :\n\n  * Written Informed consent\n  * Agreement to be followed up (including on-study assessments and sample collection) every 3 months in the first 2 years and then 6 monthly.\n  * Agreement to be followed up at a TRACERx EVO site\n\nCohort A:\n\n* Participants ≥18 years of age, with early stage I-IIIB NSCLC disease who are eligible for primary surgery\n* Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g., diagnosis determined from frozen section in theatre)\n* Primary surgery in keeping with NICE guidelines in (lobectomy, either open or thoracoscopic), lung parenchymal-sparing operations (segmentectomy or wedge resection) if a complete resection can be achieved, extensive surgery (bronchoangioplastic surgery, bilobectomy, pneumonectomy) if necessary to obtain clear margins, hilar and mediastinal lymph node sampling or en bloc resection)\n* For participants proceeding with upfront primary surgery (i.e. no neoadjuvant therapy), a minimum tumour diameter at least 15mm to allow for sampling of at least two tumour regions\n* Participants undergoing neoadjuvant treatment must have at least 1 region of fresh frozen or FFPE surgical or diagnostic biopsy tissue.\n* Considered sufficiently fit for upfront standard of care primary surgery or neoadjuvant therapy if indicated\n* Performance status 0 to 2\n\nCohort B:\n\n* Participants ≥18 years of age, with late-stage unresectable stage IIIB and above NSCLC disease (TNM 8th edition) or presenting with stage IV de novo metastatic disease.\n* Sufficient tissue (at least 1 region\u002Fbiopsy), either FFPE or fresh frozen\n* Deemed to be fit for anti-cancer treatment\n* Performance status 0 to 2 Participants who were initially consented into Cohort A with a post-surgical staging of stage IIIB\u002FC or IV could be included in Cohort B.\n\nCohort C:\n\n* Participants ≥18 years of age, with any stage SCLC or pleural mesothelioma.\n* Sufficient tissue (at least 1 region\u002Fbiopsy), either FFPE or fresh frozen\n* Deemed to be fit for anti-cancer treatment\n* Performance status 0 to 2\n\nExclusion Criteria:\n\n* Cohort A, B and C:\n\n  * Other active malignancy\n  * Any other\\* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy).\n  * Any other\\* current malignancy or malignancy diagnosed or relapsed within the past 3 years\\*\\*.\n\n    * \\*Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer\n    * \\*\\*An exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of NSCLC.\n  * Psychological condition that would preclude informed consent\n  * Diagnosis other than NSCLC, SCLC or pleural mesothelioma confirmed following surgery or biopsy\n  * Confirmed diagnosis of known high-risk infections (e.g., Human Immunodeficiency Virus) (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection, tuberculosis and Creutzfeldt-Jacob disease) unless participant case is of a particular scientific interest and agreed in advance with research staff, local mortuary staff and pathologist.\n  * Contra-indicated co-morbid conditions\n\nCohort A:\n\n* Positive margins, incomplete resection or insufficient nodal sampling\n* Insufficient tissue, i.e., for participants having upfront surgery and not having neoadjuvant therapy, a minimum of two tumour regions unlikely to be obtained for the study based on pre-operative imaging. For participants having neoadjuvant therapy i.e., at least one tissue biopsy to be obtained (Fresh Frozen or FFPE).\n* Participant found to have pre-invasive lesions rather than invasive cancer following surgery, such as adenocarcinoma in situ or minimally invasive lesions will be withdrawn. However, the surgical tissue and baseline blood already collected will be sent to the central laboratory. These participants will not be followed-up in the study or required to provide any further blood samples. If these participants subsequently develop invasive cancer, the date of diagnosis and the tumour histology will be reported on the electronic data capture system.\n\nCohort B\u002FC:\n\n• Insufficient tissue, i.e., at least one tissue biopsy to be obtained (Fresh Frozen or FFPE)",{"count":18,"type":19},[23,24,25],"2025-03-27",{"date":349,"type":30},"2025-04-02",{"date":351,"type":30},"2023-12-04",{"date":34,"type":19},{"name":36,"class":37},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":48,"phases":363,"briefSummary":364,"conditions":365,"keywords":371,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":38},"100571923","phase-1-a-study-of-mt027-in-patients-with-pleural-malignant-tumors-100571923","NCT06726564","A Study of MT027 in Patients with Pleural Malignant Tumors","A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors","Inclusion Criteria:\n\n1. voluntarily participate in the study and sign informed consent;\n2. age over 18 years old (including the cut-off value), regardless of gender;\n3. advanced malignant solid tumor pathologically and\u002For histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary);\n4. the original pleural cavity malignant tumor after standard treatment failure, or top treatment;\n5. signed informed consent not line within a month before the chest cavity medicine injection, but does not exclude the diagnostic puncture;\n6. The subjects voluntarily provided sufficient tumor cells in the pathological section of the primary lesion and\u002For pleural effusion for B7-H3 expression detection, and the tumor cells in the pathological section of the primary lesion or malignant pleural effusion were positive for B7-H3 expression;\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2;\n8. within 7 days before treatment laboratory meet the following criteria:\n\nRoutine blood (14 days) :\n\n1. Absolute neutrophil count (ANC) ≥1.5×109 \u002FL;\n2. platelet count (PLT) or 80 x 109 \u002F L;\n3. hemoglobin (HGB) or 80 g\u002FL (allowing blood transfusion and use erythropoiesis agent). The presence of active bleeding or other ongoing conditions that result in increased red-cell destruction or impaired production may require repeated transfusions or red-cell therapy, and patients had to discuss their eligibility with the sponsor on an individual basis before enrollment.) ;\n\nLiver:\n\n1. total bilirubin (TIBC) or less 2 times the upper limit of the normal range (ULN);\n2. no liver metastasis, AST and ALT 3 x ULN or less; ALT and AST≤5 times ULN in the presence of liver metastasis;\n\nKidney:\n\n1. Serum creatinine (Cr) ≤ 2 times ULN; Or creatinine clearance (CrCL) ≥ 50 mL\u002Fmin (estimated by Cockcroft-Gault formula);\n\n   Blood coagulation function:\n2. international standardization ratio (INR) or prothrombin time (PT) 1.3 x ULN or less;\n3. Partial activated thromboplastin time (APTT) ≤ 1.5 times ULN; 9) toxicity from previous systemic therapy returned to grade 1 or less or to baseline before the first dose (except alopecia); 10) Fertile men and women of childbearing age must agree to use reliable contraception from the time they provide informed consent until 180 days after the last dose of MT027 cell injection; Women of childbearing age included those who were premenopausal and those within 2 years of menopause.\n\nExclusion Criteria:\n\n1. known allergy to the study drug or its excipients;\n2. patients with pleural puncture contraindications or won't benefit from intrathoracic medication;\n3. any antineoplastic drugs other than systemic antineoplastic therapy that the subject has been taking stably and any treatment that may have an effect on the control of pleural effusion (other than diagnostic puncture or thoracentesis for investigational treatment);\n4. in the first test within 2 weeks before treatment received radiotherapy.\n5. major surgery is performed within 4 weeks before the first trial treatment and the patient has not fully recovered;\n6. are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week before the first trial treatment.\n7. participated in other drug clinical trials within 4 weeks before screening;\n8. always had targeted B7 - H3 CAR - T cells treatment;\n9. patients with active systemic or pulmonary infection, coagulopathy and other major diseases;\n10. with severe heart, lung, liver and renal insufficiency; Cardiac function: grade 3 or above according to the New York Heart Association (NYHA) criteria; Liver function: Child - Puge classification standard for grade C or above; Renal function: chronic kidney disease (CKD) stage 4 or above; Renal insufficiency stage Ⅲ or above; Pulmonary function: severe symptoms of respiratory failure involving other organs;\n11. patients with severe autoimmune diseases;\n12. recipients of previous allogeneic tissue\u002Fsolid organ transplantation;\n13. who received a live vaccine within 2 weeks before the first cell therapy or were scheduled to receive a live vaccine during the study;\n14. active HBV infection; Or hepatitis C virus infection (defined as positive for HCV antibody, allowed if HCV-RNA was below the lower limit of detection); Or human immunodeficiency virus infection (defined as HIV antibody positive); Or positive treponema pallidum antibody;\n15. subjects had severe neurocognitive impairment as judged by the investigator;\n16. pregnant or lactating women;\n17. There were any clinical or laboratory abnormalities or other reasons considered by the investigator to preclude participation in the study.",{"count":362,"type":19},18,[50],"This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK\u002FPD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy..\n\nSubjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.",[366,367,368,25,369,370],"Advanced Malignant Solid Tumor","Malignant Pleural Effusion","Pleura Carcinoma","Pleural Malignant Mesothelioma","Pleural Metastases",[372,373,374],"advanced malignant solid tumors","metastatic or primary malignant tumors in the pleural cavity","malignant pleural effusion","2024-12-05",{"date":377,"type":30},"2024-12-10",{"date":379,"type":30},"2024-05-15",{"date":381,"type":19},"2029-02",{"name":383,"class":90},"Suzhou Maximum Bio-tech Co., Ltd.",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":48,"phases":392,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":399,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":4},"100548125","phase-2-study-of-cadonilimab-combined-with-chemotherapy-in-recurrent--refractory-pleural-mesothelioma-100548125","NCT06416930","Study of Cadonilimab Combined With Chemotherapy in Recurrent \u002F Refractory Pleural Mesothelioma","Inclusion Criteria:\n\n1. Histologically confirmed advanced or metastatic pleural mesothelioma;\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n3. Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.\n4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.\n5. Adequate haematological, renal and liver function.\n\nExclusion Criteria:\n\n1. Primary mesothelioma of peritoneum, pericardium and testes\n2. Active, untreated central nervous system (CNS) metastasis.\n3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.\n4. Known active autoimmune diseases.\n5. Presence of other uncontrolled serious medical conditions.",{"count":391,"type":19},59,[140],"This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent \u002F refractory pleural mesothelioma.",[25],[396,397,398],"Cadonilimab","pleural mesothelioma","Bispecific Antibody","NOT_YET_RECRUITING","2024-05-12",{"date":402,"type":30},"2024-05-16",{"date":404,"type":19},"2024-06-20",{"date":406,"type":19},"2029-06-20",{"name":408,"class":37},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":48,"phases":418,"briefSummary":419,"conditions":420,"keywords":421,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":38},"100510763","phase-2-study-of-cadonilimab-combined-with-bevacizumab-and-standard-chemotherapy-as-first-line-therapy-in-unresectable-pleural-mesothelioma-100510763","NCT05930665","Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma","A Phase II, Prospective, Single Arm Trial of Cadonilimab in Combination With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma","Key Inclusion Criteria:\n\n1. Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n3. No previous systemic anti-tumor treatment for advanced\u002Fmetastatic disease\n4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.\n5. Adequate haematological, renal and liver function.\n\nKey Exclusion Criteria:\n\n1. Primitive peritoneal, pericardial and tunica vaginalis testis mesothelioma.\n2. Active, untreated central nervous system (CNS) metastasis.\n3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.\n4. Known active autoimmune diseases.\n5. Presence of other uncontrolled serious medical conditions.",{"count":417,"type":19},38,[140],"Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab in combination with bevacizumab and standard chemotherapy as first Line therapy in unresectable pleural mesothelioma.",[25],[422],"bispecific antibody","2024-02-19",{"date":425,"type":30},"2024-02-21",{"date":427,"type":30},"2023-11-01",{"date":429,"type":19},"2026-07",{"name":431,"class":37},"Sun Yat-sen University"]