[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Philogen S.p.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":309},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,44,74,103,126,142,167,191,215,242,264,287],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100643691","phase-1-a-phase-i-study-to-evaluate-the-safety-and-dosimetry-of-imaging-with-68ga-oncoacp3-in-prostate-cancer-100643691",false,"NCT07600554","A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer","SWAP","Inclusion Criteria:\n\n1. Prostate cancer patients with:\n\n   * suspected metastasis who are candidates for initial definitive therapy\n   * suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level \\> 0.2 ng\u002FmL)\n   * metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. (Note: patients with a negative PSMA-PET\u002FCT or discordant PSMA-PET and FDG-PET findings are eligible for this study, providing that they have a histologically confirmed diagnosis of prostate cancer)\n2. Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.\n3. Age ≥ 18\n4. ECOG ≤ 1\n5. Patient must not have any concomitant infections or active concomitant disease.\n6. All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 6.0) Grade ≤ 1.\n7. Life expectancy of more than 12 weeks.\n8. Ability to undergo imaging study procedures.\n9. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n10. Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Chronically impaired renal function as expressed by creatinine clearance \\\u003C 60 mL\u002Fmin or serum creatinine \\> 1.5 x ULN. Note: it is sufficient to evaluate either creatinine clearance or serum creatinine\n2. Presence of active hepatitis.\n3. Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia).\n4. Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.\n5. Major trauma including major surgery (such as abdominal\u002Fcardiac\u002Fthoracic surgery) within 4 weeks of administration of the study drug. Minimally invasive procedures such as biopsies are not considered as exclusion criteria.\n6. Serious, non-healing wound, ulcer, or bone fracture.\n7. Allergy to study medication or excipients in study medication.\n8. Any anti-cancer therapy (e.g., cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before \\[68Ga\\]Ga-OncoACP3-PET\u002FCT scan.\n9. Subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from one month before \\[68Ga\\]Ga-OncoACP3 injection to end of study participation.","MALE","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The aim of this study is to assess the safety and dosimetry of imaging with \\[68Ga\\]Ga-OncoACP3 in patients with prostate cancer.",[26],"Prostate Cancer",[26,28,29,30],"PET\u002FCT imaging","ACP3","PSMA","RECRUITING","2026-06-08",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":35},"2026-05-27",{"date":39,"type":20},"2027-12",{"name":41,"class":42},"Philogen S.p.A.","INDUSTRY",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100610420","phase-2-l19il2-or-l19tnf-or-l19il2tnf-in-patients-with-basal-cell-carcinoma-bcc-100610420","NCT07227350","L19IL2 or L19TNF or L19IL2\u002FTNF in Patients With Basal Cell Carcinoma (BCC)","A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2\u002FL19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)","Inclusion Criteria:\n\n* Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to intratumoral injection, not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.\n* Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.\n* Patients must not have received prior checkpoint inhibitors systemic treatment.\n* Patients may have received prior surgery and\u002For radiation therapy.\n* Radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.\n* Patients must have a histologically confirmed disease that is considered to be inoperable or medical contraindication to surgery or radiotherapy, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, plastic surgeon or surgical\u002Fmedical oncologist. Acceptable medical contraindications to surgery include:\n\n  * BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely\n  * Anticipated substantial morbidity and\u002For deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)\n  * Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing)\n  * Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.\n* Male or female patients, age 18 - 100 years.\n* ECOG Performance Status\u002FWHO Performance Status ≤ 1.\n* Hemoglobin \\> 10.0 g\u002FdL.\n* Platelets \\> 100 x 109\u002FL.\n* ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).\n* Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\\u003C 45 mL\u002Fmin\u002F1.73m2.\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.\n* Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogenand progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner.\n* Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.\n* Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin (surgically removed 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.\n* Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.\n* Current topical or systemic chemotherapy, targeted therapy immunotherapy.\n* Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.\n* Presence of active severe bacterial or viral infections or other severe concurrent disease\u002Finfection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n* History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).\n* Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.\n* Known arterial aneurysms.\n* INR \\> 3.\n* Uncontrolled hypertension.\n* Known uncontrolled coagulopathy or bleeding disorder.\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment.\n* Moderate to severe respiratory failure.\n* Active autoimmune disease that has required systemic treatment in past 2 years.\n* Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n* Known history of allergy to IL2, TNF, or other human proteins\u002Fpeptides\u002Fantibodies.\n* Pregnancy or breast-feeding.\n* Ischemic peripheral vascular disease (Grade IIb-IV).\n* Severe diabetic retinopathy.\n* Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n* Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.\n* Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n* Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.","ALL","100 Years",{"count":54,"type":20},180,[56],"PHASE2","Open label, randomized study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2\u002FL19TNF, the secondary objectives of this study are to evaluate efficacy, safety and pharmacokinetics of immunocytokines. A minimum of 60 patients and a maximum of 180 evaluable patients will be randomized in a 1:1:1 ratio to one of the three different treatment arms of the study and will receive intralesional injections of: (i) Monotherapy 13 Mio IU (\\~2.17 mg) L19IL2; or (ii) Monotherapy 0.4 mg L19TNF; or (iii) Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF, once weekly for 4 consecutive weeks. Newly injectable lesions occurring within the 4-week treatment period of the initial target lesion will also receive multiple intratumoral administrations of immunocytokines once weekly for up to 4 weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment",[59],"Locally Advanced Basal Cell Carcinoma",[61,62,63,64],"Basal Cell Carcinoma","locally advanced","subcutaneous lesions","cutaneous lesions","2026-05-29",{"date":67,"type":35},"2026-06-02",{"date":69,"type":20},"2026-06",{"date":71,"type":20},"2031-02",{"name":41,"class":42},3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100636531","phase-1-a-phase-i-study-to-evaluate-the-safety-and-efficacy-of-l19il2-in-combination-with-ruxolitinib-in-patients-with-advanced-solid-tumors-100636531","NCT07566897","A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of one of the following tumor types for which no further approved systemic treatment options are available:\n\n   1. Unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, that has progressed following:\n\n      * at least one prior line containing FOLFIRINOX and\u002For gemcitabine plus nab-paclitaxel, and\n      * at least one approved second-line regimen (e.g., 5-FU\u002Fleucovorin plus liposomal irinotecan), or where these regimens are not suitable due to contraindication or prior intolerance\n   2. Metastatic proficient mismatch repair \u002F microsatellite stable (pMMR\u002FMSS), BRAF V600E-negative colorectal adenocarcinoma, that has progressed following:\n\n      * at least one prior line of systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan, with or without anti-VEGF and, if RAS wild-type, with or without anti-EGFR, and\n      * at least one approved subsequent line of therapy with trifluridine-tipiracil, regorafenib or fruquintinib, or where these agents are not suitable due to contraindication or prior intolerance;\n   3. Metastatic clear cell renal cell carcinoma, that has progressed following:\n\n      * at least one prior PD-(L)1-based systemic regimen, and\n      * at least one VEGF-targeted tyrosine kinase inhibitor (TKI), or where these treatments are not suitable due to contraindication or prior intolerance\n2. Patients must have no further approved and available therapy options or be documented as ineligible or intolerant.\n3. Patients must have radiographic disease progression on\u002Fafter the last line of prior treatment.\n4. At least one unidimensionally measurable lesion as defined by RECIST v.1.1.\n5. Eastern cooperative oncology group (ECOG) performance status ≤ 2.\n6. Patient has an estimated life expectancy of at least 12 weeks.\n7. Hemoglobin \\> 10.0 g\u002FdL.\n8. Platelets ≥ 100 x 109\u002FL.\n9. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL.\n10. Negative TB test (e.g., Mantoux or Quantiferon assay).\n11. Documented negative test for HIV, HBV, HCV excluding active infection is needed. For HBV serology: the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and\u002For anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n12. Serum creatinine \\\u003C 1.5 x ULN and estimated Glomerular Filtration Rate (eGFR) value above 75 mL\u002Fmin\u002F1.73m2. An age-calibrated definition of Chronic Kidney Disease (CKD) has been proposed to distinguish age-related from disease-related changes in eGFR. For patients younger than 40 years, CKD is defined by estimated Glomerular Filtration Rate (eGFR) below 75 mL\u002Fmin\u002F1.73m2.\n13. All acute toxic effects (excluding alopecia) of any prior therapy must have been resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.5.0) Grade ≤ 1.\n14. Women Of Childbearing Potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to six months following the last study treatment administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner. Double-barrier contraception is required.\n15. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to six months following the last study treatment administration. Double-barrier contraception is required.\n16. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Patients with primary brain tumors, brain metastases or CNS disease will be excluded.\n2. Chemotherapy, immunotherapy, or radiation therapy at the tumor sites within 4 weeks prior to study treatment start.\n3. Active or history of autoimmune disease that might deteriorate when receiving an immunostimulatory agent.\n4. Previous or concurrent cancer type that is distinct from the cancer being evaluated in this study. Exception made for any other cancer curatively treated ≥ 2 years prior to study treatment start.\n5. Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n6. Impaired cardiocirculatory functions due to any of the following conditions:\n\n   a History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n\n   b Inadequately controlled cardiac arrhythmias including atrial fibrillation. c Heart insufficiency (\\> Grade II, New York Heart Association (NYHA) criteria). d Any abnormalities observed during baseline ECG and Echocardiogram investigations are considered clinically significant by the investigator.\n\n   e Uncontrolled hypertension defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg.\n\n   f Ischemic peripheral vascular disease (Grade IIb-IV).\n7. Known arterial aneurysms.\n8. INR \\> 3.\n9. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). At the discretion of the investigator, an increased exclusion threshold for patients with liver metastasis can be accepted as follows: ALT, AST and ALP ≥ 5 x ULN.\n10. Known uncontrolled coagulopathy or bleeding disorder, if the subject is being treated for coagulopathy or bleeding disorder and has tests within screening limits, he\u002Fshe may be included.\n11. Known hepatic cirrhosis or severe pre-existing hepatic impairment (Child-Pugh class B or C).\n12. Moderate to severe respiratory failure.\n13. Patient requires or is taking systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n14. Known history of allergy to an excipient in study medication (e.g. IL2, ruxolitinib) or other human proteins\u002Fpeptides\u002Fantibodies.\n15. Pregnancy or breast-feeding.\n16. Severe diabetic retinopathy.\n17. Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n18. Patient with iatrogenic or pathologic severe immune suppression.\n19. Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n20. Patient taking herbal medications within 7 days prior to study treatment start.\n21. Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).","75 Years",{"count":82,"type":20},96,[23],"This trial aims to address unmet medical needs in advanced solid tumors, specifically metastatic clear cell renal carcinoma, locally advanced or metastatic pancreatic adenocarcinoma, and metastatic colorectal adenocarcinoma.",[86,87,88,89],"Renal Carcinoma Metastatic","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenocarcinoma","Metastatic Colorectal Carcinoma (mCRC)",[91,92],"Ruxolitinib","Advanced solid tumors","NOT_YET_RECRUITING","2026-04-28",{"date":96,"type":35},"2026-05-05",{"date":98,"type":20},"2026-05-01",{"date":100,"type":20},"2030-05",{"name":41,"class":42},1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":52,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":125,"locationsCount":43},"100610504","phase-2-l19il2l19tnf-in-patients-with-cutaneous-squamous-cell-carcinoma-100610504","NCT07228442","L19IL2\u002FL19TNF in Patients With Cutaneous Squamous Cell Carcinoma","A Phase 2 Study of Intratumoral Administration of L19IL2\u002FL19TNF in Locally Advanced Cutaneous Squamous Cell Carcinoma Patients Progressing on or Intolerant to Systemic Treatment","Inclusion Criteria:\n\n* Patients must have histologically documented, locally advanced cSCC.\n* Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.\n* Patients must have locally advanced cSCC that has progressed on or cannot tolerate ICI treatment (adjuvant or first line) as assessed by a local multidisciplinary tumor board.\n* Patients with nodal, regional or in transit injectable cSCC lesions.\n* Patients must be willing to provide tissue from a core or excisional biopsy of a tumor lesion at screening and for confirmation of Objective Response or Stable Disease.\n* Male or female patients, age 18 - 100 years.\n* ECOG Performance Status\u002FWHO Performance Status ≤ 2.\n* Hemoglobin \\> 10.0 g\u002FdL.\n* Platelets \\> 100 x 109\u002FL.\n* ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).\n* Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\\u003C 45 mL\u002Fmin\u002F1.73m2.\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.\n* Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogenand progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.\n* Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.\n* Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated basal cell carcinoma of the skin (surgically removed at least 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.\n* Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.\n* Current topical or systemic chemotherapy, immunotherapy.\n* Presence of visceral metastasis.\n* Presence of active severe bacterial or viral infections or other severe concurrent disease\u002Finfection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n* History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).\n* Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.\n* Known arterial aneurysms.\n* INR \\> 3.\n* Uncontrolled hypertension.\n* Known uncontrolled coagulopathy or bleeding disorder.\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment.\n* Moderate to severe respiratory failure.\n* Active autoimmune disease that has required systemic treatment in past 2 years.\n* Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n* Known history of allergy to IL2, TNF, or other human proteins\u002Fpeptides\u002Fantibodies.\n* Pregnancy or breast-feeding.\n* Ischemic peripheral vascular disease (Grade IIb-IV).\n* Severe diabetic retinopathy.\n* Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n* Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.\n* Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n* Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.",{"count":111,"type":20},92,[56],"Open-label, single-arm, multicenter study in patients with locally advanced, histologically confirmed Cutaneous Squamous Cell Carcinoma (LacSCC) amenable to intratumoral injection, who have progressed on or are intolerant to Immune Checkpoint Inhibitor (ICI). The primary objective of the study is to evaluate the activity of intratumoral L19IL2\u002FL19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2\u002FL19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.",[115],"Locally Advanced Cutaneous Squamous Cell Carcinoma",[117,118,63,62,64],"Cutaneous Squamous Cell Carcinoma","Immune Checkpoint Inhibitor","2026-03-06",{"date":121,"type":35},"2026-03-09",{"date":123,"type":20},"2026-02",{"date":71,"type":20},{"name":41,"class":42},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":52,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":141,"locationsCount":73},"100610460","phase-2-l19il2tnf-in-patients-with-basal-cell-carcinoma-100610460","NCT07227870","L19IL2\u002FTNF in Patients With Basal Cell Carcinoma","A Phase 2 Study of Intratumoral Administration of L19IL2\u002FL19TNF in Locally Advanced Basal Cell Carcinoma Patients Progressing or Intolerant to Systemic Treatment.","Inclusion Criteria:\n\n* Patients must have histologically documented, locally advanced BCC.\n* Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.\n* Patients must have locally advanced BCC that has progressed on or cannot tolerate ICI treatment as assessed by a local multidisciplinary tumor board.\n* Patients with nodal, regional or in transit injectable BCC lesions.\n* Patients must be willing to provide tissue from a core or excisional biopsy of a tumor lesion at screening and for confirmation of Objective Response or Stable Disease.\n* Male or female patients, age 18 - 100 years.\n* ECOG Performance Status\u002FWHO Performance Status ≤ 2.\n* Hemoglobin \\> 10.0 g\u002FdL.\n* Platelets \\> 100 x 109\u002FL.\n* ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).\n* Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\\u003C 45 mL\u002Fmin\u002F1.73m2.\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.\n* Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesteronecontaining) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.\n* Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.\n* Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated cutaneous squamous cell carcinoma of the skin (surgically removed at least 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.\n* Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.\n* Current topical or systemic chemotherapy, immunotherapy.\n* Presence of visceral metastasis.\n* Presence of active severe bacterial or viral infections or other severe concurrent disease\u002Finfection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n* History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).\n* Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.\n* Known arterial aneurysms.\n* INR \\> 3.\n* Uncontrolled hypertension.\n* Known uncontrolled coagulopathy or bleeding disorder.\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment.\n* Moderate to severe respiratory failure.\n* Active autoimmune disease that has required systemic treatment in past 2 years.\n* Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n* Known history of allergy to IL2, TNF, or other human proteins\u002Fpeptides\u002Fantibodies.\n* Pregnancy or breast-feeding.\n* Ischemic peripheral vascular disease (Grade IIb-IV).\n* Severe diabetic retinopathy.\n* Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n* Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.\n* Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n* Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.",{"count":111,"type":20},[56],"Open-label, single-arm, multicentre study in patients with locally advanced BCC amenable to intratumoral injection, who have progressed on or are intolerant to systemic therapy as determined by a local multidisciplinary tumor board. The primary objective of the study is to evaluate the activity of intratumoral L19IL2\u002FL19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2\u002FL19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.",[59],[61,62,63,64],{"date":121,"type":35},{"date":123,"type":20},{"date":71,"type":20},{"name":41,"class":42},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},"100565302","phase-1-a-study-to-evaluate-the-safety-and-preliminary-signs-of-efficacy-of-177lulu-oncofap-23-alone-or-in-combination-with-l19-il2-as-a-treatment-of-metastatic-fap-positive-solid-tumors-100565302","NCT06640413","A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors","A Phase I Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors","TheraTri","Inclusion Criteria:\n\n1. Patients with advanced\u002Fmetastatic solid tumors, who have progressed on available standard treatments.\n2. Patients with FAP-positive tumors as evaluated by \\[68Ga\\]Ga-OncoFAP-DOTAGA-PET\u002FCT imaging.\n3. Patients without other therapeutic alternatives with curative or survival prolonging potential as per investigator judgement.\n4. Male or non-pregnant and non-breast feeding female, age 18 or more.\n5. Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. This lesion should not have been irradiated during previous treatments.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n7. Survival expectation of more than 12 weeks.\n8. Ability to undergo standard imaging.\n9. Documented negative test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV). For HBV serology: the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBsAg-Ab with no history of vaccination and\u002For anti-HBcAg-Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n10. All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1.\n11. Female patients: negative blood pregnancy test at Screening for women of childbearing potential (WOCBP)\\*. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the Recommendations for contraception and pregnancy testing in clinical ; issued by the Head of Medicine Agencies; Clinical Trial Facilitation Group (www.hma.eu\u002Fctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.\n12. Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g., condom with spermicidal gel). Double-barrier contraception is required.\n13. A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and has given consent to participate in the study.\n14. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\n    * Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).\n\nExclusion Criteria:\n\n1. Any cancer therapy within 4 weeks of study entry.\n2. Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.\n3. Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Iodine-131, Lutetium-177 conjugates or hemi-body irradiation within 6 months prior to enrollment.\n4. White blood cell count (WBC) minor than 2.5 x 109\u002FL, absolute neutrophil count (ANC) minor than 1.5 x 109\u002FL, platelets minor than 100 x 109\u002FL or hemoglobin (Hb) minor than 9.0 g\u002Fdl,\n5. Chronically impaired renal function as expressed by creatinine clearance minor than 60 mL\u002Fmin or serum creatinine major than 1.5 ULN.\n6. Inadequate liver function (Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 3 x Upper Limit of Normal (ULN), or Alkaline Phosphatase (ALP) or Gamma Glutamyl Transferase (GGT) ≥ 2.5 x ULN, or total bilirubin ≥ 1.5 x ULN). For patients with metastatic lesions in the liver ALT, AST, GGT or ALP ≥ 5 x ULN.\n7. Presence of cirrhosis or active hepatitis.\n8. Patients with Central Nervous System (CNS) metastases.\n9. History within the last year of cerebrovascular disease and\u002For acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n10. Heart insufficiency (major Grade II, New York Heart Association (NYHA) criteria).\n11. Clinically significant cardiac arrhythmias or requiring permanent medication.\n12. Abnormal Left Ventricular Ejection Fraction (LVEF) or any other abnormalities observed during baseline Electrocardiogram (ECG) and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current, or a history of QT\u002FQTc prolongation would be excluded. In particular: - patients with a marked prolongation of QT\u002FQTc interval (e.g., repeated demonstration of QTc major than 480 milliseconds using Fredricia's QT correction formula) are excluded; - patients with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of prolonged QT syndrome) are excluded; - patients who require the use of concomitant medications that prolong the QT\u002FQTc interval are excluded.\n13. Cardioversion in the previous 12 months\n14. Uncontrolled hypertension as defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg at 3 consecutive measurements performed within one week. Note: if the first blood pressure measurement is below threshold for systolic or diastolic blood pressure, it is not required to repeat the measurement.\n15. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).\n16. Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.\n17. Pregnancy or lactation or unwillingness to use adequate method of birth control.\n18. Any severe concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.\n19. Major trauma including major surgery (such as abdominal\u002Fcardiac\u002Fthoracic surgery) within 4 weeks of administration of the study drug.\n20. Serious, non-healing wound, ulcer or bone fracture.\n21. Known history of allergy to an excipient in study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies\n22. Systemic chronic steroid therapy (major than 10 mg\u002Fday prednisone or equivalent) or any other immunosuppressive therapy within 14 days prior to study treatment start. Topical, inhaled, nasal and ophthalmic steroids are allowed.\n23. Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n24. Concurrent or previous malignancies (other than the indication for this trial), unless a complete remission without further recurrence was achieved at least 2 years prior to study treatment start.\n25. Growth factors or immunomodulatory agents within 7 days prior to study treatment start.\n26. Deep vein thrombosis, pulmonary embolism, or other acute vascular events within 6 months.",{"count":151,"type":20},56,[23],"The aim of this study is to assess the safety of \\[177Lu\\]Lu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advanced\u002Fmetastatic Fibroblast Activation Protein (FAP)-positive solid tumors and to establish a Recommended Dose (RD).",[155],"FAP",[157],"Patients with advanced\u002Fmetastatic FAP-positive tumors","2026-01-13",{"date":160,"type":35},"2026-01-14",{"date":162,"type":35},"2025-10-31",{"date":164,"type":20},"2028-12-31",{"name":41,"class":42},4,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"100398733","phase-1-safety-and-early-signs-of-efficacy-of-il12-l19l19-100398733","NCT04471987","Safety and Early Signs of Efficacy of IL12-L19L19.","A Phase I Study to Evaluate Safety and Early Signs of Efficacy of the Human Monoclonal Antibody-cytokine Fusion Protein IL12-L19L19.","DODEKA","Inclusion Criteria:\n\n1. Male or Female aged 18 to 80 years at the time of consent.\n2. Patients must have a histological or cytological diagnosis of advanced\u002Fmetastatic immunotherapy responsive solid carcinoma for which immune checkpoint blockade is approved, that has progressed on immune checkpoint-blockade therapy.\n3. Patients must have received an immune checkpoint blockade therapy-based regimen as prior treatment.\n4. Only patients without other therapeutic alternatives with curative or survival prolonging potential per investigator judgement are able to participate.\n5. Subjects must have had clinical benefit in terms of disease control (CR\u002FPR\u002FSD) while on checkpoint inhibitor treatment defined as ≥ 3 month free from progression from initial imaging documenting advanced\u002Fmetastatic disease followed by radiographic disease progression after checkpoint inhibitor per investigator's opinion.\n6. Patients must have progressive disease or relapse at the time of screening.\n7. Patients may have previously received chemotherapy, immunotherapy or radiation therapy. Such therapies must be completed at least 4 weeks prior to study drug administration. Radiotherapy within 4 weeks of the first dose of study drug, is allowed for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass. During the expansion part, to allow evaluation of response to treatment, patients must have remaining measurable disease that has not been irradiated.\n8. Eastern cooperative oncology group (ECOG) performance status ≤ 2.\n9. Patient has an estimated life expectancy of at least 12 weeks.\n10. At least one unidimensionally measurable lesion either by computed tomography (CT), MRI or PET\u002FCT as defined by RECIST (v. 1.1) for solid tumors.\n11. Documented negative test for HIV-HBV-HCV. For HBV serology: the determination of HBsAg, and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and\u002For anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n12. All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1.\n13. Full resolution of checkpoint blockade therapy-related adverse effects (including immune-related adverse effects) and no treatment for these AEs for at least 4 weeks prior to the time of enrollment. The only exception are patients with checkpoint blockade induced hypothyroidism and hypophysitis if these patients are on stable maintenance therapy with on levothyroxine or steroids (≤ 10 mg prednisone equivalent) for at least 2 months prior dosing.\n14. No history of severe immune related adverse effects from prior given immune checkpoint blockade therapy (CTCAE Grade 4; CTCAE Grade 3 requiring treatment \\>4 weeks).\n15. Female patients: negative blood pregnancy test at Screening for women of childbearing potential (WOCBP)\\*. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu\u002Fctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.\n16. Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g. condom with spermicidal gel). Double-barrier contraception is required.\n17. Negative TB test (e.g. Mantoux or Quantiferon assay).\n18. A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and has given consent to participate in the study.\n19. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\n    * Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)\n\nExclusion Criteria:\n\n1. Subjects who participated in an investigational drug or device study within 4 weeks prior to study treatment start.\n2. Radiotherapy within 4 weeks prior to study treatment start.\n3. Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.\n4. Patients with primary brain tumors or CNS disease (including brain metastases).\n5. Patient taking herbal medications within 7 days prior to study treatment start.\n6. Known history of allergy to an excipient in study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies.\n7. Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL, platelets \\\u003C 100 x 10\\^9\u002FL or haemoglobin (Hb) \\\u003C 9.0 g\u002Fdl.\n8. Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin or serum creatinine \\> 1.5 ULN.\n9. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). At the discretion of the investigator, an increased exclusion threshold for patients with liver metastasis can be accepted as follows: ALT, AST, ALP and bilirubin ≥ 5 x ULN.\n10. Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.\n11. History within the last year of cerebrovascular disease and\u002For acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n12. Heart insufficiency (\\> Grade II, New York Heart Association (NYHA) criteria).\n13. Clinically significant cardiac arrhythmias or requiring permanent medication.\n14. Abnormal LVEF or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current, or a history of QT\u002FQTc prolongation would be excluded. In particular:\n\n    * patients with a marked prolongation of QT\u002FQTc interval (e.g., repeated demonstration of QTc \\>480 milliseconds using Fredricia's QT correction formula) are excluded;\n    * patients with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of prolonged QT syndrome) are excluded;\n    * patients who require the use of concomitant medications that prolong the QT\u002FQTc interval are excluded.\n15. Uncontrolled hypertension as defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg at 3 consecutive measurements performed within one week. Note: if the first blood pressure measurement is below threshold for systolic or diastolic blood pressure, it is not required to repeat the measurement.\n16. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).\n17. Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.\n18. Major trauma including major surgery (such as abdominal\u002Fcardiac\u002Fthoracic surgery) within 4 weeks of study treatment start.\n19. Pregnancy or breast-feeding.\n20. Systemic chronic steroid therapy (\\>10 mg\u002Fday prednisone or equivalent) or any other immunosuppressive therapy within 14 days prior to study treatment start. Topical, inhaled, nasal and ophthalmic steroids are allowed.\n21. Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n22. Concurrent or previous malignancies (other than the indication for this trial), unless a complete remission without further recurrence was achieved at least 2 years prior to study treatment start.\n23. Growth factors or immunomodulatory agents within 7 days prior to study treatment start.\n24. Serious, non-healing wound, ulcer or bone fracture.\n25. Deep vein thrombosis, pulmonary embolism or other acute vascular events within 6 months.\n26. Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n27. Any recent live vaccination within 4 weeks prior to treatment or plan to receive vaccination during the study.","80 Years",{"count":177,"type":20},80,[23],"The purpose of this study is to describe the safety, tolerability and early signs of efficacy of the antibody-cytokine fusion protein IL12-L19L19 in patients with advanced or metastatic solid carcinomas, after previous immune checkpoint blockade therapy.\n\nThe primary objective of the study is to evaluate the safety of IL12-L19L19 and to establish MTD in order to establish a recommended dose (RD).\n\nThe secondary objectives of the study are to assess early signs of efficacy, the determination of pharmacokinetic (PK) properties and the immunogenicity of IL12-L19L19.",[181,182],"Advanced Solid Tumor","Metastatic Solid Tumor","2026-01-12",{"date":160,"type":35},{"date":186,"type":35},"2020-07-01",{"date":188,"type":20},"2026-12",{"name":41,"class":42},11,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":175,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":43},"100611854","phase-1-a-study-of-f8il10-intra-articular-treatment-in-rheumatoid-arthritis-100611854","NCT07245992","A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis","A Dose-finding Phase I Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis","DekaJoint","Inclusion Criteria:\n\n1. Patients aged ≥18 and ≤80 years.\n2. Diagnosis of RA according to ACR\u002FEULAR classification criteria (2010) with a disease duration exceeding 6 months.\n3. Presence of arthritis flare(s) suitable for IA injection in a knee, ankle, shoulder, wrist or elbow, despite treatment with stable doses (for at least 3 months) of DMARDs (conventional, biologic, and targeted synthetic) background therapy.\n4. No or stable regimens of NSAIDs and\u002For oral corticosteroid (≤ 10 mg\u002Fday; prednisone equivalent) for a period ≥2 weeks prior to screening.\n5. All acute toxic effects of any prior therapy must have resolved or returned to classification \"mild\" (grade 1) according to CTCAE v.5.0.\n6. Sufficient hematologic, liver and renal function defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL, platelets ≥100 x109\u002FL, haemoglobin (Hb) ≥10.0 g\u002FdL.\n   * Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT) and or Aspartate Aminotransferase (AST) ≤3 x Upper Limit of Normal Range (ULN), and total bilirubin ≤2.0 mg\u002Fdl (34.2 μmol\u002FL).\n   * Creatinine ≤1.5 ULN or 24 h creatinine clearance ≥50 mL\u002Fmin.\n7. Documented negative TB test (e.g. Quantiferon or equivalent).\n8. Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and\u002For anti-HBc Ab), negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no ongoing infection are eligible.\n9. Sexually active male or female patients of childbearing potential are eligible providing that:\n\n   * Women of childbearing potential (WOCBP) have a negative pregnancy test performed within 4 weeks prior to treatment start.\n   * WOCBP agree to use, from the screening to 6 months following the last study drug administration, effective method of birth control as applicable per local law that both results in a Pearl index \\\u003C1 and considered highly effective as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the \"Clinical Trial Facilitation Group\" (e.g. combined estrogen and progestogen containing hormonal contraception, progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, vasectomized partner, total sexual abstinence or bilateral tubal occlusion).\n   * Males agree to use two acceptable methods of contraception (e.g. condom with spermicidal gel) from the screening to 6 months following the last study drug administration. Females of childbearing potential that are partners of male study participants must observe the same birth control indications that apply to female participants.\n10. Signed and dated Ethics Committee-approved informed consent form indicating that the patient, or patient's legally acceptable representative, has been informed of all pertinent aspects of the study.\n11. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Presence of additional RA flares or RA-related symptoms that, in the investigator's judgment, are likely to require local treatment during the study (defined as intra-articular or peri-articular injections\u002Fprocedures intended to treat RA; e.g., joint, tendon-sheath, or bursal corticosteroid injections; hyaluronic acid; biologic\u002FPRP injections; or radio synovectomy).\\_\n2. Presence of active infections or another severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or would interfere with the study objectives or conduct.\n3. Pregnancy, lactation or unwillingness to use adequate contraceptive methods.\n4. Diagnosis of any other inflammatory arthritis or active autoimmune diseases other than RA.\n5. Any therapy for RA apart from the allowed background therapy (i.e., stable doses of DMARDs, corticosteroids, and\u002For NSAIDs) within 4 weeks prior to the first IMP dosing.\n6. Received intra-articular administration of corticosteroids\u002FDMARDs within 4 weeks or 5 half-lives prior to the first IMP dosing, whichever is longer.\n7. History or currently active primary or secondary immunodeficiency.\n8. Concurrent malignancy or history of malignancy (except in situ melanoma and low-risk non melanoma skin cancer) from which the patient has been disease-free for less than 2 years.\n9. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n10. Treatment with warfarin or other coumarin derivatives.\n11. Clinically significant cardiac arrhythmias or requiring permanent medication.\n12. Abnormalities in baseline ECG analysis that are considered as clinically significant by the investigator; subjects with current or a history of QT\u002FQTc prolongation.\n13. Uncontrolled hypertension, despite optimal treatment.\n14. Known arterial aneurism at high risk of rupture.\n15. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche Fontaine classification).\n16. Severe diabetic retinopathy.\n17. Major trauma including surgery within 4 weeks prior to administration of study treatment.\n18. Known history of allergy\u002Fhypersensitivity or other intolerance to any component of F8IL10 (including excipients) or to other drugs based on human proteins\u002Fpeptides\u002Fantibodies.\n19. Treatment with any investigational agent within 4 weeks or 5 half-lives prior to the first dose of study drug, whichever is longer.\n20. Immunization with a live\u002Fattenuated vaccine within 4 weeks prior to baseline or plan to receive vaccines during the study.\n21. Non-RA related chronic pain disorders.\n22. Patients requiring stable doses of corticosteroids \\>10 mg\u002Fday (prednisone equivalent). Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.\n23. History of alcohol, drug or chemical substance abuse within the 6 months prior to screening.\n24. Any condition that in the opinion of the investigator could hamper compliance with the study protocol.",{"count":200,"type":20},42,[23],"The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis.",[204],"Rheumatoid Arthritis (RA)",[206],"Rheumatoid Arthritis","2026-01-07",{"date":209,"type":35},"2026-01-09",{"date":211,"type":20},"2026-01",{"date":213,"type":20},"2029-09-30",{"name":41,"class":42},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":21,"phases":225,"briefSummary":227,"conditions":228,"keywords":232,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},"100329335","phase-3-efficacy-of-daromun-neoadjuvant-intratumoral-treatment-in-clinical-stage-iiibcd-melanoma-patients-100329335","NCT03567889","Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB\u002FC\u002FD Melanoma Patients","An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB\u002FC\u002FD Melanoma Patients","NeoDREAM","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of clinical stage IIIB, IIIC, and IIID (AJCC 8th edition) locoregional melanoma that is eligible for complete surgical resection of all metastases (surgically resectable).\n2. Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm.\n3. Prior anti-tumor treatment for the primary melanoma lesion, including surgery and approved adjuvant treatments (e.g., radiotherapy, immune checkpoint inhibitors, BRAF\u002FMEK inhibitors, etc.) is allowed. Before enrollment in the study, a wash-out period of 6 weeks is required and toxicities from prior treatments should be resumed to Grade ≤1.\n4. Males or females, age ≥ 18 years.\n5. ECOG Performance Status\u002FWHO Performance Status ≤ 1.\n6. Life expectancy of \\> 24 months.\n7. Absolute neutrophil count \\> 1.5 x 109\u002FL.\n8. Hemoglobin \\> 9.0 g\u002FdL.\n9. Platelets \\> 100 x 109\u002FL.\n10. Total bilirubin ≤ 30 μmol\u002FL (or ≤ 2.0 mg\u002Fdl).\n11. ALT and AST ≤ 2.5 x the upper limit of normal (ULN).\n12. Serum creatinine \\\u003C 1.5 x ULN.\n13. LDH serum level ≤ 1.5 x ULN.\n14. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (i.e. positive anti-HBsAg with not vaccination and\u002For positive anti-HBcAg Ab), negative serum HBV-DNA is also required.\n15. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1 unless otherwise specified above.\n16. All women of childbearing potential (WOCBP) must have negative pregnancy test results at the screening. WOCBP must be using, from the screening to three months following the last study drug administration, highly effective contraception methods. WOCBP and effective contraception methods are defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the safety visit (only WOCBP and only for patients in Arm 1).\n17. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.\n18. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n19. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria\n\n1. Uveal melanoma or mucosal melanoma\n2. Evidence of distant metastases at screening.\n3. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except: cervical carcinoma in situ, curatively treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \\& T1), second primary melanoma in situ or any cancer curatively treated ≥ 5 years prior to study entry.\n4. Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n5. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n6. Inadequately controlled cardiac arrhythmias including atrial fibrillation.\n7. Heart insufficiency (\\> Grade II, New York Heart Association (NYHA) criteria).\n8. LVEF ≤ 50% and\u002For abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator.\n9. Uncontrolled hypertension.\n10. Ischemic peripheral vascular disease (Grade IIb-IV).\n11. Severe diabetic retinopathy.\n12. Active autoimmune disease.\n13. History of organ allograft or stem cell transplantation.\n14. Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n15. Known history of allergy to IL2, TNF, or other human proteins\u002Fpeptides\u002Fantibodies or any other constituent of the product.\n16. Breast feeding female.\n17. Anti-tumor therapy (except small surgery) within 4 weeks before enrollment.\n18. Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before enrollment.\n19. Planned administration of growth factors or immunomodulatory agents within 7 days before enrollment.\n20. Patient requiring or taking corticosteroids or other immunosuppressant drugs on a long-term basis will be evaluated case by case with the Sponsor for inclusion\u002Fexclusion in the study. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criteria.\n21. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.\n22. Previous enrolment and randomization in the same study.",{"count":224,"type":20},186,[226],"PHASE3","The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB\u002FC\u002FD melanoma patients with respect to the standard of care (surgery and adjuvant therapy).",[229,230,231],"Melanoma Stage IIIB","Melanoma Stage IIIC","Melanoma Stage IIID",[229,230,231],"2025-12-15",{"date":235,"type":35},"2025-12-17",{"date":237,"type":35},"2018-09-20",{"date":239,"type":20},"2031-12",{"name":41,"class":42},37,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":4},"100602244","phase-2-a-study-to-evaluate-the-safety-and-efficacy-of-l19tnf-with-alkylating-chemotherapy-for-patients-with-recurrent-idh-mutant-astrocytoma-or-oligodendroglioma-100602244","NCT07120984","A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma","A Phase II Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma","IMAGLIO","Inclusion Criteria:\n\n1. Age ≥18\n2. IDH-mutant glioma (according to WHO 2021 classification) at first recurrence or progression after alkylating chemotherapy:\n\n   * COHORT 1: Grade ≥2 oligodendroglioma or astrocytoma with planned resection, tumor tissue from prior resection must be available\n   * COHORT 2A: Grade ≥2 oligodendroglioma\n   * COHORT 2B1: Grade ≥2 oligodendroglioma previously treated with lomustine as monotherapy or in combination\n   * COHORT 2B2: Grade ≥2 oligodendroglioma previously treated with temozolomide as monotherapy or in combination\n   * COHORT 3A: Grade ≥2 astrocytoma\n   * COHORT 3B1: Grade ≥2 astrocytoma previously treated with lomustine as monotherapy or in combination\n   * COHORT 3B2: Grade ≥2 astrocytoma previously treated with temozolomide as monotherapy or in combination\n3. Measurable disease according to RANO 2.0 criteria.\n4. Documented IDH1 and\u002For IDH2 gene mutations detected by immunochemistry or sequencing.\n5. Karnofsky Performance Status (KPS) ≥ 70%.\n6. Life expectancy ≥ 3 months.\n7. Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n8. Female patients: female patients must be either documented not Women Of Childbearing Potential (WOCBP)\\* or must have a negative pregnancy test within 14 days of starting treatment. Additionally WOCBP must agree to use, from the screening to 6 months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu\u002Fctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.\n\n   Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g. condom with spermicidal gel). Double-barrier contraception is required from the screening to 6 months following the last administration of temozolomide, lomustine or L19TNF.\n9. Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Any therapy for recurrence\u002Fprogression after alkylating chemotherapy, except resection.\n2. Therapy for glioma within 4 weeks of start of study treatment.\n3. Surgical resection of glioma within 4 weeks of start of study treatment.\n4. Stereotactic biopsy of glioma within 2 weeks of start of study treatment.\n5. Inability to undergo contrast-enhanced MRI.\n6. Known history of allergy to TNF or lomustine or temozolomide, any excipient in the study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies.\n7. Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL; platelets \\\u003C 100 x 10\\^9\u002FL or hemoglobin (Hb) \\\u003C 9.0 g\u002Fdl.\n8. Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\\u003C 45 mL\u002Fmin\u002F1.73m2.\n9. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 1.5 x ULN).\n10. INR \\> 1.5 ULN.\n11. Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.\n12. Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent, in the judgement of the investigator.\n13. History within the last year of cerebrovascular disease and\u002For acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n14. Heart insufficiency (\\> Grade II, New York Heart Association (NYHA) criteria).\n15. Clinically significant cardiac arrhythmias or requiring permanent medication.\n16. LVEF \\\u003C 55% or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered clinically significant by the investigator. Patients with a marked prolongation of QT\u002FQTc interval (e.g., repeated demonstration of QTc \\>470 milliseconds using Fredricia's QT correction formula) are excluded.\n17. Uncontrolled hypertension, defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg.\n18. Arterial aneurism at high risk of rupture.\n19. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).\n20. Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders.\n21. Anxiety ≥ CTCAE Grade 3.\n22. Severe diabetic retinopathy, such as severe non-proliferative retinopathy and proliferative retinopathy.\n23. Major trauma including major surgery (such as abdominal\u002Fcardiac\u002Fthoracic surgery) within 4 weeks of administration of study treatment.\n24. Known history of tuberculosis.\n25. Pregnancy or breast feeding.\n26. Requirement of chronic administration of high dose steroids or other immunosuppressant drugs. Subjects must have been either off steroids, or on a stable or decreasing dose ≤ 4 mg daily dexamethasone (or equivalent) for 7 days prior to start of treatment. Limited or occasional use of steroids to treat or prevent acute adverse reactions is not considered an exclusion criterion.\n27. Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n28. Concurrent malignancies other than glioma unless the patient has been disease-free without intervention for at least 2 years.\n29. Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.\n30. Serious, non-healing wound, ulcer or bone fracture.\n31. Deep vein thrombosis, pulmonary embolism or other acute vascular events within 6 months.\n32. Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).\n33. Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n34. Any live vaccination within 4 weeks prior to treatment or plan to receive live vaccination during the study.",{"count":251,"type":20},52,[56],"The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.",[255],"Glioma","2025-08-06",{"date":258,"type":35},"2025-08-13",{"date":260,"type":20},"2026-01-30",{"date":262,"type":20},"2029-01-30",{"name":41,"class":42},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":102},"100537958","phase-2-study-of-the-efficacy-of-intratumoral-l19il2-or-l19tnf-or-l19il2l19tnf-in-combination-with-pembrolizumab-in-unresectable-melanoma-patients-100537958","NCT06284590","Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2\u002FL19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients","A Phase 2, Three-arm, Randomized Study of the Efficacy of Intratumorally Administered L19IL2 or L19TNF or L19IL2\u002FL19TNF, All in Combination with Systemic Anti-PD1 Pembrolizumab, in Stage III and IV Unresectable Melanoma Patients with Resistance to or Progressing Upon Anti-PD1 Checkpoint Inhibitors and with Presence of Injectable Metastases","INTACT\u002FMeRCI","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n2. Be \\> or equal to 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of unresectable metastatic melanoma at stage III B, C, D or IV M1a (AJCC 8th ed.). Patients with Stage IVM1b, M1c and M1d oligometastatic disease \\[up to 10 lesions in aggregate including lung, liver, bone or brain, with or without lymph node involvement\\], are eligible. However, patients with symptomatic or rapidly enlarging\u002Fbleeding brain lesions are excluded. Patients with acral lentiginous melanoma are eligible as well. Detailed information about prior therapies and burden of disease at study entry must be available.\n4. Patients must have confirmed primary resistance to or acquired resistance on treatment with an anti-PD1\u002FL1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria: a.) Has received at least 2 doses of an approved anti-PD-1\u002FL1 mAb.\n\n   b.) Has demonstrated disease progression (PD) after PD-1\u002FL1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression. c.) Progressive disease has been documented within 12 weeks from the last dose of anti- PD-1\u002FL1 mAb.\n\n   i. Progressive disease is determined according to iRECIST. ii. This determination is made by the investigator. Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression.\n5. Patients harboring the BRAF mutation who received BRAF\u002FMEK inhibition (or declined BRAF\u002FMEK inhibitors) and received thereafter anti-PD1 therapy showing resistance to such immunotherapy are eligible to the study. Anti-PD1 immunotherapy must be the last therapy received by the patient prior to randomization.\n6. Eligible subjects must have measurable disease (according to RECIST v1.1) as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Eligible subjects must be a candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal metastatic melanoma lesion (≥ 5 mm in longest diameter) or with multiple injectable lesions that in aggregate have a diameter of ≥ 5 mm.\n7. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) b.) A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. WOCBP must be using for the time period indicated highly effective contraception methods. WOCBP and effective contraception methods are defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the safety visit (only WOCBP).\n8. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n\n   Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut (details pertaining to tumor tissue submission can be found in the Procedures Manual).\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n10. Have adequate organ function as defined in the following table. Specimens must be collected within 14 days prior to the start of study treatment.\n11. Be able to provide a core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy at Screening. In addition, participants may provide additional biopsy at Week 18 and at the time of discontinuation due to progression\n12. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (e.g. anti-HBsAg and\u002For anti-HBc Ab) a negative serum HBV-DNA test is also required.\n13. All acute toxic effects (excluding alopecia and vitiligo) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1 or baseline unless otherwise specified above. Note: Participants with ≤Grade β neuropathy may be eligible. Participants with endocrinerelated AEs Grade ≤β requiring treatment or hormone replacement may be eligible. Note: If the participant had major surgery, the participant must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention.\n14. Full resolution of checkpoint blockade therapy-related adverse effects (including immunerelated adverse effects) and no treatment for these AEs for at least 4 weeks prior to the time of enrollment.\n15. No history of severe immune related adverse effects from prior given immune checkpoint blockade therapy (CTCAE Grade 4; CTCAE Grade 3 requiring treatment \\>4 weeks).\n16. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration. In addition, male participant must refrain from sperm donation during the treatment period.\n17. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n1. Patients with more than 10 distant melanoma lesions in lung, liver, bone or brain combined. Patients with symptomatic or rapidly enlarging\u002Fbleeding brain lesions are excluded.\n2. Uveal melanoma or mucosal melanoma or melanoma with unknown primary.\n\n   Pregnancy Exclusion\n3. A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   Prior\u002FConcomitant Therapy\n4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE.\n5. Has received prior systemic anti-cancer therapy including investigational agents or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n6. Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis. Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤β weeks of radiotherapy) to non-CNS disease.\n7. Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD).\n8. Has had an allogeneic tissue\u002Fsolid organ transplant.\n9. Has received live live or live attenuated vaccines within 30 days prior to the first dose of study treatment and while participating in the study. Note: Killed vaccines are allowed. Note: Any licensed COVID-19 vaccine (including for Emergency use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.\n\n   Diagnostic assessments\n10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n11. Has a known additional malignancy that is progressing or has required active treatment within the past two (2) years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \\& T1), second primary melanoma in situ, or carcinoma in situ, that have undergone potentially curative therapy are not excluded.\n12. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants 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 first dose of study treatment.\n13. Has severe hypersensitivity (≥Grade γ) to pembrolizumab and\u002For any of its excipients, or to (immuno)cytokines IL2, TNF and\u002For any of its excipients\n14. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n    Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has an active infection requiring systemic therapy.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n18. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\n19. Previous enrolment and randomization in this same study.",{"count":273,"type":20},162,[56],"The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.",[277,278],"Melanoma Stage III","Melanoma Stage IV","2024-10-23",{"date":281,"type":35},"2024-10-26",{"date":283,"type":35},"2024-07-12",{"date":285,"type":20},"2028-07",{"name":41,"class":42},{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":308,"locationsCount":102},"100396508","phase-1-safety-and-efficacy-of-l19tnf-plus-temozolomide-chemoradiotherapy-in-patients-with-newly-diagnosed-glioblastoma-100396508","NCT04443010","Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma","A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Standard Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma","GLIOSUN","Inclusion Criteria:\n\n1. Male or female, age ≥18.\n2. Patients with histologically confirmed newly diagnosed glioblastoma.\n3. Karnofsky Performance Score (KPS) ≥ 70%\n4. Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and\u002For anti-HBc Ab), negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n5. Female patients: negative pregnancy test for women of childbearing potential (WOCBP)\\* within 14 days of starting treatment. WOCBP must agree to use, from the screening to 6 months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu\u002Fctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.\n6. Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g. condom with spermicidal gel). Double-barrier contraception is required.\n7. Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n8. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\n   * Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).\n\nExclusion Criteria:\n\n1. Prior treatment for glioma, except surgery.\n2. Inability to undergo contrast-enhanced MRI.\n3. Intent to be treated with tumor-treating fields prior to progression.\n4. Known history of allergy to TNF or TMZ, any excipient in the study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies.\n5. Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL, platelets \\\u003C 100 x 10\\^9\u002FL or haemoglobin (Hb) \\\u003C 9.0 g\u002Fdl.\n6. Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin or serum creatinine \\> 1.5 ULN.\n7. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN).\n8. INR \\> 1.5 ULN.\n9. Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.\n10. Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.\n11. History within the last year of cerebrovascular disease and\u002For acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n12. Heart insufficiency (\\> Grade II, New York Heart Association (NYHA) criteria).\n13. Clinically significant cardiac arrhythmias or requiring permanent medication.\n14. Abnormal LVEF or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current or a history of QT\u002FQTc prolongation are excluded.\n15. Uncontrolled hypertension.\n16. Known arterial aneurism at high risk of rupture.\n17. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).\n18. Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders.\n19. Anxiety ≥ CTCAE Grade 3.\n20. Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.\n21. Major trauma including major surgery (such as abdominal\u002Fcardiac\u002Fthoracic surgery) within 3 weeks of administration of study treatment.\n22. Known history of tuberculosis.\n23. Pregnancy or breast feeding.\n24. Requirement of chronic administration of high dose corticosteroids or other immunosuppressant drugs. Subjects must have been either off corticosteroids, or on a stable or decreasing dose ≤ 4 mg daily dexamethasone (or equivalent) for 7 days prior to start of chemoradiotherapy. Limited or occasional use of corticosteroids to treat or prevent acute adverse reactions is not considered an exclusion criterion.\n25. Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n26. Concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years.\n27. Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.\n28. Serious, non-healing wound, ulcer, or bone fracture.\n29. Requirement of concurrent therapy with anticoagulants at therapeutic doses.\n30. Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n31. Any recent live vaccination within 4 weeks prior to treatment or plan to receive vaccination during the study.",{"count":296,"type":20},226,[23,56],"The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed glioblastoma.\n\nThe study will be conducted in three consecutive parts: a dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.",[300],"Glioblastoma",[300],"2023-10-06",{"date":304,"type":35},"2023-10-10",{"date":306,"type":35},"2021-01-20",{"date":188,"type":20},{"name":41,"class":42},""]