[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Spain\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":701},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,3700,0,25,[9,46,83,110,144,172,195,229,259,283,312,340,371,396,425,450,474,494,515,542,566,597,624,646,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100650429","phase-4-treatment-based-on-high-precision-cardiac-mapping-100650429",false,"NCT07746336","Treatment Based on High Precision Cardiac Mapping","Treatment Based on High Precision Cardiac Mapping: Advancing Personalized Outcomes Through Optimized Localization","APOLO-VT","Inclusion criteria\n\n* Age ≥18 years.\n* Diagnosis of structural heart disease (ischemic or non-ischemic cardiomyopathy).\n* Documented sustained monomorphic VT (clinical or inducible), or recurrent ICD therapies for VT.\n* Scheduled for catheter ablation of VT according to current international guidelines.\n* Ability to provide written informed consent.\n* Ability to remain upright or seated to allow a video for 3D torso reconstruction for ECGi acquisition.\n\nExclusion criteria\n\n* Age \\\u003C18 years.\n* Pregnant or breastfeeding women.\n* Inability to provide informed consent due to physical or mental condition.\n* Contraindication to computed tomography or cardiac magnetic resonance (magnetic resonance imaging-incompatible devices, claustrophobia).\n* Contraindication to contrast agents (gadolinium allergy or severe renal dysfunction with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n* Inability to remain upright for torso 3D reconstruction required for ECGi.\n* Life expectancy \\\u003C1 year due to non-cardiac comorbidity.","ALL","18 Years","99 Years",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","APOLO-VT aims to evaluate the feasibility, safety, and clinical impact of an integrated multimodal mapping workflow combining non-invasive structural and functional substrate characterization using Volumetric Electrocardiographic Imaging (ECGi) with invasive Electroanatomical Mapping (EAM) to support Ventricular tachycardia (VT) ablation targeting and verification.",[29,30,31,32],"VT Ablation","Arrhythmic Burden","Implantable Cardioverter-Defibrillator (ICD) Therapies","Slow-conduction Substrate","RECRUITING","2026-08-24",{"date":36,"type":37},"2026-08-25","ACTUAL",{"date":39,"type":37},"2026-07-15",{"date":41,"type":23},"2028-12-31",{"name":43,"class":44},"Hospital Clinic of Barcelona","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100630823","phase-2-a-study-of-bms-986504-monotherapy-and-in-combination-with-other-agents-in-participants-with-advanced-andor-metastatic-solid-tumors-with-homozygous-mtap-deletion-mountaintap-5-100630823","NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.",{"count":54,"type":23},260,[56],"PHASE2","This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[59],"Solid Tumors",[61,62,63,64,65,66,67,68,69,70,71,72,73],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Melanoma","NSCLC","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli",{"date":36,"type":37},{"date":76,"type":37},"2026-07-27",{"date":78,"type":23},"2032-05-20",{"name":80,"class":81},"Bristol-Myers Squibb","INDUSTRY",57,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":24,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100629770","phase-3-azacytidine-venetoclax-plus-minus-quizartinib-for-first-line-olderunfit-aml-patients-venp-a-qui-100629770","NCT07478991","Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older\u002FUnfit AML Patients (VENP-A-QUI)","A Randomized Phase III, Global, Multicentre, Open Label Clinical Trial Comparing Venetoclax Azacytidine and Quizartinib Versus Venetoclax and Azacytidine in Newly Diagnosed Acute Myeloid Leukemia Patients Unelegible for Standard Induction Chemotherapy","VENP-A-QUI","Inclusion Criteria:\n\n1. The subject must have confirmation of AML by 2022 WHO criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline based induction regimen due to age and\u002For comorbidities.\n2. Patients must be considered ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or co-morbidities defined by the following criteria:\n\n   * ≥ 75 years of age;\n   * or ≥ 18 to 75 years of age with at least one of the following co-morbidities:\n\n     * ECOG Performance Status of 2 or 3;\n     * Cardiac history of cardiac heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) \\>45% and ≤ 55% or chronic stable angina.\n     * DLCO ≤ 65% or FEV1 ≤ 65% and\u002For significant history of chronic pulmonary obstructive;\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 50 ml\u002Fmin (see Appendix 7);\n     * Moderate hepatic impairment with total bilirubin, SGPT or SGOT \\> 1.5 to ≤ 3.0 × ULN;\n     * Non active\u002Fcontrolled prior neoplastic disease;\n     * Any other patient´s comorbidity or disease condition that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Clinical Trial Coordinator before study enrollment (e.g, prior neoplastic disease, high-risk cytogenetics). All patients aged less than 60 years old must be reviewed and approved by Clinical Trial Coordinator before study enrollment.\n3. ECOG performance status ≤2 for patients \\>75 years, ≤3 for patients ≥ 60 to 75 years of age.\n4. Male subjects who are sexually active, must agree, from Study Day 1 through at least 120 days after the last dose of study drug, to practice the protocol specified contraception.\n5. Female subjects must be either postmenopausal for at least 1 year before screening OR permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) or Women of Childbearing Potential (WOCBP) must agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 7 months after the last dose of study drug (female and male condoms should not be used together), or Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception). Female subjects of childbearing potential must have negative results for pregnancy test performed and must not be lactating and breastfeeding.\n6. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study specific procedures, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years old at screening.\n2. Subject has received prior treatment with hypomethylating agent, FLT3 or BCL2 inhibitors.\n3. Confirmed diagnosis of prior myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS\u002FMPNs including CMML, aCML, JMML and others. This exclusion criterion will not be applicable to patients with FLT3 or NPM1 mutations (as per technical sensitivity threshold of local and\u002For central laboratory), who can be enrolled.\n4. Genetic diagnosis of acute promyelocytic leukemia.\n5. Treated (excluding surgery or hormone-therapy) for another malignancy within 6 months before randomization or previously diagnosed with another malignancy and have any evidence of disease which may compromise the administration of investigational treatment schedule.\n6. Presence of any severe psychiatric disease or physical condition that, according to the physician´s criteria, contraindicates the inclusion of the patient into the clinical trial.\n7. Serum creatinine ≥ 2.5 mg\u002FdL or creatinine clearance \\\u003C 30 mL\u002Fmin.\n8. Bilirubin \\>1.5 times, SGPT or SGOT \\> 3 times the upper normal limit (unless it is attributable to AML activity).\n9. WBC \\>25 x 109\u002FL before randomization.\n10. Contraindications for Azacitidine, Quizartinib or Venetoclax (such as history of hypersensitivity to any excipients in Azacitidine, Quizartinib, or Venetoclax).\n11. Known central nervous system (CNS) active leukemia, including cerebrospinal fluid positive for AML blasts.\n12. Prior treatment with any investigational drug or device within 14 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational interventional procedures.\n13. Known uncontrolled or significant cardiovascular disease, including any of the following:\n\n    1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;\n    2. QTcF interval \\>450 msec;\n    3. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);\n    4. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;\n    5. History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);\n    6. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);\n    7. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;\n    8. History of New York Heart Association Class 3 or 4 heart failure;\n    9. Known history of LVEF ≤45%;\n    10. Complete left bundle branch block;\n    11. Severe aortic stenosis\n14. Prior therapy for AML (except hydroxyurea, or maximum 1 gram\u002Fsqm\u002Fday per 2 days of cytarabine allowed to control hyperleukocytosis during the screening period).\n15. Subject must not have consumed grapefruit, grapefruit products, Seville oranges (including marmalade-containing Seville oranges), or star fruit within 3 days before anticipated first dose of Venetoclax and must consent not to consume through the last dose of Venetoclax.\n16. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy at physician discretion.\n17. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C)\n18. Known history of human immunodeficiency virus (HIV).\n19. Uncorrected Grade 3 or 4 hypokalemia, hypomagnesemia or hypocalcemia (Subjects with Grade 1 or 2 electrolyte abnormalities can be enrolled while electrolytes are being corrected).\n20. Uncontrolled hypothyroidism.",{"count":92,"type":23},376,[94],"PHASE3","The goal of this clinical trial is to learn if Venetoclax+Azacytidine+Quizartinib works better than standard therapy (Venetoclax+Azacytdine) to treat naïve adult patients with acute myeloid leukemia (AML) who are not suitable for standard induction therapy due to age, co-morbidities or other risk factors. The main question it aims to answer is:\n\n\\- Does the combination of Venetoclax+Azacytidine+Quizartinib show more probability of overall survival than Venetoclax+Azacytdine?\n\nResearchers will compare Venetoclax+Azacytidine+Quizartinib to Venetoclax+Azacytdine to see if Venetoclax+Azacytidine+Quizartinib works better than Venetoclax+Azacytdine to treat AML.\n\nParticipants will be randomized to one of the two treatment arms in a 1:1 ratio, both of which will have treatment cycles of 28 days.",[97],"Acute Myeloid Leukemia, Adult",[99,100,101],"AML","adult","old\u002Funfit",{"date":36,"type":37},{"date":104,"type":37},"2026-07-02",{"date":106,"type":23},"2030-04",{"name":108,"class":44},"PETHEMA Foundation",51,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":24,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100626090","phase-1-a-study-of-air-001-in-adults-with-alpha-1-antitrypsin-deficiency-aatd-100626090","NCT07431112","A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)","Phase 1, Open-Label, Single Ascending Dose and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered AIR-001 in Adults With AATD Due to PiZZ Genotype","RepAIR1","Inclusion Criteria:\n\n1. Male or female participants \\>18 years and \\\u003C75 years of age at the time of signing informed consent\n2. Total serum AAT levels \\\u003C 11µM (57 mg\u002FdL)\n3. Pi\\*ZZ genotype confirmed by DNA sequencing within the SERPINA1 gene with no known co-occurring SERPINA1 null variants\n4. Spirometry: Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted\n5. Non-smoker, including vaping, for at least 6 months prior to screening\n6. Body mass index between 18-33.0 kg\u002Fm²\n7. Body weight ≥ 45 kg and ≤110 kg\n8. Willing and able to give written informed consent prior to the initiation of any study procedure by the participant\n9. Negative beta human chorionic gonadotropin (β-hCG) at enrolment for women of childbearing potential (WOCBP) only.\n10. Participants who are either a WOCBP or male participant who is heterosexually active with a WOCBP must consent to use a highly effective method of contraception from screening visit until at least 4 weeks after the last dose of investigational medicinal product (IMP).\n11. Willing and able to comply with the study design schedule, all study procedures, and other requirements\n\nExclusion Criteria:\n\n1. Female participants who are nursing or lactating\n2. Participant has received AAT augmentation therapy within 30 days prior to Screening Visit or plans to receive AAT augmentation therapy at any time during study participation.\n3. Known or suspected allergy or intolerance to AIR-001 or its components\n4. Acute respiratory tract infection or clinically-diagnosed chronic obstructive pulmonary disease (COPD) exacerbation that required antibiotic treatment and\u002For systemic corticosteroids within the 8 weeks prior to dosing.\n5. Positive screening test for COVID-19 and\u002For Influenza.\n6. Lung disease that requires use of continuous oral corticosteroids, continuous supplemental oxygen, day-time ventilatory support, or any participant who is on a lung transplant waiting list.\n7. Liver Fibrosis score \\> 10 kPa defined by screening liver elastography, historical liver biopsy showing ≥ F3 fibrosis (METAVIR or comparable scoring system), or established diagnosis of hepatic cirrhosis.\n8. Any of the following screening laboratory abnormalities:\n\n   1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) \\> 3 x upper limit of normal (ULN)\n   2. Total bilirubin \\> ULN (note: for participants with documented Gilbert's syndrome and direct bilirubin ≤ ULN , exclusion criterion is total bilirubin is \\> 2.5 mg\u002FdL)\n   3. INR \\> ULN (for participants taking stable doses of anticoagulants, the exclusion criterion is INR \\> 3.0)\n   4. Platelet count ≤ 150 k\u002FμL\n   5. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin\u002F1.73m² by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation\n   6. Urine Albumin-to-Creatinine Ratio \\> 300 mg\u002Fg\n   7. Urine Protein-to-Creatinine Ratio \\> 500 mg\u002Fg\n9. Prolonged QT interval on electrocardiogram (ECG), defined as QTcF ≥ 450ms (men) or ≥ 470ms (women)\n10. ECG findings at screening that render measurements of QT interval imprecise.\n11. History of congestive heart failure, serious cardiac arrythmias requiring anti-arrhythmic medications or unexplained black-outs or fainting episodes with a suspected cardiac origin\n12. Positive screening test or known chronic infection with Hepatitis B, Hepatitis C, or HIV.\n13. Known history of coagulopathy or bleeding diathesis\n14. History or intolerance to subcutaneous (SC) injection including relevant dermatological conditions affecting standard injection sites\n15. History or presence of any medical condition, behavioral or psychiatric disorder, or planned surgical procedure or surgical history that may interfere with participation in the study or interpretation of study results, and\u002For put the participant at significant risk (in the opinion of the investigator) if he\u002Fshe participates in the study.\n16. History of any lung-volume reduction procedure in the 6 months prior to screening.\n17. Laboratory value(s) outside the laboratory reference range that is (are) considered to be clinically significant and may affect the safety, efficacy, PK, or PD assessments or interpretation by the Investigator, at screening\n18. History of alcohol or drug abuse within the past three months\n19. Current or previous participation in any other clinical study where the participant has received a dose of an IMP within 3 months or 5 half-lives of the IMP, whichever is longest, prior to Screening Visit\n20. Any previous gene replacement or DNA-editing therapy\n21. Any previous use of an RNA-based therapeutic (except for AIR-001 or RNA-based vaccines) within the 6 months prior to the Screening Visit or at any time if stopped due to drug-related adverse event.\n22. Use of any new prescription, vaccine, herbal remedy, over-the-counter medication, or supplement, or changes in chronic therapies within the 28 days prior to dosing unless approved by study Medical Monitor.","74 Years",{"count":120,"type":23},54,[122],"PHASE1","This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.",[125],"Alpha 1 Antitrypsin Deficiency",[127,128,129,130,131,132,133,134,135,125],"Lung Diseases","Liver Diseases","Respiratory Tract Diseases","Genetic Disease","Inborn Congenital, Hereditary, Neonatal Diseases and Abnormalities","Subcutaneous Emphysema","Emphysema","Pathologic Processes","Pathological Conditions, Signs and Symptoms",{"date":36,"type":37},{"date":138,"type":37},"2026-03-17",{"date":140,"type":23},"2029-01",{"name":142,"class":81},"AIRNA Corporation",8,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":24,"phases":154,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100624292","shockfast-intravascular-lithotripsy-device-for-treatment-of-calcified-coronary-lesions-100624292","NCT07407738","ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions","ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions, a Prospective, Randomised, International Trial: ShockFast IVL Trial","IVL","Inclusion Criteria:\n\n1. Patients aged ≥18 years undergoing PCI for stable or unstable angina or staged procedure after successful treatment of a myocardial infarction where heart enzymes are decreasing\n\n   Angiographic criteria:\n2. Native de novo coronary lesions\n3. Vessel diameter between 2.5mm - 4.0mm\n4. Lesion Length: ≤40mm\n5. Severe Calcification:\n\n   1. Calcification visible on the upper and the lower sides of the vessel wall in at least two angiographic projections that differ ≥ 60° from each other\n   2. Presence of severe calcified protruding noduli\n6. No flow disturbances at baseline (Thrombolysis in Myocardial Infarction \\[TIMI\\] 3 flow at baseline)\n7. Target lesion with diameter stenosis ≥70% by visual, or ≥50% with evidence of clinical ischemia\n\n   OCT Criteria:\n8. Total calcium arc \\> 180° or\n9. Presence of a protruding calcified noduli\n\nExclusion Criteria:\n\n1. Ejection fraction less than 25%\n2. Lesion located in Left Main (LM) coronary artery\n3. Calcifications located mostly \\> 0.5 mm from the vessel lumen.\n4. Severe renal Impairment; Serum Creatinine \\> 220 μmol or currently undergoing hemodialysis\n5. Severe lesion tortuosity where OCT is judged impossible to cross.\n6. Inability to tolerate dual antiplatelet therapy for 6 months or longer\n7. Inability to obtain inform consent or deemed poorly compliant by the investigator\n8. Presence of permanent pacemaker\n9. Angiographic evidence of thrombus in the target vessel\n10. Target lesion located at or involving within 5mm of the coronary ostium of the Left Anterior Descending artery (LAD), Left Circumflex artery (LCX)\n11. Target lesion is a chronic total occlusion (CTO)\n12. Presence of aneurysm within 10mm proximal or distal to the target lesion",{"count":153,"type":23},120,[155],"NA","Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed. This is a minimally invasive procedure used to treat narrowed or blocked coronary arteries. Sometimes a stent is placed to keep the artery open. If the lesions in the coronary artery are calcified, this may cause difficulties for successful stent placement. The calcified plaques can be fractured via intravascular lithotripsy (IVL) with devices like ShockWave IVL and ShockFast IVL. The aim of this study is to compare the this relatively new ShockFast IVl with the more widely used ShockWave IVL.",[158,159],"Coronary Arterial Disease","Calcified Coronary Artery Disease",[161,162,163,150],"Shockwave Intravascular Lithotripsy","Shockfast Intravascular Lithotripsy","Coronary Calcified Lesion",{"date":36,"type":37},{"date":166,"type":37},"2026-02-16",{"date":168,"type":23},"2027-03-01",{"name":170,"class":81},"Shunmei Medical",13,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":24,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698","NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","80 Years",{"count":182,"type":23},500,[94],"The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[186],"Amyotrophic Lateral Sclerosis",{"date":36,"type":37},{"date":189,"type":37},"2026-02-01",{"date":191,"type":23},"2029-03",{"name":193,"class":81},"Prilenia",56,{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":203,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":24,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100611717","mapt-protocol-fixation-versus-arthroplasty-surgical-treatments-for-early-recovery-after-hip-fracture-faster-hip-100611717","NCT07244211","MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)","Musculoskeletal Adaptive Platform Trial (MAPT): Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)","FASTER-HIP","Inclusion Criteria:\n\n* 60 years of age or older undergoing surgery due to a minimally displaced femoral neck fracture\n* The patient has a health condition affecting physical mobility.\n* Complete fracture of the femoral neck (AO\u002FOTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging.\n* Minimally displaced fracture that could be, in the judgment of the attending surgeon, managed with either arthroplasty or in situ internal fixation without reduction.\n* Low energy injury mechanism.\n* Surgeons with expertise in internal fixation and total hip arthroplasty or hemiarthroplasty are available to perform surgery.\n\nExclusion Criteria:\n\n* The patient is not clinically suitable for either compared treatment.\n* Expected injury survival of less than 12 months.\n* Terminal illness with expected survival of less than 12 months.\n* Incarceration.\n* Unable to obtain informed consent due to language barriers.\n* Unable to obtain informed consent because the legally authorized representative was unavailable.\n* Problems, in the judgment of the study personnel, with maintaining follow-up with the patient.\n* Currently enrolled in a study or intervention domain that does not permit co-enrollment.\n* Prior enrollment in the specific platform trial intervention domain.\n* Patient or legally authorized representative did not provide informed consent (declined participation).\n* Eligible patient or legally authorized representative was not approached within the screening window (missed participant).\n* Other reasons to exclude the patient, as approved by the data coordinating center.\n* Associated lower extremity injury that prevents post-operative weight-bearing.\n* Retained hardware around the hip that precludes either study treatment.\n* Infection around the hip (soft tissue or bone).\n* Pathologic fracture with a lytic lesion in the femoral neck that precludes internal fixation.\n* Injury did not occur within 21 days of screening.\n* Patient is too ill, in the judgment of the attending surgeon, for internal fixation.\n* Patient is too ill, in the judgment of the attending surgeon, for arthroplasty.","60 Years",{"count":205,"type":23},600,[155],"This study is an intervention domain of the Musculoskeletal Adaptive Platform Trial. The primary goal of this pragmatic, randomized, open-label, comparative effectiveness trial is to evaluate if arthroplasty is superior to internal fixation when used to treat minimally displaced femoral neck fractures in older adults ≥60 years old. We hypothesize that arthroplasty will reduce death, preserve ambulation, increase days alive and out of hospital, and improve health status compared to internal fixation within 4 months and 12 months from randomization.",[209],"Femoral Neck Fractures",[211,212,213,214,215,216,217,218,219,220],"Minimally displaced femoral neck fractures","arthroplasty","hip fractures","femoral fractures","orthopaedic procedures","older adults","patient-centered outcomes","adaptive trial","internal fixation","pragmatic trial",{"date":36,"type":37},{"date":223,"type":37},"2026-01-23",{"date":225,"type":23},"2030-01-31",{"name":227,"class":44},"University of Southern California",26,{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":24,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100610417","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-belantamab-mafodotin-in-combination-with-standard-of-care-in-participants-with-relapsed-refractory-multiple-myeloma-rrmm-100610417","NCT07227311","A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)","A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)","Inclusion Criteria:\n\n• Participants are eligible to be included in the study only if all of the following criteria apply:\n\nApplicable to All Arms - BPd, BVd, BKd:\n\n* Male or female, 18 years or older (at the time consent is obtained).\n* Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.\n* Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.\n* Must have at least 1 aspect of measurable disease, defined as one the following:\n\n  1. Urine M-protein excretion ≥200 mg\u002F24 h, or\n  2. Serum M-protein concentration ≥0.5 g\u002FdL (≥5.0 g\u002FL), or\n  3. Free Light Chain (FLC) assay: involved FLC level ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum free light chain ratio (\\\u003C0.26 or \\>1.65) only if patient has no measurable urine or serum M spike.\n* Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:\n\n  1. ASCT was \\>100 days prior to the first dose of study medication,\n  2. No active bacterial, viral, or fungal infection(s) present.\n* All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia.\n* Adequate organ system functions as defined by the laboratory assessments.\n* Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception.\n* Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential.\n\nSpecific Inclusion Criteria for BPd arm:\n\n• Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nApplicable for all (BPd, BVd, BKd):\n\n* Active plasma cell leukemia at Screening.\n* Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).\n* Previous or concurrent invasive malignancy other than MM, except:\n\n  1. The disease must be considered medically stable for at least 2 years; or\n  2. The patient must not be receiving active therapy, other than hormonal therapy for this disease.\n* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.\n* Plasmapheresis within 7 days prior to the first dose of study intervention.\n* Patients after prior allogeneic stem cell transplant\n* Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery.\n* Evidence of active mucosal or internal bleeding.\n* Intolerance or contraindications to anti-viral prophylaxis.\n* Current corneal epithelial disease except for mild punctate keratopathy.\n* Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.\n* Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety). Patients with isolated proteinuria resulting from MM are eligible, provided they fulfill certain criteria\n* Received prior B-cell maturation antigen (BCMA)-targeted therapy.\n* Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications. Bandage contact lenses are permitted during study treatment as directed by the treating eye care specialist.\n* HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count.\n* Significant liver dysfunction (ALT \\>2.5x ULN, bilirubin \\>1.5x ULN, cirrhosis, unstable liver\u002Fbiliary disease).\n* Positive hepatitis B or C markers unless criteria for resolved infection are met.\n* Evidence of cardiovascular risk including any of the following: untreated arrhythmias, recent MI\u002FACS\u002Fangioplasty\u002Fbypass, NYHA III\u002FIV heart failure, uncontrolled hypertension, QTc prolongation.\n\nSpecific Exclusion Criteria for BPd Arm:\n\n* Received prior treatment with or intolerant to pomalidomide.\n* Active or history of venous and arterial thromboembolism within the past 3 months.\n\nSpecific Exclusion Criteria for BVd Arm:\n\n* Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg\u002Fm² twice weekly or within 60 days of completing that treatment).\n* Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.\n\nSpecific Exclusion Criteria for BKd Arm:\n\n* Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment).\n* Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib.\n* Left ventricular ejection fraction \\\u003C40% as assessed by transthoracic echocardiogram.\n* Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment.\n* Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.\n* Known pulmonary hypertension.",{"count":237,"type":23},200,[56],"This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.\n\nThe main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.",[241],"Multiple Myeloma",[243,244,245,246,247,248,249,250],"Relapsed-Refractory Multiple Myeloma","DREAMM-15","Belantamab Mafodotin","Blenrep","Pomalidomide","Bortezomib","Carfilzomib","Dexamethasone",{"date":36,"type":37},{"date":253,"type":37},"2026-04-15",{"date":255,"type":23},"2030-08-30",{"name":257,"class":81},"GlaxoSmithKline",59,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":267,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":24,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":270,"type":23},150,[94],"The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[274],"Diabetes Mellitus, Type 1",{"date":36,"type":37},{"date":277,"type":37},"2026-01-12",{"date":279,"type":23},"2031-07",{"name":281,"class":81},"Eli Lilly and Company",113,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":24,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":311},"100604873","phase-2-a-study-to-evaluate-the-optimal-dose-adverse-events-and-change-in-disease-activity-of-intravenous-abbv-706-in-combination-with-atezolizumab-versus-standard-of-care-as-first-line-treatment-in-adult-participants-with-previously-untreated-extensive-stage-small-cell-lung-cancer-100604873","NCT07155174","A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer","A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","SEZanne","Inclusion Criteria:\n\n* Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* Suspected brain metastases at screening should have a computed tomography (CT)\u002F magnetic resonance imaging (MRI) of the brain prior to study entry.\n\nExclusion Criteria:\n\n* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).\n* Known active\u002Fsymptomatic central nervous system (CNS) metastases should be excluded.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan should be excluded.\n* Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.",{"count":292,"type":23},180,[56],"Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).\n\nABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.\n\nIn the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[296],"Small Cell Lung Cancer",[296,298,299,300,301,302,303],"SCLC","ABBV-706","Etoposide","Carboplatin","Atezolizumab","Lurbinectedin",{"date":36,"type":37},{"date":306,"type":37},"2025-11-25",{"date":308,"type":23},"2031-09",{"name":310,"class":81},"AbbVie",67,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":24,"phases":322,"briefSummary":323,"conditions":324,"keywords":327,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":339},"100600814","phase-2-a-phase-2-neoadjuvant-study-of-zanidatamab-in-combination-with-chemotherapy-in-participants-with-her2-positive-breast-cancer-100600814","NCT07102381","A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","EmpowHER 208","Inclusion Criteria:\n\n1. Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.\n2. Has histologically confirmed HER2-positive breast cancer\n3. Has a known hormone receptor (HR) status of the primary tumor\n4. Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.\n5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate organ function\n8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.\n9. Adequate contraceptive precautions\n10. Participants with known HIV are eligible unless:\n\n    1. CD4+ T Cell count is less than or equal to 350 microliters (uL)\n    2. Detectable viral load, or\n    3. Receiving protease inhibitors or cobicistat\n\nExclusion Criteria:\n\n1. Has Stage IV (metastatic) breast cancer.\n2. Has bilateral breast cancer.\n3. Has a history of any severe and\u002For uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.\n4. Has uncontrolled hypertension\n5. Has significant symptoms from peripheral neuropathy\n6. Has an active uncontrolled infection\n7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.\n8. Known active hepatitis B or C infection.\n9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible.\n10. Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer\n11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol\n12. Receipt of a live vaccine within 4 weeks prior to enrollment\n13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy",{"count":321,"type":23},125,[56],"The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer",[325,326],"HER2-positive Breast Cancer","Breast Cancer",[328,329,330,331],"HER2-positive early breast cancer","invasive breast carcinoma","zanidatamab","breast neoplasm",{"date":36,"type":37},{"date":334,"type":37},"2025-09-24",{"date":336,"type":23},"2030-08-01",{"name":338,"class":81},"Jazz Pharmaceuticals",35,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":370},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":182,"type":23},[56,94],"A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[351],"Non-Small Cell Lung Cancer",[353,354,355,356,357,358,359,360,361,301,362,363],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Cisplatin","Pemetrexed",{"date":36,"type":37},{"date":366,"type":37},"2025-11-05",{"date":368,"type":23},"2030-11-15",{"name":80,"class":81},186,{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":24,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":380,"type":23},590,[56,94],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[384],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[63,386,69,61,62,387,388,72],"Lung cancer","MRTX1719","First-line",{"date":36,"type":37},{"date":391,"type":37},"2026-01-02",{"date":393,"type":23},"2031-08-12",{"name":80,"class":81},320,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":24,"phases":406,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":424},"100594352","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100594352","NCT07018323","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","75 Years",{"count":405,"type":23},210,[56],"This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.",[409],"Graves' Disease",[411,412,413,414,415,416],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart",{"date":36,"type":37},{"date":419,"type":37},"2025-06-19",{"date":421,"type":23},"2027-05",{"name":423,"class":81},"Immunovant Sciences GmbH",163,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":24,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":434,"type":23},450,[94],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[438],"Bipolar Disorder Type I With Mania",[440,441,442],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":36,"type":37},{"date":445,"type":37},"2025-07-18",{"date":447,"type":23},"2028-06-13",{"name":80,"class":81},174,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":24,"phases":460,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":473},"100579143","phase-2-a-study-to-evaluate-the-adverse-events-and-efficacy-of-intravenous-iv-of-telisotuzumab-adizutecan-in-combination-with-iv-oxaliplatin-fluorouracil-folinic-acidleucovorin-bevacizumab-panitumumab-in-adult-participants-with-metastatic-colorectal-cancer-100579143","NCT06820463","A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid\u002FLeucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the criteria within the protocol.\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and\u002For any topoisomerase inhibitor(s) (e.g., irinotecan).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.",{"count":459,"type":23},390,[56],"CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU\u002FLV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab\u002Fpantitumumab. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[463],"Metastatic Colorectal Cancer",[463,465,466],"AndroMETa-CRC-533","Telisotuzumab Adizutecan",{"date":36,"type":37},{"date":469,"type":37},"2025-04-24",{"date":471,"type":23},"2028-04",{"name":310,"class":81},65,{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":403,"enrollmentInfo":478,"targetDuration":4,"studyType":24,"phases":480,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":493},"100572003","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100572003","NCT06727604",{"count":479,"type":23},240,[56],"This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.\n\nThe primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \\[T3\\] or free triiodothyronine \\[FT3\\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.",[409],[411,484,485,486,416],"Anti Thyroid Drug","Hyperthyroidism","Autoimmune thyroid disease",{"date":36,"type":37},{"date":489,"type":37},"2024-12-17",{"date":491,"type":23},"2028-06",{"name":423,"class":81},134,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":24,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":514},"100563701","phase-1-a-study-to-evaluate-safety-pharmacokinetics-and-activity-of-gdc-7035-as-a-single-agent-and-in-combination-in-patients-with-advanced-solid-tumors-100563701","NCT06619587","A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors","A Phase I\u002FII Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation","Inclusion Criteria:\n\n* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation\n* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm\n\nExclusion criteria:\n\n* Malabsorption or other condition that would interfere with enteral absorption\n* Active brain metastases\n* Clinically significant cardiovascular dysfunction or liver disease",{"count":502,"type":23},410,[122],"This is a first-in-human Phase I\u002FII, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.",[506],"Solid Tumor",{"date":36,"type":37},{"date":509,"type":37},"2024-11-14",{"date":511,"type":23},"2028-05-31",{"name":513,"class":81},"Genentech, Inc.",42,{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":523,"maxAge":524,"enrollmentInfo":525,"targetDuration":4,"studyType":24,"phases":527,"briefSummary":528,"conditions":529,"keywords":532,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":541},"100557714","phase-3-a-study-investigating-subcutaneously-administered-pozelimab-in-combination-with-cemdisiran-or-cemdisiran-alone-in-adult-participants-with-geographic-atrophy-100557714","NCT06541704","A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","SIENNA","Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n2. Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol\n3. BCVA of 55 letters or better using ETDRS charts (20\u002F80 Snellen equivalent) in the study eye as described in the protocol\n4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nKey Exclusion Criteria:\n\n1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n2. History or current evidence of Macular Neovascularization (MNV) and\u002For exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization\n4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization\n5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study\n6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol\n\n   Systemic Exclusion criteria\n7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n8. History of solid organ or bone marrow transplantation\n9. Use of chronic (\\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol\n10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol\n11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n12. Carrier of Neisseria meningitidis based on culture collected during screening\n13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n\nNOTE: Other protocol-defined Inclusion\u002F Exclusion Criteria apply","50 Years","85 Years",{"count":526,"type":23},975,[94],"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).\n\nThe purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)",[530,531],"Age-related Macular Degeneration (AMD)","Geographic Atrophy (GA)",[533],"GA secondary to AMD",{"date":36,"type":37},{"date":536,"type":37},"2024-10-30",{"date":538,"type":23},"2033-04-09",{"name":540,"class":81},"Regeneron Pharmaceuticals",224,{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":549,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":24,"phases":551,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":82},"100544252","phase-3-a-study-of-pitolisant-in-patients-with-prader-willi-syndrome-100544252","NCT06366464","A Study of Pitolisant in Patients With Prader-Willi Syndrome","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome","Inclusion Criteria:\n\n* Genetically confirmed diagnosis of PWS\n* Excessive daytime sleepiness\n* Has a consistent parent\u002Fcaregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.\n* In the opinion of the Investigator, the patient\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.\n\nExclusion Criteria:\n\n* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled\n* Has a diagnosis of hypersomnia due to another sleep\u002Fmedical disorder\n* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening","6 Years",{"count":493,"type":23},[94],"This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.\n\nThe primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.\n\nSecondary objectives include assessing the impact of pitolisant on:\n\nIrritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity\u002Fnoncompliance, and inappropriate speech",[554],"Prader-Willi Syndrome",[556,557,558,559],"pitolisant","excessive daytime sleepiness","irritable and disruptive behaviors","Prader-Willi syndrome",{"date":36,"type":37},{"date":562,"type":37},"2024-05-28",{"date":471,"type":23},{"name":565,"class":81},"Harmony Biosciences Management, Inc.",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":573,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":24,"phases":576,"briefSummary":577,"conditions":578,"keywords":584,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":596},"100537335","phase-1-phase-1-safety-and-tolerability-study-of-xmab541-in-advanced-solid-tumors-100537335","NCT06276491","Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors","A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years. For US only: subjects with GCTs, age ≥15 years\n* CLDN6+ tumor\n* Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT resistant to previous treatment\n* Adequate Eastern Cooperative Oncology Group performance status\n* Life expectancy ≥ 3 months\n* Adequate liver, kidney, and bone marrow function\n\nKey Exclusion Criteria:\n\n* Participants with untreated brain metastases are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable.\n* Active known or suspected autoimmune disease\n* Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug\n* Clinically significant cardiovascular, pulmonary or gastrointestinal disease\n* Active hepatitis B or hepatitis C","15 Years",{"count":575,"type":23},282,[122],"The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.",[579,580,581,582,583],"Ovarian Cancer","Endometrial Cancer","Germ Cell Tumor","Testicular Germ Cell Tumor","Ovarian Germ Cell Tumor",[585,579,586,587,581,580,588],"Phase 1","CLDN6","Testicular Cancer","T-cell Engager",{"date":36,"type":37},{"date":591,"type":37},"2024-04-04",{"date":593,"type":23},"2028-12",{"name":595,"class":81},"Xencor, Inc.",22,{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":605,"minAge":573,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":24,"phases":608,"briefSummary":609,"conditions":610,"keywords":612,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":623},"100522211","phase-3-study-of-volrustomig-in-women-with-high-risk-locally-advanced-cervical-cancer-evolve-cervical-100522211","NCT06079671","Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","eVOLVECervical","Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\\u003C 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO\u002FECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg\u002Fday of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","FEMALE",{"count":607,"type":23},800,[94],"This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.",[611],"Locally Advanced Cervical Cancer",[613,614,615],"Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig",{"date":36,"type":37},{"date":618,"type":37},"2023-09-22",{"date":620,"type":23},"2030-09-30",{"name":622,"class":81},"AstraZeneca",205,{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":24,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":645},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674","NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant",{"count":182,"type":23},[155],"A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[635,636,637],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":36,"type":37},{"date":640,"type":37},"2023-12-27",{"date":642,"type":23},"2029-08",{"name":644,"class":81},"Orchestra BioMed, Inc",130,{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":652,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":656,"phases":4,"briefSummary":657,"conditions":658,"keywords":661,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":665,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":672},"100492944","coroflex-isar-neo-pmcf-study-100492944","NCT05698732","Coroflex® ISAR NEO PMCF Study","Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study","rEPIC07","Inclusion Criteria:\n\nCoroflex® ISAR NEO is intended to be used for\n\n* Patients must be at least 18 years of age AND\n* The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his\u002F her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND\n* Patients with Novo lesion length 2-4 mm AND\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients with express refusal by the patient to participate in the study.\n* Patients pregnant women and lactating women.\n* Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).\n* Patients in whom anti-platelet and\u002For anti-coagulation therapy is contraindicated\n* Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation\n* Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent\n* Patients with known sensitivity to contrast agents who cannot be premedicated.\n* Patients with contraindications or hypersensitivity to sirolimus\n* Patients with a life expectancy of less than 2 years\n* Patients included in other clinical trials",{"count":655,"type":23},3000,"OBSERVATIONAL","International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.",[659,660],"Coronary Artery Disease (CAD)","Ischemic Heart Disease",[662,663,664],"MDR (Medical Device Regulations)","PMCF (Post-Market Clinical Follow-up)","Drug Eluting Stent",{"date":36,"type":37},{"date":667,"type":37},"2023-08-04",{"date":669,"type":23},"2027-02-01",{"name":671,"class":44},"Fundación EPIC",24,{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":4,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":680,"targetDuration":4,"studyType":24,"phases":682,"briefSummary":683,"conditions":684,"keywords":687,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":693,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":700},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":681,"type":23},626,[56,94],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[685,686],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[688,689,69,686,690,691,692],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":36,"type":37},{"date":695,"type":37},"2020-12-02",{"date":697,"type":23},"2029-10-31",{"name":699,"class":81},"Mirati Therapeutics Inc.",770,""]