[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Panama\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":712},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,47,74,102,140,172,199,227,250,281,308,339,364,396,421,447,469,501,527,552,574,600,622,654,691],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100634630","nanochon-chondrograft-first-in-human-fih-early-feasibility-study-efs---panama-100634630",false,"NCT07542184","Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Panama","A First in Human (FIH) Early Feasibility Study (EFS) to Evaluate the Safety and Performance of the Nanochon Chondrograft™ Implant for Re-surfacing of Cartilage Lesions","Inclusion Criteria:\n\n* Male or female ≥22 years and ≤ 60 years of age\n* MRI knee evaluation completed within 6 months prior to enrollment\n* Participant must be able to read and speak English and\u002For Spanish\n* Participant must voluntarily sign the REB approved informed consent form (ICF)\n\nExclusion Criteria:\n\n* Any known systemic cartilage and\u002For bone disorder, such as, but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta\n* Requires bilateral knee surgery\n* Pregnancy, planning to become pregnant or breast feeding\n* Any significant illness (metastasis cancer of any type) that decreases the probability of the participant's survival to 12 months\n* Known insulin dependent diabetes mellitus\n* Steroid treatment (oral or IV) within the past 6 months\n\nParticipant is:\n\n1. receiving workman's compensation\n2. receiving prescription narcotic medication\n3. active with litigation relating to musculoskeletal injuries or disorders\n4. a prisoner or pending incarceration\n\n   * Comorbidities that could impact study participation or results (e.g., autoimmune disorder, HIV, neuropathic pain or fibromyalgia, restless leg syndrome, active infection, or pain requiring chronic pain management), in the opinion of the investigator at the time of enrollment\n   * Significant psychiatric disorders (e.g., major depression, anxiety disorders, bipolar disorder, and schizophrenia)\n   * Substance and\u002For alcohol dependence and\u002For abuse based on clinical history, physical exam and participant presentation\n   * Current participation in another drug or device study that, in the opinion of the investigator at the time of enrollment, would interfere with participation in this study\n   * Participant has claustrophobia or implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI\n   * Known allergy or hypersensitivity to any investigational device materials.","ALL","22 Years","60 Years",{"count":21,"type":22},5,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this First in Human study is to learn if the Nanochon Chondrograft Implant is a safe primary surgical treatment for participants with cartilage lesions in the knee. This study will include males and females between the ages of 22 and 60.",[28],"Knee Cartilage Lesions",[30,31,32,33],"Knee cartilage lesions","Medial femoral condyle lesion","Lateral femoral condyle lesion","Trochlea articular cartilage lesion","RECRUITING","2026-08-19",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":38},"2026-07-30",{"date":42,"type":22},"2027-09",{"name":44,"class":45},"Nanochon, Inc.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100579098","phase-3-a-study-to-assess-the-efficacy-and-safety-of-induction-and-maintenance-therapy-with-afimkibart-ro7790121-in-participants-with-moderately-to-severely-active-crohns-disease-100579098","NCT06819878","A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease","SIBERITE-1","Inclusion Criteria:\n\n* Confirmed diagnosis of CD\n* Moderately to severely active CD\n* Bodyweight \\>= 40 kilogram (kg)\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced CD therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis\n* Participant with a history of \\>= 3 bowel resections (\\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)\n* Diagnosis of short gut or short bowel syndrome\n* Presence of an ileostomy, colostomy or ileoanal pouch\n* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \\>3 openings\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia\n* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy","16 Years","80 Years",{"count":58,"type":22},600,[60],"PHASE3","This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).",[63],"Moderately to Severely Active Crohns Disease","2026-08-18",{"date":66,"type":38},"2026-08-20",{"date":68,"type":38},"2025-03-17",{"date":70,"type":22},"2033-12-31",{"name":72,"class":45},"Hoffmann-La Roche",373,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100482471","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-qmf149-indacaterol-acetatemometasone-furoate-versus-budesonide-in-children-from-6-to-less-than-12-years-of-age-with-asthma-100482471","NCT05562466","A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate\u002FMometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate \u002F Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Inclusion Criteria\n\n1. Male or female children ≥ 6 years and \\\u003C12 years in age at randomization.\n2. Parents\u002Flegal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).\n3. Confirmed\u002Fdocumented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.\n4. Written and signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.\n5. Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug\u002Fday) for at least 3 weeks (run-in period) prior to randomization.\n6. All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n\n   Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\\u003C1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n7. Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).\n\n   Withholding period of bronchodilators prior to spirometry at all time:\n\n   SABA for ≥ 6 hours. For loose combinations of ICS\u002FLABA\\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.\n\n   \\* In case of combination ICS\u002FLABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.\n\n   A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.\n\n   If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.\n8. FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \\> and\u002For = 12% (performed according to ATS\u002FERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.\n9. Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.\n10. A parent\u002Flegal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent\u002Flegal guardian to complete the e-diary entries and attend clinic visits with the patient.\n11. Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.\n12. For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.\n\nExclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.\n\n1. Prior intubation for asthma.\n2. Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours).\n3. Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.\n4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.\n5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.\n6. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and\u002For urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.\n\n   * Evidence of urinary obstruction, or difficulty in voiding\n   * Evidence of congenital renal abnormalities with an established effect on renal function\n   * Calculated eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2 using the Bedside Schwartz formula.\n7. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.\n\n   Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.\n8. Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.\n9. Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.\n10. History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma\u002FCOPD overlap syndrome (ACOS).\n11. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).\n12. Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).\n13. Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).\n14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n15. Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.\n16. Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.\n17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and\u002For during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.\n18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and\u002For during the screening period.\n19. Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.\n20. Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition\u002Fdisease exacerbated during the study.\n21. History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol\u002Falbuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.\n22. Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c\\>8 or as per judgement of investigator prior to End of Run-In (Visit 30)\n23. Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.\n24. Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.\n25. Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.","6 Years","11 Years",{"count":84,"type":22},200,[60],"The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) \u002F mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.\n\n* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.\n* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.",[88],"Asthma",[88,90,91,92,93],"Pediatric","Breezhaler","QMF149","Budesonide",{"date":35,"type":38},{"date":96,"type":38},"2023-05-11",{"date":98,"type":22},"2028-05-30",{"name":100,"class":45},"Novartis Pharmaceuticals",64,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100172884","product-surveillance-registry-100172884","NCT01524276","Product Surveillance Registry","Medtronic Product Surveillance Registry","PSR","Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements\n* Patient has or is intended to receive or be treated with an eligible Medtronic product\n* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment\n\nExclusion Criteria:\n\n* Patient who is, or will be, inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound results",{"count":111,"type":22},100000,"OBSERVATIONAL","The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.",[115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130],"Cardiac Rhythm Disorders","Urological Disorders","Neurological Disorders","Cardiovascular Disorders","Digestive Disorders","Intracranial Aneurysm","Mechanical Circulatory Support","Respiratory Therapy","Aortic, Peripheral Vascular and Venous Disorders","Minimally Invasive Surgical Procedures","Diagnostic Techniques and Procedures","Surgical Procedures, Operative","Renal Insufficiency","Neurovascular","Coronary Artery Disease","Ear, Nose and Throat Disorder","2026-08-17",{"date":64,"type":38},{"date":134,"type":4},"2012-01",{"date":136,"type":22},"2040-01",{"name":138,"class":45},"Medtronic",400,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100584107","phase-1-a-study-to-test-the-safety-and-effectiveness-of-gsk5764227-alone-or-with-other-treatments-in-participants-with-advanced-gastrointestinal-cancers-that-cannot-be-surgically-removed-embold-pangi-201-100584107","NCT06885034","A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)","A Phase1 b\u002F2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors","Inclusion criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF).\n\nCRC Cohort\n\n* Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).\n\nPDAC Cohort\n\n* Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).\n\nAll Cohorts\n\n* Is willing to use adequate contraception.\n* Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Has an ECOG performance status of 0 or 1.\n* Has adequate organ function.\n\nExclusion criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of disease.\n* Has had any major surgery within 28 days prior to randomization or first dose of study intervention, depending on sub-cohort\u002Fcohort assignment\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has severe, uncontrolled or active cardiovascular disorders.\n* Has serious or poorly controlled hypertension.\n* Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.\n* Has untreated brain or Central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed.\n* Has evidence of current ILD\u002Fnon-infectious pneumonitis or a prior history of ILD\u002Fnon-infectious pneumonitis requiring high-dose glucocorticoids Or suspected ILD\u002Fnon-infectious pneumonitis that cannot be ruled out by imaging.\n* Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy.\n* Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.\n* Is pregnant or breastfeeding.","18 Years",{"count":149,"type":22},451,[151,152],"PHASE1","PHASE2","This study will check how well a new medicine, Risvutatug rezetecan, (Ris-Rez, also known as GSK5764227) works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.",[155],"Gastrointestinal Neoplasms",[157,158,159,160,161,162],"GSK5764227","Risvutatug Rezetecan","Ris-Rez","Solid Tumors","Colorectal Cancer","Pancreatic ductal adenocarcinoma",{"date":164,"type":38},"2026-08-03",{"date":166,"type":38},"2025-06-11",{"date":168,"type":22},"2029-01-09",{"name":170,"class":45},"GlaxoSmithKline",85,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":180,"minAge":181,"maxAge":56,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":46},"100650139","vivifi-device-safety-evaluation-for-the-treatment-of-benign-prostatic-hyperplasia-100650139","NCT07745621","Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia","Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia","BPH","Inclusion Criteria:\n\n1. Male 45-80 years of age\n2. Diagnosed with Benign prostatic hyperplasia (BPH)\n3. Prostate volume: ≥ 40 ≤ 100 cc measured by MRI\n4. Qmax ≤ 10 mL\u002Fs on two measures (voided volume ≥ 125 mL)\n5. Assessment of future paternity plans\n6. Signed the study informed consent\n7. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12\n\nExclusion Criteria:\n\n1. Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.\n2. Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable\n3. Intravesical prostatic protrusion (IPP) \\> 10 mm\n4. Post-void residual volume (PVR) \\> 200ml\n5. IPSS QoL score ≤ 3\n6. Prostate cancer diagnosis, suspicious DRE, or PSA \\> 10ng\u002FmL\n7. Patients with clinical history of chronic prostatitis.\n8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures.\n9. Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury\n10. Patients who are unable to undergo the required anesthesia for the procedure\n11. Patients on testosterone replacement therapy\n12. Patients unable to hold blood thinners, or with coagulation related issues\n13. Patients currently taking medication for BPH (eg. Alpha-blockers or 5-ARIs) who are unwilling or unable to discontinue (washout) prior to treatment (14 days for α-blockers (tamsulosin, alfuzosin, silodosin, doxazosin, terazosin), 8 weeks for finasteride, 5 months for dutasteride)\n14. Diagnosis of Hidradenitis suppurativa","MALE","45 Years",{"count":183,"type":22},20,[25],"The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).",[187],"Benign Prostatic Hyperplasia",[178],"NOT_YET_RECRUITING","2026-07-29",{"date":192,"type":38},"2026-08-04",{"date":194,"type":22},"2026-09",{"date":196,"type":22},"2028-12",{"name":198,"class":45},"Vivifi Medical",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":46},"100595750","phase-1-safety-and-efficacy-of-timod-sustained-release-implant-in-participants-with-glaucoma-or-ocular-hypertension-undergoing-cataract-surgery-100595750","NCT07036510","Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery","Early Feasibility Study to Evaluate the Safety and Efficacy of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* In good general and mental health without ongoing clinically significant abnormalities in medical history.\n* Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement.\n* Successful, uncomplicated cataract surgery\n\nExclusion Criteria:\n\n* Subjects with a history of hypersensitivity or contraindications to β- blockers.\n* Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure\n* Significant risks caused by washout of ocular hypotensive medications.\n* Clinically significant ocular pathology other than OHT, glaucoma and cataract.","40 Years",{"count":208,"type":22},42,[151,152],"The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery.\n\nThe study is conducted in two stages. The first stage (Stage 1\u002FPhase 1) is intended to study the safety of 3 different doses of the study medication (called TimoD implant). The second stage (Stage 2\u002FPhase 2) of the study is intended to study in greater detail the efficacy and safety of the 3 doses of the TimoD implant in comparison to a standard approved medication, timolol eye drops for 3 years.",[212,213],"Glaucoma","Ocular Hypertension",[212,215,216,217,218,219],"Ocular hypertension","OHT","Cataract","Timolol","Lens diseases",{"date":40,"type":38},{"date":222,"type":38},"2025-06-12",{"date":224,"type":22},"2027-01",{"name":226,"class":45},"EyeD Pharma",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100444427","phase-1-a-study-of-calderasib-mk-1084-in-kras-mutant-advanced-solid-tumors-mk-1084-001-100444427","NCT05067283","A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)","A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors","KANDLELIT-001","Inclusion Criteria:\n\nFor all participants:\n\n* Has measurable disease by RECIST 1.1 criteria\n* Has adequate organ function\n* Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic\n* Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention\n\nFor Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease\n\nFor Arm 2\n\n\\- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%\n\nFor Arm 3\n\n* Has locally advanced unresectable or metastatic solid-tumor malignancy with histological or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC\n* Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample\n* Previous treatment failure of at least 1 line of systemic therapy Expansion Group B\n* Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease\n\nArm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation\n\nArm 5 only\n\n* Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation\n* Previous treatment failure of one or 2 previous line(s) of systemic therapy\n\nArm 6 only\n\n\\- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation\n\nExclusion Criteria:\n\n* Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention\n* Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years\n* Has clinically active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active infection requiring systemic therapy\n* Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection\n* Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis\n* Has an active autoimmune disease requiring systemic therapy\n* Has not fully recovered from any effects of major surgical procedure without significant detectable infection\n* Has one or more of the following ophthalmological findings\u002Fconditions: intraocular pressure \\>21 mm Hg and\u002For any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and\u002For a diagnosis of retinal degenerative disease excluding age-related macular degeneration\n* Has received live or live-attenuated vaccine within 4 weeks of study start\n\nArm 4 Only\n\n* Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents \\[for example, piroxicam\\]) before, during, and for at least 2 days after administration of pemetrexed.\n* Is unable\u002Funwilling to take folic acid, vitamin B12, and dexamethasone",{"count":236,"type":22},830,[151],"This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.",[240],"Advanced Solid Tumors",{"date":242,"type":38},"2026-07-31",{"date":244,"type":38},"2021-12-17",{"date":246,"type":22},"2030-02-25",{"name":248,"class":45},"Merck Sharp & Dohme LLC",75,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100478314","lumbar-operatively-inserted-perqdisc-artificial-implant-following-nulcectomy-lopain2-100478314","NCT05508360","\"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy\" (LOPAIN2)","LOPAIN2","Inclusion Criteria:\n\n* Patient is skeletally mature aged 22-70.\n* Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.\n* Patient has adequate disc height (6mm) at the level to be treated\n* Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).\n* Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40\u002F100)\n* Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)\n* Patient has signed the approved Informed Consent Form.\n* All surgeries must be approved by the Medical Advisory Board (MAB)\n\nExclusion Criteria:\n\n* Patient has less than 6 mm of disc height.\n* Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).\n* Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.\n* Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.\n* Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.\n* Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).\n* Patient has any known active malignancy.\n* Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.\n* Patient has active or local systemic infection.\n* Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, ARC and HIV.\n* Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.\n* Patient has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan should be performed to rule out patients considered at risk for osteopenia.\n* Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.\n* Patient has a known allergy to silicone or barium sulfate.\n* Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.\n* Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).\n* Patient has motion of less than 3 degrees on pre-operative lateral flexion\u002Fextension radiographs.\n* Patient belongs to a vulnerable population or has a condition such that his\u002Fher ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally, disabled, prisoner, chronic alcohol\u002F substance abuser)\n\nIntraoperative Exclusion Criteria:\n\n* Protrusion of the 20A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps.\n* Patient has a violated endplate as determined by imaging balloons during fluoroscopy.\n* Patient has a disc space that is too narrow for implantation. MIPL Specific\n* Poor radiological visualization of Kambin's triangle.\n* Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite or repositioning instruments.",{"count":258,"type":22},72,[25],"This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.",[262,263],"Degenerative Disc Disease","Chronic Low-back Pain",[262,265,266,267,268,269,270],"DDD","Chronic Low Back Pain","cLBP","Disc Herniation","Nucleus Replacement","Low Back Pain","2026-07-24",{"date":273,"type":38},"2026-07-27",{"date":275,"type":38},"2022-08-22",{"date":277,"type":22},"2030-08-22",{"name":279,"class":45},"Spinal Stabilization Technologies",11,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":19,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":307},"100648131","suicidal-risk-in-adults-in-panama-validation-of-a-clinical-intervention-protocol-100648131","NCT07717320","Suicidal Risk in Adults in Panama: Validation of a Clinical Intervention Protocol","Inclusion Criteria:\n\n* Age and consent\n* Presence of suicidal ideation or active behavior in the last month, assessed using the C-SSRS (e.g., intentional ideation, plan, or preparatory behavior)\n* Depressive or anxious symptoms (Score ≥ 10 on the PHQ-9, indicating at least moderate depressive symptoms, or Score ≥ 10 on the GAD-7, suggesting clinically significant anxiety.)\n* Availability and commitment to participate in the full assessment using all the aforementioned scales.\n\nExclusion Criteria:\n\n* Clinical Safety (exclude and refer immediately)\n* Imminent suicide risk according to the C-SSRS (e.g., attempt within the last 7 days, current intentional plan, access to lethal means, and low ambivalence).\n* PHQ-9 item 9 = 3 (\"almost every day\") with clinical corroboration of imminent risk.\n* Current self-harm with lethality\u002Fhigh-harm moderator requiring acute restraint.\n* Refusal to establish a safety plan or allow emergency contact.\n* Acute Psychiatric Conditions\u002FContraindications of Assessment\n* Active psychosis or unstabilized manic episode.\n* Substance use disorder in intoxication or acute withdrawal (e.g., last 24-72 hours) that precludes valid assessment.\n* Uncontrolled risk of severe other-directed violence.\n* Medical or neurological conditions that preclude valid participation\n* Severe cognitive impairment (e.g., dementia, recent moderate-to-severe traumatic brain injury) that prevents understanding\u002Fanswering scales.\n* Decompensated medical illness (e.g., desaturation, delirium, severe uncontrolled pain).\n* Unstable neurological condition (e.g., uncontrolled seizures).\n* Methodological interferences\n* Recent changes in baseline psychotropic medications within the last 2 weeks.\n* Concurrent intensive psychotherapy initiated within the last 4 weeks.\n* Simultaneous participation in another trial that could contaminate results.\n* Language other than that of the scales without available validation.\n* Logistical impossibility for follow-up (no telephone\u002Fstable contact; imminent relocation plan).\n* Legal aspects\u002Fconsent\n* Incapacity to consent (legal or clinical) and no available representative.\n* Legal restrictions that prevent participation.",{"count":288,"type":22},300,[25],"This study aims to validate MBT as an effective and viable intervention for implementation in public health services, with the potential to directly impact suicide prevention policies in the region.",[292],"Suicide Risk",[294,295,296,297],"Psychotherapy","Clinical Trial","Reflective Function","Public Health","2026-07-23",{"date":273,"type":38},{"date":301,"type":22},"2026-11-01",{"date":303,"type":22},"2028-05-01",{"name":305,"class":306},"Fundación Judío Panameña (JUPA)","OTHER",2,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":315,"minAge":147,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},"100614956","phase-3-a-study-to-investigate-mocertatug-rezetecan-compared-with-chemotherapy-in-participants-with-endometrial-cancer-after-platinum-based-chemotherapy-and-immunotherapy-behold-endometrial01-100614956","NCT07286331","A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)","A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).\n* Has histologically confirmed endometrial carcinoma including but not limited to endometroid, serous, clear cell, and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted.\n* Has undergone at least 1 and no more than 2 lines of prior systemic treatment for EC. Up to 3 lines of prior systemic treatment are acceptable if one line was administered in the adjuvant\u002Fneo-adjuvant setting. The definition of prior lines of therapy is as follows:\n\n  * Adjuvant ± neo-adjuvant therapy counts as one line of treatment.\n  * Maintenance therapy is considered part of the preceding line and does not count as an independent line.\n  * Switching to another agent within the same class due to toxicity (without disease progression) is considered part of the same line of therapy.\n  * Unplanned addition or switching to a new anti-cancer therapy in a different class is considered a separate line of therapy.\n  * Hormonal therapy is NOT counted as a separate line.\n* Must have progressed on or after prior platinum-based chemotherapy and have received anti- Programmed cell death 1 (PD-1) \u002Fanti- Programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination. Participants deemed unsuitable for a prior PD-1\u002FPD-L1 inhibitor therapy (contraindications such as immunodeficiency, autoimmune disease that required systemic treatment) as determined by the investigator or treating physician are eligible.\n* Participants must have a platinum-free interval of less than 12 months if they previously received platinum-based therapy solely in the adjuvant setting. The platinum-free interval is defined as the date of the last dose of platinum-based chemotherapy to the date of disease progression.\n\n  * If PD-L1\u002FPD-1 inhibitor therapy was administered with platinum-based treatment, participant is eligible regardless of whether the Platinum-free interval (PFI) exceeds 12 months.\n  * Participants with metastatic disease who underwent treatment including gynecological surgery followed by a platinum-based regimen, or those deemed intolerant to platinum-based therapy, are eligible regardless of whether the PFI exceeds 12 months.\n* Has provided a Formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample sufficient for the central assessment of B7 homolog 4 protein (B7-H4) expression, with the result of B7-H4 expression testing available prior to date of randomization.\n* Has ≥1 Target Lesion per RECIST 1.1 by BICR eligibility review of screening scans.\n* Is willing to use adequate contraception. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:\n\n  * Is a Participant of non-childbearing potential (PONCBP) OR\n  * Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, 30 days prior to Cycle 1 Day 1 (C1D1) and during the study intervention period and for at least 8 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n* A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n\n  * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n  * Additional requirements for pregnancy testing during and after study intervention are described in protocol.\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy.\n* Is capable of giving signed informed consent including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has adequate organ function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has untreated brain or Central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain\u002FCNS metastases). Participants with previously treated and clinically stable brain\u002FCNS metastases and who have completed all corticosteroid therapy for ≥14 days before date of C1D1 are not excluded from participation.\n* Has any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.\n* Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤ Grade 1 or to the baseline status preceding prior therapy, excluding alopecia, hearing loss, vitiligo and endocrinopathy managed with replacement therapy, or that the investigator, with the agreement of the sponsor, considers to be stable or not clinically relevant for the tolerability of study intervention in the current clinical study.\n* Has any serious and\u002For unstable medical condition (including infection) or any serious and\u002For unstable psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.\n* Has had any major surgery within 28 days prior to date of C1D1 or history of local radiotherapy within 21 days prior to C1D1.\n* Has received treatment with an investigational agent within 30 days prior to C1D1.\n* Has received prior therapy with Topo1i (e.g. irinotecan or topotecan) or ADC with a Topo1i payload, or B7-H4 targeted therapy.\n* Has received treatment with any cytotoxic chemotherapy drugs or other antitumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy and investigational drug) within 30 days or 5 half-lives, whichever is shorter, prior to C1D1; or need to continue these drugs during the study.\n* Has received any live vaccine within 30 days prior to C1D1.Note: mRNA and adenoviral-based Coronavirus disease 2019 (COVID-19) vaccines are considered non-live.\n* Has received treatment with inhibitors of P-glycoprotein (P-gp), Breast cancer resistant protein (BCRP), or OATP1B1\u002F1B3 transporters within 7 days prior to first dose of study drug. P-gp inducers should be discontinued for at least 14 days before the start of the study drug.\n* Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony stimulating factor (G-CSF), Granulocyte-macrophage colony stimulating factor (GM-CSF), or recombinant erythropoietin) within 14 days prior to C1D1.\n* Has a known Human immunodeficiency virus (HIV) infection AND meets at least 1 of the following criteria:\n\n  * Has documented evidence of plasma HIV-1 Ribonucleic acid (RNA) ≥50 c\u002FmL within 3 months prior to or at screening. In the 3 to 12 months prior to screening, plasma HIV1 RNA levels consistently \\\u003C50 c\u002FmL are required for enrollment; if multiple instances of plasma HIV-1 RNA values ≥50 c\u002FmL occurred in the 3 to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR\n  * Has not had Cluster of differentiation (CD)4 cell counts measured in the past 12 months (i.e., at least 2 separate measurements taken a minimum of 28 days apart, 1 of which must be conducted at screening); OR\n  * Has had any CD4 cell count values ≤350 cells\u002Fmm3 in the past 12 months. OR\n  * Has had 1 or more changes in their combination antiretroviral therapy regimen or has received an antiretroviral therapy regimen that is inconsistent with locally recommended guidelines during the 3 months prior to screening; OR\n  * Has a history of HIV-associated non-Hodgkin lymphoma within 5 years prior to screening or a history of HIV-associated invasive cervical cancer; OR\n  * Has received treatment with an HIV1 immunotherapeutic vaccine within 90 days prior to screening.\n* Has an Alanine aminotransferase (ALT) value \\>2.5× Upper limit of normal (ULN) and\u002For for participants documented liver metastases\u002Ftumor infiltration has an ALT value \\>5x ULN\n* Has a total bilirubin value \\>1.5x ULN.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Has documented presence of Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb) at screening unless they meet both the following criteria:\n\n  * Participants with chronic Hepatitis B virus (HBV) infection (HBsAg+) or positive HBcAb are required to be receiving effective antiviral therapy (i.e., with nucleos(t)ide analogs \\[Tenofovir or Entecavir\\]) for at least 14 days prior to C1D1 and are willing to continue for at least 6 months after treatment discontinuation or longer at the discretion of the treating hepatologist.\n  * HBV Deoxyribonucleic acid (DNA) must be adequately suppressed, as per institutional or local guidelines, prior to initiation of study intervention.\n* Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to C1D1 unless HCV RNA is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment.\n* Has a positive HCV RNA test result at screening or within 3 months prior to C1D1.\n* Has QTc \\>470 milliseconds (msec)\n* Has a history within 12 months prior to screening of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure \\[NYHA 1994\\], or clinically significant arrhythmia not controlled by standard of care therapy.\n* Has Left ventricular ejection fraction (LVEF) \\\u003C50% or less than institutional lower limit of normal.\n* Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).","FEMALE",{"count":58,"type":22},[60],"This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care. The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to standard of care and will help provide a better understanding of the main side effects of the drugs.",[320],"Neoplasms, Endometrial",[322,323,324,325,326,327,328,329],"Endometrial Cancer","Mocertatug rezetecan","Mo-Rez","GSK5733584","Paclitaxel","Doxorubicin","Antibody-drug conjugate","BEHOLD-Endometrial01","2026-07-14",{"date":332,"type":38},"2026-07-15",{"date":334,"type":38},"2026-06-04",{"date":336,"type":22},"2029-05-30",{"name":170,"class":45},18,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":363},"100577331","phase-1-a-study-of-mocertatug-rezetecan-in-combination-with-anti-cancer-therapies-for-advanced-solid-tumors-behold-2-100577331","NCT06796907","A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)","A Phase 1\u002F2 Randomized Multi-Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction in which the study is taking place.\n* Participant capable of giving signed informed consent including compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.\n* Participants with pathologically confirmed advanced solid tumor specific for study Module (key local diagnostic molecular and\u002For immunophenotyping testing results\u002Ftumor cell phenotype results for confirmed diagnosis should be provided) with no more than 4 lines of prior systemic therapies. Please note:\n\n  1. Adjuvant +\u002F- neoadjuvant considered one line of therapy\n  2. Maintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently)\n  3. Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy. If an agent in a regimen is switched to another agent in the same class due to toxicity or intolerance (e.g. hypersensitivity reaction) this is considered part of the same line (i.e. not counted independently).\n* Requirements for tumor tissue samples: Archival or fresh tumor tissue is required for retrospective central assessment of B7H4 expression by immunohistochemistry (IHC) and other biomarker analysis. The archival tumor tissue should be from the most recent procedure (ideally obtained after the last anti-cancer treatment). If an archival tissue is not available a new biopsy should be performed, and the newly obtained tissue provided.\n* Participants have at least one target lesion as assessed per RECIST 1.1. A target lesion is defined as a measurable lesion that has not undergone locoregional treatment such as irradiation or that has unequivocal progression following locoregional treatment, with the longest diameter of ≥ 10 millimeter (mm) at Baseline (for lymph node lesions, the short axis should be ≥ 15 mm).\n* Participants have a life expectancy of at least 12 weeks per investigator assessment based on disease burden and extent of supportive care needed.\n\nInclusion criteria of participants under arm Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer Part 1A:\n\na. Participants with histologically documented, advanced (metastatic and\u002For unresectable) or recurrent endometrial cancer who have failed in adequate standard treatments, do not have effective standard treatment or are intolerant to standard of care, and who are not candidates for further curative external radiotherapy or brachytherapy.\n\nInclusion criteria of participants under arm Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer Part 1B:\n\n1. Diagnosis of endometrial cancer with confirmed mismatch repair proficient (MMRp) or microsatellites stable (MSS) tumor status by local test.\n2. Participants who have progressed on or are intolerant to at least 1 line of standard prior systemic therapy (including neoadjuvant or adjuvant as prior line), and who are not candidates for curative external radiotherapy or brachytherapy. Maintenance therapy will be considered part of the preceding line of therapy (i.e, not counted independently).\n\nInclusion criteria of participants under arm Module 2 (Mo-Rez +\u002F- Bevacizumab) Ovarian Cancer Part 2A:\n\na. Participants with histologically or cytologically confirmed advanced epithelial ovarian cancer\u002Ffallopian tube\u002Fperitoneal cancer (any epithelial histology - mucinous, clear cell, carcinosarcoma, high\u002Flow grade serous, endometrioid) who have failed in adequate standard treatments, do not have effective standard treatment or are intolerant to standard of care.\n\nInclusion criteria of participants under arm Module 2 (GSK5733584 +\u002F- Bevacizumab) Ovarian Cancer Part 2B:\n\n1. Participants whose advanced ovarian cancer\u002Ffallopian tube\u002Fperitoneal cancer has relapsed more than 6 months from the last dose of platinum before enrollment, i.e., platinum sensitive.\n2. Participants who have progressed on or are intolerant to at least 1 line of standard prior lines of chemotherapy and are not candidates for second cytoreductive surgery.\n\n   * Participants willing to use adequate contraception.\n\nFemale participants:\n\nA female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n* Is a Woman of non-childbearing potential (WONCBP) OR\n* Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective.\n* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n\n  * Has an ECOG performance status of 0 to 1.\n  * Participants with normal organ and bone marrow function.\n\nExclusion Criteria:\n\n* Has a second malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of metastatic disease.\n* Has had any major surgery within 28 days prior to enrolment.\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has known sensitivity to study intervention components, Mo-Rez (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination partner, or its excipients or other allergy that, in the opinion of the investigator, contraindicates participation in the study.\n* Has any following cardiological examination abnormality:\n\n  1. history in prior year of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, NYHA Class III or IV congestive heart failure or clinically significant arrhythmia not controlled by standard of care therapy.\n  2. Corrected QT Interval (QTcF) \\>450 millisecond (msec) or QTcF \\>480 msec for participants with bundle branch block\n* Has untreated brain or CNS metastases or brain\u002FCNS metastases rapidly progressing requiring urgent medical intervention.\n* Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.\n* Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).\n* Clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 1 month prior to the first dose of study treatment.\n* Serious or poorly controlled hypertension, including history of hypertensive crisis, hypertensive encephalopathy; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose of study treatment;\n* Has any active renal condition (e.g., infection, requirement for dialysis, or any other active significant renal condition or dehydrated condition that could affect the participant's safety). Note: renal obstruction successfully managed by stenting is permitted.\n* Has any serious and\u002For unstable medical condition (such as clinical symptoms of intestinal obstruction) or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.\n* Participants with known history of Human immunodeficiency virus (HIV).\n\nExclusion criteria of participants under arm Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer:\n\n1. Has mesenchymal tumor of the uterus (uterine sarcoma).\n2. Has experienced symptomatic pericarditis of any etiology within 6 months of study treatment or any of the following with prior immunotherapy: any imAE ≥ Grade 3, immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome\u002Fmyasthenia gravis, encephalitis Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (SJS, TEN, or DRESS syndrome), or myocarditis of any grade.\n\nExclusion criteria of participants under arm Module 2 (Mo-Rez +\u002F-Bevacizumab) Ovarian Cancer:\n\n1. Participants with wound healing complications or incompletely healed wounds.\n2. Participants with history or evidence of gastrointestinal perforation, tracheoesophageal fistula, or any grade 4 fistula; participants with gastrointestinal fistula, visceral fistula, or abdominal abscess within 6 months prior to the first dose, participants with history of osteonecrosis of the jaw.\n3. Participants who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.\n4. Participants with congenital bleeding diathesis, acquired coagulopathy, recent pulmonary haemorrhage\u002F haemoptysis (\\> 2.5 mL of red blood or ½ teaspoon) within the last 3 months. Participants receiving treatment for thromboembolism are permitted as long as they have been on a stable dose of anticoagulation for at least 1 month.\n5. Participant has history of congestive heart failure (CHF) or baseline LVEF \\\u003C50% or institutional lower limits of normal.\n6. Participant with history of nephrotic syndrome or grade 3 proteinuria. Participants has proteinuria as demonstrated by urine dipstick for proteinuria ≥2 (participants discovered to have ≥2 proteinuria on dipstick at baseline should undergo 24-hour urine collection and must demonstrate ≤1 g of protein in 24 hours to be eligible).\n\n   * Has an Alanine transaminase (ALT) value \\>2.5x Upper Limit of Normal (ULN) and for participants with documented liver metastases\u002Ftumor infiltration has an ALT value \\>5x ULN.\n   * Has a total bilirubin value \\>1.5x ULN.\n   * Has documented presence of HBsAg and\u002For HBcAb, or HBsAb (except for presence of HBsAb attributable to previous vaccination) at screening or within 3 months prior to the first dose of study intervention.\n   * Has a positive HCV antibody test result at screening or within 3 months prior to the first dose of study intervention.\n   * Has received prior therapy with topoisomerase-1 inhibitors or ADC with topoisomerase-1 inhibitor warhead, or B7H4 targeted therapy.\n   * Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy, and investigational drug) within 30 days or 5 half-lives, whichever is shorter of a medicinal product prior to the first dose of study drug; or need to continue these drugs during the study.\n   * Use of inhibitors of P-gp, breast cancer resistance protein (BCRP) or OATP1B1\u002F1B3 within 7 days prior to the first dose of study drug. P-gp inducers should be discontinued for at least 14 days before the start of the study.\n   * Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.\n   * Has serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with intravenous antibiotics for ≥2 weeks.",{"count":347,"type":22},305,[151,152],"Advanced solid tumors are cancers that have spread to other parts of the body. While many treatments exist, most people become resistant to them, and the cancer returns. Researchers are developing new treatments that combine different medicines for those who do not respond to single medicine. This study is looking at how safe and tolerable Mocertatug Rezetecan (Mo-Rez) is, how the body handles it, and how well it works when used with other cancer medicines. The study will include participants with advanced solid tumors who have either not responded to standard treatments or cannot tolerate them or have no available effective treatment.",[351],"Tumours, Gynecological",[160,353,324,325,354],"Mocertatug Rezetecan","BEHOLD-2","2026-07-03",{"date":357,"type":38},"2026-07-07",{"date":359,"type":38},"2025-03-04",{"date":361,"type":22},"2028-10-10",{"name":170,"class":45},81,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":372,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},"100621503","phase-1-a-study-of-gsk5926371-in-participants-with-b-cell-driven-autoimmune-rheumatic-diseases-ard-100621503","NCT07371468","A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)","A Phase 1, Open-label, Dose-escalation Study (ELEVATE-1) to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19\u002FCD20 T-cell Engager in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)","ELEVATE-1","Inclusion Criteria:\n\n* Part 1 will enroll adult participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).\n* Part 2 will enroll adult participants with SLE, RA, idiopathic inflammatory myopathies (IIM) or Sjogren's disease (SjD).\n* Participants must be 18 to 70 years of age inclusive at the time of signing the informed consent form.\n* Body mass index (BMI) between 18-35 kilograms per square meter (kg\u002Fm\\^2) inclusive with a body weight of greater than or equal to (\\>=) 45 kilograms (kg).\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n* Is a participant of non-childbearing potential (PONCBP), OR\n* Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C) 1 percent (%), 28 days prior to and during the study intervention period and for at least 28 weeks after the first dose of GSK5926371. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention.\n\nA POCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention.\n\nIf a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n\\- Signed and dated informed consent form indicating that the participant is willing and able to comply with hospitalization, clinic visits and scheduled study assessments as detailed in the protocol.\n\nExclusion Criteria:\n\n* Any acute, severe autoimmune disease-related flare before, or during the Screening Period (up to and including Day 1) that needs immediate treatment or is expected to require escalation of treatment to prohibited medications for the duration of the study.\n* Significant allergies to humanized monoclonal antibodies or significant sensitivity to any constituents of the study drug (including excipients).\n* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to the autoimmune condition under study (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, or infectious diseases) and\u002For a planned surgical procedure, which, in the opinion of the investigator, could confound the results of the clinical study or put the participant at undue risk.\n* Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data.\n* Participant has a diagnosis of primary or acquired immunodeficiency, except for selective IgA deficiency.\n* Have an acute or chronic infection including requiring management as follows:\n* An acute infection within 2 weeks of dosing on Day 1.\n* An active infection requiring current systemic antibiotic, antiviral or anti-fungal treatment with the exception of topical treatments for fungal nail infections. Prophylactic medications are permitted.\n* History of, or currently being treated for, a clinically significant recurrent or chronic infection (except for minor localized infections, for example tinea pedis).\n* Any opportunistic infections within past 3 years. Uncomplicated herpes zoster, localized herpes simplex virus, and oral candidiasis are not considered as opportunistic infections for this purpose.\n* Herpes zoster within 3 months before screening.\n* A serious infection requiring treatment with intravenous (IV)\u002Fintramuscular (IM) antibiotics and\u002For hospitalization if the last dose of antibiotics or the hospital discharge date was within 30 days of the first day of dosing (Day 1).\n* History of a serious infection associated with low serum immunoglobulin levels.\n* Evidence of active or latent tuberculosis (TB) as documented by medical history and examination (including chest X-rays \\[CXR\\], if available), and a positive (not indeterminate) TB test such as QuantiFERON-TB Gold Plus test. In cases where the QuantiFERON test is indeterminate, the participant may have the test repeated once, but if the test remains indeterminate further investigation may be required including CXR (posteroanterior \\[PA\\] and lateral) in order to exclude TB. Note: The QuantiFERON-TB Gold Plus test can only be used in countries where it is licensed, and the use of this test is dependent on previous treatment(s). This test may not be suitable if previous treatment(s) produced significant immunosuppression.\n* Confirmed progressive multifocal leukoencephalopathy (PML) within 12 months or has unexplained or deteriorating neurologic signs and symptoms.\n* History or positive test at Screening for human immunodeficiency virus (HIV).\n* History of clinically significant neurological or psychiatric disorder including history of epilepsy, dementia, increased risk of suicide as judged by the investigator or major depression deemed to interfere with study assessments, or a history of intracranial hemorrhage.\n* Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years. The investigator should also ensure that occult malignancy associated with the autoimmune condition under study has been adequately ruled out prior to screening (for example, malignancy-associated dermatomyositis).\n* History of hematological or solid organ transplant.\n* Live or live-attenuated vaccine(s) within 30 days before Screening or plans to receive such vaccines during the screening period or during the clinical study.\n* Current or prior treatment with any of the medications specified below during the relevant exclusion periods prior to Day 1. The following medications are prohibited from the periods before the study, until the last study visit:\n* IV or IM dose of corticosteroids within 5 weeks of Day 1.\n* Any T-cell engager (TCE) including blinatumomab, mosunetuzumab or other approved or investigational T cell engagers within 12 months of Day 1.\n* Chimeric antigen receptor (CAR)-T-cell treatment, at any time.\n* B-cell depleting agents, including but not limited to anti-CD20 (e.g. Rituximab, Obinutuzumab, Ocrelizumab), anti-CD38 (e.g. Daratumumab, TAK079, MOR202, isatuximab) within 4 months of Day 1.\n* Belimumab within 8 weeks of Day 1.\n* Anifrolumab within 8 weeks of Day 1.\n* Oral or IV cyclophosphamide within 12 weeks of Day 1.\n* Immune-Modulating Biologic agents, including anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab and etanercept), abatacept, and interleukin (IL)-1 receptor antagonist \\[anakinra\\] or IL-6 receptor antagonist (tocilizumab) within 4 weeks of Day 1. Except infliximab, golimumab, and certolizumab within 8 weeks of Day 1. (NOTE: tocilizumab is permitted for cytokine release syndrome (CRS) Grade 3\u002F4 management after dosing)\n* Small molecule inhibitors, including tyrosine kinase 2 inhibitor (TYK2i, Deucravacitinib); inhibitors of Janus kinases (JAKis, baricitinib, tofacitinib, upadacitinib, filgotinib); or Bruton tyrosine kinase inhibitors (ibrutinib, fenebrutinib) within 4 weeks of Day 1.\n* IV immunoglobulin within 8 weeks of Day 1.\n* Plasmapheresis within 8 weeks of Day 1.\n* Current enrolment or past participation in any other clinical study involving an investigational study treatment (including investigational vaccines) within 3 months or 5 half-lives of the investigational drug or twice the duration of pharmacological activity (whichever is longer) before Day 1.\n* Contra-indications to prophylactic medications for CRS (corticosteroid, ant histamines and antipyretics), or CRS rescue medication (tocilizumab or IV corticosteroids).\n* Current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 12 months before Day 1.\n* Alanine transaminase (ALT) greater than (\\>) 1.5 x upper limit of normal (ULN).\n* Total bilirubin \\> 1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\> 1.5 x ULN if direct bilirubin is \\> 1.5 x ULN.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).\n* Presence of hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at screening or within 3 months prior to first dose of study intervention.\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.\n* Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. Note: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.\n* Corrected QT (QTc) interval \\> 450 milliseconds (msec) or QTc interval \\> 480 msec for participants with bundle branch block. Frederica's formula (QT interval corrected using Fridericia's formula \\[QTcF\\]) should be used to calculate the corrected QT interval. If a single electrocardiogram (ECG) at screening shows QTcF \\> 450 msec (or \\> 480 msec for participants with bundle branch block), a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion.","70 Years",{"count":374,"type":22},44,[151],"This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.",[378],"Systemic Lupus Erythematosus",[380,381,382,383,384,385,386],"GSK5926371","Autoimmune rheumatic disease","Dose escalation","Systemic lupus erythematosus","Rheumatoid arthritis","Idiopathic inflammatory myopathies","Sjogren's disease","2026-06-18",{"date":389,"type":38},"2026-06-23",{"date":391,"type":38},"2026-02-10",{"date":393,"type":22},"2028-03-15",{"name":170,"class":45},19,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":403,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},"100541989","phase-4-a-study-to-provide-continued-access-to-study-drug-to-children-and-adolescents-who-have-completed-clinical-studies-involving-gilead-hiv-treatments-100541989","NCT06337032","A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments","An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments","Key Inclusion Criteria:\n\n* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.\n\nKey Exclusion Criteria:\n\n* Individuals planning to switch to B\u002FF\u002FTAF on Day 1 with plasma HIV RNA ≥ 50 copies\u002FmL during the last parent study visit prior to screening\u002FDay 1 visit.\n\n  * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies\u002FmL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL).\n* Individuals planning to switch to B\u002FF\u002FTAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B\u002FF\u002FTAF prior to treatment switch.\n* For those on B\u002FF\u002FTAF or planning to switch to B\u002FF\u002FTAF: previous treatment discontinuation of any component of B\u002FF\u002FTAF due to toxicity or intolerance.\n* For those planning to switch to B\u002FF\u002FTAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.\n* Ongoing treatment with or prior use of any prohibited medications.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","1 Month",{"count":405,"type":22},350,[407],"PHASE4","The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.\n\nThe primary objectives of this study are as follows:\n\n* To provide continued access to the study drug received in the parent protocol or switch to bictegravir\u002Femtricitabine\u002Ftenofovir (B\u002FF\u002FTAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.\n* To evaluate the safety of the study drug(s) in participants with HIV-1.",[410],"HIV-1-infection","2026-06-09",{"date":413,"type":38},"2026-06-10",{"date":415,"type":38},"2024-08-27",{"date":417,"type":22},"2034-03",{"name":419,"class":45},"Gilead Sciences",15,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":446},"100558440","phase-1-a-study-of-gsk5764227-in-participants-with-advanced-solid-tumors-embold-100558440","NCT06551142","A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 as Monotherapy and in Combination in Participants With Advanced Solid Tumors","PanTumor-101","Inclusion criteria\n\n* Male or female participants at least 18 years of age (≥18 years)\n* Participants with histologically confirmed advanced\u002Fmetastatic solid tumors, as defined per study phase and cohort, as follows:\n\nPhase 1a:\n\n1. Participants with advanced\u002Fmetastatic solid tumors.\n2. For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies.\n3. For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced\u002Fmetastatic setting\n\n   * Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.\n   * Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.\n   * Has adequate organ function.\n   * Where available, participants should provide a formalin fixed and paraffin embedded (FFPE) tumor sample from the most recent biopsy of primary cancer or from a metastatic site for central testing.\n\nExclusion criteria\n\n* Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy.\n* Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.\n* Primary brain tumor or evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 4 weeks prior to initial dosing; and no midline shift due to herniation); or untreated progression due to brain metastasis or primary brain tumor during or after the last treatment prior to screening; or evidence of meningeal\u002Fbrainstem involvement; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not).\n* Any of the following cardiac examination abnormality:\n\n  1. Has QT interval, corrected for heart rate (QTc) \\>450 msec or QTc \\>480 msec for participants with bundle branch block.\n  2. Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular \\[AV\\] block, second-degree AV block, PR interval \\>250 msec).\n  3. Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval.\n  4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n* Has severe, uncontrolled or active CV disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events\n* Participants with evidence of current ILD\u002Fnon-infectious pneumonitis OR a prior history of ILD\u002Fnon-infectious pneumonitis requiring high-dose glucocorticoids OR suspected ILD\u002Fnon-infectious pneumonitis that cannot be ruled out by imaging.\n* Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has received prior anticancer therapy within 28 days of the first dose of study intervention or having to continue these medications during the study.",{"count":430,"type":22},845,[151],"The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227. The study will also see how the levels of Ris-Rez will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab, tarlatamab, dostarlimab",[434],"Neoplasms",[160,157,434,436,437,159],"EMBOLD PanTumor-101","Risvutatug rezetecan","2026-05-20",{"date":440,"type":38},"2026-05-22",{"date":442,"type":38},"2024-09-30",{"date":444,"type":22},"2029-06-08",{"name":170,"class":45},67,{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":468},"100604259","feasibility-study-of-an-accommodating-iol-design-100604259","NCT07147192","Feasibility Study of an Accommodating IOL Design","Key Inclusion Criteria:\n\n* Able to understand and sign an Informed Consent Form.\n* Willing and able to attend all scheduled study visits required per protocol.\n* Diagnosed with bilateral cataracts requiring removal by phacoemulsification.\n* Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes.\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding.\n* Taking medications that could increase risk or may affect accommodation.\n* Eye conditions as specified in the protocol, including glaucoma or ocular hypertension.\n* Medical conditions that could increase operative risk as specified in the protocol.\n* Other protocol-defined exclusion criteria may apply.",{"count":171,"type":22},[25],"The purpose of this clinical study is to assess safety and explore usability and effectiveness of the test product, AAL-FAIOL. This study will be conducted in Central America.",[457],"Aphakia",[217],"2026-05-18",{"date":461,"type":38},"2026-05-19",{"date":463,"type":38},"2025-12-03",{"date":465,"type":22},"2028-01",{"name":467,"class":45},"Alcon Research",4,{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":476,"sex":17,"minAge":477,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":485,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":500},"100489541","phase-2-study-of-a-novel-type-3-oral-poliomyelitis-vaccine-in-panama-100489541","NCT05654467","Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama","A Phase 2, Randomized, Observer-Blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess the Safety and Immunogenicity of a Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Panama","Inclusion Criteria\n\nInclusion Criteria for all participants:\n\n1. Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator.\n2. Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.\n3. Resides in study area and parent(s) or guardian(s) understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form \\[ICF\\] and assessment by the investigator).\n4. Parent(s) or guardian(s) agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol adjusted schedule.\n\nInclusion Criteria for cohort 1 participants only:\n\n1. Male or female child from ≥1 to \\\u003C5 years-of-age at the time of initial study vaccination.\n2. Based on available documentation or parental\u002Fguardian(s) report, previously completed the primary poliomyelitis immunization series for the jurisdiction, with last dose received more than 28 days prior to initial study vaccination.\n\nInclusion Criteria for cohort 2 participants only:\n\n1. Male or female infant expected to be 6 weeks of age (43rd to 49th day of life \\[with day of birth being the first day of life\\], inclusive + 6 day window), at the time of initial study vaccination.\n2. Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available parental\u002Fguardian(s) report or documentation.\n\nInclusion Criteria for Cohort 3 participants only:\n\n1. Male or female newborn (1st day of life + 3-day window), at the time of initial study vaccination.\n2. Prior to study vaccination has received no doses of IPV or OPV vaccine, based on no evidence of such vaccination per available parental\u002Fguardian(s) report or documentation.\n\nExclusion Criteria\n\nExclusion Criteria for all participants:\n\n1. For all participants the presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete \"age appropriate\" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration. For household members younger than 10 years of age appropriate vaccination is complete series of the primary poliomyelitis immunization series for the jurisdiction.\n2. For all participants having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous three months before study vaccine administration.\n3. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.\n4. Moderate or severe (grade ≥ 2) acute illness at the time of enrollment\u002Ffirst study vaccination-temporary exclusion (see Appendix II: Severity Grading Tables). Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator.\n5. Presence of fever on the day of enrollment\u002Ffirst study vaccination (axillary temperature\n\n   ≥37.5˚C)-(Temporary exclusion for cohorts 1 and 2). If resolved in 48 hrs., can be enrolled.\n6. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).\n7. Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof\u002Fin the same building rather than in the same compound).\n8. Receipt of any systemic immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household member.\n9. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.\n10. Presence of severe malnutrition (weight-for-length\u002Fheight z-score ≤-3SD median \\[per WHO published child growth standards\\])-temporary exclusion if marginal and subsequently gains weight.\n11. Participation in another investigational product (drug or vaccine) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior to the first administration of study vaccine, or planned use during the study period.\n12. Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned use during the study period.\n13. Parent(s) or guardian(s) or participant has any condition that in the opinion of the investigator would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments).\n\nExclusion Criteria for cohort 2 and 3 participants only:\n\n1. Premature birth (less than 37 weeks gestation or less than 2500 grams birth weight).\n2. From multiple birth (due to increased risk of OPV transmissions between siblings).",true,"1 Day","4 Years",{"count":480,"type":22},1532,[152],"The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).",[484],"Poliomyelitis",[486,487,488,489,490],"Vaccine tolerability","Vaccine safety","Vaccine reactogenicity","Vaccine viral shedding","Vaccine immunogenicity","2026-05-06",{"date":493,"type":38},"2026-05-11",{"date":495,"type":38},"2023-12-05",{"date":497,"type":22},"2027-03-20",{"name":499,"class":306},"PATH",3,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":476,"sex":17,"minAge":508,"maxAge":509,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":516,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":526},"100600873","phase-3-a-phase-iii-control-study-of-the-safety-and-immunogenicity-of-vyf-in-pediatric-population-100600873","NCT07103148","A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population","A Parallel Group, Phase III Randomized, Modified Double-blind, Active Controlled Study to Investigate the Immunogenicity and Safety of vYF Compared to Licensed YF Vaccines in Pediatric Population Aged 9 Months to 5 Years of Age","Inclusion Criteria:\n\n* Aged 9 months to 5 years on the day of inclusion\\*\n\n  \\* \"9 months to 5 years\" means from the day of the 9th month after birth to the day before the 6th year birthday\n* Aged 11 to 15 months\\* on the day of inclusion for participants enrolled in the MMR co-administration group\n\n  \\* \"11 to 15 months\" means from the day of the 11th month after birth to the day before the 16th month birthday\n* Participants who are healthy as determined by medical evaluation including medical history and physical examination\n* For infants\\*, born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: \"Medically stable\" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention\n\n  \\* Infants aged 9 months to 11 months up to the day before the 12th month birthday\n* Participant and parent\u002FLAR are able to attend all scheduled visits and to comply with all study procedures\n* ICF has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations)\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy irradiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n* Known history of FV infection\n* Known systemic hypersensitivity to any of the study intervention components, eggs or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances\n* Moderate or severe acute illness\u002Finfection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \\[≥ 100.4°F\\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.\n* Chronic illness\\* that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion , including malignancy, such as leukemia, or lymphoma\n\n  \\*Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders or chronic infection\n* History of central nervous system disorder or disease, including seizures and febrile seizures\n* Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration. Vaccine to be administered as part of the National Immunization Schedule will be postponed after the D29 visit\n* Previous vaccination against a FV disease at any time including YF with an investigational or marketed vaccine\n* Receipt of immune globulins, blood or blood-derived products in the past 6 months\n* Administration of any anti-viral within 2 months preceding the study intervention administration and up to the 6 weeks following the study intervention administration\n* For participants enrolled in the MMR co-administration group: previous vaccination against measles, measles\u002Fmumps\u002Frubella\n* For participants enrolled in the MMR co-administration group: history of measles, mumps, rubella confirmed either clinically, serologically, or microbiologically\n* Known history or laboratory evidence of HIV infection\n* Known history of hepatitis B or hepatitis C seropositivity\n* Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia)\n* Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the first year of the 3-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 6 months of follow-up is permitted, assuming it does not exclude participation in this study.\n* In an emergency setting, or hospitalized involuntary\n* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study","9 Months","5 Years",{"count":511,"type":22},2440,[60],"The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and when they are co-administered with Measles Mumps Rubella (MMR) vaccines in infants aged 11-15 months.\n\nNumber of Participants:\n\nA total of 2440 participants is planned to be enrolled in VYF04 study.\n\nStudy Arms and Duration:\n\nEligible participants will be randomized in 2 independent groups (9-24 months, 2-5 years) to receive 1 dose of either vYF or Stamaril or YF-VAX in a 2:1:1 ratio within each age group. An additional group with participants of 11-15 months of age will also receive at the same vaccination visit vYF and a single dose of MMR vaccine.\n\nFor the 2nd step (YF booster vaccine administration in a subset), at the Year (Y) 3 visit, a subset of 120 participants of the 9-24 months of age group who did receive a YF vaccine on Day(D) 01 will be invited to join a booster dose assessment (booster dose administered after the Y3 visit blood sample has been taken). Participants aged 11 to 15 months at the time of the concomitant administration of vYF and MMR will not be eligible for receiving a booster dose.\n\nThe duration of each participation will be approximately 3 years for all participants (including participants co-administered on D01 with vYF and MMR), and 6 more months post-booster dose administration for the participants enrolled in the booster subset.",[515],"Yellow Fever Immunization",[517],"Yellow fever","2026-05-05",{"date":491,"type":38},{"date":521,"type":38},"2025-07-11",{"date":523,"type":22},"2030-03-04",{"name":525,"class":45},"Sanofi",13,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":476,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":468},"100597571","phase-4-intestinal-preparation-in-colonoscopy-lactulose-vs-sodium-phosphate-100597571","NCT07060222","Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate.","Intestinal Preparation in Colonoscopy: Lactulose vs Sodium Phosphate, a Multicenter, Randomized, Double-Blind Comparative Clinical Trial.","Inclusion Criteria:\n\n* Indication for Scheduled Colonoscopy: Participants must have a valid clinical indication for undergoing a scheduled colonoscopy, such as part of a colorectal cancer screening program, evaluation of gastrointestinal symptoms, or follow-up of previously diagnosed colorectal conditions.\n* Ability to Provide Informed Consent: Participants must have the physical and mental capacity to understand the nature of the study and voluntarily provide informed consent to participate.\n\nExclusion Criteria:\n\n* History of Intestinal Obstruction: Participants with a known or suspected history of intestinal obstruction will be excluded due to the potential risks associated with the administration of bowel preparation agents.\n* Known Intolerance to Lactulose or Sodium Phosphate: Participants with a known intolerance to lactulose or sodium phosphate will be excluded due to the risk of severe adverse reactions.\n* Pregnancy and Lactation: Pregnant or breastfeeding women will be excluded due to the lack of safety data on bowel preparation agents in this population.\n* Interfering Clinical Conditions (Comorbidities): Participants with medical conditions that could interfere with study participation or affect the interpretation of results will be excluded, such as decompensated heart failure, chronic renal or liver disease, and a history of colonic resection.",{"count":288,"type":22},[407],"To compare intestinal preparation with Lactulose vs. Sodium Phosphate as the better agent for performing high-quality colonoscopies at the Civil Hospital Fray Antonio Alcalde and the Civil Hospital Juan I. Menchaca, both in Guadalajara, Mexico; as well as Hospital Santo Tomás in Panama City, Panama; and Hospital Gustavo Nelson Collado Ríos in Chitré, Panama; during the period from April 1, 2025, to November 30, 2025. The comparison will focus on colonoscopy quality, patient tolerance, satisfaction, and electrolyte changes, using the agents orally as part of the bowel preparation prior to the colonoscopy procedure.",[538],"Bowel Preparation for Colonoscopy",[540,541,542,543],"lactulose","Colonoscopy","sodium phosphate","bowel preparation","2026-04-30",{"date":518,"type":38},{"date":547,"type":38},"2025-09-20",{"date":549,"type":22},"2026-12-31",{"name":551,"class":306},"Hospital Civil de Guadalajara",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":21},"100592725","phase-2-a-clinical-trial-to-investigate-efficacy-safety-and-pharmacokinetics-pk-of-two-lxe408-oral-regimens-and-oral-miltefosine-as-active-control-in-participants-aged--18-years-old-with-localized-cutaneous-leishmaniasis-in-the-region-of-the-americas-amr-100592725","NCT06997159","A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).","A Randomized, Multicentre, Observer-blind Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Regimens and Miltefosine as an Active Control in Patients With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).","Inclusion Criteria:\n\n1. Participant must be aged ≥18 years old and weighing \\> 50kg\n2. Participant with first episode of CL fulfilling the following characteristics:\n\n   * ≤ 6 lesions\n   * At least one lesion of \\> 50 mm2 of area\n   * a history of CL of no longer than 6 months\n3. a diagnosis of CL confirmed by at least one of the following methods:\n\n   * microscopic identification of amastigotes in stained lesion tissue, or\n   * demonstration of Leishmania by PCR, or\n   * positive culture for promastigotes\n4. In the opinion of the investigator, the participant is capable of understanding and complying with the protocol, including visits up to 6 months after study start.\n5. Written informed consent must be obtained before any study protocol specific assessment is performed other than procedures performed as part of standard of care.\n\nParticipants must be able to give written informed consent.\n\nExclusion Criteria:\n\n1. Female with a positive blood pregnancy test at screening or who is breastfeeding, lactating or women of childbearing potential (defined as women physiologically capable of becoming pregnant) who does not agree to use two methods of contraception, one barrier method and one highly effective method. In Brazil: for 30 days prior to the treatment onset and up to D180 visit. In Panama: during treatment period up to D180 visit.\n2. Sexually active male, including those post-vasectomy, unwilling to use a condom during intercourse with female partner while taking the investigational drug and for 5 days, after stopping the investigational drug.\n3. Has diagnosis or suspected diagnosis of mucocutaneous, disseminated or diffuse leishmaniasis based on physical exam.\n4. Current clinically significant medical problems (e.g., cardiac, renal, hepatic, pancreatic diseases, current cutaneous conditions that may interfere with CL evolution or healing, past and current ocular disorders, especially keratitis, uveitis, scleritis), including any immunocompromising condition (such as having a known diagnosis for HIV, transplanted patients, those in treatment for auto immune diseases, patients receiving immunosuppressant, immunobiological or antineoplastic treatments).\n5. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).\n6. Participants newly diagnosed with HIV infection on the basis of the trial screening testing or other recent testing (\\\u003C 6 months) are excluded. Participants with documented stable HIV infection are allowed to participate in the study. Stable HIV infection is defined as: clinically stable with no signs or symptoms of advanced HIV infection and taking their current anti-retroviral therapy for ≥ 6 months with an undetectable viral load for ≥ 6 months. Participants taking anti-retroviral therapy prohibited in Section 6.9.4 are excluded.\n7. Participants with active infectious conditions, such as tuberculosis, or history or active hepatitis B virus (HBV) infection or hepatitis C virus (HCV) infection are excluded. Active HBV is defined as a positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test and all participants with a positive HBV core antibody screening test must have HBsAg measured. Active HCV is defined as having detectable HCV RNA and all participants with a positive HCV antibody test at screening must have HCV RNA measured. Participants taking therapy for HBV or HCV are excluded.\n8. ECG abnormalities, either historic (no longer present) or current which, in the view of the investigator, indicate a significant risk to study participation. These include, but are not limited to, the following:\n\n   * Clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia and clinically significant second- or third-degree AV block without a pacemaker).\n   * QTcF ≥450 ms.\n   * History of familial long QT syndrome or known family history of Torsades de Pointes.\n   * Resting heart rate (physical exam or 12 lead ECG) \\\u003C60 bpm.\n9. Participants who are receiving or have received antileishmanial medication, or prohibited medication or any medication that might interfere with the therapeutic response or cause harmful interactions with study medications, as defined in concomitant treatments in Section 6.9.4.\n10. Has laboratory values at screening as follows:\n\n    Serum creatinine: ≥1.5 times ULN\\*, ALT, AST, GGT, ALP: \\>1.5 times above upper normal level\\*. Total bilirubin \\> 1.5 times ULN\\* amylase or lipase \\> 1.5 times ULN\\*\n\n    \\*Normal ranges obtained from local laboratory.\n11. Known history of addiction\u002F alcohol abuse.\n12. Hypersensitivity to miltefosine or any study medication excipients.\n13. Participants with Sjogren-Larsson Syndrome.",{"count":560,"type":22},250,[152],"The purpose of this clinical trial is to measure efficacy, safety and pharmacokinetics (PK) of two LXE408 oral regimens and oral miltefosine tablets as active control in localized cutaneous leishmaniasis in the region of the Americas (AMR), and assess its suitability for use in monotherapy for the treatment of patients with cutaneous leishmaniasis (CL).",[564],"Localized Cutaneous Leishmaniasis",[564],"2026-04-29",{"date":518,"type":38},{"date":569,"type":22},"2026-06-15",{"date":571,"type":22},"2028-04-05",{"name":573,"class":306},"Drugs for Neglected Diseases",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":56,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":584,"conditions":585,"keywords":587,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":46},"100575427","early-phase-1-early-feasibility-of-the-nervonik-peripheral-nerve-stimulation-device-100575427","NCT06772142","Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device","Inclusion Criteria:\n\n1. Subject is between 18 to 80 years of age at the time of enrollment.\n2. Subject has been diagnosed with knee, arm, or shoulder chronic pain (NRS of at least 5 out of 10).\n3. Post-surgical\u002Fpost-traumatic peripheral neuralgia including but not limited to pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment; Mononeuropathy, specified or unspecified or in diseases classified elsewhere; Other neuralgia or neuropathic pain\n4. Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.\n5. Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.\n6. Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.\n7. Subject is psychologically qualified to receive a peripheral nerve stimulator as per the clinician's standard clinical practice and judgment and does not have clinically relevant psychological condition(s) that would interfere with their ability to accurately report outcomes or complete study procedures.\n8. Subject has demonstrated the ability to appropriately place the wearable in the location where the IPG is most likely to be implanted. Alternatively, subject is able to appropriately use the relief belt and\u002For limb cuff to keep the wearable in place.\n\nExclusion Criteria:\n\n1. Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, and\u002For cardiac pacemaker.\n2. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.\n3. Pain is completely absent at rest.\n4. Patient has clinical evidence of complex regional pain syndrome (CRPS), peripheral neuralgia of metabolic origin, post-herpetic neuralgia, biochemical evidence of a metabolic or genetic neuropathy (e.g., Charcot'- Marie- Tooth Disease) or mixed motor\u002Fsensory polyneuropathy.\n5. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.\n6. Subject has had a successful (≥ 50% pain relief) interventional procedure within the past 3 months to treat the same pain condition(s) being examined in this study including, nerve blocks.\n7. Uncontrolled depression or uncontrolled psychiatric disorders\n8. Subject is currently participating in another clinical investigation with an active treatment arm.\n9. Subject is allergic or sensitive to materials used in the device components including, skin adhesives or does not tolerate the wearable aspect of the device.\n10. Subject has pending or ongoing legal issues (including unresolved worker's compensation claims or equivalent) or other conflicting secondary gain issues related to their chronic pain condition.\n11. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.\n12. Subject has an active systemic infection.\n13. Subject is unable to read and\u002For write in Spanish or give informed consent.\n14. Subject has a life expectancy of less than 1 year\n15. Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.\n16. Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.\n17. Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.\n18. Subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post-menopausal).\n19. Subject is nursing\u002Fbreastfeeding.\n20. Subject is on ≥90 mg-morphine equivalents per 24 hours. Recommend 60.\n21. Subject has undergone an ablative treatment of the target peripheral nerve, or proximal nerve trunk giving rise to the target nerve, or dorsal roots (and DRGs) that ultimately make up the target nerve. No ablative procedures directed at the spinal cord, dorsal roots, or peripheral nerve(s) being treated in the study. To note, subjects who have undergone RF ablation of the dorsal rami, cool pulsed RF of the facet innervation may be considered for enrollment",{"count":581,"type":22},30,[583],"EARLY_PHASE1","A multicenter, 30 patient prospective single arm evaluation of the Nervonik system in symptomatic patients with chronic severe knee, elbow or shoulder pain.\n\nCOHORT 1: The initial cohort of patients will receive the Nervonik neurostimulator for up to 8 hours. The patient will remain local to the care facility for implant stimulator program changes until the patient is satisfied with the degree of pain relief. The implant will be removed from the patient at the end of the evaluation.\n\nCOHORT 2: The second cohort of patients will include those patients from cohort 1 who have determined the Nervonik implant provides suitable pain relief and agree to have a permanent implant placed. In addition, the second cohort includes non-cohort one patients meeting the trial requirements and agreeing to participate in the trial.",[586],"Peripheral Nerve Disorder",[588,589,590],"peripheral","nerve","stimulation","2026-04-08",{"date":593,"type":38},"2026-04-13",{"date":595,"type":38},"2024-11-27",{"date":597,"type":22},"2028-12-31",{"name":599,"class":45},"Nervonik",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":23,"phases":609,"briefSummary":610,"conditions":611,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":619,"locationsCount":621},"100568910","phase-3-a-study-to-compare-pharmacokinetics-efficacy-safety-and-immunogenicity-of-mb12-proposed-pembrolizumab-biosimilar-to-keytruda-in-non-small-cell-lung-cancer-benito-study-100568910","NCT06687369","A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)","Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)","Inclusion Criteria:\n\n1. Adult male\u002Ffemale patients ≥18 years old at the time of signing the informed consent form (ICF).\n2. Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8th edition of the Tumor Node Metastasis \\[TNM\\] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC. In those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.\n3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.\n4. Known status of PD-L1 expression.\n5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.\n\nExclusion Criteria:\n\n1. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible.\n2. Known history of central nervous system metastases and\u002For carcinomatous meningitis.\n3. Prior anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).\n4. Major surgery within 3 weeks of the first dose of study treatment.\n5. Active autoimmune disease that has required systemic treatment in the last 2 years.\n6. Contraindication and\u002For intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.\n7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.",{"count":608,"type":22},726,[60],"This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.",[612],"Non Squamous Non Small Cell Lung Cancer","2026-03-10",{"date":615,"type":38},"2026-03-11",{"date":617,"type":38},"2024-12-30",{"date":42,"type":22},{"name":620,"class":45},"mAbxience Research S.L.",151,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":636,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":653},"100560072","phase-3-a-study-of-the-efficacy-and-safety-of-belimumab-in-adults-with-interstitial-lung-disease-associated-with-connective-tissue-disease-100560072","NCT06572384","A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease (ILD) Associated With Connective Tissue Disease (CTD)","BEconneCTD-ILD","Inclusion criteria:\n\n* Participants with persistent\u002Fworsening active inflammatory disease who have failed to achieve their treatment goal, i. e., those who have experience lack of expected treatment benefit (clinically meaningful improvement in FVC), fail to demonstrate sustained lung function stability or continue to experience worsening of ILD despite initiation of standard therapy or failed to tolerate standard therapy.\n* Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM; including polymyositis, dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome (pSS), or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria\n* Diagnosis of inflammatory and\u002For fibrotic ILD on High Resolution Computed Tomography (HRCT) with a total disease extent of greater than or equal to (≥) 10% of the whole lung\n* Evidence of persistent active\u002Fworsening ILD\n* Must be currently receiving stable standard therapy to manage ILD and\u002For underlying CTD, or to have failed or failed to tolerate standard therapy.\n* Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n  * Is a woman of nonchildbearing potential (WONCBP) OR\n  * Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C)1%\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Diagnosis of ILD other than CTD-ILD.\n* Primary diagnosis of Systemic Sclerosis (SSc).\n* Participants with rapidly progressive disease (absolute drop of 10% or more of FVC between screening and baseline visit and\u002For recent pulmonary hospitalization).\n* FVC ≤ 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) ≤ 40% of predicted at screening as confirmed by central reader\n* History or presence of diffuse alveolar hemorrhage (DAH) or other confounding pulmonary disease, signs, or symptoms\n* Pulmonary arterial hypertension requiring therapy, as determined by the investigator at, or prior to first day of dosing (Day 1)\n* Dependence on continuous oxygen supplementation\n* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data\n* Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) \u002FFVC \\\u003C0.7) as confirmed by central reader\n* Significant emphysema on screening or historical HRCT (extent of emphysema exceeds extent of ILD) as confirmed by central reader\n* Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms\n* Participants with patient health questionnaire (PHQ-9) score ≥10, that in the opinion of a mental healthcare professional pose a serious suicide risk, have or any history of suicidal behavior in the last 6 months and\u002For any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk.\n* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years\n* Breast cancer within the past 10 years\n* Major surgery (including joint surgery) within 3 months prior to screening or planned during the duration of the study\n* An active infection, or a history of infections",{"count":631,"type":22},440,[60],"Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and\u002For improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.",[635],"Lung Diseases, Interstitial",[637,638,639,640,641,635,642,643,644],"Interstitial lung disease","Belimumab","Connective Tissue Disease","Autoimmune disease","Lung Diseases","Safety","Efficacy","Monoclonal antibody","2026-03-02",{"date":647,"type":38},"2026-03-03",{"date":649,"type":38},"2024-09-11",{"date":651,"type":22},"2028-12-13",{"name":170,"class":45},131,{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":23,"phases":663,"briefSummary":664,"conditions":665,"keywords":668,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":690},"100504966","phase-3-study-of-perioperative-dostarlimab-in-participants-with-untreated-t4n0-or-stage-iii-dmmrmsi-h-resectable-colon-cancer-100504966","NCT05855200","Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR\u002FMSI-H Resectable Colon Cancer","A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR\u002FMSI-H Resectable Colon Cancer","Inclusion Criteria:\n\n* Has untreated pathologically confirmed colon adenocarcinoma\n* Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III\n* Has radiologically evaluable disease\n* Has a tumor demonstrating the presence of either dMMR status or MSI-H\n\nExclusion Criteria:\n\n* Has distant metastatic disease.\n* Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer\n* Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent\u002Femergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.\n* Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization\n* Has any history of interstitial lung disease or pneumonitis and\u002For history of radiation induced enteritis.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice\n* Has a history of allogenic stem cell transplantation or organ transplantation\n* Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention\n* Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study\n* Has a history of severe allergic and\u002For anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX",{"count":662,"type":22},892,[60],"The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair\u002F microsatellite instability high (dMMR\u002FMSI-H) colon cancer.",[666,667],"Colonic Neoplasms","Neoplasms, Colon",[669,670,671,672,673,674,675,676,677,678,679,680,681],"JEMPERLI","Dostarlimab","dostarlimab-gxly","TSR-042","GSK4057190A","FOLFOX","CAPEOX","Colon Cancer","Resectable colon cancer","dMMR\u002FMSI","Perioperative","Neoadjuvant","Adjuvant","2026-01-22",{"date":684,"type":38},"2026-01-23",{"date":686,"type":38},"2023-08-01",{"date":688,"type":22},"2031-03-27",{"name":170,"class":45},266,{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":4,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":23,"phases":699,"briefSummary":700,"conditions":701,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":46},"100592272","omni-31-surgical-system-in-subjects-with-primary-open-angle-glaucoma-100592272","NCT06991270","OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma","A Pilot Study of the OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma","Inclusion Criteria:\n\n* Male or female subjects, 45 years or older\n* Visually significant age-related cataract and requiring phacoemulsification cataract surgery, OR, pseudophakic and a minimum of six months since cataract surgery.\n* Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months.\n* Diagnosed with mild to moderate primary open angle glaucoma (POAG). Diagnosis must include evidence of glaucomatous optic nerve damage or visual field defect consistent with glaucomatous optic nerve damage\n\nExclusion Criteria:\n\n* Any of the following prior ocular procedures:\n\n  * Laser trabeculoplasty ≤180 days prior to baseline\n  * Durysta ≤12 months prior to baseline\n  * Any implanted glaucoma device\n  * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy\n  * Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU), ≤180 days prior to baseline\n  * Retinal laser procedure ≤3 months prior to baseline\n* Any form of glaucoma other than POAG.\n* Use of topical ocular steroids.\n* Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet age-related macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits). Dry AMD and Non- proliferative diabetic retinopathy are not excluded.\n* History of penetrating keratoplasty or another corneal transplant; corneal abnormality that would prevent reliable IOP measurement, e.g. keratoconus or abnormally thick (≥ 620 µM) or thin (≤ 480 µM) cornea.\n* Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.\n* BCVA of logMAR 0.4 (20\u002F50) or worse in the study eye not due to cataract.\n* BCVA of logMAR 0.6 (20\u002F80) or worse in the non-study eye not due to cataract.",{"count":7,"type":22},[25],"To gain early evidence of safety and assess the effectiveness of the intraocular pressure (IOP)-lowering effectiveness of the OMNI 3.0 Surgical System in primary open-angel glaucoma (POAG).",[702],"Primary Open Angle Glaucoma","2026-01-12",{"date":705,"type":38},"2026-01-14",{"date":707,"type":22},"2026-02",{"date":709,"type":22},"2027-05",{"name":711,"class":45},"Sight Sciences, Inc.",""]