[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Moldova\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":687},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,51,80,108,133,158,187,216,240,263,299,327,351,379,410,431,453,474,507,530,552,581,602,634,664],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100627153","validation-of-sudden-cardiac-arrest-risk-factors-in-patients-with-cad-100627153",false,"NCT07444931","Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD","Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD - CVDLINK Clinical Validation Study.","SCAR","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Ability to give informed consent\n* Imaging confirmed diagnosis within the past 12 months (coronary artery angiography or contrast enhanced coronary computed tomography)\n\n  •\\>50% of stenosis and\u002For fractional flow-reserve \\\u003C0.8 verified by selective coronary angiography or by contrast enhanced coronary computed tomography (CT) or type I MI with atherosclerotic origin (despite stenosis percentage)\n* Patients may be recruited during index event visit (out-patient clinic visit, invasive procedure, hospitalization) (or if logistically possible recall patients previously diagnosed within 12 months)\n\nExclusion Criteria:\n\n* Age \\> 75 years of age\n* Clinically significant previously treated valvular heart disease or requiring operative (surgical or endovascular) treatment within following three months\n* Diagnosed severe neurodegenerative disease (ALS, myositis, multiple sclerosis, or Parkinson's disease) or known impaired cognitive function (MMSE \\\u003C23)\n* Known developmental disability impairing legal ability to give written consent\n* Serious\u002Factive malignancy with possibly reduced life expectancy of \\\u003C1 year (estimated by a physician)\n* Inability to give written consent for some other reason\n* Other significant cardiac condition severely linked to the risk of fatal ventricular arrhythmia (for example ARVCD, non-ischemic DCM, HCM or genetic long or short QT syndrome)\n* Other cardiac disease with \\\u003C1 years of life expectancy\n* Do-Not-Resuscitate (DNR) order made due to any reason\n* Previously done or planned cardiac, renal, or liver transplant\n* Participation in another clinical trial where the active treatment","ALL","18 Years","75 Years",{"count":22,"type":23},1500,"ESTIMATED","1 Year","OBSERVATIONAL","Long-term sudden cardiac death (abbreviation: SCAR) focuses on improving the predictability of sudden cardiac death (SCD) in patients diagnosed with coronary artery disease. The aim of the study is to determine the predictive value of measurable biological variables (including genetic factors, cardiac electrical activity, biological markers measured from circulation, and coronary artery anatomy) as well as the patients' psychosocial factors in predicting SCDs.\n\nThe purpose of this study is the identification of a subgroup of coronary artery disease patients at sufficiently high risk in whom it may be possible to prevent sudden cardiac arrests and subsequent deaths using implantable cardioverter-defibrillators. The study is intended to establish a clear foundation for future interventional studies targeting high-risk coronary artery disease patients.\n\nThe primary endpoint of the study is SCD\u002Fsudden cardiac arrest (SCA) or a comparable malignant arrhythmic event (i.e., resuscitation). Secondary endpoints include other major cardiovascular events occurring during the follow-up period (such as cerebrovascular events, myocardial infarctions, revascularizations, and new arrhythmias like atrial fibrillation following procedures or after the patient has been discharged following recruitment) or the occurrence and mortality of other significant life-threatening diseases (such as cancer). Secondary endpoints also include poor success in secondary prevention, which can be assessed through completed medication purchases and the achievement of secondary prevention goals.\n\nThis observational, prospective study includes collecting multimodal data from hospitals in Finland (TAUH), Israel (HYMC), Moldova (IMSP) and Romania (UMFCD). Each participating institution has followed a process structured by Tampere Heart Hospital (TAUH) for securing permissions in line with EU and national regulations.",[28,29,30],"Coronary Arterial Disease (CAD)","Sudden Cardiac Arrest","Sudden Cardiac Death",[32,33,34,35,36,37],"Coronary artery disease","Sudden cardiac arrest","Sudden cardiac death","post operative atrial fibrillation","genetics","risk factors","RECRUITING","2026-08-24",{"date":41,"type":42},"2026-08-25","ACTUAL",{"date":44,"type":42},"2025-01-05",{"date":46,"type":23},"2027-12-31",{"name":48,"class":49},"Tampere Heart Hospital","OTHER",3,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":60,"type":23},645,"INTERVENTIONAL",[63],"PHASE2","This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[66,67,68,69],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative","2026-08-21",{"date":41,"type":42},{"date":73,"type":42},"2025-05-27",{"date":75,"type":23},"2028-03",{"name":77,"class":78},"Spyre Therapeutics, Inc.","INDUSTRY",267,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":61,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100568362","phase-1-phase-1-study-to-evaluate-safety-and-antiviral-activity-of-pbgene-hbv-in-adult-patients-with-chronic-hepatitis-b-100568362","NCT06680232","Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B","A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)","ELIMINATE-B","Key Inclusion Criteria:\n\n* Male or women of non-child bearing potential\n* BMI 18.0 to 35.0\n* Good overall health deemed by the study Investigator\n* CHB infection documented at least 12 months prior to screening\n* HBeAg-negative CHB\n* Must be virologically suppressed on current NA treatment\n\nKey Exclusion Criteria:\n\n* No history of cirrhosis of the liver\n* No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.\n* No signs of hepatocellular carcinoma\n* Not received an organ transplant\n* No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)\n* No investigational agent received within 6 months of screening","70 Years",{"count":90,"type":23},45,[92],"PHASE1","This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.",[95],"HEPATITIS B CHRONIC",[95,97,98,99],"Gene Therapy","Gene Editing","PBGENE-HBV",{"date":39,"type":42},{"date":102,"type":42},"2024-11-14",{"date":104,"type":23},"2027-06",{"name":106,"class":78},"Precision BioSciences, Inc.",7,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":61,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100635042","a-study-of-ly3971297-in-participants-with-heart-failure-100635042","NCT07547540","A Study of LY3971297 in Participants With Heart Failure","A Phase 1, Single-Blinded, Single-Ascending Dose Study to Evaluate the Safety and Tolerability of a Single Dose of LY3971297 in Participants With HFpEF and Participants With HFrEF","Inclusion Criteria:\n\n* Are diagnosed with chronic heart failure with New York Heart Association Class II-III (Heart Failure) HF symptomatology at screening and on guideline-directed HF therapy for at least 6 months prior to screening.\n* Have not changed optimal guideline-directed HF therapy, either medication or medication dose, in the last 4 weeks prior to screening and during screening period, and do not plan to change HF therapy for the next 90 days.\n* Must be on a stable dose of vasodilator therapy for at least 4 weeks prior to screening, with no dose adjustments planned during the study.\n* Have an estimated glomerular filtration rate of greater than or equal to (≥) 30 milliliter per minute per 1.73 square meters (mL\u002FMinute\u002F1.73m²) at screening.\n* Have systolic blood pressure (SBP) greater than (\\>) 110 millimeters of mercury (mmHg) at screening and at enrollment.\n* Have a body mass index within the range of 18.5 to 40 kilograms per square meter (kg\u002Fm²) (inclusive).\n* Are individuals assigned male or female at birth, who are not of childbearing potential.\n* Have venous access sufficient to allow blood sampling.\n* Applicable to heart failure with preserved ejection fraction (HFpEF) participants only\n\n  * Have left ventricular ejection fraction (LVEF) \\>45 percent (%).\n  * Left atrial volume index \\>34 milliliters per square meter (mL\u002Fm²) in participants in sinus rhythm, or \\>40 mL\u002Fm² in participants with atrial fibrillation (AF).\n  * N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>300 picograms per milliliter (pg\u002FmL) for participants without AF or \\>850 pg\u002FmL for participants with AF.\n  * Have a documented history of signs, symptoms, or both, consistent with HFpEF.\n* Applicable to heart failure with reduced ejection fraction (HFrEF) participants only:\n\n  * Have LVEF \\\u003C40% .\n  * NT-proBNP \\>600 pg\u002FmL for participants without AF or \\>900 pg\u002FmL for participants with AF.\n  * Have a documented history of signs, symptoms, or both, consistent with HFrEF.\n\nExclusion Criteria:\n\n* Have known allergies to related compounds of LY3971297 or any components of the formulation, or a history of significant atopy.\n* Had a myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, revascularization or other major cardiovascular surgery, stroke, or transient ischemic attack in the last 90 days prior to screening.\n* Have New York Heart Association (NYHA) Class 4, acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, within 30 days prior to screening, and\u002For during screening period until randomization.\n* Have SBP ≥180 mmHg at screening.\n* Have symptomatic hypotension.\n* Have resting heart rate \\>90 beats per minute (bpm) at screening.\n* Have known cardiac amyloidosis, infiltrative myocardial diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease.\n* Have any history of moderate-to-severe stenosis of the mitral and\u002For aortic valve or severe mitral and\u002For aortic regurgitation.\n* Have any history of moderate-to-severe tricuspid or pulmonic valve stenosis or severe tricuspid or pulmonic regurgitation.\n* Have a history of syncope that, in the opinion of the investigator, may affect the participant's safety.\n* Bioprosthetic valve replacement within 12 months prior to screening or any history of mechanical valve replacement, or planned valve replacement or repair during the study period.\n* Have any history of greater than moderate pulmonary hypertension.\n* Have a pacemaker or implantable cardioverter-defibrillator placement within 90 days prior to screening.\n* Have severe chronic obstructive pulmonary disease (COPD).\n* Have clinically significant or uncontrolled cardiac arrhythmia.\n* Have a significant history of, or presence of, hepatic disease, including any abnormal liver function tests.\n* Have, within 3 years prior to screening, a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (Exceptions: basal or squamous cell skin cancer).\n* For US sites: have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study.\n* For Japan sites: have donated any blood within the last 4 weeks, any apheresis (blood components) within the last 2 weeks, at least 400 mL of blood within the last 16 weeks for female participants or 12 weeks for male participants, or at least 800 mL of blood for female participants or 1200 mL of blood for male participants within 12 months.\n* Other sites: Participants who have recently donated blood or blood components, or who intend to donate during the course of the study.\n* Have not been on a stable dose of medications for at least 4 weeks prior to screening, or have planned dose adjustments during the study.\n* Participants must abstain from taking new prescription or nonprescription drugs.\n* Have concurrent use or intend to use phosphodiesterase 5 inhibitor or soluble guanylyl cyclase activators.\n* Have any history of intolerance to vasodilator medications that, in the opinion of the investigator, would put them at risk of not tolerating study drug.\n* Have BP and\u002For pulse rate constituting a risk when taking the Investigational Medicinal Product (IMP).\n* Are diagnosed with orthostatic hypotension.\n* Show evidence of an acute infection with fever or infectious disease at screening.\n* Applicable to HFrEF participants only\n\n  * Have been listed for cardiac transplantation and\u002For anticipated or implanted ventricular assist device.\n  * Have received cardiac resynchronization therapy for less than 6 months.\n* Hospitalization for heart failure within 30 days of screening.","65 Years",{"count":117,"type":23},90,[92],"The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart failure with preserved ejection fraction (HFpEF) and participants with heart failure with reduced ejection fraction (HFrEF). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 2 months and will include 1 inpatient visit lasting approximately 4 days and 5 outpatient visits.",[121,122,123],"Heart Failure","Heart Failure, Diastolic","Heart Failure, Systolic","2026-08-20",{"date":70,"type":42},{"date":127,"type":42},"2026-08-11",{"date":129,"type":23},"2027-11",{"name":131,"class":78},"Eli Lilly and Company",12,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":61,"phases":143,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100599987","phase-3-a-study-to-assess-the-efficacy-and-safety-of-empasiprubart-in-adults-with-cidp-100599987","NCT07091630","A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP","A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","emnergize","Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has residual disability and active disease\n* Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)\n* Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP\n\nExclusion Criteria:\n\n* Meets the criteria for possible CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Sensory CIDP (including sensory-predominant CIDP)\n* Polyneuropathy of other causes\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation",{"count":142,"type":23},160,[144],"PHASE3","The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Femnergize",[147,148,149],"Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","Chronic Inflammatory Demyelinating Polyradiculoneuropathy",{"date":70,"type":42},{"date":152,"type":42},"2025-09-16",{"date":154,"type":23},"2031-01-23",{"name":156,"class":78},"argenx",78,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":61,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100533520","phase-2-a-phase-2-study-to-evaluate-morf-057-in-adults-with-moderately-to-severely-active-crohns-disease-100533520","NCT06226883","A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","GARNET","Key Inclusion Criteria:\n\n* Has signs\u002Fsymptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and\u002For an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and\u002For advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and\u002For more than 3 resections, and\u002For has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and\u002For a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease","85 Years",{"count":168,"type":23},385,[63],"This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).",[67,172],"Crohn's Disease",[174,175,176,177,178,164],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin",{"date":70,"type":42},{"date":181,"type":42},"2024-07-18",{"date":183,"type":23},"2030-06",{"name":185,"class":78},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",225,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":61,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":60,"type":23},[92,63],"Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[199,200,201,202,203,204,205,206,207],"B-cell Malignancy","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma",{"date":70,"type":42},{"date":210,"type":42},"2021-09-13",{"date":212,"type":23},"2029-11",{"name":214,"class":78},"BeOne Medicines",115,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":61,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"100607164","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100607164","NCT07184996","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis.","SUNSCAPE-1","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \\\u003C18 years of age who meet the definition of Tanner Stage 5 for development\n* Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline\n* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies\n\nExclusion Criteria:\n\n* Participants with Crohn's Disease (CD), indeterminate colitis\n* Current diagnosis of Ulcerative Proctitis\n* Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \\>3 bowel resections\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapies prior to baseline\n* Participants with prohibited medications or therapies prior to baseline\n* Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","16 Years","80 Years",{"count":227,"type":23},980,[144],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* Screening period\n* 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction)\n* 12-week Sub-Study 3 (Extended Induction for non-responders)\n* 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)\n\nThe treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.",[66],"2026-08-19",{"date":124,"type":42},{"date":234,"type":42},"2025-10-08",{"date":236,"type":23},"2028-05-09",{"name":238,"class":78},"Sanofi",219,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":61,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100629272","phase-3-dareon---lung-1-a-study-in-people-with-advanced-small-cell-lung-cancer-to-compare-obrixtamig-plus-atezolizumab-carboplatin-and-etoposide-treatment-with-standard-chemotherapy-100629272","NCT07472517","DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy","DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria :\n\n1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)\n2. Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.\n3. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.\n4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:\n\n   * Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation\n   * Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy\n7. Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply.\n\nExclusion Criteria :\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n3. Radiotherapy of any anatomical site within 7 days prior to randomisation\n4. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and\u002For CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described\n5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma\u002Fatopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and\u002For controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.\n\nFurther exclusion criteria apply.",{"count":248,"type":23},670,[144],"This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.\n\nParticipants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.\n\nParticipants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[252,253],"Small Cell Lung Cancer (SCLC)","Extensive-stage Small Cell Lung Cancer (ES-SCLC)","2026-08-18",{"date":231,"type":42},{"date":257,"type":42},"2026-04-13",{"date":259,"type":23},"2029-07-30",{"name":261,"class":78},"Boehringer Ingelheim",245,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":61,"phases":272,"briefSummary":273,"conditions":274,"keywords":284,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":271,"type":23},399,[92],"This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[275,276,277,278,279,280,281,282,283],"Advanced Solid Tumor","Advanced Breast Cancer","Metastatic Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","HER2-negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[285,286,287,288,289,282,290,291],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer",{"date":231,"type":42},{"date":294,"type":42},"2023-12-01",{"date":296,"type":23},"2028-11",{"name":214,"class":78},62,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":61,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100609376","phase-3-regn7508-versus-acetylsalicylic-acid-asa-for-venous-thromboprophylaxis-after-total-knee-arthroplasty-in-adult-participants-100609376","NCT07213778","REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants","A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)","ROXI-ASPEN","Key Inclusion Criteria:\n\n1. Is undergoing a primary elective unilateral TKA\n2. Is in good health based on laboratory safety testing as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation\n2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency)\n3. History of thromboembolic disease or thrombophilia\n4. History of platelet dysfunction\n5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":308,"type":23},2000,[144],"This study is researching an experimental drug called REGN7508 (called \"study drug\") and how it compares against another treatment called Acetylsalicylic Acid (ASA). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.\n\nThe aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)",[312],"Symptomatic Venous Thromboembolism (VTE)",[314,315,316,317],"Total Knee Arthroplasty (TKA)","Elective Unilateral TKA","Deep Vein Thrombosis (DVT)","Pulmonary Embolism (PE)","2026-08-17",{"date":231,"type":42},{"date":321,"type":42},"2025-11-24",{"date":323,"type":23},"2027-07-16",{"name":325,"class":78},"Regeneron Pharmaceuticals",34,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":61,"phases":336,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":342,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":50},"100646391","phase-1-a-study-testing-sot109-for-the-first-time-in-patients-to-assess-how-safe-sot109-is-how-well-it-works-and-how-the-body-handles-it-in-patients-with-advanced-colorectal-cancer-that-can-not-be-removed-by-surgery-or-is-metastatic-100646391","NCT07693751","A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer","A First-in-human Phase 1\u002F2 Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. ≥18 years of age on the day of signing the ICF\n2. Able to understand, sign, and provide written informed consent to participate in the trial\n3. Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1. Patients with ECOG performance score 2 will be discussed with the sponsor's medical monitor to be agreed for inclusion\n4. Estimated life expectancy ≥3 months as assessed by the investigator\n5. An appropriate candidate for experimental therapy as assessed by the investigator\n6. Agrees not to participate in other interventional clinical trial while enrolled in the present trial (with the exception of survival follow-up period)\n7. Absolute neutrophil count ≥1.5×109\u002FL, platelets ≥100×109\u002FL, hemoglobin ≥9 g\u002FdL\n8. Creatinine clearance ≥60 mL\u002Fmin calculated by Cockcroft-Gault formula\n9. Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN\n\n   • Participants with a documented history of Gilbert syndrome may be eligible if:\n   * Total bilirubin is ≤2.0 × ULN,\n   * Direct (conjugated) bilirubin is within normal limits (≤ULN), and\n   * There is no evidence of active liver disease, clinically significant hepatic impairment, hemolysis, or biliary obstruction, as determined by the investigator\n10. Prothrombin time\u002Finternational normalized ratio ≤1.5×ULN\n11. Albumin ≥3.0 mg\u002FdL\n12. Serum concentrations of potassium, magnesium, and calcium with abnormalities of maximum grade 1 that should be treated according to standard practice\n13. Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiography or nuclear medicine methodology (MUGA)\n14. QTcF interval ≤470 msec on screening ECG\n15. Histological or cytological evidence of advanced unresectable or metastatic colorectal cancer\n16. Participants that received and progressed on standard systemic therapies (fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, and, only when locally indicated and available, a BRAF\u002FRAS\u002FHER2 inhibitor) and who have no further standard treatment options. Participants with a known microsatellite instability-high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated\n17. Measurable or non-measurable disease according to RECIST 1.1\n18. Previous cancer therapies:\n\n    18.1. Europe: previous cancer therapies and any agents that have not received regulatory approval for any indication must have been discontinued either ≥21 days prior to day 1 of cycle 1 or ≥5x half-life, whichever is longer; toxicities of earlier anticancer therapy must be grade ≤1 at the time of screening and prior to cycle 1 day 1 (exception: alopecia) 18.2. US: eligibility should be determined based on patient recovery from clinically significant adverse events from their most recent therapy or intervention prior to study enrollment\n19. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies: 19.1. Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche, and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient.\n\n    19.2. A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 6 months after the last dose of SOT109\n    * WOCBP can only be included after a negative serum pregnancy test at screening\n    * Highly effective contraception includes:\n\n      * Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:\n\n        * Oral\n        * Intravaginal\n        * Transdermal\n      * Progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n        * Oral\n        * Injectable\n        * Implantable\n      * Intrauterine device\n      * Intrauterine hormone-releasing system\n      * Bilateral tubal occlusion\n      * Vasectomized partner provided the partner is the sole sexual partner of the WOCBP participant and that the vasectomized partner has received medical assessment of the surgical success\n      * Sexual abstinence defined as refraining from heterosexual intercourse during the entire treatment period and for at least 6 months after the last dose of SOT109. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.\n20. Male participants must agree to use a condom during the treatment period and for at least 6 months after the last dose of SOT109. Male participants wishing to become a father during or after the trial should consider sperm preservation. WOCBP partners of male participants should use highly effective contraception methods for 6 months after SOT109 discontinuation.\n\nExclusion Criteria:\n\n1. Received radiation therapy ≤14 days before day 1 of cycle 1 or not recovered to grade ≤1 from treatment-related side effects\n2. Any prior systemic therapy for metastatic cancer other than colorectal cancer; exception:\n\n   stable disease under hormonal treatment for prostate cancer, stable disease under hormonal treatment for breast cancer; radiochemotherapy is allowed if such treatment is completed at least 4 weeks prior to day 1 of cycle 1; participants must have recovered to grade ≤1 from all side effects (exception: alopecia)\n3. Participants must not receive any concurrent antitumor therapy while participating in the trial. In exceptional circumstances where urgent palliative radiotherapy to symptomatic non-target lesions is clinically indicated, the case must be reviewed with the Principal Investigator (PI) and the intervention must receive prior approval from the sponsor\n4. Vaccination with a live or live-attenuated vaccine within 30 days prior to the first dose of trial interventions; the full series (e.g., both doses of a two dose vaccination series) should be completed prior to dosing if feasible\n5. Time since last transfusion of red blood cells ≤14 days before day 1 of cycle 1\n6. Severe preexisting medical conditions as per judgment of the investigator\n7. History of interstitial pneumonitis or pulmonary fibrosis\n8. Symptomatic central nervous system malignancy. Participants with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days\n9. Peripheral sensory neuropathy grade ≥2\n10. Active infection requiring systemic therapy that is not clinically controlled before the signature of the ICF\n11. Known symptomatic HIV positive, symptomatic active HBV, or symptomatic active HCV\n\nNote:\n\n* Participants with HIV will be eligible if:\n\n  * CD4+ T-cell counts ≥350 cells\u002FμL\n  * They have no history of AIDS-defining opportunistic infections\n  * They are not currently on HIV therapy\n* Participants with HBV will be eligible if there is serologic evidence of a resolved prior HBV infection (HBsAg-negative and HBcAb-positive)\n* Participants with HCV will be eligible if they have completed curative antiviral treatment and have HCV viral load below the limit of quantification 12. Alcohol or drug abuse as determined by the investigator 13. Psychiatric condition or social situation that, in the opinion of the investigator, preclude that the participant is able to comply with trial requirements 14. New York Heart Association class ≥2 heart failure, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, myocardial infarction, cerebrovascular accident or hypertensive crisis within 6 months prior to day 1 of cycle 1 15. History of major ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes) 16. History or family history of congenital long QT syndrome 17. Bradycardia (\\\u003C50 beats per minute) 18. Family history of sudden cardiac death before age 50 19. Major surgical intervention ≤28 days prior to ICF signature or incomplete wound healing after surgical intervention 20. Hypersensitivity or intolerance to any component of trial intervention 21. Medical history of inflammatory bowel disease or active inflammatory bowel disease (IBD)\n* Participants with signs or symptoms suggestive of IBD who have not undergone colonoscopy to rule out IBD will be excluded",{"count":335,"type":23},100,[92,63],"SOT109 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called CDH17, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B. The goal of Part A is to collect information about SOT109, understand its effects, and see whether it is safe and well tolerated at different dose levels. Part B of the study collects information on which of the two selected safe dose levels chosen in Part A gives the best balance between benefit and risk.",[339],"Colorectal Cancer (Locally Advanced or Metastatic)",[341],"Colorectal Cancer","NOT_YET_RECRUITING","2026-08-14",{"date":254,"type":42},{"date":346,"type":23},"2026-08-29",{"date":348,"type":23},"2028-07-04",{"name":350,"class":78},"SOTIO Biotech a.s.",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":61,"phases":360,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":342,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":378},"100629565","phase-1-pharmacokinetics-safety-and-immunogenicity-comparison-of-bmab1700-and-opdivo-as-adjuvant-monotherapy-in-participants-with-melanoma-100629565","NCT07476326","Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma","A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB\u002FC, Stage III, or Stage IV Melanoma","Inclusion Criteria:\n\n1. Participants greater than or equal to (\\>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n2. Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before any study-specific procedures are performed.\n3. Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th edition) that was completely surgically resected. Complete surgical resection requires removal of all clinically or radiographically evident regional disease. Completion of lymph node dissection is not required unless clinically indicated. Participants must have been surgically rendered free of disease with negative margins on resected specimens documented by appropriate pathology and surgical reports.\n4. Complete surgical resection of melanoma must have been performed within 12 weeks before randomization.\n5. All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n7. Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator.\n\nExclusion Criteria:\n\n1. History of ocular\u002Fuveal melanoma.\n2. Participants with an active, known, or suspected autoimmune disease are to be excluded from participation. Participants who have received systemic treatment for an autoimmune disease within the past 2 years before randomization (eg, with disease-modifying agents, corticosteroids, or immunosuppressive drugs) are also excluded.\n3. History of active malignancy other than melanoma under study within 3 years before randomization, except for locally curable early-stage cancers (carcinoma in situ or Stage I) that have been curatively treated, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n4. Participants with a condition requiring systemic treatment with either corticosteroids \\>10 mg daily prednisone or equivalent or other immunosuppressive medications within 14 days before randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \\\u003C=10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease\n5. Female participants who are pregnant or breastfeeding at the screening visit, or who intend to become pregnant or breastfeed at any time during the study and for 150 days after the last dose of study intervention.\n6. Use of an investigational agent or an investigational device within 28 days or 5 half-lives (if half-life is known for the investigational agent), whichever is longer, before randomization or have not recovered from AEs associated with such therapies to Grade 1 or below (based on CTCAE Version 6.0).\n7. Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion).\n8. Participants who have received a live\u002Fattenuated vaccine within 28 days before randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.\n9. Expected to receive any other form of antineoplastic therapy during the clinical study.\n10. Participants who received previous systemic therapy with any of the following: anti-programmed cell death-protein 1 (PD-1), anti programmed cell death-ligand 1 (PD-L1), anti-programmed cell death-ligand 2 (PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including nivolumab or pembrolizumab or ipilimumab or other CTLA-4 targeting agents), chimeric antigen receptor T-cell therapy cells, or any agents targeting the IL-2 pathway or other T-cell co-stimulation\u002F checkpoint pathways.\n11. Treatment with complementary medications (eg, herbal supplements or traditional medicines) with an antineoplastic intent to treat the melanoma within 2 weeks before randomization. Such medications are permitted if they are used as supportive care.\n12. Participants will be excluded if clinical assessment or laboratory investigations before randomization demonstrate any of the following:\n\n    1. White blood cells: less than (\\\u003C) 2000 per microliter\n    2. Neutrophils: \\\u003C1500 per microliter\n    3. Platelets: \\\u003C100 \\*103 per microliter\n    4. Hemoglobin: \\\u003C9.0 gram per deciliter (g\u002FdL)\n    5. Participants with estimated creatinine clearance (CrCl) (measured or calculated) less than or equal to (\\\u003C=) 40 milliliter per minute (mL\u002Fmin).\n\n       • CrCl: using the Cockroft-Gault formula:\n       * Female CrCl = \\[(140 - age in years) \\* weight in kilogram (kg) \\* 0.85\\] divided by (72 \\* serum creatinine in milligram per deciliter \\[mg\u002FdL\\])\n       * Male CrCl = \\[(140 - age in years) \\* weight in kg \\* 1.00\\] divide by (72 \\* serum creatinine in mg\u002FdL)\n    6. Aspartate aminotransferase: greater than (\\>) 2.5 \\* upper limit of normal (ULN)\n    7. Alanine aminotransferase: \\>2.5 \\* ULN\n    8. Total bilirubin \\>1.5 \\* ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \\\u003C3.0 \\* ULN)\n13. Participants positive for human immune deficiency virus (HIV-1 and HIV-2) tests. Screening for HIV infection must adhere to local regulatory guidelines and confirm the absence of HIV-1 and HIV-2 infection.\n\n    Note: Participants with documented HIV infection may be enrolled where required by local regulatory or ethics committee guidance, provided all the following criteria are met:\n    * The participant is on stable antiretroviral therapy for at least 12 weeks prior to the first dose of study treatment, and no planned change in antiretroviral therapy regimen during the PK sampling period.\n    * Adequate immune function, defined as: CD4+ T cell count greater than or equal to (\\>=) 350 cells per millimeter cube (cells\u002Fmm\\^3) at screening\n    * No history of uncontrolled or recent Acquired Immunodeficiency Syndrome (AIDS) defining illness, that is \\[ie\\], no active AIDS defining condition within the past 12 months\n    * Undetectable viral RNA load\n14. Participants having positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, eg, hepatitis B surface antigen (Australia antigen) positive, or hepatitis C antibody (anti- HCV) positive (except if HCV RNA negative).\n15. Participants with history or current evidence of any clinically significant medical condition (including but not limited to physical examination, vital signs, electrocardiogram \\[ECG\\] findings, laboratory results), or ongoing therapy, that could confound study results, increase participation risk, or are deemed not in the participant's best interest by the treating investigator.\n16. Known history of allergy or hypersensitivity to IMP components.\n17. Known history of severe hypersensitivity reaction (Grade \\>=3) to any monoclonal antibody.\n18. Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.\n19. Has documented or known current alcohol\u002Fdrug abuse that precludes the participant's ability to adhere to the protocol.\n20. Prisoners or participants who are involuntarily incarcerated.",{"count":359,"type":23},120,[92],"The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.",[363],"Melanoma",[365,366,367,368,369],"Neoplasm","Programmed cell death-protein 1(PD-1)","Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)","Monoclonal antibody","Immunoglobulins",{"date":371,"type":42},"2026-08-13",{"date":373,"type":23},"2026-08",{"date":375,"type":23},"2028-02-16",{"name":377,"class":78},"Biocon Biologics UK PLC",48,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":61,"phases":388,"briefSummary":389,"conditions":390,"keywords":398,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":409},"100591414","phase-1-dose-determining-study-of-exs73565-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100591414","NCT06980116","Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1 Open-label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of EXS73565 in Participants With Relapsed or Refractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically confirmed diagnosis of one of the following B-cell malignancies: chronic lymphocytic leukemia (CLL), including Richter's transformation from CLL, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, or waldenström macroglobulinaemia.\n* Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy\n\nKey Exclusion Criteria:\n\n* Any medical or psychiatric condition that, in the view of the Principal Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.\n* Known central nervous system (CNS) malignancy or primary CNS lymphoma.\n* Concurrent active or previous malignancy (other than the primary lymphoma\u002FCLL for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented Sponsor approval.\n* Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.",{"count":387,"type":23},85,[92],"The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EXS73565 administered orally as a single agent in participants with relapsed\u002Frefractory B-cell malignancies.",[391,392,393,394,395,396,397],"Relapsed or Refractory B-cell Malignancies","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)","Follicular Lymphoma (FL)","Marginal Zone Lymphoma (MZL)","Mantle Cell Lymphoma (MCL)","Diffuse-large B-cell Lymphoma (DLBCL)","Waldenstrom's Macroglobulinemia (WM)",[399,400,393,394,395,396,397,401],"B-cell Malignancies","Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL)","MALT1",{"date":371,"type":42},{"date":404,"type":42},"2025-03-31",{"date":406,"type":23},"2028-12",{"name":408,"class":78},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",17,{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":115,"enrollmentInfo":417,"targetDuration":4,"studyType":61,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":430},"100493377","phase-1-a-study-to-investigate-the-safety-tolerability-and-processing-by-the-body-of-intravenous-and-subcutaneous-ro7121932-administration-in-participants-with-multiple-sclerosis-100493377","NCT05704361","A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis","A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3), and Long-term Safety (Part 4), Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1 and 4) and Subcutaneous (Parts 2, 3 and 4) Administration in Participants With Multiple Sclerosis","Inclusion Criteria:\n\n* Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening\n* Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria)\n* Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up)\n* Biological male and female participants\n* Female participants must practice abstinence or otherwise use contraception\n\nExclusion Criteria:\n\n* Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \\>1 clinical relapse within 12 months prior to screening\n* Evidence of brain magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan\n* Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML\n* Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism\n* Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1\n* Participants with a current diagnosis of epilepsy\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, gastrointestinal or other major diseases\n* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \\>1 year prior to screening is not exclusionary\n* History of inflammatory bowel disease or other clinically significant gastrointestinal disorders\n* Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study\n* History of currently active primary or secondary (non-drug-related) immunodeficiency\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation\n* Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.\n\nPrior\u002FConcomitant Therapy:\n\n* Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial\n* Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab\n* Previous treatment with anti-CD20 B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)\n\n  * \\\u003C12 months prior to acquiring any screening laboratory tests,\n  * ≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available),\n  * If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons\n* Current or prior treatment with natalizumab (if \\\u003C24 months prior to acquiring any screening laboratory tests)\n\nPrior\u002FConcurrent Clinical Study Experience:\n\n\\- Participation in an investigational drug medicinal product or medical device study within 30 days before Screening or within five times the pharmacodynamic (PD) or pharmacokinetic (PK) half-life (if known), whichever is longer\n\nDiagnostic Assessments:\n\n* Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B\n* Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk\n* Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1",{"count":418,"type":23},119,[92],"The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3), and multiple-ascending SC doses following a single IV dose (Part 4) of RO7121932 in participants with multiple sclerosis (MS). Only Parts 1 and 2 of the study will be conducted in the United States, whereas Parts 1, 2, 3, and 4 will be conducted in all other participating countries outside the United States.",[422],"Multiple Sclerosis",{"date":371,"type":42},{"date":425,"type":42},"2021-08-11",{"date":427,"type":23},"2027-07-08",{"name":429,"class":78},"Hoffmann-La Roche",32,{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":438,"targetDuration":4,"studyType":61,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":342,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":452},"100651656","phase-2-a-study-to-assess-the-safety-pharmacokinetics-and-efficacy-of-abi-6250-in-participants-with-chronic-hepatitis-d-virus-infection-100651656","NCT07762027","A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection","A Phase 2, Multicenter, Open Label, Parallel-Group Study of the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection","Inclusion Criteria:\n\n* Participant has a body mass index ≥18.0 and \\\u003C35.0 kg\u002Fm2 at Screening\n* Other than HBV and HDV infection, the participant is in good health (as determined by the Investigator) based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory results.\n* Participant agrees to comply with protocol-specified contraception requirements.\n\nExclusion Criteria:\n\n* Participant has a current coinfection with acute hepatitis A virus (HAV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Participant has a history of any significant food or drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or urticaria.\n* Participant has been treated for HDV infection in the past 6 months prior to Day 1.\n* Participant took part in another clinical trial of a drug or device (other than for HDV infection) whereby the last study drug\u002Fdevice administration is within 30 days or 5 half-lives, whichever is longer, prior to Day 1.",{"count":439,"type":23},80,[63],"This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.",[443],"Chronic Hepatitis D Infection","2026-08-07",{"date":371,"type":42},{"date":447,"type":23},"2026-10",{"date":449,"type":23},"2028-09",{"name":451,"class":78},"Assembly Biosciences",22,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":460,"targetDuration":4,"studyType":61,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":342,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":469,"leadSponsor":471,"locationsCount":473},"100651460","phase-1-a-trial-of-hrs-7085-tablets-in-patients-with-moderate-to-severe-active-ulcerative-colitis-100651460","NCT07760831","A Trial of HRS-7085 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis","A Phase IB Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-7085 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis","Inclusion Criteria:\n\n1. At least 18 years old and not more than 75 years old at the time of signing the Informed Consent Form (ICF), regardless of their sex.\n2. Body mass index \\[BMI = weight (kg)\u002Fheight2(m2)\\] ≥ 18 kg\u002Fm2 at screening.\n3. Participants with active UC who have a modified 9-point Mayo score of 5 to 9 and an endoscopic subscore of 2 to 3 at baseline (the interval between screening endoscopy and baseline cannot exceed 14 days), with a rectal bleeding subscore of at least 1.\n4. At the time of first dose, the participant is diagnosed with UC for at least 90 days, and UC is confirmed by investigation during the screening visit.\n5. The investigator considers that the participant has an inadequate response, loss of response, or intolerance to conventional therapy (oral 5-ASA, immunomodulators, or corticosteroids), anti-tumor necrosis factor (TNF) or other biologic therapy, JAK inhibitor therapy, or is unable to receive these treatments for other reasons.\n\n   Note: definitions of insufficient response, loss of response, or intolerance are provided in Appendix 13.5.\n6. If the participant is currently receiving the following UC therapy at screening, a stable dosage should be administered within the specified time:\n\n   1. Oral 5-ASA (mesalazine) (with stable dosage at least 2 weeks before baseline and during the study treatment period), AND\u002FOR\n   2. Oral corticosteroids (prednisone or prednisolone ≤ 20 mg\u002Fday) (with stable dosage for at least 2 weeks prior to baseline and during the treatment period). All other systemic corticosteroid routes are prohibited.\n7. The participant voluntarily signs the Informed Consent Form (ICF) before any study-related procedures, can communicate smoothly with the investigator, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study.\n\nWomen of childbearing potential must agree to use highly effective contraceptive methods during the trial and within 3 months after the last dose of trial intervention. Serum or urine pregnancy tests must be negative before and during the trial. Females who are lactating are not eligible to participate in the trial (see Section 13.1 for details). Males must use highly effective contraceptive methods during the trial and within 3 months after the last dose of trial intervention during intercourse with a female of childbearing potential. Donation of sperm during this period is prohibited.\n\nExclusion Criteria:\n\n1. Any of the following medical histories or concomitant diseases:\n\n   1. Participants clinically diagnosed with unclassified colitis or suggestive of Crohn's disease.\n   2. Participants with UC, limited to proctitis (distal ≤15 cm).\n   3. Participants diagnosed with UC who are treatment-naive (no prior treatment received).\n   4. Participants presenting with clinical symptoms of ischemic colitis, fulminant colitis, or toxic megacolon.\n   5. Participants who have previously undergone surgery for UC or might require surgery during the study phase.\n   6. Screening investigation finds that the participant has a medical history of gastrointestinal dysplasia (atypical hyperplasia)\u002Fcancer or dysplasia (atypical hyperplasia)\u002Fcancer. Completely resected low-grade dysplasia will be excluded.\n   7. Participants with a positive Clostridium difficile (C. difficile) test at screening may be enrolled only if they have:\n\n      1. Completed appropriate standard-of-care treatment for C. difficile infection;\n      2. Achieved clinical resolution of diarrheal symptoms; AND\n      3. A documented negative repeat stool test (toxin A\u002FB assay or NAAT\u002FPCR) conducted after completion of treatment and within 7-14 days prior to baseline\u002Frandomization.\n   8. Participants with evidence of other intestinal infections within 30 days of endoscopic screening, or other intestinal pathogen screening.\n   9. The participant has or previously had:\n\n      1. Clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy or opportunistic infection) within 1 month before baseline.\n      2. History of herpes zoster occurring twice or more, or herpes zoster disseminated (occurring once).\n      3. Any other infection history that the investigator considers might be aggravated by participation in this study.\n      4. Presence of any infection requiring antimicrobial therapy within 2 weeks before screening (excluding local antimicrobial therapy).\n2. Use of any of the following drugs or participation in clinical study (defined as signing the ICF and receiving at least one dose of drug or device therapy):\n\n   1. Received JAK inhibitors (upadacitinib, tofacitinib) within 4 weeks before baseline.\n   2. Received biological agents before baseline (for specific washout time, see Section 6.8.1):\n\n      1. Received anti-TNFα antibody therapy within 8 weeks before baseline;\n      2. Received anti-α4β7 antibody therapy within 12 weeks before baseline;\n      3. Received anti-interleukin (IL)-23 antibody therapy within 12 weeks before baseline.\n   3. Received treatment with azathioprine\u002F6-mercaptopurine, methotrexate, or thalidomide within 2 weeks before baseline.\n   4. Treatment with ciclosporin, mycophenolate mofetil, or tacrolimus within 4 weeks before baseline.\n   5. Received intravenous corticosteroids, or corticosteroids by rectal use, or 5-ASA by rectal use within 2 weeks before baseline.\n   6. Participation in any clinical study of drugs (including investigational vaccine) or medical devices within 3 months before baseline or within 5 half-lives of the investigational drug(s) (whichever is longer).\n3. Presence of the following important medical history or pre-existing diseases affecting safety:\n\n   1. The participant has a medical history of lymphoproliferative diseases, including lymphoma or symptoms and signs of potential lymphoproliferative disorders.\n   2. Participants with any active neoplasm malignant or history of neoplasm malignant within 5 years prior to the screening visit, except for recovered cutaneous squamous cell carcinoma or basal cell carcinoma or cervix carcinoma in situ.\n   3. Within 3 months prior to screening, participants with a medical history of moderate to severe cardiac failure congestive (New York Heart Association \\[NYHA\\] Grade 3 or above), occurrence of cardiovascular events or severe hemorrhage events, which the investigator considers unsuitable for the participant to participate in the clinical study.\n   4. Active tuberculosis (TB) or latent TB infection (defined as meeting at least one of the following criteria):\n\n      1. Presence of active TB or symptoms of active TB at screening.\n      2. A positive TB test (by QuantiFERON-TB Gold Test or other interferon-gamma release assay \\[IGRA\\]). If the IGRA result is indeterminate, a retest is allowed; participants within determinate results on both tests will be considered positive. For participants with a positive TB test but no clinical symptoms or imaging findings, prophylactic anti-TB treatment for at least 1 month is recommended before re-screening, and a positive result upon re-screening does not lead to exclusion criterion. For participants with a positive TB test but no clinical symptoms or imaging findings who have previously received prophylactic anti-TB treatment for at least 1 month, they should not be excluded based on this criterion;\n      3. Imaging examination within 3 months prior to screening indicating signs of active TB;\n      4. Participants with a medical history of active TB but with medical records proving completion of a full course of anti-TB treatment may confirm with the sponsor whether they could enter the study.\n   5. Hepatitis B Virus Surface Antigen (HBsAg), human immunodeficiency virus (HIV) antibody, syphilis antibody investigation, anti-Hepatitis C Virus (HCV) antibody test positive; if HBsAg-negative, but Hepatitis B core antibody (HBcAb)-positive and Hepatitis B Virus (HBV) DNA-positive or above the upper limit of normal (ULN).\n   6. Presence of severe, progressive, or uncontrolled diseases of the cardiovascular and cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematopoietic, endocrine, nervous system (e.g., depression, suicidal tendency, and psychological disorders), or other conditions that the investigator considers inappropriate for the patient to participate in this trial.\n4. Screening:\n\n   1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 × ULN.\n   2. Total bilirubin ≥ 1.5 × ULN.\n   3. Serum creatinine \\> 2.0 mg\u002FdL (177 μmol\u002FL).\n   4. Male participants with hemoglobin \\\u003C 85.0 g\u002FL, female participants \\\u003C 80.0 g\u002FL.\n   5. White blood cell count \\\u003C 3.0 × 10\\^9\u002FL.\n   6. Neutrophil count \\\u003C 1.5 × 10\\^9\u002FL.\n   7. Platelet count \\\u003C 100 × 10\\^9\u002FL.\n   8. 12-lead ECG investigation suggesting abnormalities with clinical significance that may affect the safety of the participant, including but not limited to acute myocardial ischemia myocardial infarction, severe arrhythmia or significant QTc prolongation. ECG exclusion criteria are detailed in Appendix 0.\n5. General conditions:\n\n   1. Pregnant or breastfeeding women (pregnancy is defined as the state after conception to the termination of gestation), or with a positive human chorionic gonadotropin (hCG) test result.\n   2. Allergy to the study drug or any component of the study drug.\n   3. A history of alcoholism or illegal drug abuse within 1 year prior to screening.\n   4. Received a live attenuated vaccine within 12 weeks before the first drug administration, or intends to receive a live attenuated vaccine during the study period, or participated in a vaccine clinical trial within 12 weeks before the first drug administration.\n   5. Donated approximately 500 mL or more of blood within 8 weeks prior to the first dose and\u002For plans to donate blood during the study period.\n\nThe investigator judges that there are circumstances affecting the evaluation of the safety and efficacy of the study drug.",{"count":461,"type":23},8,[92],"The study is being conducted to evaluate the safety, tolerability and pharmakokinetics of HRS-7085 in adults.",[465],"Moderate to Severe Ulcerative Colitis",{"date":467,"type":42},"2026-08-12",{"date":373,"type":23},{"date":470,"type":23},"2027-09",{"name":472,"class":78},"Jiangsu HengRui Medicine Co., Ltd.",1,{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":61,"phases":483,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":505,"locationsCount":387},"100601517","phase-1-a-clinical-trial-to-test-if-an-investigational-combination-therapy-with-bnt326-and-bnt327-is-safe-and-potentially-beneficial-for-people-with-advanced-non-small-cell-lung-cancer-nsclc-100601517","NCT07111520","A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)","A Phase Ib\u002FII, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)","Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):\n\n* Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older.\n* Have measurable disease defined by RECIST v1.1.\n* Have Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have adequate organ and bone marrow function within 7 days before randomization\u002Fenrollment as defined in the protocol.\n* Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous NSCLC.\n\nCohort-specific inclusion criteria\n\nPart 1, 2L+, squamous or non-squamous NSCLC, AGA-negative\u002Fpositive, any PD-L1 (NOTE: regimens used as neoadjuvant and\u002For adjuvant treatment may be considered as prior lines for advanced disease if relapse occurred within 6 months of the last dose.)\n\n* for AGA-negative NSCLC only:\n\n  * Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.\n  * Have experienced relapse or progression during or after treatment with standard systemic therapy in the advanced\u002Fmetastatic setting or discontinued from prior therapy due to intolerance.\n  * Participants must have received 1 to 3 lines of systemic treatment in the metastatic setting, which can include anti-PD-1\u002FPD-L1 therapy, chemotherapy, and anti-angiogenic agents. These treatments may be administered concurrently or sequentially. However, prior chemotherapy treatment must be limited to 2 lines or less.\n* for AGA-positive NSCLC only (excluding EGFR activating mutation):\n\n  * Have documented positive test results for one or more actionable genomic alteration: EGFR (other than activating mutations), ALK, ROS proto-oncogene 1 (ROS1), gene encoding the hepatocyte growth factor receptor (MET), human gene that encodes a protein called B-Raf (BRAF), rearranged during transfection (RET), neurotrophic tropomyosin-receptor kinase (NTRK), human epidermal growth factor receptor 2 (HER2), Kirsten rat sarcoma virus (KRAS), or other genomic alteration with available targeted therapy.\n  * Must have received at least one prior systemic therapy for advanced disease, which must have included targeted treatment for actionable genomic alterations, which include alterations such as EGFR (other than activating mutations), ALK, ROS1, MET, BRAF, RET, NTRK, HER2, KRAS, or other alterations for which targeted therapies are available as a part of local SoC.\n  * Participants may have received between 1 to 3 lines of systemic treatment of anti-PD-1\u002FPD-L1 therapy, chemotherapy, and\u002For anti-angiogenic agents. These treatments may be administered concurrently (including with tyrosine kinase inhibitor \\[TKI\\]) or sequentially. However, chemotherapy treatment must be limited to 2 lines or less.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n* for AGA-positive NSCLC only (with EGFR activating mutation):\n\n  * Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).\n  * Participants must have received one or two prior lines of systemic therapy for advanced and\u002For metastatic disease, which must include treatment with an approved EGFR TKI, with at least one being a third-generation EGFR TKI.\n  * Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.\n  * Chemotherapy is permitted only if it was administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first line) treatment for advanced\u002Fmetastatic disease.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n\nPart 2a (Cohort A), 2L+, squamous or non-squamous NSCLC, AGA-negative\u002Fpositive, any PD-L1 (NOTE: regimens used as neoadjuvant and\u002For adjuvant treatment may be considered as prior lines for advanced disease if relapse occurred within 6 months of the last dose.)\n\n* for AGA-positive NSCLC only, excluding EGFR activating mutation:\n\n  * Have documented positive test results for one or more actionable genomic alterations: EGFR (other than activating mutations), ALK, ROS1, MET, BRAF, RET, NTRK, HER2, KRAS, or other genomic alterations, with available targeted therapy.\n  * May have received 1 to 4 lines of systemic treatment, of which one prior systemic therapy for advanced disease must have included targeted treatment for actionable genomic alterations, which include alterations such as EGFR (other than activating mutations), ALK, ROS1, MET, BRAF, RET, NTRK, HER2, KRAS, or other genomic alterations for which targeted therapies are available as part of local SoC.\n  * Other therapies may include anti-PD-1\u002FPD-L1 therapy, chemotherapy, and anti-angiogenic agents. These treatments may be administered concurrently\u002Fin combination (including with TKI) or sequentially. However, chemotherapy treatment must be limited to 2 lines or less.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n* for AGA-positive NSCLC only, with EGFR activation mutation:\n\n  * Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).\n  * Participants must have received one or two prior lines of systemic therapy for advanced and\u002For metastatic disease, which must include treatment with an approved EGFR TKI, with at least one being a third-generation EGFR TKI.\n  * Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.\n  * Chemotherapy is permitted only if it was administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first line) treatment for advanced\u002Fmetastatic disease.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n\nPart 2a (Cohort B), 1L, squamous or non-squamous NSCLC, AGA-negative, any PD-L1\n\n* Have no actionable genomic alterations, such as EGFR mutations, ALK rearrangements, or other genomic alterations for which targeted molecular therapies are available.\n* Have received no systemic anti-cancer treatment in the advanced\u002Fmetastatic setting. May have received neoadjuvant and\u002For adjuvant treatment if progression to advanced\u002Fmetastatic disease occurred at least 6 months after completing such therapy and have not received treatment in the advanced\u002Fmetastatic setting.\n\nPart 2b (Cohort C), 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1\n\n* for AGA-negative NSCLC only:\n\n  * Have no actionable genomic alterations, such as EGFR mutations, ALK rearrangements, or other genomic alterations for which targeted molecular therapies are available.\n  * Participants should have received 1 to 4 lines of systemic treatment, which can include anti-PD-1\u002FPD-L1 therapy, chemotherapy, and\u002For anti-angiogenic agents.\n  * Regimens used as neoadjuvant and\u002For adjuvant treatment may be considered as prior lines for advanced disease if relapse occurred within 6 months of the last dose.\n* for EGFR-sensitizing mutation NSCLC only:\n\n  * Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).\n  * Have received 1 or 2 prior systemic therapies for advanced and\u002For metastatic disease with an approved EGFR TKI, which must include one third-generation anti-EGFR TKI.\n  * Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.\n  * Chemotherapy is permitted only if it was administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first line) treatment for advanced\u002Fmetastatic disease.\n  * May have received neoadjuvant and\u002For adjuvant treatment if progression to advanced\u002Fmetastatic disease occurred at least 6 months after completing such therapy and have experienced disease progression on or after EGFR TKI treatment administered in the advanced\u002Fmetastatic setting.\n  * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.\n\nPart 2b (Cohort D1) 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50% and Part 2b (Cohort D2) 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \\\u003C50%\n\n* Have no actionable genomic alterations, such as EGFR mutations (Cohort D1)\u002FEGFR-sensitizing mutations (Cohort D2), ALK rearrangements, or other genomic alterations for which targeted molecular therapies are available.\n* Have not received prior systemic therapy for advanced and\u002For metastatic disease. May have received neoadjuvant and\u002For adjuvant treatment if progression to advanced\u002Fmetastatic disease occurred at least 6 months after completing such therapy and have not received treatment in the advanced\u002Fmetastatic setting.\n\nKey Exclusion Criteria (applicable to all participants and all parts):\n\n* Had disease progression on or were intolerant to prior treatment with an agent targeting HER3 (including antibody, ADC, cell therapy, and other drugs) or with a topoisomerase I inhibitor payload (including topoisomerase I inhibitor-containing ADCs). Note: For Part 2a Cohort A, prior exposure to agents targeting HER3 or topoisomerase I inhibitor payload may be allowed on a case-by-case basis after discussion with and approval by the sponsor.\n* Have an uncontrolled concomitant or intercurrent illness, that contra-indicates study participation, limits compliance with study procedures or substantially increases the risk of incurring AEs, including:\n\n  * Bleeding diathesis or active hemorrhage\n  * Clinically significant active infection, including respiratory viral infection\n  * Child-Pugh class B or C cirrhosis\n  * Known pulmonary disease with significant impact in lung function and\u002For with potential risk of severe infection\n  * Oncologic emergencies or complications (e.g., malignant hypercalcemia, superior vena cava syndrome, carcinoid syndrome that is unstable and with available alternative therapies)\n  * Psychiatric or abuse condition\n  * Infectious colitis Grade ≥2 not resolved to Grade 1 within 72 h within the past 3 months\n* Have left ventricular ejection fraction \\\u003C50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization\u002Fenrollment.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have a history of (non-infectious) interstitial lung disease (ILD) \u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening. Asymptomatic interstitial changes caused by previous radiation therapy, chemotherapy, or other factors such as smoking are acceptable.\n* Have had exposure to protocol-specific treatments with a washout period before randomization\u002Fenrollment.\n* Have clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n* Are participants of childbearing potential who are pregnant or breastfeeding or are planning pregnancy within the time specified in the protocol or are potentially fertile males, who are planning to father children during the study or within the time specified in the protocol.\n* Are subject to exclusion periods from another investigational study.\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have urine protein ≥2+ and 24-hour urine protein excretion ≥1 g. If qualitative urine protein is ≤1+, a 24-hour urine protein quantitative test is not required.\n* Have a history of Grade ≥3 immune-related adverse events that led to treatment discontinuation of a prior checkpoint inhibitor.\n* Have a significant risk of hemorrhage (per investigator clinical judgment) indicated by protocol defined criteria.\n* Have active or chronic clinically significant corneal disorders or any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":482,"type":23},880,[92,63],"This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) in participants with relapsed, progressive as well as treatment-naïve, advanced\u002Fmetastatic non-small cell lung cancer (NSCLC).\n\nThis study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).\n\nThe main goals of this study are:\n\n1. To find the best dose levels (DLs) for the combination of BNT326 and pumitamig.\n2. To look at how well participants with advanced NSCLC tolerate the combination therapy (for example, which side effects participants experience and how severe they are).\n3. To look at how well the combination therapy works to shrink the tumor in participants with advanced NSCLC.",[283],[487,488,489,490,491,492,493,494,495,496,497,498],"Combination with other investigational agents","Programmed death-ligand 1 (PD-L1)","Antibody-drug conjugate (ADC)","Human epidermal growth factor receptor 3 (HER3)","Programmed Death-1 (PD-1)","Programmed Death-1 monoclonal antibodies","Anti vascular endothelial growth factor-A (anti-VEGF-A)","Bispecific antibody","Immunotherapy","Dose optimization","Time to progression","Vascular endothelial growth factor (VEGF)","2026-08-03",{"date":501,"type":42},"2026-08-05",{"date":503,"type":42},"2025-09-22",{"date":183,"type":23},{"name":506,"class":78},"BioNTech SE",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":61,"phases":516,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":50},"100610651","phase-1-a-phase-1b-open-label-study-to-evaluate-safety-of-plamotamab-in-participants-with-rheumatoid-arthritis-100610651","NCT07230353","A Phase 1b Open-label Study to Evaluate Safety of Plamotamab in Participants With Rheumatoid Arthritis","A Phase 1b, Open-label, Dose-Escalation Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Plamotamab in Participants With Rheumatoid Arthritis","Inclusion Criteria: Adult participants with moderately to severely active RA.\n\n* Documented diagnosis of RA and meeting the 2010 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology classification criteria for RA at least 3 months prior to screening\n* Inadequate response to, loss of response to, or intolerance to available RA therapies.\n* Stable doses of RA medications prior to screening\n* Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing\n* Recurrent infections or active clinically significant infection\n* Active or untreated latent tuberculosis\n* Cancer or history of cancer or lymphoproliferative disease within the previous 5 years\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n\nNote: Additional, more specific inclusion\u002Fexclusion criteria are defined in the protocol.",{"count":515,"type":23},68,[92],"The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.",[519],"Rheumatoid Arthritis",[521],"Rheumatoid Arthritis, Arthritis Rheumatoid, Arthritis","2026-07-31",{"date":499,"type":42},{"date":525,"type":42},"2025-10-21",{"date":527,"type":23},"2028-06",{"name":529,"class":78},"Xencor, Inc.",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":537,"targetDuration":4,"studyType":61,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":551},"100620897","phase-1-a-clinical-study-of-mk-1045-in-people-with-lupus-or-rheumatoid-arthritis-mk-1045-004-100620897","NCT07363590","A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)","A Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis","Inclusion Criteria:\n\n* Has a body mass index between 18 and 32 kg\u002Fm\\^2, inclusive\n* Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)\u002F American College of Rheumatology (ACR) 2019 classification criteria\n* SLE: Is taking at least one background therapy for SLE\n* RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA\n\nExclusion Criteria:\n\n* Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing\n* History of serious recurrent or chronic infection\n* Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus\n* Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB\n* Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE\n* For RA participants, has a history of any arthritis with onset before age 17 years\n* Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments\n* History of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years before Day 1 dosing\n* Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study.\n* Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening\n* Has a severe chronic pulmonary disease requiring oxygen therapy\n* Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease",{"count":538,"type":23},21,[92],"This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).",[542,519],"Systemic Lupus Erythematosus","2026-07-30",{"date":522,"type":42},{"date":546,"type":42},"2026-02-19",{"date":548,"type":23},"2029-07-16",{"name":550,"class":78},"Merck Sharp & Dohme LLC",19,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":559,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":560,"targetDuration":4,"studyType":61,"phases":561,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":580},"100622855","phase-1-a-study-on-ib-001-dose-response-and-tolerability-in-healthy-adults-and-those-with-chronic-hepatitis-b-100622855","NCT07389044","A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B","A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of Single and Multiple Ascending Doses of IB-001 in Healthy Participants and Participants With Chronic Hepatitis B","PART A: Healthy Volunteers\n\nInclusion Criteria:\n\n1. Able and willing to provide written informed consent.\n2. Male or female aged 18 to 70 years.\n3. Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use a highly effective method of contraception. Males whose partners are of childbearing potential must either be surgically sterile or willing to use a highly effective acceptable method of contraception.\n4. Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.\n\nExclusion Criteria:\n\nHealthy Volunteer participants must not meet any of the following criteria at Screening or upon admission to the site (on Day -1).\n\n1. Major surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study.\n2. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.\n3. Blood donation or blood loss of ≥ 1 unit (450 mL) of whole blood within 4 weeks before Screening or plasma donations within 7 days prior to dosing of investigational product (IP).\n4. Any underlying medical condition (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases).\n5. History of malignancy, except for non-melanoma skin cancer, excised more than 1 year prior to Screening or cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.\n6. Current hepatitis A virus (HAV) infection, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection.\n7. Positive test for HIV-1 or HIV-2 antibodies.\n8. Any other active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing.\n9. Clinically significant abnormalities on Screening ECG or history of cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and a QTcF \\> 450 ms (males) or QTcF \\> 470 ms (females) at Screening.\n10. Physical examination findings at Screening that are considered clinically significant by the Investigator and likely to adversely impact study conduct and\u002For interpretation.\n11. Clinically significant abnormal vital signs\n12. Laboratory abnormalities considered clinically significant by the Investigator at Screening. From Cohort A3 onwards, participants with blood platelet counts \\\u003C 150 × 109\u002FL or absolute neutrophil counts \\\u003C 1.5 × 109\u002FL will be excluded.\n13. Use of any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks of first dosing or within 5 times the elimination half-life of the medication prior to first dosing.\n14. Any suspicion or history of drug and\u002For alcohol abuse within the last year.\n15. Pregnant or planning to become pregnant during the course of the study, or currently breastfeeding.\n16. Use of more than 5 cigarettes, or equivalent, a day in the 3 months prior to Screening. Is unwilling to abstain from nicotine-containing products for 48 hours prior to admission to the site and during the in-house stay at the clinical research unit.\n17. Receipt of any investigational drug or product within 90 days of Study Day 1 or within 5 times the elimination half-life of the medication prior to first dosing with the IP, whichever is earlier. Receipt of an invasive medical device within 90 days before first dosing with the IP that in the opinion of the PI or designee may impact the ability of the participant to complete all protocol-required procedures. Participants must not have participated in interventional clinical studies more than 4 times per year.\n18. Use of any prescribed or over-the-counter medications (including vitamins, supplements, or herbal remedies) within 2 weeks of first dosing with the IP or within 5 times the elimination half-life of the medication prior to first dosing with the IP (whichever is longer). Note: Simple analgesia (paracetamol \\\u003C 2 g\u002Fday, nonsteroidal anti-inflammatory drug \\[NSAID\\] at therapeutic doses) may be permitted at the discretion of the PI, and may only be used as premedication prior to dosing of IP if recommended by the SRC.\n19. Has received live vaccine(s) within 28 days of Screening or plans to receive live vaccines within 28 days of dosing with the IP on Study Day 1. Note: COVID-19 vaccines are not considered live vaccines.\n20. Any suspicion or history of drug and\u002For alcohol abuse within the last year.\n21. Positive toxicology Screening panel (urine test including qualitative identification of tetrahydrocannabinol, cocaine, amphetamines, benzodiazepines, opiates, methadone, methamphetamines, ecstasy, and phencyclidine).\n22. Positive alcohol breath test at Screening and\u002For on Study Day -1.\n23. History (within 90 days of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before dosing with the IP on Study Day 1, and during the in-house stay at the clinical research unit.\n24. Uses more than 5 cigarettes, or equivalent, per day in the 3 months prior to Screening, and\u002For is unwilling to abstain from nicotine-containing products for 48 hours prior to admission to the site and during the in-house stay at the clinical research unit.\n25. Pregnant (positive serum pregnancy test at Screening or a positive urine pregnancy test predose on Study Day -1), planning to become pregnant during the course of the study, or currently breastfeeding.\n26. Any other factor that makes it inappropriate for study participation per the Investigator's judgment.\n\nPART B: Participants with Chronic Hepatitis B (CHB)\n\nInclusion Criteria:\n\n1. Able and willing to provide written informed consent.\n2. Male or female aged 18 to 70 years,\n3. BMI between 18 and 35 kg\u002Fm2.\n4. Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use a highly effective method of contraception. Males whose partners are of childbearing potential must either be surgically sterile or willing to use a highly effective acceptable method of contraception.\n5. Diagnosed with CHB and are HBeAg-negative (on 2 occasions at least 6 months apart) and have HBsAg titers of ≥ 100 IU\u002FmL at Screening.\n6. Participants must be treatment naive (i.e., have never received treatment with HBV antiviral medicines \\[NUCs, IFN\\] or an investigational anti-HBV agent) or currently not treated (i.e., not been on treatment with approved \\[NUCs, IFN\\] or investigational anti-HBV medicines within 12 months prior to randomization).\n7. Vital signs and physical examination are normal, or abnormal values are not clinically significant in the opinion of the Investigator.\n\nExclusion Criteria:\n\n1. Evidence or history of liver disease of non-HBV etiology, including but not limited to HAV, HCV, HDV, or HEV (endemic regions only) infections; drug- or alcohol-related liver disease; autoimmune hepatitis; hemochromatosis; Wilson's disease; α-1 antitrypsin deficiency; primary biliary cirrhosis; primary sclerosing cholangitis; non-alcoholic steatohepatitis; or any other non-HBV liver disease considered clinically significant by the Investigator. Participants with metabolic dysfunction-associated steatotic liver disease without any signs of steatohepatitis or those with documented Gilbert's Syndrome, are eligible.\n2. Diagnosed or suspected hepatocellular carcinoma (HCC).\n3. Significant liver fibrosis or cirrhosis (FibroScan result \\> 8.5 kPa within 12 months of Screening; Prior liver biopsy with Metavir F3 fibrosis or F4 cirrhosis within 2 years of Screening; AST-to-Platelet Index (APRI) \\> 1 and FibroTest result \\> 0.5 within 12 months of Screening).\n4. Positive for HIV-1 or HIV-2 at Screening.\n5. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing of investigational product (IP).\n6. Any of the following clinical laboratory values at Screening: ALT or AST ≥ 3 × ULN; blood platelet counts \\\u003C 120 × 109\u002FL; absolute neutrophil count \\\u003C 1.3 × 109\u002FL; hemoglobin \\\u003C 10.0 g\u002FdL; serum total bilirubin ≥ 1 × ULN (Note: for participants with documented Gilbert's Syndrome, total bilirubin ≥ 2 × ULN is acceptable); serum albumin \\\u003C 35 g\u002FL; eGFR of \\\u003C 60 mL\u002Fmin\u002F1.73 m2; INR \\> 1.2 × ULN.\n7. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or constituents.\n8. Blood donation or blood loss of ≥ 1 unit (450 mL) of whole blood within 4 weeks before Screening or plasma donations within 7 days prior to first dosing with the IP.\n9. History or presence of immune-mediated disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, psoriasis of greater than mild severity, autoimmune uveitis), or cerebrovascular, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease (thyroid stimulating hormone \\[TSH\\] \\> 10 or \\\u003C 0.4 mU\u002FL), or uncontrolled seizure disorder, as determined by the Investigator. Participants who are positive for anti-thyroglobulin antibodies or anti-thyroid peroxidase antibodies will be excluded.\n10. History or presence of significant (as judged by the Investigator) cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological disorders, or diagnosed central or peripheral neurological disease, capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a safety-related risk when taking the study treatment, requiring premedication, or of interfering with the interpretation of the data.\n11. Clinically significant 12-lead ECG abnormalities on Screening ECG or history of cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and QTcF \\> 450 ms for males or QTcF \\> 470 ms for females at Screening.\n12. Physical examination findings that are considered clinically significant by the Investigator and likely to adversely impact study conduct and\u002For interpretation.\n13. Clinically significant abnormal vital signs, confirmed with retesting after at least 5 minutes of additional rest.\n14. History (within 90 days of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).\n15. Positive alcohol breath test at Screening and\u002For on Study Day 1. Alcohol consumption will be prohibited at least 48 hours before each dose with the IP, and during any in-house stays in the clinical research unit or investigational site (if applicable).\n16. Use of more than 5 cigarettes per day or equivalent (e.g., cigarettes, vapes, nicotine patches, cigars, chewing tobacco) in the 3 months prior to Screening. Nicotine-containing products (eg, cigars, cigarettes, vapes) will be prohibited at least 48 hours before each dose with the IP, and during any in-house stays in the clinical research unit or investigational site (if applicable).\n17. Participants must not have participated in interventional clinical studies more than 4 times per year. Receipt of any investigational drug or product within 90-days of Study Day 1 or within 5 times the elimination half-life of the medication prior to first dosing with the IP, whichever is earlier. Receipt of a device within 90 days before first dosing with the IP that in the opinion of the Investigator may impact the ability of the participant to complete all protocol-required procedures or testing.\n18. Received solid organ or bone marrow transplant.\n19. Any immunosuppressing, immunomodulator (e.g., thymosin) or cytotoxic drug administrations within 6 months before first dosing with the IP (Day 1).\n20. Received any antiplatelet (e.g., aspirin, clopidogrel) or antithrombotic therapy (e.g., warfarin, dabigatran, apixaban) within 14 days prior to first dosing with the IP and throughout the study.\n21. Has received live vaccine(s) within 28 days of Screening or plans to receive live vaccines within 28 days of dosing with the IP. Note: COVID-19 vaccines are not considered live vaccines.\n22. Use of corticosteroids above 5 mg\u002Fday of prednisone (or equivalent) or other immunosuppressive medications within 4 weeks prior to Screening. Note: topical, intra-articular and inhaled steroids allowed.\n23. Use of any herbal medicines or supplements within 3 months prior to Screening visit that are known to be hepatotoxic based on Investigator's opinion or who have initiated any new herbal medicine or supplement within 30 days prior to Study Day 1. Eligibility to participate should be discussed with the Sponsor's medical representative.\n24. Pregnant (positive serum pregnancy test at Screening or a positive urine pregnancy test predose on Study Day 1), planning to become pregnant during the course of the study, or currently breastfeeding.\n25. Any other factor that makes it inappropriate for study participation per the Investigator's judgment.\n\nOther prohibited medications during the study: Treatments that may increase ALT or AST (eg, augmentin, \\> 2 g paracetamol\u002Fday, initiating treatment with an HMG-CoA \\[3-hydroxy-3-methylglutaryl coenzyme A\\] reductase inhibitor \\[statins\\]) should be avoided. The use of these drugs, if necessary, should be discussed with the PI or Sponsor's medical representative or designee, preferably before initiation of their administration. Simple analgesia (paracetamol \\\u003C 2 g\u002Fday, NSAID at therapeutic doses) may be prescribed as premedication prior to dosing of IP, if recommended by the SRC.",true,{"count":439,"type":23},[92],"This study will examine the safety and tolerability of single and multiple doses of IB-001, and will be conducted in two parts:\n\nPart A: SAD study in approximately 50 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).",[564],"Chronic Hepatitis B Virus Infection",[566,567,568,569,570,571],"First in Human","Hepatitis B virus","HBV","Chronic Hepatitis B","Dose finding","Dose Ranging","2026-07-29",{"date":543,"type":42},{"date":575,"type":42},"2026-02-20",{"date":577,"type":23},"2027-07-01",{"name":579,"class":78},"IntegerBio",2,{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":559,"sex":18,"minAge":19,"maxAge":588,"enrollmentInfo":589,"targetDuration":4,"studyType":61,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":452},"100600338","phase-1-study-of-gs-4321-in-healthy-participants-and-participants-with-chronic-hepatitis-delta-virus-100600338","NCT07096193","Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus","Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta","Key Inclusion Criteria:\n\nPart A:\n\n* Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n* Have a body mass index (BMI) of ≤ 30.0 kg\u002Fm2 at screening and at admission.\n\nPart B:\n\n* Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n* Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.\n* Must be receiving a commercially available entecavir, TAF, or TDF for the treatment of hepatitis B virus (HBV) infection at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of HIV is permitted.\n* Non-cirrhotic or compensated cirrhosis.\n* Hepatitis delta virus ribonucleic acid (HDV RNA ) \\> 500 IU\u002FmL at screening.\n* Alanine aminotransferase (ALT) level \\> 1 × Upper limit of normal (ULN), but \\\u003C 10 × ULN at screening.\n\nKey Exclusion Criteria:\n\nPart A:\n\n* Positive serum or urine pregnancy test.\n* Participants with plans to breastfeed during the study period.\n\nPart B:\n\n* Positive serum or urine pregnancy test.\n* Participants with plans to breastfeed during the study period.\n* Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.\n* Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","69 Years",{"count":590,"type":23},200,[92,63],"The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD).\n\nThe primary objective of Phase 1 of this study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of the escalating single doses of GS-4321 administered in healthy participants.\n\nThe primary objective of Phase 2 of this study is to evaluate the efficacy and safety of the multiple escalating doses of GS-4321 in participants with CHD.",[594],"Chronic Hepatitis Delta",{"date":543,"type":42},{"date":597,"type":42},"2025-07-31",{"date":599,"type":23},"2030-01",{"name":601,"class":78},"Gilead Sciences",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":61,"phases":611,"briefSummary":612,"conditions":613,"keywords":618,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":633},"100532986","phase-2-azd0901-in-participants-with-advanced-solid-tumours-expressing-claudin182-100532986","NCT06219941","AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2","A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)","The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.\n\nMaster Inclusion Criteria applicable to all sub studies:\n\n* Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.\n* Participants who are CLDN18.2 positive.\n* Must have at least one measurable lesion according to RECIST v1.1.\n* ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.\n* Predicted life expectancy of ≥ 12 weeks.\n* Adequate organ and bone marrow function as defined by protocol.\n* Body weight \\> 35 kg.\n* Participants are willing to comply with contraception requirements.\n\nSub study 1 Specific Inclusion criteria:\n\n* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* Advanced or metastatic GC\u002FGEJC.\n* Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nSub study 2 Specific Inclusion criteria:\n\n* Participants diagnosed with histologically confirmed metastatic or advanced PDAC.\n* Availability of an archival sample or a fresh tumour biopsy taken at screening.\n* No prior treatments for unresectable or metastatic disease. Prior neoadjuvant\u002Fadjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.\n\nSub study 3 Specific Inclusion criteria\n\n* Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).\n* Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nMaster Exclusion Criteria applicable to all sub studies:\n\n* Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n* Participants with clinically significant ascites that require drainage.\n* A history of drug-induced non-infectious ILD\u002Fpneumonitis.\n* Central nervous system metastases or CNS pathology.\n* Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.\n* History of another primary malignancy.\n* Prior exposure to any MMAE-based ADC.\n* Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.\n\nSub study 1 Specific Exclusion criteria:\n\n* Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC\u002FGEJC unless they have failed\u002Fnot tolerated\u002For are not eligible for standard anti-HER2 therapy, where available.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.\n* The use of concomitant medications known to prolong the QT\u002FQTc interval.\n\nSub study 2 Specific Exclusion criteria:\n\n* Known DPD enzyme deficiency based on local testing where testing is SoC.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Use of strong inhibitors or inducers of CYP3A4.\n* Known homozygous for the UGT1A1\\*28 allele based on local testing where testing is SoC.\n\nSub study 3 Specific Exclusion criteria\n\n• Clinically significant biliary obstruction that has not resolved before enrollment.",{"count":610,"type":23},226,[63],"The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.",[614,615,616,617],"Gastric Cancer","Gastroesophageal Junction Cancer","Biliary Tract Cancer","Pancreatic Ductal Adenocarcinoma",[619,620,621,616,622,623,624],"Gastric cancer","Gastroesophageal junction cancer","Pancreatic Ductal adenocarcinoma","Phase II","Claudin 18.2","AZD0901","2026-07-28",{"date":572,"type":42},{"date":628,"type":42},"2023-12-13",{"date":630,"type":23},"2027-06-28",{"name":632,"class":78},"AstraZeneca",52,{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":559,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":641,"targetDuration":4,"studyType":61,"phases":643,"briefSummary":644,"conditions":645,"keywords":646,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":662,"locationsCount":107},"100608930","phase-1-study-of-lfd-200-in-healthy-adults-and-adults-with-moderate-to-severe-rheumatoid-arthritis-100608930","NCT07207954","Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis","A Phase 1a\u002F1b, Randomized, Double-Blind, Placebo- and Active-Controlled, Single and Multiple Ascending Dose Study Evaluating the Comparative Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFD-200 in Adult Participants Who Are Healthy or Have Moderate to Severe Rheumatoid Arthritis","Inclusion Criteria for Healthy Participants:\n\n* Age 18-55\n* BMI - 18-32\n* Participants must be deemed by the Investigator to be generally healthy individuals based on a medical evaluation that includes a physical examination, medical history, vital signs, and the results from clinical labs and other safety assessments collected during the Screening period.\n\nExclusion Criteria for Healthy Participants:\n\n* Participants with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional, unacceptable risk to the participant or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation.\n* Recent serious or ongoing infection\n* Known\u002Fsuspected primary immunodeficiency\n* Receipt of injected or systemic glucocorticoids within 6 weeks prior to screening\n* Use of prohibited medications\n* Any of the following lab abnormalities:\n\n  * White blood cell (WBC) count \\\u003C3.0 x 109\u002FL\n  * Absolute neutrophil count (ANC) \\\u003C2.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\\u003C12.5 g\u002FdL for males and \\\u003C11.5 g\u002FdL for females\n  * Platelet count \\\u003C140 x 109\u002FL\n  * Alanine transaminase (ALT) ≥1.2x upper limit of normal (ULN)\n  * Total bilirubin ≥1.2x ULN (except if Gilbert's disease is suspected etiology)\n  * Estimated glomerular filtration rate (eGFR) \\\u003C80 mL\u002Fmin\u002F1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula.\n  * International normalized ratio (INR) ≥1.2 × ULN\n  * Glycated hemoglobin (HbA1c) \\>6%\n  * Positive urine cotinine test (Day -1 only), alcohol breath test or urine drug screen for substances of abuse. Positive tetrahydrocannabinol (THC) is not exclusionary.\n  * A Screening thyroid stimulating hormone (TSH) level that is \\\u003C0.9 × lower limit normal (LLN) or ≥1.2 × ULN\n  * Cortisol level \\\u003C1.0 × LLN (Collected in the AM at the Baseline Visit)\n\nInclusion Criteria for RA Participants:\n\n* Adults of age 18 to 75 years, inclusive, at the time of signing the ICF.\n* BMI within the range of 18.0- to 35.0 kg\u002Fm² (inclusive).\n* Has RA for ≥6 months.\n* Positive rheumatoid factor (RF) or anti-citrullinated protein antibody (ACPA) test at Screening (low or high positive acceptable).\n* A high-sensitivity C-reactive protein (hsCRP) level at Screening must be \\>ULN.\n* Has active RA disease defined as follows:\n\n  * Disease Activity Score of 28 joints-CRP (DAS28-CRP) \\>3.2 at Screening and Baseline\n  * Has ≥4 swollen and ≥4 tender joints on a 28-joint count at Screening and Baseline\n* On MTX orally or subcutaneously for at least 12 weeks prior to Screening. Dose of MTX (including route of administration) must have been stable at 15 to 25 mg weekly (or 10 to15mg in case of documented intolerance) for ≥ 12weeks at Randomization with plans to continue it at the same dose and route of administration for the duration of the study.\n\nExclusion Criteria for RA Participants:\n\n* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases (e.g., cardiac \\[including congestive heart failure, angina, or history of myocardial infarction\\], pulmonary \\[including chronic obstructive pulmonary disease, asthma requiring systemic GC therapy, pulmonary hypertension, or pulmonary fibrosis\\], hematologic, gastrointestinal, hepatic, renal, neurological, psychiatric, dermatologic, musculoskeletal, or infectious diseases) that, in the opinion of the Investigator or Sponsor, constitutes an inappropriate risk or contraindication for participation in study or that could interfere with study objectives, conduct, or evaluation\n* Any other autoimmune or autoinflammatory disorder, which in the opinion of Investigator\u002FSponsor would constitute an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.\n* Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection\n* Known seropositivity for or active infection by HIV or strongyloides (if at risk of exposure (e.g., travel from\u002Freside in endemic area))\n* Active or latent TB infection, as suggested by a positive chest radiograph OR positive\u002Findeterminate QFT-TB Gold Plus or T-SPOT within the 12 weeks prior to Screening or a positive Screening CXR or QFT test. Indeterminate screening QFT tests are also exclusionary but may be repeated once and will be considered positive if retest results are positive or indeterminate\u002Fborderline.\n* Clinically significant abnormalities on ECG per the Investigator or Sponsor or any of the following mean ECG parameters on screening\u002Fbaseline (triplicate) ECG:\n\n  * HR \\\u003C40 or \\>100 beats per minute\n  * QTcF (Fridericia corrected QT) interval \\>450 ms (males) or \\>470 ms (females)\n  * QRS interval \\>120 ms\n  * PR interval \\>220 ms\n* Use or anticipated use of medications for the timeframes specified below:\n\n  * Unstable use of any herbal medicines (e.g., St. John's wort) and supplements within 4 weeks prior to Screening through Baseline or anticipated changes in use during study.\n  * Systemic or local (e.g., topical, oral, ophthalmic) corticosteroid (CS) use within 6 weeks prior to randomization or anticipated use during the study (other than as study intervention).\n  * Any intra-articular injection within 4 weeks prior to Screening through Baseline or anticipated use during the study.\n  * Use of cyclophosphamide, chlorambucil, leflunomide for \\\u003C6 months or cyclosporine, mycophenolic acid, azathioprine, tacrolimus, or gold \\\u003C8 weeks prior to Screening through Baseline or anticipated use during the study.\n  * Receipt of rituximab or any other cell depleting biologic therapy within 1 year of Screening through Baseline or anticipated use during the study.\n  * Use of any other commercial injectable biologic (including those for other non- arthritic conditions such as asthma, osteoporosis, lipids, atopic dermatitis) within 12 weeks or 5 half-lives (whichever is longer) prior to Screening through Baseline, or anticipated use during the study.\n  * Use of any other oral DMARD, including JAK-inhibitors, within 12 weeks prior to Screening through Baseline or anticipated used during the study. MTX or HCQ use is permitted as specified in the Inclusion Criteria\n  * Use of \\>1 systemic biologic therapy for the treatment of RA prior to Screening or Baseline. For those participants that have used no more than one systemic biologic therapy, the systemic biologic therapy must have been discontinued at least 12 weeks or 5 half-lives (whichever is longer) prior to Screening with no use through Baseline or anticipated use during the study.\n  * Receiving or has received any investigational drug (or is currently using an investigational device) within 30 days or 5 half-lives (whichever is longer), prior to Screening.\n  * Unstable use of topical or systemic nonsteroidal anti-inflammatory drugs (NSAIDs) OR use above the maximum allowed doses OR use of more than 1 systemic NSAID (other than prophylactic aspirin ≤325mg daily) in the 2 weeks prior to Screening through Baseline or anticipated use during the study.\n* The presence at Screening of any laboratory values of concern in the opinion of the Investigator or Sponsor or of any of the below based on central laboratory testing at Screening:\n\n  * WBC count \\\u003C3.0 × 10⁹\u002FL\n  * ANC \\\u003C2.0 × 10⁹\u002FL\n  * Hgb \\\u003C10 g\u002FdL\n  * Platelet count \\\u003C100 × 10⁹\u002FL\n  * ALT \\>2 × ULN\n  * Total bilirubin ≥1.5 × ULN (unless Gilbert's disease is suspected)\n  * eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² estimated based on CKD-EPI 2021 formula\n  * International normalized ratio \\>1.2 × ULN\n  * HbA1c \\>8%\n  * AM cortisol level at Baseline Visit \\\u003C0.9 × LLN\n  * Positive alcohol breath test or urine drug screen for substances of abuse. Positive THC or positivity for other substances due to ongoing use of these drugs under physician supervision (e.g., prescription narcotics for known pain disorder) are not exclusionary.\n  * A Screening TSH level that is \\\u003C0.9 × LLN or \\> 1.1 × ULN.",{"count":642,"type":23},176,[92],"This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. The study design includes: a single ascending dose (SAD) study in up to 66 adult healthy participants (HPs) to investigate the effects of a single SC dose, with a 30-day follow-up; a multiple ascending dose (MAD) study in up to 40 HPs to assess up to 4 weekly SC doses, with a 30-day follow-up after the last dose; and a MAD study in up to 70 participants with moderate to severe rheumatoid arthritis (RA) to evaluate up to 13 weekly SC doses, with a 30-day follow-up after the last dose.",[519],[647,519,648,649,650,651,652,653,654,655,656],"RA","Healthy Participants","Phase 1a\u002F1b","Safety","Tolerability","Pharmacokinetics","Pharmacodynamics","First in human","Single Ascending Dose","Multiple Ascending Dose","2026-07-24",{"date":625,"type":42},{"date":660,"type":42},"2025-10-06",{"date":323,"type":23},{"name":663,"class":78},"Lifordi Immunotherapeutics, Inc.",{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":559,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":671,"targetDuration":4,"studyType":61,"phases":673,"briefSummary":674,"conditions":675,"keywords":677,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":682,"completionDateStruct":684,"leadSponsor":686,"locationsCount":117},"100563732","phase-1-study-of-xmab942-in-healthy-participants-and-participants-with-ulcerative-colitis-100563732","NCT06619990","Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study in Participants With Moderate-To-Severe Active Ulcerative Colitis.","Inclusion Criteria:\n\nParts A and B\n\n* Age 18-55\n* Must be in good health with no significant medical history\n* Clinical laboratory values within normal range\n* BMI 18-35 (inclusive)\n* Contraceptive use by men or women consistent with local regulations\n* Able and willing to provide written informed consent\n\nPart C\n\n* Age 18-75\n* Must be in good health with no significant medical history\n* UC diagnosis ≥ 3 months prior to screening\n* Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1\n* Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy\n* Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies of UC\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\nParts A and B\n\n* Any physical or psychological condition that prohibits study completion\n* History of suicidal behavior or suicidal ideation\n* Heavy use of nicotine containing products\n* HIV, hepatitis B and hepatitis C positive\n* Cardiac arrhythmia, or clinically significant abnormal ECG\n* Active use of prescription medications within 14 days of Day -1\n* Active use of over-the-counter, or herbal medication within 7 days of Screening\n* Other investigational products within 30 days\n* Blood or plasma donation within 60 days\n* Pregnant or breastfeeding\n\nPart C\n\n* Any physical or psychological condition that prohibits study participation\n* Diagnosis of Crohn disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.\n* Positive screen for Clostridium difficile (C. Difficile) toxins\n* HIV, hepatitis B and hepatitis C positive\n* Cardiac arrhythmia, or clinically significant abnormal ECG\n* Pregnant or breastfeeding\n\nOther protocol defined inclusion\u002Fexclusion criteria apply.",{"count":672,"type":23},270,[92,63],"The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).",[676],"Ulcerative Colitis (UC)",[66,678,679],"Inflammatory Bowel Disease","Healthy Volunteers","2026-07-22",{"date":657,"type":42},{"date":683,"type":42},"2024-10-10",{"date":685,"type":23},"2029-01",{"name":529,"class":78},""]