[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GlaxoSmithKline\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":680},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,94,0,25,[9,50,79,106,132,164,193,221,245,268,295,320,347,373,404,431,453,477,507,529,553,577,603,629,655],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100614956","phase-3-a-study-to-investigate-mocertatug-rezetecan-compared-with-chemotherapy-in-participants-with-endometrial-cancer-after-platinum-based-chemotherapy-and-immunotherapy-behold-endometrial01-100614956",false,"NCT07286331","A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)","A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).\n* Has histologically confirmed endometrial carcinoma including but not limited to endometroid, serous, clear cell, and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted.\n* Has undergone at least 1 and no more than 2 lines of prior systemic treatment for EC. Up to 3 lines of prior systemic treatment are acceptable if one line was administered in the adjuvant\u002Fneo-adjuvant setting. The definition of prior lines of therapy is as follows:\n\n  * Adjuvant ± neo-adjuvant therapy counts as one line of treatment.\n  * Maintenance therapy is considered part of the preceding line and does not count as an independent line.\n  * Switching to another agent within the same class due to toxicity (without disease progression) is considered part of the same line of therapy.\n  * Unplanned addition or switching to a new anti-cancer therapy in a different class is considered a separate line of therapy.\n  * Hormonal therapy is NOT counted as a separate line.\n* Must have progressed on or after prior platinum-based chemotherapy and have received anti- Programmed cell death 1 (PD-1) \u002Fanti- Programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination. Participants deemed unsuitable for a prior PD-1\u002FPD-L1 inhibitor therapy (contraindications such as immunodeficiency, autoimmune disease that required systemic treatment) as determined by the investigator or treating physician are eligible.\n* Participants must have a platinum-free interval of less than 12 months if they previously received platinum-based therapy solely in the adjuvant setting. The platinum-free interval is defined as the date of the last dose of platinum-based chemotherapy to the date of disease progression.\n\n  * If PD-L1\u002FPD-1 inhibitor therapy was administered with platinum-based treatment, participant is eligible regardless of whether the Platinum-free interval (PFI) exceeds 12 months.\n  * Participants with metastatic disease who underwent treatment including gynecological surgery followed by a platinum-based regimen, or those deemed intolerant to platinum-based therapy, are eligible regardless of whether the PFI exceeds 12 months.\n* Has provided a Formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample sufficient for the central assessment of B7 homolog 4 protein (B7-H4) expression, with the result of B7-H4 expression testing available prior to date of randomization.\n* Has ≥1 Target Lesion per RECIST 1.1 by BICR eligibility review of screening scans.\n* Is willing to use adequate contraception. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:\n\n  * Is a Participant of non-childbearing potential (PONCBP) OR\n  * Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, 30 days prior to Cycle 1 Day 1 (C1D1) and during the study intervention period and for at least 8 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n* A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n\n  * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n  * Additional requirements for pregnancy testing during and after study intervention are described in protocol.\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy.\n* Is capable of giving signed informed consent including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has adequate organ function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has untreated brain or Central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain\u002FCNS metastases). Participants with previously treated and clinically stable brain\u002FCNS metastases and who have completed all corticosteroid therapy for ≥14 days before date of C1D1 are not excluded from participation.\n* Has any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.\n* Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤ Grade 1 or to the baseline status preceding prior therapy, excluding alopecia, hearing loss, vitiligo and endocrinopathy managed with replacement therapy, or that the investigator, with the agreement of the sponsor, considers to be stable or not clinically relevant for the tolerability of study intervention in the current clinical study.\n* Has any serious and\u002For unstable medical condition (including infection) or any serious and\u002For unstable psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.\n* Has had any major surgery within 28 days prior to date of C1D1 or history of local radiotherapy within 21 days prior to C1D1.\n* Has received treatment with an investigational agent within 30 days prior to C1D1.\n* Has received prior therapy with Topo1i (e.g. irinotecan or topotecan) or ADC with a Topo1i payload, or B7-H4 targeted therapy.\n* Has received treatment with any cytotoxic chemotherapy drugs or other antitumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy and investigational drug) within 30 days or 5 half-lives, whichever is shorter, prior to C1D1; or need to continue these drugs during the study.\n* Has received any live vaccine within 30 days prior to C1D1.Note: mRNA and adenoviral-based Coronavirus disease 2019 (COVID-19) vaccines are considered non-live.\n* Has received treatment with inhibitors of P-glycoprotein (P-gp), Breast cancer resistant protein (BCRP), or OATP1B1\u002F1B3 transporters within 7 days prior to first dose of study drug. P-gp inducers should be discontinued for at least 14 days before the start of the study drug.\n* Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony stimulating factor (G-CSF), Granulocyte-macrophage colony stimulating factor (GM-CSF), or recombinant erythropoietin) within 14 days prior to C1D1.\n* Has a known Human immunodeficiency virus (HIV) infection AND meets at least 1 of the following criteria:\n\n  * Has documented evidence of plasma HIV-1 Ribonucleic acid (RNA) ≥50 c\u002FmL within 3 months prior to or at screening. In the 3 to 12 months prior to screening, plasma HIV1 RNA levels consistently \\\u003C50 c\u002FmL are required for enrollment; if multiple instances of plasma HIV-1 RNA values ≥50 c\u002FmL occurred in the 3 to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR\n  * Has not had Cluster of differentiation (CD)4 cell counts measured in the past 12 months (i.e., at least 2 separate measurements taken a minimum of 28 days apart, 1 of which must be conducted at screening); OR\n  * Has had any CD4 cell count values ≤350 cells\u002Fmm3 in the past 12 months. OR\n  * Has had 1 or more changes in their combination antiretroviral therapy regimen or has received an antiretroviral therapy regimen that is inconsistent with locally recommended guidelines during the 3 months prior to screening; OR\n  * Has a history of HIV-associated non-Hodgkin lymphoma within 5 years prior to screening or a history of HIV-associated invasive cervical cancer; OR\n  * Has received treatment with an HIV1 immunotherapeutic vaccine within 90 days prior to screening.\n* Has an Alanine aminotransferase (ALT) value \\>2.5× Upper limit of normal (ULN) and\u002For for participants documented liver metastases\u002Ftumor infiltration has an ALT value \\>5x ULN\n* Has a total bilirubin value \\>1.5x ULN.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Has documented presence of Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb) at screening unless they meet both the following criteria:\n\n  * Participants with chronic Hepatitis B virus (HBV) infection (HBsAg+) or positive HBcAb are required to be receiving effective antiviral therapy (i.e., with nucleos(t)ide analogs \\[Tenofovir or Entecavir\\]) for at least 14 days prior to C1D1 and are willing to continue for at least 6 months after treatment discontinuation or longer at the discretion of the treating hepatologist.\n  * HBV Deoxyribonucleic acid (DNA) must be adequately suppressed, as per institutional or local guidelines, prior to initiation of study intervention.\n* Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to C1D1 unless HCV RNA is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment.\n* Has a positive HCV RNA test result at screening or within 3 months prior to C1D1.\n* Has QTc \\>470 milliseconds (msec)\n* Has a history within 12 months prior to screening of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure \\[NYHA 1994\\], or clinically significant arrhythmia not controlled by standard of care therapy.\n* Has Left ventricular ejection fraction (LVEF) \\\u003C50% or less than institutional lower limit of normal.\n* Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).","FEMALE","18 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care. The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to standard of care and will help provide a better understanding of the main side effects of the drugs.",[27],"Neoplasms, Endometrial",[29,30,31,32,33,34,35,36],"Endometrial Cancer","Mocertatug rezetecan","Mo-Rez","GSK5733584","Paclitaxel","Doxorubicin","Antibody-drug conjugate","BEHOLD-Endometrial01","RECRUITING","2026-07-01",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":41},"2026-06-04",{"date":45,"type":21},"2029-05-30",{"name":47,"class":48},"GlaxoSmithKline","INDUSTRY",14,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100608399","phase-2-a-study-to-assess-the-effectiveness-and-safety-of-gsk3862995b-in-adults-with-bronchiectasis-100608399","NCT07201051","A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis","A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants With Bronchiectasis","Inclusion Criteria:\n\n* Body mass index (BMI) between 18-35 kilograms per square meters (kg\u002Fm\\^2)\n* Clinical history consistent with bronchiectasis (cough, chronic sputum production, and\u002For recurrent respiratory infections) that is confirmed on chest computed tomography (CT)\n* Meet one of the two criteria:\n\n  * In the 12 months prior to screening, have had 2 or more documented pulmonary exacerbations that required a new antibiotic prescription by a physician or 1 pulmonary exacerbation that required hospitalization; or\n  * In the 12 months prior to screening, have had 0 or 1 pulmonary exacerbation and a QOL-B RSS of less than (\\\u003C)50 at screening\n* Current sputum producers\n* Post-bronchodilator FEV1 greater than or equal to (\\>=) 30 percent (%) or greater of predicted normal value\n* Non-smokers or former cigarette smokers\n* Males and females of childbearing and non-childbearing potential\n* A female participant is eligible to participate if she is not pregnant or breastfeeding\n* Is a Woman of non-childbearing potential (WONCBP) or is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1\n* A WOCBP must have a negative highly sensitive serum pregnancy test within 28 days before the first dose of study intervention\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol\n\nExclusion Criteria:\n\n* Participants with a primary diagnosis of asthma or Chronic Obstructive Pulmonary Disorder (COPD) as judged by the investigator\n* Bronchiectasis due to cystic fibrosis, alpha-1-antitrypsin deficiency, common variable immunodeficiency, hypogammaglobinemia, or traction bronchiectasis due to fibrotic lung disease\n* Active non-tuberculosis mycobacterial (NTM) lung infection on treatment or meeting ATS\u002FInfectious Diseases Society of America (IDSA) criteria for active lung infection\n* Active tuberculosis, untreated latent Tuberculosis (TB), invasive fungal lung infections or allergic bronchopulmonary aspergillosis needing treatment\n* Participant uses long-term oxygen therapy for more than 12 hours per day\n* Participants with an acute lower respiratory tract pulmonary infection needing treatment or pulmonary exacerbation within 4 weeks of the screening visit.\n* Participant has a past or current medical condition(s) or disease(s) that is\u002Fare not well controlled and, which in the judgment of the Investigator, may affect participant safety or affect study endpoints\n* Participants with an unstable cardiac disease, myocardial infarction, Cerebrovascular Accident (CVA), stroke or New York Heart Association Class III or IV heart failure within 12 months prior to screening\n* Participants with clinically significant abnormal Electrocardiogram (ECG) at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints\n* Significant allergies to humanized monoclonal antibodies\n* Participants with a history of lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected for cure with no evidence of recurrence or metastatic disease for 1-year\n* A known or suspected immunodeficiency that has led to opportunistic infections, recurrent invasive infections, or prolonged infections that suggest an underlying immunocompromised state by the judgement of the investigator. Positive HIV antibody test\n* Alanine aminotransferase (ALT) \\>2x Upper limit of normal (ULN)\n* Total bilirubin \\>1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5xULN as long as direct bilirubin is less than or equal to (\\\u003C=)1.5xULN\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n* Presence of hepatitis B surface antigen (Hepatitis B surface antigen \\[HBsAg\\]) and\u002For hepatitis B core antibody (Hepatitis B core antibody \\[HBcAb\\]) at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C Hepatitis B core antibody (RNA) test result at screening or within 3 months prior to first dose of study intervention\n* Corrected QT interval (QTc) \\>450 milliseconds (msec) at screening visit based on the average of triplicate ECGs The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","85 Years",{"count":60,"type":21},446,[62],"PHASE2","This study is designed to find out how effective and safe a new drug, GSK3862995B, is for adult participants with bronchiectasis, a chronic lung disease. The study will also test how the body processes the drug and to check for any immune reactions. Participants will be divided into groups randomly to receive either one of two different doses of the study drug or a placebo. The main goal of the study is to see how well the drug works compared to the placebo in helping those with bronchiectasis.",[65],"Bronchiectasis",[67,65,68,69,70,71],"GSK3862995B","Efficacy","Safety","Immunogenicity","Pharmacokinetics",{"date":40,"type":41},{"date":74,"type":41},"2025-10-30",{"date":76,"type":21},"2027-12-10",{"name":47,"class":48},45,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100591353","phase-3-depemokimab-asthma-imaging-and-bronchoscopy-sub-study-100591353","NCT06979323","Depemokimab Asthma Imaging and Bronchoscopy Sub-Study","The IMAGINE Study: A Phase 3b Open Label, Single Arm Study to Assess the Effect of Depemokimab on Airway Structure and Function in Asthma With Type 2 Inflammation Characterized by an Eosinophilic Phenotype Utilizing Quantitative High-resolution CT and Bronchoscopic Airway Sampling in a Sub Study","Inclusion Criteria:\n\n* Documented clinical diagnosis of asthma for greater than or equal to (\\>=) 2 years as per the National Heart, Lung, and Blood Institute guidelines (NHLBI, 2020) or GINA guidelines (GINA, 2024), or joint guidance from the British Thoracic Society, National Institute for Health and Care Excellence, and Scottish Intercollegiate Guidelines Network \\[NICE, 2024\\] along with the following: an eosinophilic phenotype as evidenced by a blood eosinophil count of \\>=300 cells\u002Fmicroliters (mcL) at screening or a documented history of blood eosinophil count \\>=300 cells\u002FmcL within 3 months prior to screening; Exhaled nitric oxide (FeNO) measure of \\>=25 parts per billion (ppb) recorded at screening; and a previously confirmed history of \\>= 2 exacerbations requiring treatment with systemic corticosteroid (SCS; intramuscular \\[IM\\], intravenous \\[IV\\], or oral), in the 12 months prior to screening, despite the use of medium to high dose Inhaled corticosteroids (ICS)\n* Uncontrolled asthma indicated by Astha Control Questionnaire-5 (ACQ-5) greater than (\\>) 1.5 recorded at screening\n* Persistent airflow obstruction as indicated by pre-bronchodilator Forced Expiration Volume in 1 second (FEV1) less than (\\\u003C) 80 percentage (%) predicted (GLI 2012) and recorded at screening\n* A well-documented requirement for regular treatment with medium or high dose ICS (in the 12 months prior to screening with or without maintenance oral corticosteroids \\[OCS\\])\n* Current treatment with at least one additional asthma controller medication, besides ICS, for at least 3 months \\[for example, Long-acting Beta 2 agonists \\[LABA\\], Long-acting muscarinic antagonists \\[LAMA\\], leukotriene receptor antagonist (LTRA), or theophylline\\]\n* Male Participants: No additional requirements for male participants\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: is a participant of non-childbearing potential (PONCBP) or is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency,\n* A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n* Capable of giving written informed consent,\n* For the bronchoscopy sub study participants who sign the Informed Consent for the biopsy sub study, the following additional eligibility criteria will apply:\n\n  * Participants not on maintenance OCS (oral corticosteroids) at the time of screening.\n  * Participants with post bronchodilator FEV1 \\>= 50% predicted\n  * Participants with no known increased risk for bleeding or clotting abnormalities including: No history of easy bleeding, bruising or known bleeding diathesis; No current anticoagulant and antiplatelet therapy; No acetylsalicylic acid use within 2 weeks of the planned procedure; Normal screening platelet count\n  * Participants with no specific contraindication to bronchoscopy with endobronchial biopsy in the opinion of the investigator\n  * No history of allergic reaction to local anesthesia or general anesthetic agent, whichever is relevant to the procedure being performed\n\nExclusion Criteria:\n\n* Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic obstructive pulmonary disease \\[COPD\\] other than asthma) are excluded\n* Participants with other conditions that could lead to elevated eosinophils such as hyper eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis\n* Participants who developed an exacerbation within 4 weeks before screening\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved\n* A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma\n* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening\n* Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic abnormalities or any other system abnormalities that are uncontrolled with standard treatment\n* Participants with current diagnosis of vasculitis\n* Participants who have a previous documented failure with anti-IL-5\u002F5R therapy\n* Participants who have received monoclonal antibody (mAb) therapy targeting IL 5\u002F5R, IL 4R\u002FIL 13, IL 33, IgE, or Thymic Stromal Lymphpoietin (TSLP) within 12 months or 5 terminal phase half-lives of the drug, whichever is longer prior to the screening. Authorized treatments for Coronavirus disease-2019 (COVID-19) are permitted\n* Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to the first dose of study intervention (this also includes investigational formulations of marketed products)\n* Previously participated in any clinical study with biologic treatments for asthma (for example, omalizumab, mepolizumab, dupilumab, reslizumab, benralizumab, other mAbs (including Tezepelumab) or depemokimab and received study intervention (including placebo) within 12 months prior to the first dose of study intervention\n* A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention\n* Current smokers or former smokers with a smoking history \\>=20 pack years (number of pack years = \\[number of cigarettes per day\u002F20\\] x number of years smoked) and vapers\n* Participants with allergy\u002Fintolerance to a mAb or biologic or any of the excipients of depemokimab\n* Participants who are pregnant or breastfeeding\n* Participants who have known evidence of lack of adherence to controller medications and\u002For ability to follow physician's recommendations\n* Participants who have occupational ionizing-radiation exposure exceeding 10 Millisievert (mSV) over 3 years as documented with a dosimeter; have been exposed to elevated ionizing radiation from research imaging studies, for example, Participation in a research study with a single positron emission tomography scan in the past 3 years, and Participation in a research study with 2 or more computed tomography (CT) scans in the past 3 years in the following anatomical regions: chest, abdomen, cardiac, or spine\n* Presence of metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis\n* Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator",{"count":87,"type":21},150,[24],"Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably.\\\\xa0The purpose of this study is to assess how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic participants with type 2 inflammation, characterized by an eosinophilic phenotype.",[91],"Asthma",[93,91,94,95,96,97,98],"Depemokimab","Type 2 Inflammation","Eosinophilic Phenotype","High Resolution Computed Tomography (HRCT)","Bronchoscopy","IMAGINE study",{"date":40,"type":41},{"date":101,"type":41},"2024-07-19",{"date":103,"type":21},"2028-02-11",{"name":47,"class":48},50,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100556651","study-to-assess-real-world-effectiveness-of-belimumab-for-treatment-of-adults-with-ln-100556651","NCT06527872","Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN","The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study","OBSErve-LN","Inclusion Criteria:\n\n* Participants to provide a signed informed consent at the time of enrollment per protocol,\n* Male or female aged 18 or over at initiation of belimumab,\n* Participants received belimumab in any formulation (subcutaneous or intravenous) for the treatment of active LN prescribed as per local label in combination with standard immunosuppressive therapy\u002Fies at initiation of belimumab,\n* Participants initiated belimumab 6 to 24 months prior to study enrollment,\n* Accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy at any time prior to belimumab initiation),\n* Biopsy-confirmed LN diagnosis at any time prior to belimumab initiation for treatment of LN\n* Class III (focal LN) with or without Class V (membranous LN),\n* Class IV (diffuse LN) with or without Class V,\n* Class V.\n\nExclusion Criteria:\n\n* Participants receiving renal replacement therapy (i.e., dialysis, kidney transplant, or those in end-stage kidney disease) at initiation of belimumab,\n* Participant is concomitantly receiving another SLE targeted monoclonal antibody (MAb), or a MAb expected to compromise immune responses, at initiation of belimumab,\n* Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies),\n* Participant is pregnant at the initiation of belimumab,\n* Participant with a kidney transplant at the initiation of belimumab,\n* Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.",{"count":115,"type":21},300,"OBSERVATIONAL","The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.",[119],"Lupus Nephritis",[121,122,112,123,124],"Belimumab","Lupus nephritis","Renal function","Real world data",{"date":40,"type":41},{"date":127,"type":41},"2024-10-04",{"date":129,"type":21},"2029-03-29",{"name":47,"class":48},7,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":57,"minAge":139,"maxAge":58,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100628643","phase-1-a-study-on-the-safety-and-immune-response-of-investigational-mrna-seasonal-flucovid-19-combination-vaccine-in-adults-100628643","NCT07464314","A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu\u002FCOVID-19 Combination Vaccine in Adults","A Phase 1, Observer-Blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of an Investigational mRNA Seasonal Flu\u002FCOVID-19 Combination Vaccine in Adults","Inclusion Criteria:\n\n1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver.\n2. Informed consent obtained from the participant prior to performance of any study-specific procedure.\n3. A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.\n4. Healthy participants or medically stable patients as established by medical history and clinical examination.\n5. Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n1. Any clinically significant laboratory abnormality.\n2. History of symptomatic influenza\u002F SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration.\n3. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.\n4. Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for \\>5 years.\n5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n6. History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.\n7. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).\n8. Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, or renal functional abnormality, as determined by physical examination and\u002For laboratory screening tests.\n9. History of hypersensitivity or allergic reaction to any previous influenza or COVID-19 vaccine.\n10. History of hypersensitivity or allergic reaction to any previous mRNA vaccine.\n11. Administration of any influenza vaccine within 181 days before the study intervention administration (Day -180 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.\n12. Administration of a SARS-CoV-2 antigen-containing vaccine in the period starting 91 days before the study intervention administration (Day -90 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.\n13. Administration of any mRNA-based vaccine in the period starting 29 days before the study intervention administration (Day -28 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.\n14. Administration of any other vaccine not foreseen by the study protocol in the period starting 29 days (Day -28 to Day 1) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.\n15. Other protocol-defined exclusion criteria may apply.","65 Years",{"count":141,"type":21},225,[143],"PHASE1","This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.",[146],"Influenza, Human+COVID-19",[148,149,150,151,152,153,154],"Influenza","COVID-19","SARS-CoV-2","mRNA vaccine","combination vaccine","immunogenicity","older adults","2026-06-29",{"date":157,"type":41},"2026-06-30",{"date":159,"type":41},"2026-03-09",{"date":161,"type":21},"2027-06-03",{"name":47,"class":48},12,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100639427","phase-2-study-of-alternative-and-approved-dosing-regimens-of-belantamab-mafodotin-bortezomib-and-dexamethasone-bvd-in-participants-with-relapsedrefractory-multiple-myeloma-100639427","NCT07614360","Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed\u002FRefractory Multiple Myeloma","A Phase 2, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Alternative and Approved Dosing Regimens of Belantamab Mafodotin in Combination With Bortezomib and Dexamethasone (BVd) in Participants With Relapsed\u002FRefractory Multiple Myeloma","DREAMM-16","Inclusion Criteria:\n\n* Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).\n* Has histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by the IMWG.\n* Previously treated with at least 2 prior lines of MM therapy, including a proteasome inhibitor and an immunomodulatory agent.\n* Has at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as at least 1 of the following:\n\n  * Urine M-protein excretion \\>=200 milligrams (mg)\u002F24 hours (\\>=0.2 grams \\[g\\]\u002F24 hours)\n  * Serum M-protein concentration \\>=0.5 grams per deciliter (g\u002FdL) (\\>=5.0 g\u002FL)\n  * Serum free light chain (FLC) assay: involved FLC level \\>=10 milligrams per deciliter (mg\u002FdL) (\\>=100 mg\u002FL) and an abnormal serum FLC ratio (less than \\[\\\u003C\\] 0.26 or greater than \\[\\>\\] 1.65).\n* Participants with a history of autologous stem cell transplants are eligible for study participation provided the following eligibility criteria are met:\n\n  * Transplant was \\> 100 days prior to study enrollment\n  * No active infection(s)\n  * Participant meets the remainder of the eligibility criteria\n* All prior treatment-related toxicities (defined by NCI-CTCAE version \\[v\\] 6.0) must be Grade less than or equal to (\\\u003C=)1 at the time of treatment assignment, except for alopecia (any grade), neuropathy (Grade \\\u003C=2), or endocrinopathy managed with replacement therapy (any grade).\n* Is willing to use adequate contraception male and female participants. Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n  1. Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 6 months after the last dose of belantamab mafodotin and 5 months after the last dose of bortezomib, whichever is longest, to allow for clearance of any altered sperm:\n\n     * Refrain from donating fresh unwashed semen PLUS either\n     * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), including any activity or passage of ejaculate to another person, and agree to remain abstinent. OR\n     * Must agree to use contraception\u002Fbarrier as detailed below:\n\n     Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1 percent (%) per year when having sexual intercourse with a partner who can become pregnant and is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females\n  2. Female participants are eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:\n\n     * Is a Person of non-childbearing potential (PONCBP) OR\n     * Is a Person of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency, during the study intervention period and for at 4 months after the last dose of belantamab mafodotin or 8 months after the last dose of bortezomib, whichever is longest, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n     * A POCBP must have a negative highly sensitive serum pregnancy tests within 72 hours before the first dose of study intervention.\n     * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a person with an early undetected pregnancy.\n* Is capable of giving signed informed consent.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Has adequate organ system functions as defined by the laboratory assessments.\n* Participants with a history of Hepatitis B virus (HBV) and\u002For Hepatitis C virus (HCV) and Human immunodeficiency virus (HIV) exposure are eligible under specific conditions.\n\nExclusion Criteria:\n\n* Intolerant to bortezomib\n* Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) or Primary Plasma Cell Leukemia (defined as circulating plasma cells \\>5%)\n* Has previous or concurrent invasive malignancy other than Multiple myeloma (MM), except:\n\nThe disease must be considered medically stable for at least 2 years; or\n\n* The participant must not be receiving active therapy, other than hormonal therapy for this disease.\n\n  * Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.\n  * Evidence of active mucosal or internal bleeding.\n  * Active infection requiring treatment\n  * Any major surgery within 4 weeks prior to the first dose of study drug. Exception allowed for bone stabilizing surgery after consultation with Medical Monitor.\n  * Active or history of venous and arterial thromboembolism within the past 3 months.\n  * Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.\n  * Current corneal epithelial disease except for mild punctate keratopathy\n  * Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.\n  * Participants after prior allogeneic stem cell transplant.\n  * Has received prior belantamab mafodotin therapy.\n  * Has received treatment with an investigational agent within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study drug. This includes prior treatment with a monoclonal antibody and any other B-cell maturation antigen (BCMA) targeting-therapy. The only exception is emergency use of a short course of systemic corticosteroids (equivalent to, or less than: dexamethasone 40 mg\u002Fday for a maximum of 4 days) before treatment.\n  * Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.\n  * Plasmapheresis within 7 days prior to the first dose of study treatment. Screening laboratory values must be performed after last plasmapheresis\n  * Has received any live vaccine within 30 days of randomization\u002Fenrollment. Vaccination against Coronavirus Disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms (e.g., Emergency Use Authorization, Conditional Marketing Authorization, or Marketing Authorization Application) are not exclusionary.\n  * Is currently enrolled or has participated in any other clinical study involving an investigational drug within 14 days or 5 half-lives (whichever is shorter) preceding the first dose of study intervention.\n  * Known Human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:\n* Established anti-retroviral therapy for at least 4 weeks and HIV viral; load \\\u003C400 copies\u002Fmilliliter (mL)\n* Cluster of differentiation 4 (CD4+) T-cell counts \\>=350 cells\u002Fmicroliter;\n* No history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months.\n\n  * Is pregnant, plan to become pregnant, or breastfeeding.\n  * Has an Alanine aminotransferase (ALT) value \\>2.5 times Upper limit of normal (ULN).\n  * Has a total bilirubin value \\>1.5 times ULN\n  * Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.\n  * Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to the first dose of study intervention unless HCV Ribonucleic acid (RNA) is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment.\n  * Has a positive HCV RNA test result at screening or within 3 months prior to the first dose of study intervention.\n  * Has documented presence of Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B virus antibody (HBcAb) at screening or within 3 months prior to the first dose of study intervention unless specific criteria are met.\n  * Evidence of cardiovascular risk including any of the following:\n* Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or third degree atrioventricular block.\n* History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Uncontrolled hypertension • Has QT interval corrected (QTc) \\>450 milliseconds (msec) or QTc \\>480 msec for participants with bundle branch block.",{"count":87,"type":21},[62],"The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy. The study will further characterize the risk of ocular toxicity and impact on efficacy measures and PK evaluations using alternative and approved dosing regimens.",[176],"Multiple Myeloma",[178,179,180,181,170,182,183],"Belantamab mafodotin","Bortezomib","Corneal events","Dexamethasone","Proteasome inhibitor","Immunomodulatory agent","NOT_YET_RECRUITING","2026-06-23",{"date":187,"type":41},"2026-06-24",{"date":189,"type":21},"2026-08-03",{"date":191,"type":21},"2031-02-11",{"name":47,"class":48},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100632877","phase-2-a-study-to-investigate-abdominal-symptoms-with-camlipixant-compared-with-placebo-in-adults-with-irritable-bowel-syndrome---diarrhea-ibs-d-and-irritable-bowel-syndrome---mixed-ibs-m-100632877","NCT07519395","A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)","BALANCE - A Two-part, 26-week, Randomized, Double-Blind, Dose-rAnging, pLAcebo-coNtrolled, Phase 2b Study to Evaluate the effiCacy and safEty of Camlipixant in Adults With IBS-D and IBS-M","BALANCE","Inclusion Criteria:\n\n* Male or female aged 18 to 80 years inclusive, at the time of signing the Informed consent form (ICF).\n* Diagnosis of IBS-D or IBS-M according to the Rome IV criteria at screening\n* Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Scoring System (IBS SSS) at screening visit\n* Weekly API score \\>=4.0 in each week of the run-in period\n* IBS-D: at least one stool with BSFS Type 6 or 7 consistency on at least 2 days in each week of the run-in period\n* IBS-M: an average of 2 days per week with abnormal bowel movements (BSFS Type 1, 2, 6, or 7) during the run-in period, and greater than (\\>)25% of abnormal bowel movements must be Type 6 or 7 and \\>25% Type 1 or 2\n\nExclusion Criteria:\n\n* Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U)\n* History or presence of inflammatory or immune-mediated Gastrointestinal (GI) disorders e.g. inflammatory bowel disease, microscopic colitis, or celiac disease\n* History or presence of GI infection (confirmed with stool culture) within 3 months prior to screening\n* History or presence of bile salt diarrhea\n* History of a primary psychiatric diagnosis that the Investigator considers may interfere with study assessments (e.g., schizophrenia, schizoaffective disorder, major depression, anxiety, panic attacks or bipolar disorder) OR Hospital Anxiety and Depression Scale (HADS) score of \\>10 at screening.\n* Prior use of more than two of the following therapies or classes of therapy for the management of IBS:\n\n  * Antidepressants or neuromodulators (e.g., Tricyclic antidepressant \\[TCAs\\], Selective serotonin reuptake inhibitor \\[SSRIs\\], gabapentinoids)\n  * Antibiotics (e.g., rifaximin, neomycin)\n  * 5-hydroxytryptamine 3 (5-HT3) receptor antagonists (e.g., alosetron, ramosetron, ondansetron)\n  * Mu-opioid receptor agonists (e.g., eluxadoline)\n  * Secretagogues (e.g., linaclotide, lubiprostone, plecanatide, tenapanor)\n  * 5-hydroxytryptamine 4 (5-HT4) receptor agonists (e.g., tegaserod)\n* Abnormal thyroid function tests less than (\\\u003C) Lower limit of normal (LLN) or greater than (\\>) upper limit of normal (ULN) confirmed at screening with Thyroid stimulating hormone (TSH)\n* Positive celiac serology\n* Elevated fecal calprotectin levels\n* QT interval corrected using Fridericia's formula (QTcF) \\>450 millisecond (msec) or QTcF \\>480 msec for participants with bundle branch block using the Fridericia's corrected QT interval.\n* Clinically significant abnormal laboratory tests at screening, after one repeat laboratory test if allowed by the Medical Monitor, including the following:\n\n  * Alanine aminotransferase (ALT) \\>2\\*ULN\n  * Total Bilirubin \\>1.5\\*ULN\n  * Aspartate aminotransferase (AST) \\>2\\*ULN\n* Current or chronic history of liver disease (Child-Pugh class A, B, or C) or biliary abnormalities (with the exception of asymptomatic gallstones). Participants with known or suspected Gilbert's Syndrome are not permissible.","80 Years",{"count":203,"type":21},420,[62],"This study is designed to evaluate the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The study has two parts. After the first part, some participants will be randomly chosen again to either get a higher dose or stop the drug.",[207],"Irritable Bowel Syndrome",[209,210,211,212],"Camlipixant","Irritable bowel syndrome - Mixed","Irritable bowel syndrome - Diarrhea","Dose Ranging",{"date":214,"type":41},"2026-06-25",{"date":216,"type":41},"2026-04-08",{"date":218,"type":21},"2027-07-13",{"name":47,"class":48},110,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":57,"minAge":229,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100628007","phase-3-a-study-of-efficacy-and-safety-of-depemokimab-compared-with-placebo-in-adults-and-adolescents-with-at-risk-type-2-asthma-100628007","NCT07456033","A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma","The MODIFY Study: A Phase 3b\u002F4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks","MODIFY","Inclusion Criteria:\n\n* Adults and adolescents \\>=12 years of age, at the time of signing the informed consent\u002Fassent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be \\>=18 years of age.\n* Participants must have a documented physician diagnosis of asthma for \\>=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines\n* Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.\n\n  * Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)\u002F Long-acting beta2-adrenergic receptor agonist (LABA).\n* A well-documented requirement for treatment with low to medium dose ICS\u002FLABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy\u002FSingle Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS.\n\n  * Study will limit enrolment to a maximum of 40 percent (%) of participants on low dose ICS\u002FLABA.\n* Sex and Contraceptive\u002FBarrier Requirements Male or eligible female Participants:\n\n  * Male Participants: Contraception for male participants with female partners is not required.\n  * Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n  * Is a participant of nonchildbearing potential (PONCBP) OR\n  * Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C)1%, from at least 14 days prior to the first dose of study intervention until at least 35 weeks after the last administered dose of study intervention.\n  * A POCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1, Exit Visit 11 or Withdrawn from study visit, and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention.\n  * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n  * The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Capable of giving signed informed consent\u002Fassent as which includes compliance with the requirements Randomization inclusion criteria-\n* Type 2 high disease at risk of asthma exacerbations as defined by either:\n\n  * An elevated peripheral blood eosinophils (EOS) count of \\>=500 cells\u002Fmilliliter (mL) at screening or \\>=500 cells\u002FmL in the last 3 months prior to the screening visit.\n\nOR\n\n* An elevated peripheral blood EOS count of \\>=300 cells\u002FmL at screening OR \\>=300 cells\u002FmL in the last 3 months prior to the screening visit AND\n\n  * Fractional exhaled nitric oxide \\>=35 parts per billion (ppb) at screening. OR\n  * Documented current Chronic Rhinosinusitis with Nasal Polyps.\n\nExclusion Criteria:\n\n* Participants have had 3 or more exacerbations in the last year prior to Visit 1.\n* Participants on maintenance OCS or high dose ICS\u002FLABA for asthma.\n* Participants with a duration of asthma greater than (\\>)20 years.\n* Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.\n* Participants with other conditions that could lead to elevated EOS such as hypereosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis.\n* Participants who developed an exacerbation within 4 weeks before screening.\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved.\n* A known immunodeficiency (e.g. human immunodeficiency virus), other than that explained by the use of CS taken as therapy for asthma.\n* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.\n* Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic or any other system abnormalities that are uncontrolled with standard treatment.\n* Participants with current diagnosis of vasculitis.\n* Participants who have received treatment with any approved or investigational biologic monoclonal antibody (mAb).\n* A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention.\n* Current smokers or former smokers with a smoking history of \\>=20 pack years (number of pack years = \\[number of cigarettes per day\u002F20\\] \\* number of years smoked) and vapers.\n* Participants with allergy\u002Fintolerance to a mAb or biologic or any of the excipients of depemokimab.\n* Participants who are pregnant or breastfeeding.\n* Participants who have known evidence of lack of adherence to controller medications and\u002For ability to follow physician's recommendations.\n* Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator.\n\nLiver safety exclusion criteria:\n\n* Alanine aminotransferase (ALT) \\>2\\* Upper limit of normal (ULN).\n* Total bilirubin \\>1.5\\*ULN; For participants with Gilbert's syndrome: can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is less than or equal to (\\\u003C=)1.5\\*ULN.\n* Cirrhosis or current unstable liver or biliary disease as per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.\n\nCardiac safety exclusion criteria:\n\n* Electrocardiogram (ECG) Assessment: QTc corrected by Fridericia's formula (QTcF) \\>=450 millisecond (msec) or QTcF \\>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12-lead ECG machine read at Visit 1.\n* Participants are excluded if an abnormal ECG finding from central over read of the 12 lead ECG conducted at Screening Visit is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the investigator.\n\nRandomization exclusion criteria:\n\n* ECG Assessment: QTcF \\>=450 msec or QTcF \\>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12 lead ECG machine read at Visit 1.\n* ALT \\>2\\*ULN.\n* Total bilirubin \\>1.5\\*ULN; For participants with Gilbert's syndrome can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is \\\u003C=1.5\\*ULN.\n* Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable.\n* Maintenance Asthma Therapy: Any changes in the dose or regimen of baseline ICS and\u002For additional controller medication (except for treatment of an exacerbation) during the run-in period.","12 Years",{"count":231,"type":21},456,[24],"The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).",[91],[236,93,227,237],"GSK3511294","Type 2 asthma",{"date":214,"type":41},{"date":240,"type":41},"2026-03-13",{"date":242,"type":21},"2030-07-08",{"name":47,"class":48},8,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100549252","phase-1-a-study-to-evaluate-the-safetytolerability-pharmacokinetics-and-clinical-activity-of-mocertatug-rezetecan-for-injection-in-participants-with-advanced-solid-tumors-behold-1-100549252","NCT06431594","A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care.\n* PROC cohort\n\n  1. Histologically documented, advanced (metastatic and\u002For unresectable) high-grade serous\u002Fendometrioid ovarian, primary peritoneal, or fallopian tube cancer.\n  2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.\n  3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.\n  4. Must have had prior bevacizumab , unless there is a documented contraindication or intolerance.\n  5. Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtansine if the regimen is locally available, unless there is a documented contraindication or intolerance.\n\nParticipants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the regimen is locally available, unless there is a documented contraindication or intolerance.\n\n* Endometrial cancer cohort\n\n  1. Histologically documented, advanced (metastatic and\u002For unresectable) or recurrent endometrial cancer.\n  2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.\n  3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if the regimen is locally available, unless there is a documented contradiction or intolerance\n  4. All epithelial histologies are permitted including carcinosarcoma.\n* Participants have at least one target lesion as assessed per the RECIST 1.1\n* Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by IHC in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n* Have received any B7-H4-targeted therapy\n* Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.\n* Presence of pleural\u002Fabdominal effusion\u002Fascites requiring clinical intervention; presence of pericardial effusion\n* Major surgery within 28 days prior to the first dose of study treatment.\n* Evidence of brain metastasis unless asymptomatic;\n* Has inadequate bone marrow reserve or hepatic\u002Frenal functions .\n* Mean Fridericia-corrected QT interval (QTcF) QTcF \\>450 msec or QTcF \\>480 msec for participants with bundle branch blocK;\n* Evidence of current clinically significant arrhythmias or ECG abnormalities\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events\n* Has current active pneumonitis\u002FILD or any history of ILD, any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned randomization\u002Fenrollment or any history of drug-induced pneumonitis\u002FILD.Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)\n* PROC\n\n  1. Primary platinum refractory disease defined as those who have progressed on or within 12 weeks of last dose of first line platinum therapy not permitted.\n  2. Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted.\n* Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.",{"count":253,"type":21},675,[143],"The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan . The study will also see how the levels of Mo-Rez change over time at different dose amount",[257,258],"Solid Tumors","Neoplasms",[257,30,31,32,260],"BEHOLD-1",{"date":214,"type":41},{"date":263,"type":41},"2024-07-02",{"date":265,"type":21},"2029-12-31",{"name":47,"class":48},65,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":57,"minAge":276,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":292,"leadSponsor":294,"locationsCount":4},"100644513","phase-3-a-study-of-depemokimab-in-participants-of-6-to-11-years-of-age-100644513","NCT07671001","A Study of Depemokimab in Participants of 6 to 11 Years of Age","A Phase 3, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Depemokimab (GSK3511294) Administered Subcutaneously as Add on Maintenance Treatment of Asthma With Type 2 Inflammation Characterised by an Eosinophilic Phenotype in Participants Aged 6 to 11 Years Old","GLIDE","Inclusion Criteria:\n\n* Participants who have a documented physician diagnosis of asthma for at least 12 months prior to Visit 1 that meets the National Heart, Lung, and Blood Institute guidelines \\[NHLBI, 2007\\] or Global Initiative of Asthma (GINA) guidelines \\[GINA, 2025\\] or Japanese Pediatric Guidelines for The Treatment and Management of Asthma \\[JPGL, 2023\\]\n* Asthma with type 2 inflammation characterised by an eosinophilic phenotype as indicated by: elevated peripheral blood eosinophil count of greater than or equal to (\\>=)300 cells\u002Fmicroliters (mcL) demonstrated in the past 12 months, or elevated peripheral blood eosinophil count of \\>=150 cells\u002F mcL at visit 1\n* Participants who are \\>=15 Kilograms (kg) in body weight\n* A well-documented requirement for regular treatment with inhaled corticosteroid (\\>=200 mcg\u002Fday fluticasone propionate (DPI) or equivalent daily) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS). The Inhaled corticosteroids (ICS) dose should represent medium or high dose in children aged 6-11 years of age\n* Current treatment with an additional controller medication for at least 3 months prior to screening \\[e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline\\]. For Japan only: This inclusion criterion does not apply to the participants in Japan. As long as the ICS dose represent high dose, the current treatment or previous failure of an additional controller will not be required for eligibility\n* Previously confirmed history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (CS) (intramuscular \\[IM\\], intravenous, or oral), in the 12 months prior to visit 1, despite the use of ICS. For participants receiving maintenance OCS, treatment for the exacerbations must have been a two-fold increase or greater in the CS dose\n* Male or eligible female\n* A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies: Is prepuberal or having periods but no sexual activity or using an acceptable contraceptive method, if sexual activity. prior to and during the study intervention period (at a minimum until 35 weeks after the last dose of study intervention).\n* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a girl with an early undetected pregnancy\n* The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant and the participant's assent, when applicable, before any study-specific activity is performed unless a waiver of informed consent has been granted by an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC). All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand\n* A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day according to the Schedule of activities (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant, as needed\n\nExclusion Criteria:\n\n* Participants with any history of life-threatening asthma (e.g. requiring intubation and assisted ventilation), immunosuppressive medications intake with the exception of oral CS for asthma, or immunodeficiency disorder\n* Or presence of a known pre-existing, clinically important lung condition other than asthma\n* Participants with other conditions that could lead to elevated eosinophils\n* Participants who have known, pre-existing, clinically significant medical conditions that could affect the conduct of the study\n* Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis excluded prior to enrolment\n* Participants who have received mepolizumab (Nucala), reslizumab (Cinqair\u002FCinqaero) or benralizumab (Fasenra) within 130 days or 5-half-lives (whichever is longer) prior to Visit 1 or who have previous documented failure with anti- Interleukin-5 Receptor (IL5\u002F5R) therapy\n* Participants who have received omalizumab (e.g., Xolair, Omlyclo), tezepelumab (Tezspire) or dupilumab (Dupixent) within 130 days or 5-half-lives (whichever is longer) prior to Visit 1\n* Participants who have received any monoclonal Antibody (mAb) within 130 days or 5-half-lives (whichever is longer) of Visit 1. Authorised treatments for Coronavirus disease 2019 (COVID-19) are permitted and should be used in line with local regulatory guidance\n* Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products)\n* Participants who have received treatment with an experimental anti-inflammatory drug (non-biologicals) within 3 months prior to Visit 1\n* Concurrent enrollment in another clinical trial\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1\n* Participants with allergy\u002Fintolerance to a mAb or biologic or any of the excipients of the investigational products\n* Participants who have known evidence of lack of adherence to controller medications and\u002For ability to follow physician's recommendations\n* Liver safety exclusion criteria: Participants who meet the following criteria based on results from the sample taken at Screening Visit\n\n  * Alanine aminotransferase (ALT) greater than (\\>)2 \\* Upper limit of normal (ULN)\n  * Total bilirubin \\>1.5 \\* ULN; for participants with Gilbert's syndrome can be included with total bilirubin \\>1.5xULN as long as direct bilirubin is less than or equal to (=\\\u003C) 1.5 \\* ULN\n  * Cirrhosis or current liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice\n* An abnormal Electrocardiogram (ECG) finding from the 12-lead ECG conducted at Screening, if considered clinically significant and likely to impact the participant's study participation, based on the evaluation of both the investigator and a pediatric cardiologist, or measured results of QT Corrected for Heart Rate using Fridericia's Formula (QTcF)\n\n  * \\>460 milliseconds (msec)\n  * \\>480 msec for participants with bundle branch block","6 Years","11 Years",{"count":279,"type":21},30,[24],"This study is aimed at assessing depemokimab as an add-on medicine for the treatment of asthma with type-2 inflammation in participants of 6 to 11 years of age. This study will test how the body processes depemokimab, how the drug works in the body, and its safety and tolerability.",[91],[93,236,284,285,286,287],"Asthma with Type 2 Inflammation","Pediatric Asthma","Eosinophilic Asthma","Eosinophilic phenotype","2026-06-22",{"date":290,"type":41},"2026-06-26",{"date":290,"type":21},{"date":293,"type":21},"2029-03-19",{"name":47,"class":48},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":7},"100411722","phase-2-a-long-term-treatment-extension-study-of-niraparib-in-participants-who-completed-a-prior-glaxosmithklinetesaro-sponsored-niraparib-study-100411722","NCT04641247","A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline\u002FTESARO-sponsored Niraparib Study","An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline\u002FTESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib","Inclusion Criteria:\n\n* Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.\n* Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.\n* Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline\u002FTESARO-sponsored study that has fulfilled the requirements for the primary objective.\n* Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.\n* Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug.\n\nExclusion Criteria:\n\n* Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.\n* Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.\n* Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).",{"count":303,"type":21},37,[62],"This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline\u002FTESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.",[307,308],"Ovarian Neoplasms","Breast Neoplasms",[310,311,312,313,69],"Adverse events","Open-label extension","Parent study","Niraparib",{"date":187,"type":41},{"date":316,"type":41},"2021-04-16",{"date":318,"type":21},"2026-12-28",{"name":47,"class":48},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":327,"sex":57,"minAge":18,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":344,"leadSponsor":346,"locationsCount":4},"100644507","phase-1-drug-interaction-assessment-of-gsk3772701-in-healthy-male-and-female-participants-aged-18-to-55-years-100644507","NCT07670377","Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years","A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 55 Years to Investigate the CYP3A4 Interaction Potential of GSK3772701","Inclusion Criteria:\n\n1. Aged 18 to 55 years (inclusive), at the time of signing the informed consent form (ICF).\n2. Weight of at least 50 kg with a body-mass index \\\u003C=18.0 and \\\u003C=30.0 kg\u002Fm².\n3. Written informed consent obtained from the participant prior to performance of any study specific procedure, and which includes agreement to compliance, with the requirements and restrictions listed in the ICF and in this protocol.\n4. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of study assessments, return for follow-up visits).\n5. Participants who are healthy as established by medical evaluation including medical history, physical examination, cardiac monitoring, and clinical laboratory assessment before entering into the study.\n\n   Contraception:\n   * Male participants are eligible to participate.\n   * A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:\n6. Is a participant of non-childbearing potential (PONCBP). OR\n7. Is a POCBP and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1%, for 30 days prior to and during the study intervention period and for at least 7 days after the last dose of GSK3772701 and at least 2 days after the last dose of MDZ.\n8. A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening and within 24 hours before the first dose of study intervention.\n9. A blood sample for simultaneous follicle-stimulating hormone (FSH) may be collected, and estradiol levels may be included at investigator's discretion to confirm non-reproductive potential when menopausal status is uncertain according to the local laboratory reference range.\n\nExclusion Criteria:\n\n1. History or presence\u002Fsignificant history of or current cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, immunological, dermatological, endocrine, hematologic, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n2. Any condition where the administration of MDZ could be contraindicated, including but not limited to, hypersensitivity (MDZ, any of its excipients, or to any benzodiazepines), sleep apnea, glaucoma (narrow-angle glaucoma, acute or open angle glaucoma, untreated), myasthenia gravis, respiratory insufficiency, impaired pulmonary function, or severe hepatic impairment.\n3. History of any malignancy within the past 5 years. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which is considered cured with minimal risk of recurrence. Participants under evaluation for possible malignancy are not eligible.\n4. History of any reaction or hypersensitivity likely to be exacerbated by any component (formulation, capsule, or excipients) of the study intervention(s) (including hypromellose \\[hydroxypropyl methylcellulose\\] for GSK3772701) or allergies to cherries (as per MDZ USPI).\n5. Acute or chronic clinically significant pulmonary, endocrinological, cardiovascular, muscular, neurological, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.\n6. Participants should have baseline clinical laboratory values (renal, hepatic, and hematological) within normal limits or clinically acceptable to the investigator. A participant with a clinical abnormality or laboratory parameter(s) which is\u002Fare not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the investigator considers that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.\n7. Participants with supine blood pressure (BP) \\>=140 mm Hg (systolic) or \\>=90 mm Hg (diastolic).\n8. Estimated glomerular filtration rate (eGFR) of \\\u003C80 mL\u002Fmin\u002F1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021).\n9. The participant must agree to and adhere to the concomitant therapy (including non-drug therapies) restrictions from the Screening Visit through to the end of the study.\n10. Any other clinical condition that, in the opinion of the investigator, might pose an additional risk to the participant due to participation in the study or would make adhering to study procedures for the duration of the study difficult.\n11. Sensitivity to heparin or heparin-induced thrombocytopenia.\n12. Past or intended use of over-the-counter or prescription medication (including herbal medications, vitamins and supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer), or 5 times the half-life (whichever is longer) prior to dosing.\n13. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) or investigational drugs or non-registered product (drug, vaccine, or medical device) within 3 months or 5 times the half-life (whichever is longer) prior to dosing.\n14. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n15. Current or prior enrolment in this or any other clinical study involving an investigational study intervention, or any other type of medical research, within the last 30 days or 5 half-lives, whichever is longer, prior to signing of the ICF.\n\n    Participants who screen fail for the current study are not eligible for re-screening or enrollment.\n16. Positive drug\u002Falcohol screen, including tetrahydrocannabinol at Screening or Admission.\n17. Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months prior to Screening.\n18. Positive human immunodeficiency virus (HIV) antibody test.\n19. Regular alcohol consumption within 6 months prior to the clinical study defined as: An average weekly alcohol intake of 14 units for males or 7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint. (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.\n20. Regular use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to \"vape\".\n21. Participants who have lost or donated over 500 mL of blood within 90 days prior to enrollment or intend to donate blood or blood products during the study.\n22. Participants who have donated plasma within 7 days prior to enrollment.\n23. Any study personnel or their immediate dependents, family, or household members.\n24. Regular use of known drugs of abuse, including tetrahydrocannabinol.\n25. The following liver safety criteria are exclusionary:\n\n    * Alanine aminotransferase (ALT) \\>1.5 × the upper limit of normal (ULN).\n    * Total bilirubin \\>1.5 × ULN. Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5 × ULN if direct bilirubin is \\\u003C=1.5 × ULN.\n    * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n    * Presence of hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) at Screening or within 3 months prior to first dose of study intervention.\n    * Positive hepatitis C antibody test results at Screening or within 3 months prior to first dose of study intervention.\n    * Positive hepatitis C RNA test results at Screening or within 3 months prior to first dose of study intervention.\n26. QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\>450 msec.\n27. The participant has congenital long QT syndrome or known prolongation of the QTc interval.\n28. The participant has a family history of QT prolongation or sudden death.\n29. The participant has any current or previous history of episodes of symptomatic bradycardia or bradyarrhythmia.",true,"55 Years",{"count":330,"type":21},20,[143],"This study aims to evaluate whether GSK3772701 alters the pharmacokinetics (PK) of midazolam (MDZ), a standard probe substrate for the CYP3A4 enzyme. The findings are planned to be used to determine whether GSK3772701 acts as an inducer and\u002For inhibitor of CYP3A4 and will help guide recommendations for safe co-administration with CYP3A4 substrates.",[334],"Malaria, Falciparum",[336,71,337,338,339,340],"GSK3772701","Midazolam","CYP3A4","Healthy participants","Open label","2026-06-19",{"date":290,"type":41},{"date":290,"type":21},{"date":345,"type":21},"2026-08-31",{"name":47,"class":48},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":139,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":360,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},"100549430","phase-1-a-study-to-compare-the-relative-potency-of-salbutamol-administered-via-metered-dose-inhalers-mdi-containing-propellants-hfa-152a-to-hfa-134a-in-mild-asthmatics-aged-18-to-65-inclusive-100549430","NCT06433921","A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive","A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects","Inclusion Criteria:\n\n1. Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.\n2. Participant must be 18 to 65 years of age inclusive, at the time of screening.\n3. ≥50 kg, at the time of screening.\n4. Body mass index (BMI) with 19.0-35.0 kg\u002Fm2 inclusive, at the time of screening.\n\n4\\. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg\u002Fday fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.\n\niii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg\u002Fday fluticasone propionate or equivalent as defined by GINA \\[GINA, 2023\\]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.\n\n6\\. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.\n\n7\\. Pre-bronchodilator FEV1 ≥80% of predicted, at screening. 8. PC20 to methacholine of ≤8 mg\u002FmL, at screening. 9. Participants should be able to withhold SABA for ≥12 hours and LABA-containing medications for ≥48 hours for the purposes of performing the spirometry and methacholine challenge at screening and during the study visits (treatment periods).\n\n10\\. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective.\n\n11\\. Provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n\n12\\. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.\n   2. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.\n   3. Asymptomatic gallstones.\n   4. History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.\n   5. Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.\n   6. Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.\n2. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.\n3. Participants who are currently or in the last 15 days have worked nightshifts.\n4. Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \\>21 units for males or \\>14 units for females.\n5. A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.\n6. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to \"vape\" within 12 months prior to the start of the study.",{"count":355,"type":21},84,[143],"The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \\[PC20\\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.",[91,359],"Mild Asthma",[361,362,363,364,365],"Salbutamol","Propellant HFA-152a","Propellant HFA-134a","Metered dose inhalers","Mild asthma",{"date":187,"type":41},{"date":368,"type":41},"2024-08-14",{"date":370,"type":21},"2027-02-26",{"name":47,"class":48},1,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"100621503","phase-1-a-study-of-gsk5926371-in-participants-with-b-cell-driven-autoimmune-rheumatic-diseases-ard-100621503","NCT07371468","A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)","A Phase 1, Open-label, Dose-escalation Study (ELEVATE-1) to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19\u002FCD20 T-cell Engager in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)","ELEVATE-1","Inclusion Criteria:\n\n* Part 1 will enroll adult participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).\n* Part 2 will enroll adult participants with SLE, RA, idiopathic inflammatory myopathies (IIM) or Sjogren's disease (SjD).\n* Participants must be 18 to 70 years of age inclusive at the time of signing the informed consent form.\n* Body mass index (BMI) between 18-35 kilograms per square meter (kg\u002Fm\\^2) inclusive with a body weight of greater than or equal to (\\>=) 45 kilograms (kg).\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n* Is a participant of non-childbearing potential (PONCBP), OR\n* Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C) 1 percent (%), 28 days prior to and during the study intervention period and for at least 28 weeks after the first dose of GSK5926371. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention.\n\nA POCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention.\n\nIf a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n\\- Signed and dated informed consent form indicating that the participant is willing and able to comply with hospitalization, clinic visits and scheduled study assessments as detailed in the protocol.\n\nExclusion Criteria:\n\n* Any acute, severe autoimmune disease-related flare before, or during the Screening Period (up to and including Day 1) that needs immediate treatment or is expected to require escalation of treatment to prohibited medications for the duration of the study.\n* Significant allergies to humanized monoclonal antibodies or significant sensitivity to any constituents of the study drug (including excipients).\n* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to the autoimmune condition under study (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, or infectious diseases) and\u002For a planned surgical procedure, which, in the opinion of the investigator, could confound the results of the clinical study or put the participant at undue risk.\n* Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data.\n* Participant has a diagnosis of primary or acquired immunodeficiency, except for selective IgA deficiency.\n* Have an acute or chronic infection including requiring management as follows:\n* An acute infection within 2 weeks of dosing on Day 1.\n* An active infection requiring current systemic antibiotic, antiviral or anti-fungal treatment with the exception of topical treatments for fungal nail infections. Prophylactic medications are permitted.\n* History of, or currently being treated for, a clinically significant recurrent or chronic infection (except for minor localized infections, for example tinea pedis).\n* Any opportunistic infections within past 3 years. Uncomplicated herpes zoster, localized herpes simplex virus, and oral candidiasis are not considered as opportunistic infections for this purpose.\n* Herpes zoster within 3 months before screening.\n* A serious infection requiring treatment with intravenous (IV)\u002Fintramuscular (IM) antibiotics and\u002For hospitalization if the last dose of antibiotics or the hospital discharge date was within 30 days of the first day of dosing (Day 1).\n* History of a serious infection associated with low serum immunoglobulin levels.\n* Evidence of active or latent tuberculosis (TB) as documented by medical history and examination (including chest X-rays \\[CXR\\], if available), and a positive (not indeterminate) TB test such as QuantiFERON-TB Gold Plus test. In cases where the QuantiFERON test is indeterminate, the participant may have the test repeated once, but if the test remains indeterminate further investigation may be required including CXR (posteroanterior \\[PA\\] and lateral) in order to exclude TB. Note: The QuantiFERON-TB Gold Plus test can only be used in countries where it is licensed, and the use of this test is dependent on previous treatment(s). This test may not be suitable if previous treatment(s) produced significant immunosuppression.\n* Confirmed progressive multifocal leukoencephalopathy (PML) within 12 months or has unexplained or deteriorating neurologic signs and symptoms.\n* History or positive test at Screening for human immunodeficiency virus (HIV).\n* History of clinically significant neurological or psychiatric disorder including history of epilepsy, dementia, increased risk of suicide as judged by the investigator or major depression deemed to interfere with study assessments, or a history of intracranial hemorrhage.\n* Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years. The investigator should also ensure that occult malignancy associated with the autoimmune condition under study has been adequately ruled out prior to screening (for example, malignancy-associated dermatomyositis).\n* History of hematological or solid organ transplant.\n* Live or live-attenuated vaccine(s) within 30 days before Screening or plans to receive such vaccines during the screening period or during the clinical study.\n* Current or prior treatment with any of the medications specified below during the relevant exclusion periods prior to Day 1. The following medications are prohibited from the periods before the study, until the last study visit:\n* IV or IM dose of corticosteroids within 5 weeks of Day 1.\n* Any T-cell engager (TCE) including blinatumomab, mosunetuzumab or other approved or investigational T cell engagers within 12 months of Day 1.\n* Chimeric antigen receptor (CAR)-T-cell treatment, at any time.\n* B-cell depleting agents, including but not limited to anti-CD20 (e.g. Rituximab, Obinutuzumab, Ocrelizumab), anti-CD38 (e.g. Daratumumab, TAK079, MOR202, isatuximab) within 4 months of Day 1.\n* Belimumab within 8 weeks of Day 1.\n* Anifrolumab within 8 weeks of Day 1.\n* Oral or IV cyclophosphamide within 12 weeks of Day 1.\n* Immune-Modulating Biologic agents, including anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab and etanercept), abatacept, and interleukin (IL)-1 receptor antagonist \\[anakinra\\] or IL-6 receptor antagonist (tocilizumab) within 4 weeks of Day 1. Except infliximab, golimumab, and certolizumab within 8 weeks of Day 1. (NOTE: tocilizumab is permitted for cytokine release syndrome (CRS) Grade 3\u002F4 management after dosing)\n* Small molecule inhibitors, including tyrosine kinase 2 inhibitor (TYK2i, Deucravacitinib); inhibitors of Janus kinases (JAKis, baricitinib, tofacitinib, upadacitinib, filgotinib); or Bruton tyrosine kinase inhibitors (ibrutinib, fenebrutinib) within 4 weeks of Day 1.\n* IV immunoglobulin within 8 weeks of Day 1.\n* Plasmapheresis within 8 weeks of Day 1.\n* Current enrolment or past participation in any other clinical study involving an investigational study treatment (including investigational vaccines) within 3 months or 5 half-lives of the investigational drug or twice the duration of pharmacological activity (whichever is longer) before Day 1.\n* Contra-indications to prophylactic medications for CRS (corticosteroid, ant histamines and antipyretics), or CRS rescue medication (tocilizumab or IV corticosteroids).\n* Current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 12 months before Day 1.\n* Alanine transaminase (ALT) greater than (\\>) 1.5 x upper limit of normal (ULN).\n* Total bilirubin \\> 1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\> 1.5 x ULN if direct bilirubin is \\> 1.5 x ULN.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).\n* Presence of hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at screening or within 3 months prior to first dose of study intervention.\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.\n* Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. Note: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.\n* Corrected QT (QTc) interval \\> 450 milliseconds (msec) or QTc interval \\> 480 msec for participants with bundle branch block. Frederica's formula (QT interval corrected using Fridericia's formula \\[QTcF\\]) should be used to calculate the corrected QT interval. If a single electrocardiogram (ECG) at screening shows QTcF \\> 450 msec (or \\> 480 msec for participants with bundle branch block), a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion.","70 Years",{"count":383,"type":21},44,[143],"This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.",[387],"Systemic Lupus Erythematosus",[389,390,391,392,393,394,395],"GSK5926371","Autoimmune rheumatic disease","Dose escalation","Systemic lupus erythematosus","Rheumatoid arthritis","Idiopathic inflammatory myopathies","Sjogren's disease","2026-06-18",{"date":185,"type":41},{"date":399,"type":41},"2026-02-10",{"date":401,"type":21},"2028-03-15",{"name":47,"class":48},19,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":327,"sex":57,"minAge":18,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100644373","phase-1-a-study-to-evaluate-the-safety-reactogenicity-and-immune-response-of-the-gsk-vaccines-institute-for-global-health-gvgh-quadrivalent-pan-salmonella-vaccine-with-and-without-alum-in-healthy-young-adults-100644373","NCT07663032","A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults","A Phase 1, Randomized, Controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GVGH Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Adults 18 to 45 Years of Age in Africa","Inclusion Criteria:\n\n1. Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., completion of the Diary cards, return for follow-up visits).\n2. Written informed consent obtained from the participant prior to performance of any study specific procedure.\n3. Healthy participants as established by medical history, clinical examination, and laboratory assessment\\*.\n\n   \\*Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, and human immunodeficiency virus (HIV) antibodies will also be tested at Screening.\n4. A male or female between and including 18 to 45 years of age at the time of the first study intervention administration, and no older than 45 years of age at second dose administration.\n5. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or menopause.\n6. Participants of childbearing potential may be enrolled in the study if the participant:\n\n   * Has practiced adequate contraception (as indicated in Section 10.5) for at least 30 days prior to study intervention administration, and\n   * Has a negative pregnancy test within 24 hours prior to the study intervention administration, and\n   * Has agreed to continue adequate contraception during the entire treatment period and for 8 weeks after completion of the study intervention administration series.\n7. Negative HLA-B27 testing.\n8. Body mass index of 18\\>= to \\\u003C=30 kg\u002Fm2 at Screening.\n9. Living in the study area and plan to remain in the study area for the study duration.\n\nExclusion Criteria:\n\nMedical Conditions:\n\n1. Known exposure to S. Typhi, S. Paratyphi A, and non-typhoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration as confirmed using medical history.\n2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.\n3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n4. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.\n5. Recurrent history or uncontrolled neurological disorders or seizures.\n6. Any clinically significant hematological and\u002For biochemical laboratory abnormality.\n7. Clinical conditions representing a contraindication to intramuscular (IM) injections and\u002For blood draws.\n8. Any behavioral or cognitive impairment or psychiatric disease that in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.\n9. Acute or chronic illness which may be severe enough to preclude participation.\n10. Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.\n\n    Prior\u002FConcomitant Therapy:\n11. History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant's life.\n12. History of receiving any investigational iNTS, S. Paratyphi A, or GMMA vaccines in the participant's life.\n13. Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days (Days -30 to 1) before the first dose of study interventions, or their planned use during the study period.\n\n    Use of herbs and traditional treatments is not considered an exclusion criterion.\n14. A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 30 days after the last dose of study interventions administration, with the exception of flu vaccines or Coronavirus disease 2019 vaccine.\n15. Administration of long-acting immune-modifying drugs (e.g., infliximab) at any time during the study period.\n16. Administration of immunoglobulins and\u002For any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period.\n17. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will be prednisone equivalent \\>=20 mg\u002Fday for adult participants. Inhaled and topical steroids are allowed.\n\n    Prior\u002FConcurrent Clinical Study Experience:\n18. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (vaccine and drug).\n\n    Other Exclusions:\n19. Pregnant or lactating female.\n20. Female planning to become pregnant or planning to discontinue contraceptive precautions.\n21. History of\u002Fcurrent chronic alcohol consumption and\u002For drug abuse. This will be decided at the discretion of the Investigator.\n22. Any study personnel or their immediate dependents, family, or household members.","45 Years",{"count":413,"type":21},196,[143],"The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa. The purpose of the current Phase 1 study is to evaluate the safety, reactogenicity, and the immune response induced by the Pan-Salmonella vaccine.",[417],"Salmonella Infections",[419,420,421,422,423,70,424,69],"GVGH Quadrivalent Pan-Salmonella vaccine","Salmonella (S.) Typhi","S. Paratyphi A","S. Typhimurium (STm)","S. Enteritidis (SEn)","Reactogenicity","2026-06-17",{"date":185,"type":41},{"date":187,"type":21},{"date":429,"type":21},"2027-11-14",{"name":47,"class":48},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},"100641130","phase-1-a-study-to-evaluate-safety-and-clinical-activity-of-gsk5926371-in-adult-participants-with-relapsed-or-refractory-b-nhl-100641130","NCT07607925","A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL","A Phase 1\u002F2 Open-label, Multi-center Study to Evaluate the Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)","Inclusion Criteria:\n\n* Has histologically confirmed Relapsed\u002FRefractory (R\u002FR) B-NHL, for which systemic treatment is indicated,\n\n  1. Has measurable disease,\n  2. Has received at least 2 prior lines of systemic anti-neoplastic therapy, including an anti-CD20-containing combination appropriate for the indication;\n  3. Has documented disease relapse, progression or disease refractory to the most recent line of therapy, per Lugano criteria.:\n* Willing to use adequate contraception (Participant of childbearing potential \\[POCBP\\] only).\n* Is capable of giving signed informed consent\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Has adequate organ function.\n\nExclusion Criteria:\n\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease.\n* Has had any major surgery within 4 weeks prior to the first dose of GSK5926371 or has not recovered from prior surgeries or complications.\n* Has a history of Progressive multifocal leukoencephalopathy (PML), current central nervous system (CNS) involvement by lymphoma, or a history of significant CNS disease such as uncontrolled seizures, stroke, epilepsy, CNS vasculitis, and neurodegenerative conditions.\n* Has an active uncontrolled infection.\n* Has received a prior Allogeneic stem cell transplant (allo-SCT) within 12 months prior to the first dose of GSK5926371 or has active graft-versus-host disease requiring systemic immunosuppressive therapy.\n* Has received a prior autologous stem cell transplant within 100 days prior to the first dose of GSK5926371.\n* Has received prior treatment with Chimeric antigen receptor T-cell (CAR-T) therapy within 12 weeks of first GSK5926371 administration.\n* Has received prior treatment with CD19- or CD20-targeting Bispecific antibody (BsAbs) within 8 weeks of the first dose of study intervention.\n* Has QT interval corrected (QTc) \\>450 milliseconds (msec) or QTc \\>480 msec for participants with bundle branch block.\n* Has significant cardiovascular disease such as uncontrolled arrhythmias, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, ejection fraction \\\u003C=45% by any methods in the 12 months of enrollment, unstable angina or acute coronary syndrome including myocardial infarction within 6 months of enrollment.",{"count":439,"type":21},49,[143,62],"The goal of this clinical trial is to learn if drug GSK5926371 works to treat a form of B-cell cancer (a type of blood cancer) that has returned or failed to respond to prior therapies in adults. The study will primarily assess the drugs safety and tolerability in participants. Additionally, it seeks to determine the clinical efficacy and pharmacokinetic (PK) properties of GSK5926371.",[443],"Lymphoma, Non-Hodgkin",[445,389],"Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL)",{"date":396,"type":41},{"date":448,"type":21},"2026-06-12",{"date":450,"type":21},"2029-09-24",{"name":47,"class":48},3,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":460,"minAge":18,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":474,"leadSponsor":476,"locationsCount":244},"100618502","phase-1-first-time-in-human-study-of-gsk5471713-in-adults-with-mcrpc-100618502","NCT07332455","First-Time-in-Human Study of GSK5471713 in Adults With mCRPC","A Phase 1\u002F2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate.\n* Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n* Progression on ADT and \\>=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens.\n\nExclusion Criteria:\n\n* Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality.\n* Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion\u002Fexclusion criteria apply.","MALE",{"count":462,"type":21},54,[143,62],"This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit\u002Frisk of GSK5471713 given as a monotherapy in mCRPC.",[466],"Neoplasms, Prostate",[468,469,470,471],"Metastatic castration-resistant prostate cancer","First-Time-in-Human","GSK5471713","Prostate cancer",{"date":396,"type":41},{"date":399,"type":41},{"date":475,"type":21},"2030-03-26",{"name":47,"class":48},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":403},"100609363","phase-1-a-study-to-investigate-the-safety-and-preliminary-efficacy-of-gsk5460025-alone-or-in-combination-with-other-anti-cancer-agents-in-participants-with-solid-tumors-100609363","NCT07213609","A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors","A Phase 1\u002F2 Open-label, Multicenter Study of Oral GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors","Inclusion Criteria:\n\n* Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor\n* Has a known dMMR\u002FMSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)\u002F Microsatellite Instability (MSI) status at the time of Pre-screening and MMR\u002FMSI status will be determined by central reference laboratory\n* Provides an archival or fresh (preferred) formalin fixed, paraffin embedded (FFPE) sample\n* Intends to receive GSK5460025 as next treatment\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Is expected to have a minimum of 3 months life expectancy\n* Has adequate organ function, as defined in the protocol\n\nPart 1 inclusion criteria:\n\n• Has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options\n\nPart 2 inclusion criteria:\n\n* Has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC)\n* Has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy\n* Has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator\n\nExclusion Criteria:\n\n* Has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced Adverse Events (AEs)\n* Has received prior treatment with a Werner (WRN) inhibitor or Nucleotide Excision Repair Targeting (NERT) agent.\n* Is unable to swallow and retain orally administered study treatment\n* Has untreated or progressed metastases in brain or CNS\n* Has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal or squamous cell carcinomas of the skin or in situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of metastatic disease.\n* Has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs\n* Has cirrhosis or current unstable liver or biliary disease\n* Has known hypersensitivity to any of the study interventions or any of their excipients",{"count":485,"type":21},47,[143,62],"Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat. The study will test whether GSK5460025 alone or in combination (potential combinations may be included in future amendments to the protocol) with other anti-cancer agents can decrease tumor size, is safe, well-tolerated, and how the drug is processed in the body over time.",[489,258],"Neoplasms, Colorectal",[491,492,493,494,495,496,497,498,499,500],"GSK5460025","Solid tumors","Colon cancer","Rectal cancer","Colorectal cancer","Endometrial cancer","Mismatch repair deficient","dMMR","microsatellite instability high","MSI-H",{"date":396,"type":41},{"date":503,"type":41},"2025-10-20",{"date":505,"type":21},"2028-10-27",{"name":47,"class":48},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":460,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":403},"100592242","phase-1-a-study-of-gsk5458514-administered-alone-or-in-combination-with-other-anti-cancer-agents-in-participants-with-prostate-cancer-100592242","NCT06990880","A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer","A Phase 1\u002F2 First-Time-In-Human, Open-Label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-Cancer Agents in Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Male participants ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.\n\nMale participants are eligible to participate if they agree to the following during the study intervention period and for at least 195 days, after the last dose of study intervention:\n\nRefrain from donating sperm\n\nPLUS either:\n\nBe abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.\n\nOR\n\nMust agree to use contraception as detailed below:\n\nAgree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.\n\n* Participants with mCRPC:\n\n  * Histologically or cytologically confirmed adenocarcinoma of the prostate\n  * Metastatic disease diagnosed either by radiologic imaging (Positron emission tomography \\[PET\\]- Computed tomography \\[CT\\]) and\u002For regular CT and\u002For Magnetic resonance imaging (MRI) and\u002For bone scan\n  * Castration-resistant status as per PCWG3 criteria\n* Has prior novel anti-androgen receptor therapy failure and had treatment failure with 1-2 taxane-based chemotherapy regimens including for metastatic hormone sensitive prostate cancer.\n* Has (1) at least 1 soft tissue target lesion per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) OR (2) if Non-Target soft tissue disease only per PCWG3-modified RECIST 1.1, may be included if a rise in PSA on 2 successive determinations at least 1 week apart (the most recent screening measurement must have been ≥ 2 ng\u002FmL) with testosterone levels \\\u003C50 ng\u002FdL, OR (3) bone disease defined by PCWG3 (2 or more lesions on bone scan at screening), as determined by the investigator.\n* Documented disease progression on most recent systemic therapy defined by fulfilling at least 1 of the PCWG3 criteria\n* Have serum testosterone \\\u003C50 ng\u002FdL (\\\u003C1.7 nM). Patients must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a GnRH agonist or antagonist; this therapy must have been initiated at least 4 weeks prior to randomization and treatment must be continued throughout the study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1, with no deterioration in the 2 weeks before step-up treatment period Day 1.\n* Have supplied tumor tissue from a newly obtained biopsy or archival tumor tissue for retrospective detection of Prostate-specific membrane antigen (PSMA) expression and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue preferably taken after the completion of the participant's last line of therapy prior to the first dose of study drug is acceptable.\n* Participants must have adequate organ function\n\nExclusion Criteria:\n\n* Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any histology different from adenocarcinoma.\n* History of central nervous system (CNS) metastases or leptomeningeal disease.\n* Diagnosis of invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below:\n\n  * History of an invasive malignancy for which the participant was definitively treated, and in which the participant has been disease free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted disease under study\n  * Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and\u002For in situ breast cancer may be enrolled\n  * • Has ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, excluding \\[e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy\\], or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.\n* Confirmed history or recurrent autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).\n* Has evidence of interstitial lung disease, non-infectious pneumonitis, and\u002For a history of interstitial lung disease, non-infectious pneumonitis that required steroid .\n* Any anti-cancer therapy or prior systemic biologic therapy, including immunotherapy within 4 weeks of start dose.\n* Prior PSMA radionuclide therapy within 2 months prior to GSK5458514 unless participant received \\\u003C2 cycles.\n* Prior PSMA-Chimeric antigen receptor T cell therapy (CAR-T) cell therapy and PSMA (T cell engager) TCE\u002F Bispecific T cell engagers (BiTE) or other prostate Tumor-associated antigens (TAA) specific T cell engager (TCE).\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* History of severe neurological or psychiatric disorder, including epilepsy, dementia, or major depression deemed to interfere with study assessments.\n* Has had any major surgery (such as craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks prior to first dose of study intervention.\n* Serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with IV antibiotics for ≥2 weeks; active infections with therapeutic IV antibiotics within 2 weeks prior to the first dose or oral antibiotics within 1 week prior to the first dose. Participants who are receiving or have received prophylactic antibiotics (e.g., prophylaxis against urinary infections) are allowed.\n\nLiver safety exclusion criteria:\n\n* Has an Alanine aminotransferase (ALT) value \\>2.5x upper limit of normal (ULN) or \\>5x ULN if documented history of liver metastases.\n* Has a total bilirubin value \\>1.5x ULN.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Has documented presence of Hepatitis B surface antigen (HBsAg), at screening or within 3 months prior to the first dose of study intervention.\n* Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to Cycle 1 Day 1 unless the participant can meet the following criteria: NOTE: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled if a confirmatory negative HCV RNA test is obtained and the participant otherwise meets entry criteria\n* Has a positive HCV ribonucleic acid (RNA) test result at screening or within 3 months prior to the first dose of study intervention. NOTE: The HCV RNA test is optional, and participants with a negative HCV antibody test are not required to undergo HCV RNA testing as well.\n* Is unable to adhere to the protocol defined SoA, including requirements for the Follow-up Period of the study, study procedures, restrictions, and requirements as determined by the investigator.",{"count":515,"type":21},85,[143,62],"The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).",[466],[520,521,391,522],"Metastatic castration-resistant prostate cancer (mCRPC)","GSK5458514","Dose expansion",{"date":396,"type":41},{"date":525,"type":41},"2025-06-12",{"date":527,"type":21},"2028-08-09",{"name":47,"class":48},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":327,"sex":57,"minAge":18,"maxAge":139,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":552},"100560371","phase-1-a-study-of-gsk4527363-in-healthy-participants-systemic-lupus-erythematosus-sle-participants-healthy-chinese-and-japanese-participants-and-ctd-ild-participants-100560371","NCT06576271","A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants","A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)","Inclusion criteria:\n\nFor Part A and Part C (Healthy Participants):\n\n* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (vital signs and 12-lead ECG)\n* Part C only: Be of Japanese (Cohort C1) or Chinese (Cohort C2) ancestry i. Born in Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2); and ii. Descendent of 2 ethnic Japanese (Cohort C1) or Chinese (Cohort C2) parents and 4 ethnic grandparents; and iii. Have lived outside Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2) for less than 10 years at the time of screening\n* Body weight greater than or equals to (\\>=) 45 kilograms (kg)\n* Body mass index (BMI) within the range 18-32 kilograms per square meter (kg\u002Fm\\^2) (inclusive)\n* Male or female of non-childbearing potential\n\nFor Part B (SLE participants):\n\n* 18 to 65 years of age inclusive, at the time of signing the informed consent form\n* Documented clinical diagnosis of SLE according to the (European alliance of associations of rheumatology \\[EULAR\\]\u002F American College of Rheumatology \\[ACR\\] SLE classification criteria)\n* Body weight \\>= 45 kg\n* BMI within the range 18-32 kg\u002Fm\\^2 (inclusive)\n* Male or female\n* Capable of giving signed informed consent For Part D (CTD-ILD Participants)\n* Participants must be 18 to 65 years of age, at the time of signing the informed consent form\n* Documented clinical diagnosis of specific Connective Tissue Diseases in accordance with internationally recognised classification criteria\n* Documented clinical diagnosis of interstitial lung disease (ILD) as determined by historical High-resolution computed tomography (HRCT)\n* Participants must be on a stable dose of therapy to manage ILD and\u002For underlying connective tissue disease (CTD)\n* Body weight \\>= 45 kg\n* BMI within the range 18-32 kg\u002Fm\\^2 (inclusive)\n* Male or female\n* Capable of giving signed informed consent\n\nExclusion criteria:\n\nFor Part A and Part C (Healthy Participants):\n\n* History or presence or cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders\n* A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug\n* Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks before dosing\n* Symptomatic herpes zoster within 3 months prior to screening\n* Have a history of malignancy, or a strong family history of malignancies related to immunosuppression\n* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions\n* Abnormal blood pressure\n* Evidence of active or latent Tuberculosis (TB)\n* Alanine transaminase (ALT) \\>=1.1\\* Upper limit of normal (ULN)\n* Total bilirubin \\>1.0\\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>=1.5\\*ULN as long as direct bilirubin is less than or equal to (\\\u003C=)1.5\\*ULN\n* Presence of Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention\n* Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention\n* Positive Human immunodeficiency virus (HIV) antibody test at screening\n* Prior medical history of anaphylaxis\n* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\>450 milliseconds (msec)\n* Live vaccine(s) within 30 days before the dosing day or plans to receive such vaccines during the study\n\nFor Part B (SLE participants):\n\n* Any acute, severe lupus related flare during the Screening Period that needs immediate treatment\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE which, in the opinion of the principal investigator (PI), could confound the results of the clinical study or put the participant at undue risk\n* Have an acute or chronic infection requiring management as follows:\n\n  i. Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria ii. A serious infection requiring treatment with antibiotics and\u002For hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed\n* Evidence of active or latent TB\n* Confirmed Progressive Multifocal Leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms\n* ALT \\>2\\*ULN\n* Total bilirubin \\>1.5\\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is \\>1.5\\*ULN\n* Presence of HBsAg and\u002For HBcAb at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention\n* History or positive test at Screening for HIV\n* QTcF \\>450 msec\n* Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, Cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years\n* Live or live-attenuated vaccine(s) within 30 days prior to Screening\n\nFor Part D Participants:\n\n* A diagnosis of: ILD other than CTD-ILD and\u002For SLE\n* FVC \\\u003C= 45% predicted at Screening Pulmonary arterial hypertension, as determined by the Investigator, prior to Day 1\n* Major surgery (including joint surgery) within 3 months prior to Screening or planned during the duration of the study\n* Previous or planned major organ transplant (e.g. heart, lung, kidney, liver) or bone marrow transplant (e.g. autologous stem cell transplant)\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to CTD-ILD (i.e., cardiovascular, metabolic, hematologic, GI, hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) which, in the opinion of the PI, could confound the results of the clinical study or put the participant at undue risk\n* Have an acute or chronic infection including requiring management\n* Evidence of active or latent TB\n* Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms\n* ALT \\>2\\*ULN\n* Total bilirubin \\>1.5\\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is \\>1.5\\*ULN\n* Presence of HBsAg and\u002For HBcAb at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention\n* History or positive test at Screening for HIV\n* Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, CIN or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years\n* Live or live-attenuated vaccine(s) within 30 days prior to Screening or plans to receive such vaccines during the Screening period or during the clinical study",{"count":537,"type":21},142,[143],"This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and Japanese descent (Part C), and participants with interstitial lung disease associated with connective tissue disease (Part D)",[387],[121,542,543,339,70,71,392,544,545],"First time in human study","GSK4527363","Interstitial lung disease","Connective tissue disease",{"date":288,"type":41},{"date":548,"type":41},"2024-09-02",{"date":550,"type":21},"2028-01-11",{"name":47,"class":48},28,{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":4},"100642161","phase-4-a-study-to-evaluate-the-safety-of-dostarlimab-in-adult-participants-in-india-with-primary-advanced-or-recurrent-endometrial-cancer-100642161","NCT07652515","A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer","Phase 4, Open Label, Single-arm, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Primary Advanced or Recurrent Endometrial Cancer","Inclusion Criteria:\n\n* Participant with greater than or equals to (\\>=) 18 years of age, at the time of signing the informed consent.\n* Participant has histologically or cytologically proven EC with recurrent or advanced disease.\n* Participant must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination based on investigator's assessment.\n* Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.\n* Woman of childbearing potential (WOCBP) agrees to use contraceptive from screening through at least 180 days after the last dose.\n* Negative urine pregnancy test at most 24 hours prior to the first dose of study intervention.\n* Capable of giving signed informed consent.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participant has had greater than (\\>) 1 recurrence of endometrial cancer.\n* Participant has a concomitant malignancy, or participant has a prior non endometrial invasive malignancy who has been disease-free for less than (\\\u003C) 3 years or who received any active treatment in the last 3 years for that malignancy.\n* Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.\n* Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.\n* Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.\n* Participant has not recovered (i.e., to Grade less than or equal to \\[\\\u003C=\\] 1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony-stimulating factor \\[G-CSF\\], Granulocyte macrophage colony-stimulating factor \\[GM-CSF\\], or recombinant erythropoietin) within 21 days prior to the first dose of study drug.\n* Either the history of hypersensitivity to excipients of the study intervention or to drugs with a similar chemical structure or class of the study intervention.\n* Participant has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid \\[qualitative\\] is detected).\n* Participant has received neo-adjuvant\u002Fadjuvant systemic anticancer therapy for primary Stage III or IV disease and:\n\n  * has not had a recurrence or Progressive disease (PD) prior to first dose on the study, or\n  * has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study.\n* Participant has received prior therapy with an anti- Programmed death protein 1 (anti-PD-1), anti- Programmed death ligand 1 (anti-PD-L1), or Programmed death ligand 2 (anti PD L2) agent.\n* Participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days or \\\u003C5 times the half life of the most recent therapy prior to study Day 1, whichever is shorter.\n* Systemic glucocorticoids for any purpose other than to manage symptoms of suspected irAEs. If medically deemed necessary (e.g., acute asthma or chronic obstructive pulmonary disease exacerbation, prophylaxis for intravenous (IV) contrast if indicated), Investigators are allowed to use their judgment to treat participants with systemic steroids. In such cases, systemic steroids should be stopped at least 24 hours prior to the next dose of study treatment.\n* Participant has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study intervention, during study treatment, and for up to 180 days after receiving the last dose of study intervention.\n* Participant has a diagnosis of immunodeficiency and is receiving systemic steroid therapy (\\>10 milligrams \\[mg\\] daily prednisone or equivalent) within 7 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication.\n* Participant is currently receiving study intervention, or is enrolled or has participated in any other clinical study involving an investigational intervention and received investigational treatment or used an investigational device within 4 weeks of the first dose of dostarlimab.\n* Participant is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study intervention.\n* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.",{"count":561,"type":21},100,[563],"PHASE4","This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).",[27],[567,568,496,569,33],"Carboplatin","Dostarlimab","First line treatment","2026-06-11",{"date":425,"type":41},{"date":573,"type":21},"2026-08-17",{"date":575,"type":21},"2030-08-30",{"name":47,"class":48},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":201,"enrollmentInfo":585,"targetDuration":4,"studyType":22,"phases":587,"briefSummary":588,"conditions":589,"keywords":591,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":602},"100641795","phase-3-a-24-week-study-of-the-efficacy-and-safety-of-blu-5937-in-adults-with-refractory-chronic-cough---china-extension-100641795","NCT07650084","A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough - China Extension","A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough Including Unexplained Chronic Cough (CALM-2) - China Extension","CALM-2","Inclusion Criteria:\n\n* Capable of giving signed informed consent\n* Refractory chronic cough (including unexplained chronic cough) for at least one year\n\n  * Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose\n\nExclusion Criteria:\n\n* Current smoker\u002Fvaper (all forms of smoking and inhaled substances, including, cannabis\u002Ftobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \\>20 pack-year smoking history\n* Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, uncontrolled asthma, or other significant or progressive airway\u002Frespiratory disorder that might affect cough based on clinician assessment\n* Respiratory tract infection within 4 weeks before screening\n* Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening\n* History of malignancy in the last 5 years\n* History of alcohol or drug abuse within the last 3 years\n* Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.\n* Previous participation in a BLU-5937 trial",{"count":586,"type":21},75,[24],"This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).",[590],"Refractory Chronic Cough",[592,593],"Cough","Chronic Cough","2026-06-10",{"date":596,"type":41},"2026-06-16",{"date":598,"type":41},"2025-11-21",{"date":600,"type":21},"2028-06-02",{"name":47,"class":48},38,{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":628},"100609772","phase-3-a-study-of-idrx-42-gsk6042981-versus-vs-sunitinib-in-participants-with-gastrointestinal-stromal-tumors-after-imatinib-therapy-100609772","NCT07218926","A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy","A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and\u002For Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed GIST that is metastatic and\u002For surgically unresectable.\n* Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable\u002Fmetastatic disease.\n* Documented mutation status of KIT and\u002For PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay.\n* Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.\n\nExclusion Criteria:\n\n* GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation.\n* Known untreated or active central nervous system metastases.\n* Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease.",{"count":611,"type":21},450,[24],"The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.",[615],"Gastrointestinal Neoplasms",[617,618,619,620,621],"GSK6042981","IDRX-42","Sunitinib","Imatinib","Gastrointestinal Stromal Tumors",{"date":448,"type":41},{"date":624,"type":41},"2025-12-03",{"date":626,"type":21},"2030-11-29",{"name":47,"class":48},124,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":327,"sex":57,"minAge":18,"maxAge":139,"enrollmentInfo":636,"targetDuration":4,"studyType":22,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":651,"completionDateStruct":652,"leadSponsor":654,"locationsCount":4},"100642860","phase-1-first-in-human-dose-escalation-of-gsk4425689a-safety-tolerability-and-pk-in-healthy-adults-100642860","NCT07646353","First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults","A First-in-Human Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK4425689A in Healthy Adult Participants","Inclusion Criteria:\n\n1. Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.\n2. Participants must have a body weight between 50 and 100 kg, inclusive and body-mass index (BMI) within the range of 18.0 to 32.0 kg\u002Fm\\^2.\n3. Participants must be healthy male or female participant of non-childbearing potential (PONCBP).\n4. Participants must be capable of giving signed informed consent prior to any study-specific procedures, which include compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n5. Participants must demonstrate the ability to understand and comply with the study requirements, including attendance for all scheduled visits and adherence to protocol-specified procedures and restrictions. Participants must be willing to remain in close contact with study personnel and reliably record data as instructed.\n6. Participants must be in good general health and have no significant ongoing medical conditions, as determined by comprehensive medical history, thorough physical examination, vital signs assessment, 12-lead ECG, and clinical laboratory evaluations (including hematology, biochemistry, and urinalysis).\n7. Participants should have baseline (screening) clinical laboratory values (renal, hepatic, and hematological) within normal limits or clinically acceptable to the investigator. A participant with a clinical abnormality or laboratory parameter(s) which is\u002Fare not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the investigator considers that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.\n8. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin levels must be within the normal range at Screening.\n\nExclusion Criteria:\n\n1. Participants with a history of malaria infection or who have previously participated in malaria vaccine trials or studies involving experimental anti-malarial monoclonals, small molecule drugs, or experimental malaria challenge are excluded. Participants who have been vaccinated against malaria with an investigational or approved vaccine (e.g., RTS,S and R21\u002FMatrix-M) are excluded.\n2. History of allergy to humanized monoclonal antibodies (mAbs) or constituents of the formulation.\n3. Any history of anaphylaxis or other severe allergic reactions, or food, or drug allergy that may impact participant safety in the opinion of the investigator.\n4. Recent history of, or presence of a current or suspected chronic disease that may impact participant safety, or impact interpretation of clinical study results. This includes illnesses such as (but not limited to) cardiac disease, autoimmune disease, diabetes, progressive neurological disease, severe malnutrition, hepatic or renal disease, epilepsy, chronic obstructive pulmonary disease or asthma (except resolved childhood asthma, which is acceptable). Conditions that in the opinion of the investigator constitute a risk to the individual when taking the study intervention or likely to interfere with the interpretation of data.\n5. Have a history of malignant neoplasm (other than localized basal or squamous cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years of Screening, regardless of whether there is evidence of local recurrence or metastases.\n6. Current enrolment or participation in another clinical study.\n7. Participation in another clinical study involving any investigational product within the past 90 days or within a period equivalent to 5 half-lives of the investigational drug, whichever is longer, or receipt of experimental non-malaria vaccines or mAbs within the past 12 months prior to signing the informed consent.\n8. QT corrected for heart rate by Fridericia's formula (QTcF) \\>450 msec.\n9. Presence or history of cardiac arrhythmias or cardiac disease or a family or personal history of long-QT syndrome.\n10. Average heart rate of \\\u003C40 or \\>100 beats per minute (bpm).\n11. Evidence of previous myocardial infarction or any clinically significant conduction abnormality such as left bundle branch block, atrioventricular (AV) block (2nd degree or higher), Wolff-Parkinson-White syndrome, atrial fibrillation, and atrial flutter. A long-standing right bundle branch block is permitted.\n12. Participants cannot take investigational product with biologic agents (such as mAbs including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to signing the informed consent.\n13. Past or intended use of over the counter or prescription medication, including herbal medications or cannabidiol (CBD)-based products within 14 days prior to administration of study intervention.\n14. Recent infection or illness:\n\n    * Participants with any acute illness or infection requiring treatment within 28 days prior to Screening are excluded (but may be re-screened if appropriate).\n    * Participants with evidence of active infections, such as Coronavirus disease 2019 (COVID-19) or tuberculosis are excluded.\n15. Participants who have received any live vaccines within 3 months prior to Screening or plan to receive such vaccines during the clinical study.\n16. Positive drug screen at Screening, including tetrahydrocannabinol, indicating use of known recreational drugs or drugs of abuse.\n17. An average weekly alcohol intake of \\>21 units per week for male participants and \\>14 units per week for female participants within 6 months prior to Screening. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.\n18. Any individual who is a current smoker or has a history of cigarette smoking of more than 5 pack years or regular use of tobacco- or nicotine-containing products within 6 months prior to Screening (including e-cigarettes or vaping).\n19. Pregnancy and lactation:\n\n    * Participants of childbearing potential (POCBP) are excluded.\n    * Pregnant or breastfeeding females are excluded.\n20. Participants who have donated 500 mL or more of blood or blood products within 12 weeks before administration of study intervention are excluded.\n21. Concomitant conditions:\n\n    * Positive human immunodeficiency virus (HIV) antibody test.\n22. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for clinically established Gilbert's syndrome or asymptomatic gallstones).\n23. Presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to first dose of study intervention.\n24. Positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study intervention.\n25. Positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention.\n26. History of severe reactions to IV or SC injections (e.g., anaphylaxis, vasovagal syncope).",{"count":637,"type":21},40,[143],"This study will assess the safety, tolerability, and pharmacokinetic properties of GSK4425689A monoclonal antibody (mAb) in healthy adults, when administered by either intravenous (IV) or subcutaneous (SC) routes.",[334],[642,643,644,69,645,646,647,391,648],"Malaria","GSK4425689A","First-in-human","Tolerability","Pharmacokinetic","Healthy Adults","Monoclonal antibody (mAb)","2026-06-09",{"date":448,"type":41},{"date":448,"type":21},{"date":653,"type":21},"2028-04-19",{"name":47,"class":48},{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":22,"phases":664,"briefSummary":665,"conditions":666,"keywords":667,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":674,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":678,"locationsCount":679},"100610417","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-belantamab-mafodotin-in-combination-with-standard-of-care-in-participants-with-relapsed-refractory-multiple-myeloma-rrmm-100610417","NCT07227311","A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)","A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)","Inclusion Criteria:\n\n• Participants are eligible to be included in the study only if all of the following criteria apply:\n\nApplicable to All Arms - BPd, BVd, BKd:\n\n* Male or female, 18 years or older (at the time consent is obtained).\n* Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.\n* Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.\n* Must have at least 1 aspect of measurable disease, defined as one the following:\n\n  1. Urine M-protein excretion ≥200 mg\u002F24 h, or\n  2. Serum M-protein concentration ≥0.5 g\u002FdL (≥5.0 g\u002FL), or\n  3. Free Light Chain (FLC) assay: involved FLC level ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum free light chain ratio (\\\u003C0.26 or \\>1.65) only if patient has no measurable urine or serum M spike.\n* Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:\n\n  1. ASCT was \\>100 days prior to the first dose of study medication,\n  2. No active bacterial, viral, or fungal infection(s) present.\n* All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia.\n* Adequate organ system functions as defined by the laboratory assessments.\n* Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception.\n* Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential.\n\nSpecific Inclusion Criteria for BPd arm:\n\n• Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nApplicable for all (BPd, BVd, BKd):\n\n* Active plasma cell leukemia at Screening.\n* Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).\n* Previous or concurrent invasive malignancy other than MM, except:\n\n  1. The disease must be considered medically stable for at least 2 years; or\n  2. The patient must not be receiving active therapy, other than hormonal therapy for this disease.\n* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.\n* Plasmapheresis within 7 days prior to the first dose of study intervention.\n* Patients after prior allogeneic stem cell transplant\n* Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery.\n* Evidence of active mucosal or internal bleeding.\n* Intolerance or contraindications to anti-viral prophylaxis.\n* Current corneal epithelial disease except for mild punctate keratopathy.\n* Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.\n* Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety). Patients with isolated proteinuria resulting from MM are eligible, provided they fulfill certain criteria\n* Received prior B-cell maturation antigen (BCMA)-targeted therapy.\n* Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications. Bandage contact lenses are permitted during study treatment as directed by the treating eye care specialist.\n* HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count.\n* Significant liver dysfunction (ALT \\>2.5x ULN, bilirubin \\>1.5x ULN, cirrhosis, unstable liver\u002Fbiliary disease).\n* Positive hepatitis B or C markers unless criteria for resolved infection are met.\n* Evidence of cardiovascular risk including any of the following: untreated arrhythmias, recent MI\u002FACS\u002Fangioplasty\u002Fbypass, NYHA III\u002FIV heart failure, uncontrolled hypertension, QTc prolongation.\n\nSpecific Exclusion Criteria for BPd Arm:\n\n* Received prior treatment with or intolerant to pomalidomide.\n* Active or history of venous and arterial thromboembolism within the past 3 months.\n\nSpecific Exclusion Criteria for BVd Arm:\n\n* Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg\u002Fm² twice weekly or within 60 days of completing that treatment).\n* Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.\n\nSpecific Exclusion Criteria for BKd Arm:\n\n* Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment).\n* Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib.\n* Left ventricular ejection fraction \\\u003C40% as assessed by transthoracic echocardiogram.\n* Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment.\n* Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.\n* Known pulmonary hypertension.",{"count":663,"type":21},200,[62],"This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.\n\nThe main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.",[176],[668,669,670,671,672,179,673,181],"Relapsed-Refractory Multiple Myeloma","DREAMM-15","Belantamab Mafodotin","Blenrep","Pomalidomide","Carfilzomib",{"date":594,"type":41},{"date":676,"type":41},"2026-04-15",{"date":575,"type":21},{"name":47,"class":48},27,""]