[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Japan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":719},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1193,0,25,[9,55,85,110,139,171,196,225,250,289,313,341,369,408,443,467,494,519,545,571,595,616,650,677,698],{"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":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100630823","phase-2-a-study-of-bms-986504-monotherapy-and-in-combination-with-other-agents-in-participants-with-advanced-andor-metastatic-solid-tumors-with-homozygous-mtap-deletion-mountaintap-5-100630823",false,"NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[27],"Solid Tumors",[29,30,31,32,33,34,35,36,37,38,39,40,41],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Melanoma","NSCLC","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli","RECRUITING","2026-08-24",{"date":45,"type":46},"2026-08-25","ACTUAL",{"date":48,"type":46},"2026-07-27",{"date":50,"type":21},"2032-05-20",{"name":52,"class":53},"Bristol-Myers Squibb","INDUSTRY",57,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"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":63,"type":21},200,[24],"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.",[67],"Multiple Myeloma",[69,70,71,72,73,74,75,76],"Relapsed-Refractory Multiple Myeloma","DREAMM-15","Belantamab Mafodotin","Blenrep","Pomalidomide","Bortezomib","Carfilzomib","Dexamethasone",{"date":45,"type":46},{"date":79,"type":46},"2026-04-15",{"date":81,"type":21},"2030-08-30",{"name":83,"class":53},"GlaxoSmithKline",59,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":96,"type":21},150,[98],"PHASE3","The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[101],"Diabetes Mellitus, Type 1",{"date":45,"type":46},{"date":104,"type":46},"2026-01-12",{"date":106,"type":21},"2031-07",{"name":108,"class":53},"Eli Lilly and Company",113,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100604873","phase-2-a-study-to-evaluate-the-optimal-dose-adverse-events-and-change-in-disease-activity-of-intravenous-abbv-706-in-combination-with-atezolizumab-versus-standard-of-care-as-first-line-treatment-in-adult-participants-with-previously-untreated-extensive-stage-small-cell-lung-cancer-100604873","NCT07155174","A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer","A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","SEZanne","Inclusion Criteria:\n\n* Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* Suspected brain metastases at screening should have a computed tomography (CT)\u002F magnetic resonance imaging (MRI) of the brain prior to study entry.\n\nExclusion Criteria:\n\n* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).\n* Known active\u002Fsymptomatic central nervous system (CNS) metastases should be excluded.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan should be excluded.\n* Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.",{"count":119,"type":21},180,[24],"Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).\n\nABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.\n\nIn the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[123],"Small Cell Lung Cancer",[123,125,126,127,128,129,130],"SCLC","ABBV-706","Etoposide","Carboplatin","Atezolizumab","Lurbinectedin",{"date":45,"type":46},{"date":133,"type":46},"2025-11-25",{"date":135,"type":21},"2031-09",{"name":137,"class":53},"AbbVie",67,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":147,"type":21},500,[24,98],"A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[151],"Non-Small Cell Lung Cancer",[153,154,155,156,157,158,159,160,161,128,162,163],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Cisplatin","Pemetrexed",{"date":45,"type":46},{"date":166,"type":46},"2025-11-05",{"date":168,"type":21},"2030-11-15",{"name":52,"class":53},186,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":180,"type":21},590,[24,98],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[184],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[31,186,37,29,30,187,188,40],"Lung cancer","MRTX1719","First-line",{"date":45,"type":46},{"date":191,"type":46},"2026-01-02",{"date":193,"type":21},"2031-08-12",{"name":52,"class":53},320,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100594352","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100594352","NCT07018323","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","75 Years",{"count":205,"type":21},210,[24],"This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.",[209],"Graves' Disease",[211,212,213,214,215,216],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart",{"date":45,"type":46},{"date":219,"type":46},"2025-06-19",{"date":221,"type":21},"2027-05",{"name":223,"class":53},"Immunovant Sciences GmbH",163,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":234,"type":21},450,[98],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[238],"Bipolar Disorder Type I With Mania",[240,241,242],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":45,"type":46},{"date":245,"type":46},"2025-07-18",{"date":247,"type":21},"2028-06-13",{"name":52,"class":53},174,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":258,"minAge":18,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100581820","phase-3-study-comparing-aaa817arpi-versus-standard-of-care-in-adult-participants-with-psma-positive-mcrpc-100581820","NCT06855277","Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer","AcTFirst","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have histological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.\n* Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.\n* Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).\n* Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.\n* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).\n\n  * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.\n\nKey Exclusion Criteria:\n\n* Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \\[177Lu\\]Lu-PSMA, \\[177Lu\\]-DOTA, or Radium- 223.)\n* Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).\n\n  * Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.\n\nNote: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE","100 Years",{"count":261,"type":21},940,[98],"The purpose of this study is to determine whether \\[225Ac\\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +\u002F- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \\[177Lu\\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.",[265],"Prostate Cancer",[267,268,269,270,271,272,273,274,275,276,277,278,256,279,280],"Positive Metastatic Castration Resistant Prostate Cancer","PSMA","PSMA-positive","AAA817","[225AC] AC-PSMA-617","Radioligand Therapy","RLT","Androgen receptor pathway inhibitor","ARPI","Taxane","Metastatic castration resistant prostate cancer","mCRPC","[177Lu]Lu- PSMA-617","AAA617",{"date":45,"type":46},{"date":283,"type":46},"2025-07-01",{"date":285,"type":21},"2032-11-04",{"name":287,"class":53},"Novartis Pharmaceuticals",93,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100579143","phase-2-a-study-to-evaluate-the-adverse-events-and-efficacy-of-intravenous-iv-of-telisotuzumab-adizutecan-in-combination-with-iv-oxaliplatin-fluorouracil-folinic-acidleucovorin-bevacizumab-panitumumab-in-adult-participants-with-metastatic-colorectal-cancer-100579143","NCT06820463","A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid\u002FLeucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the criteria within the protocol.\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and\u002For any topoisomerase inhibitor(s) (e.g., irinotecan).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.",{"count":298,"type":21},390,[24],"CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU\u002FLV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab\u002Fpantitumumab. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[302],"Metastatic Colorectal Cancer",[302,304,305],"AndroMETa-CRC-533","Telisotuzumab Adizutecan",{"date":45,"type":46},{"date":308,"type":46},"2025-04-24",{"date":310,"type":21},"2028-04",{"name":137,"class":53},65,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":321,"minAge":322,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":340},"100522211","phase-3-study-of-volrustomig-in-women-with-high-risk-locally-advanced-cervical-cancer-evolve-cervical-100522211","NCT06079671","Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","eVOLVECervical","Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\\u003C 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO\u002FECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg\u002Fday of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","FEMALE","15 Years",{"count":324,"type":21},800,[98],"This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.",[328],"Locally Advanced Cervical Cancer",[330,331,332],"Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig",{"date":45,"type":46},{"date":335,"type":46},"2023-09-22",{"date":337,"type":21},"2030-09-30",{"name":339,"class":53},"AstraZeneca",205,{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":355,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":349,"type":21},626,[24,98],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[353,354],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[356,357,37,354,358,359,360],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":45,"type":46},{"date":363,"type":46},"2020-12-02",{"date":365,"type":21},"2029-10-31",{"name":367,"class":53},"Mirati Therapeutics Inc.",770,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":259,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":380,"conditions":381,"keywords":386,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.",{"count":377,"type":21},100,[379],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[36,382,383,384,385],"Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers","High Grade Glioma",[387,388,389,390,391,36,392,393,394,395,396,382,397,398,399,400,385],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":45,"type":46},{"date":403,"type":46},"2018-01-26",{"date":405,"type":21},"2032-12-28",{"name":287,"class":53},33,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":427,"overallStatus":434,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},"100653395","phase-2-a-study-of-clazakizumab-ly5724886-in-adults-with-elevated-hscrp-and-at-increased-risk-for-cardiovascular-event-100653395","NCT07783802","A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Clazakizumab in Reducing hsCRP in Adults With Elevated hsCRP and Established ASCVD or at Increased Risk for ASCVD Events","CLARITY-CRP","Inclusion Criteria:\n\n* hsCRP ≥2 mg\u002FL and ≤15 mg\u002FL at screening\n* At least one of the following chronic conditions:\n\n  * Established atherosclerotic cardiovascular disease (ASCVD)\n  * Obesity (body mass index (BMI) ≥30 kg\u002Fm2)\n  * Type 2 diabetes\n  * Hypertension\n  * Chronic kidney disease Grade 3 or 4\n\nExclusion Criteria:\n\n* Acute cardiovascular event within 60 days prior to screening\n* Acute decompensated heart failure hospitalization within 60 days prior to screening\n* Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or major surgery at the time of randomization\n* New York Heart Association Class III or IV heart failure\n* Uncontrolled hypertension at screening (systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg)\n* Type 1 diabetes\n* Type 2 diabetes with Hemoglobin A1c ≥9.0% (86 mmol\u002Fmol) at screening\n* Nephrotic syndrome, estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m², or history of kidney transplant\n* Dialysis or acute kidney injury within 60 days prior to screening\n* Congenital\u002Fhereditary kidney disease, polycystic kidney disease, lupus nephritis, or antineutrophil cytoplasmic antibody-associated vasculitis\n* Active tuberculosis, untreated latent tuberculosis, or known hepatitis B or hepatitis C infection\n* Serious, opportunistic, chronic, or recurrent infection requiring treatment within 12 weeks prior to screening\n* Significant active autoimmune disease\n* Suspected or confirmed immunocompromised state (e.g., HIV infection)\n* History of peptic ulcer disease or gastrointestinal ulceration within 12 months prior to screening\n* History of diverticular disease, gastrointestinal perforation, or major gastrointestinal surgery\n* Mechanical heart valve prosthesis requiring chronic vitamin K antagonist anticoagulation\n* Use of colchicine within 14 days prior to screening or anticipated need during the study\n* Use of immunosuppressive or immunomodulatory agents, including other biologic anti-IL-6 therapies, within specified windows prior to screening\n* Use of systemic corticosteroids within 14 days prior to screening\n* Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs)",{"count":417,"type":21},120,[24],"The purpose of this study is to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with placebo in adults who have elevated hsCRP and at increased risk for cardiovascular event.\n\nParticipation in the study will last about 9 months.",[421,422,423,424,425,426],"Atherosclerosis","Cardiovascular Disease","Obesity","Hypertension","Diabetes Mellitus, Type 2","Renal Insufficiency, Chronic",[428,429,430,431,432,433],"Interleukin-6 (IL-6)","IL-6 inhibition","C-reactive protein","Residual inflammatory risk","Cardiovascular risk","Monoclonal antibody","NOT_YET_RECRUITING","2026-08-21",{"date":45,"type":46},{"date":438,"type":21},"2026-09",{"date":440,"type":21},"2027-10",{"name":108,"class":53},47,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100653263","phase-3-a-study-to-evaluate-effect-of-azd6234-in-adult-participants-with-obesity-or-overweight-with-weight-related-comorbidity-without-type-2-diabetes-mellitus-100653263","NCT07784725","A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus","A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)","SELENE 1","Inclusion Criteria:\n\n* Males \\& females (inclusive of all gender identities) age ≥18 years\n* BMI ≥30 kg\u002Fm2 OR BMI ≥27 kg\u002Fm2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence\n* Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation\n* History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime\n\nExclusion Criteria:\n\n* Obesity primarily caused by other endocrine disorders\n* History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol\u002Fmol), and\u002For treatment with glucose-lowering agent(s) within 3 months prior to Screening\n* Significant hepatobiliary disease and\u002For any of the following results at Screening:\n\n  * ALT ≥ 3.0 × ULN\n  * AST ≥ 3.0 × ULN\n  * TBL \\> 1.5 × ULN (except for cases of known Gilbert's Syndrome)\n* Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.",{"count":452,"type":21},2500,[98],"The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment",[456],"Obesity or Overweight",[423,458,459],"Overweight","AZD6234",{"date":45,"type":46},{"date":462,"type":46},"2026-08-19",{"date":464,"type":21},"2029-05-21",{"name":339,"class":53},212,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":493},"100651806","phase-2-a-phase-2-bridging-study-of-elacestrant-monotherapy-in-advanced-or-metastatic-breast-cancer-100651806","NCT07766018","A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer","A Phase 2 Open-Label, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Elacestrant Monotherapy for the Treatment of Japanese Participants With ER+\u002FHER2- Advanced or Metastatic Breast Cancer With ESR1-mutation Following CDK4\u002F6 Inhibitor Therapy","Key Inclusion Criteria:\n\n* Must have a histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy\n* Female participants must be post-menopausal (as defined by the protocol)\n* Must have ER+ and HER2- tumor status confirmed per local laboratory testing\n* Participants must be ESR1-mutant positive determined via testing with the Guardant360 Companion Diagnostic panel test prior to enrollment\n* Must have disease progression during or within 28 days of completion of prior treatment with a CDK4\u002F6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (this counts as a line of prior endocrine therapy) for metastatic breast cancer\n\nKey Exclusion Criteria:\n\n* Prior treatment with: elacestrant or investigational or approved selective estrogen receptor degrader or ER antagonist; antibody-drug conjugate therapy for advanced\u002Fmetastatic breast cancer; anti-cancer or investigational drug treatment\n* Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug\n* Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion)\n* Diagnosis of any other malignancy within 5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or second primary breast cancer\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":475,"type":21},70,[24],"This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) therapy in combination with fulvestrant or an aromatase inhibitor.",[479],"Breast Cancer",[481,482,483,484,479,485],"Elacestrant","Bridging Study","Japan","ESR1-mutation","CDK4\u002F6i",{"date":45,"type":46},{"date":488,"type":21},"2026-08",{"date":490,"type":21},"2028-10",{"name":492,"class":53},"Stemline Therapeutics, Inc.",1,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":502,"maxAge":203,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":505,"briefSummary":506,"conditions":507,"keywords":509,"overallStatus":434,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":515,"leadSponsor":517,"locationsCount":518},"100651359","phase-2-a-study-of-brenipatide-ly3537031-in-adult-participants-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-copd-100651359","NCT07759245","A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","RENEW-COPD","Inclusion Criteria:\n\n* Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:\n\n  * Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years\n  * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)\u002Fforced vital capacity (FVC) less than (\\\u003C) 70 percent (%)\n  * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2\n  * Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.\n  * Background double therapy \\[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\\] or triple therapy \\[inhaled corticosteroids (ICS) + LABA + LAMA)\\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.\n\nExclusion Criteria:\n\n* Have a known pre-existing, clinically important lung condition other than COPD.\n* Have a current or recent acute, active infection before screening and up to randomization.","40 Years",{"count":504,"type":21},606,[24],"The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.",[508],"Pulmonary Disease, Chronic Obstructive",[510,511,512],"Emphysema","Chronic Bronchitis","Lung Disease",{"date":43,"type":46},{"date":488,"type":21},{"date":516,"type":21},"2028-11",{"name":108,"class":53},128,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":526,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":533,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":544},"100650113","phase-3-a-study-of-secutrelvir-in-participants-with-coronavirus-disease-2019-covid-19-who-are-at-high-risk-for-progression-to-severe-disease-100650113","NCT07743580","A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease","A Phase 3 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19 Who Are at High Risk for Progression to Severe Disease","Key Inclusion Criteria:\n\n* Must be 12 to \\\u003C18 years of age (where permitted by local regulations) with a body weight ≥40 kilograms, or ≥18 years of age regardless of body weight, at the time of signing the informed consent form.\n* Presence of risk factors for progression to severe COVID-19 at the time of screening.\n* Must have ≥1 COVID-19 signs\u002Fsymptoms that are at least mild in severity, and the symptoms must still be present in the 24 hours prior to randomization.\n* Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test (for example, quantitative reverse transcription polymerase chain reaction, antigen test) approved according to local regulations, of any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva), collected ≤72 hours prior to randomization.\n* Must be randomized within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs.\n* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receiving the investigational intervention.\n* Unable or unwilling to take other locally available COVID-19 antivirals (for example, nirmatrelvir\u002Fritonavir, molnupiravir, remdesivir, ensitrelvir).\n\nKey Exclusion Criteria:\n\n* Planned \\>24 hours hospitalization for any medical procedure through Day 28.\n* Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit.\n* Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).\n* Known history of any of the following abnormalities in the following clinical laboratory tests (within 6 months prior to the screening visit):\n* Total bilirubin ≥2\\*upper limit of normal (ULN) (except for Gilbert's syndrome)\n* Aspartate aminotransferase or alanine aminotransferase ≥3\\*ULN\n* Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to randomization.\n* Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.\n* Ongoing long COVID-19 or post-acute sequelae of COVID-19 diagnosis.\n* Current severely immunocompromised conditions.\n* Received any other COVID-19-specific therapies within the following timeframes:\n* Antiviral agents (for example, remdesivir, nirmatorelvir\u002Fritonavir, molnupiravir, ensitrelvir) within 30 days or 5 half-lives (whichever is longer) prior to randomization\n* Anti-SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 6 months prior to randomization\n\nNote: Other protocol-define criteria apply","12 Years",{"count":528,"type":21},2000,[98],"The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.",[532],"SARS-CoV-2",[532,534,535,536],"COVID-19","Secutrelvir","S-892216",{"date":45,"type":46},{"date":539,"type":21},"2026-08-31",{"date":541,"type":21},"2028-12-31",{"name":543,"class":53},"Shionogi",27,{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":556,"conditions":557,"keywords":561,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":570},"100645357","first-in-human-trial-of-ds1025a-in-participants-with-advanced-solid-tumors-100645357","NCT07681882","First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","To be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Sign and date the main ICF, prior to the start of any trial-specific procedures.\n2. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n3. Histologically documented, advanced, metastatic, or unresectable solid tumors.\n4. Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.\n5. Is willing to provide a newly obtained tumor tissue sample at screening, if not clinically contraindicated and at an acceptable risk as determined by the Investigator. If a fresh tumor biopsy is not clinically feasible or would pose unacceptable risk, an archival tumor tissue sample (obtained within 24 months of consent) must be submitted.\n6. Has measurable disease based on local CT\u002FMRI imaging as assessment by the Investigator using RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.\n7. ECOG PS of 0 or 1 assessed no more than 28 days prior to initiation of trial intervention.\n8. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as defined in the protocol.\n9. A WOCBP is eligible to participate if the following conditions are met:\n\n   * Participant is not pregnant as confirmed by highly sensitive pregnancy test\n   * Participant does not plan to breastfeed during the Trial Intervention Period and for at least 8 months after last dose of trial intervention.\n   * Participant agrees to adhere to a contraceptive method that is highly effective with low user dependency only and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during the Treatment Period and for at least the time needed to eliminate the trial intervention after the last dose.\n10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate the trial intervention:\n\n    * Avoid donating sperm.\n    * Adhere to approved contraception method as specified in the protocol.\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Prior treatment with an anti-CD25 therapy.\n2. Treatment discontinuation history due to toxicity to a DXd-ADC agent and considered not able to tolerate DS1025a based on the discussion between the investigator and the Sponsor (for participants who have DXd-ADC treatment history).\n3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n4. Has spinal cord compression or clinically active central nervous system tumors, including metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n6. Any of the following within the past 6 months prior to initiation of trial intervention: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n7. Participants with any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n8. Lung-specific intercurrent clinically significant illnesses as specified in the protocol.\n9. Has clinically significant pulmonary compromise or requirement for supplemental oxygen.\n10. History of other active malignancy within 3 years prior to initiation of trial intervention, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \\>90%) and treated with expected curative outcome\n11. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 6.0, Grade ≤1 or baseline.\n12. History of hypersensitivity to any excipients in DS1025a or any known contraindication to treatment with, including hypersensitivity to, the trial intervention.\n13. Has a known history of HLH.\n14. Has a known active infection, or reactivation of latent following infections as specified in the protocol among participants who received treatment such as antivirals, antifungals, or IV antibiotics within 14 days prior to first dose of trial intervention.\n15. Has active or uncontrolled HBV infection.\n16. Has active or uncontrolled HCV infection.\n17. Has active or uncontrolled HIV infection.\n18. Has an active, known, or suspected autoimmune disease.\n19. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.",{"count":553,"type":21},45,[555],"PHASE1","This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.",[558,559,560],"Advanced Solid Tumor","Metastatic Solid Tumor","Unresectable Solid Tumor",[558,559,560,562],"DS1025a",{"date":45,"type":46},{"date":565,"type":46},"2026-08-06",{"date":567,"type":21},"2029-01-21",{"name":569,"class":53},"Daiichi Sankyo",3,{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":434,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":594},"100645337","phase-3-study-of-izalontamab-brengitecan-bms-986507-in-combination-with-osimertinib-versus-osimertinib-monotherapy-or-osimertinib-in-combination-with-platinum-based-chemotherapy-for-egfrmt-non-small-cell-lung-cancer-izabright-lung02-100645337","NCT07680790","Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)","A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB\u002FIIIC), metastatic (Stage IVA\u002FIVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment\n* Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)\n* Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator\n* Participants must have ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and\u002For spinal cord compression\n* Participants must not have history of ILD\u002Fpneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD\u002Fpneumonitis\n* Participants must not have clinically significant cardiac disease\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":579,"type":21},850,[98],"The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy",[151],[37,584,585,159,155,586,587],"EGFR","First line","ADC","IZABRIGHT-Lung02",{"date":43,"type":46},{"date":590,"type":21},"2026-09-30",{"date":592,"type":21},"2031-12-30",{"name":52,"class":53},208,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":22,"phases":605,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":434,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":615},"100643877","phase-3-amaze-13-a-research-study-investigating-how-well-the-medicine-zenagamtide-helps-people-in-asia-with-excess-body-weight-lose-weight-100643877","NCT07668401","AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight","Efficacy and Safety of Zenagamtide s.c. Once-weekly in Asian Participants With Overweight or Obesity (AMAZE 13)","AMAZE 13","Inclusion Criteria:\n\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n* Age 18 years or above at the time of signing the informed consent\n\nExclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol\u002Fmol) as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes mellitus.\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.",{"count":604,"type":21},400,[98],"The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.",[423,458],{"date":43,"type":46},{"date":610,"type":21},"2027-01-07",{"date":612,"type":21},"2029-01-11",{"name":614,"class":53},"Novo Nordisk A\u002FS",44,{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":17,"minAge":623,"maxAge":624,"enrollmentInfo":625,"targetDuration":4,"studyType":22,"phases":627,"briefSummary":628,"conditions":629,"keywords":634,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":649},"100642012","phase-2-a-study-of-donanemab-ly3002813-in-participants-with-early-cognitive-decline-trailblazer-alz-7-100642012","NCT07589595","A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)","A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology","Inclusion Criteria:\n\n* Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.\n* Have least 1 core clinical feature of dementia with Lewy bodies (DLB).\n* Have a score ≥20 on Montreal Cognitive Assessment (MoCA).\n* Meet plasma P-tau217 criteria.\n* Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.\n* Have a CSF result consistent with the presence of alpha-synuclein pathology.\n* Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.\n\nExclusion Criteria:\n\n* Have a disease or condition that could interfere with this study or is a current serious or unstable illness.\n* Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.\n* Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.\n* Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.\n* Have previously received amyloid-targeting therapy.\n* Active immunization against amyloid-beta.\n* Have a centrally read MRI that does not meet study entry criteria.\n* Have contraindication to MRI or PET scans.\n* Have any contraindication to lumbar puncture.","55 Years","85 Years",{"count":626,"type":21},350,[24],"The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.",[630,631,632,633],"Cognitive Dysfunction","Lewy Body Disease","Synucleinopathies","Amyloid",[635,636,637,638,639,640,641,642,630],"Mild Cognitive Impairment","Mild Dementia","Brain Diseases","Nervous System Diseases","Neurodegenerative Diseases","Neurocognitive Disorders","Cognition Disorders","Alzheimer Disease",{"date":45,"type":46},{"date":645,"type":46},"2026-05-20",{"date":647,"type":21},"2028-08",{"name":108,"class":53},72,{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":22,"phases":659,"briefSummary":660,"conditions":661,"keywords":663,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":676},"100636466","phase-3-a-study-to-compare-setidegrasib-asp3082-with-docetaxel-in-people-with-non-small-cell-lung-cancer-with-a-kras-g12d-mutation-100636466","NCT07566052","A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation","A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum Based Chemotherapy and Checkpoint Inhibitor Therapy (CPI)","Inclusion Criteria:\n\n* Participant has histologically confirmed locally advanced (unresectable) or metastatic non-small cell lung cancer (NSCLC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation result status, based on local or central testing.\n\n  * The participant's positive KRAS G12D mutation result (either in tumor tissue or plasma ctDNA) must be available prior to randomization.\n  * If the participant is enrolling based on a local testing result, the result may have been based on tissue or liquid (blood) testing. If the participant is enrolling via central testing, the eligibility sample must be from tissue.\n* Participant must have progressed or experienced disease recurrence on or after platinum based chemotherapy (which includes but is not limited to platinum combinations with pemetrexed, paclitaxel, etoposide or gemcitabine) in combination with anti-PD-1\u002FPD-L1 antibody OR platinum-based chemotherapy and anti-PD-1\u002FPD-L1 antibody (in either order) sequentially in the locally advanced (unresectable) or metastatic setting (participant who received anti PD-1\u002Fanti-PD-L1 antibody or platinum-based chemotherapy as first-line therapy in the locally advanced \\[unresectable\\] or metastatic setting may have received the combination of platinum-based chemotherapy and anti PD1\u002Fanti PD L1 antibody in the second line locally advanced \\[unresectable\\] or metastatic setting).\n\n  * No additional treatments are allowed in the locally advanced (unresectable) or metastatic setting, with the exception of: Anti-vascular endothelial growth factor (VEGF) therapy (e.g., bevacizumab), when administered in combination with platinum-based chemotherapy and\u002For anti-PD-1\u002FPD-L1 as part of a standard regimen in the locally advanced (unresectable) or metastatic setting and\n  * Anti-CTLA-4 antibodies (e.g., ipilimumab, tremelimumab), when administered in combination with anti-PD-1\u002FPD-L1 (with or without platinum-based chemotherapy) as part of a standard regimen in the locally advanced (unresectable) or metastatic setting.\n  * For the purposes of eligibility, for a participant who has received prior neoadjuvant or adjuvant therapy and has had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant therapy will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting (for those who received perioperative therapy, the entire course will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting).\n  * For the purposes of eligibility, for a participant with a history of unresectable Stage III disease who has received prior multi-modal therapy and has had recurrence on or within 6 months of completion of therapy, the multi-modal therapy will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting. If chemoradiation was followed by treatment with checkpoint inhibitor therapy (CPI) without documented progression between chemoradiation and CPI, the entire treatment course will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting, for the purposes of eligibility.\n  * Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate line of therapy.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP).\n  * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview) and agrees to follow the contraceptive guidance from the time of informed consent through ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable.\n  * Must not be breastfeeding or lactating starting at screening and throughout the investigational period and for ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable. (Note that this is stricter than some docetaxel product information\u002Flabeling documents due to the uncertainty regarding excretion of docetaxel in human milk.)\n  * Must not donate ova starting at first administration of study intervention and throughout the investigational period and for ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable.\n* Participant consents to and provides a baseline tumor tissue and plasma specimen during prescreening and\u002For screening.\n* Participant has an ECOG performance status of 0 or 1 within 7 days prior to randomization.\n\nExclusion Criteria:\n\n* Participant has known untreated or symptomatic central nervous system (CNS) metastases. Participant with previously treated brain metastases may be eligible if they have stable CNS disease for ≥ 2 weeks prior to randomization, all neurologic symptoms have returned to baseline, there is no evidence of new or enlarging brain metastases on brain imaging performed within 28 days prior to randomization and they are receiving ≤ 10 mg\u002Fday of prednisone or equivalent. Participants with untreated CNS metastases, even if asymptomatic, are not eligible.\n* Participant has mixed small-cell lung cancer and NSCLC histology.\n* Participant has leptomeningeal disease as a manifestation of the current malignancy.\n* Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.\n* Participant has known hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen \\[HBsAg\\]-positive or anti HBV core antibody-positive) or known hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\] detected) infection.\n* Participant with human immunodeficiency virus (HIV) infection may be eligible if the participant has not had an opportunistic infection within the past 12 months. Participant must be on established antiretroviral therapy for ≥ 4 weeks, have a CD4+ T cell ≥ 200 cells\u002FµL and must have an HIV viral load \\\u003C 400 copies\u002FmL prior to randomization (HIV testing is not required unless mandated by the local health authority).\n* Participant has current grade ≥ 2 peripheral neuropathy.\n* Participant has uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Participant with PleurX catheters in place may be considered for the study with medical monitor approval.\n* Participant has received therapeutic or palliative radiation therapy within 14 days prior to randomization (see first Exclusion Criteria for CNS metastases); participant must have recovered from all radiotherapy related toxicity to ≤ grade 1, with the exception of alopecia (any grade of alopecia allowed).\n* Participant has a known actionable mutation for which an approved targeted therapy is locally available, including, but not limited to, KRAS G12C mutation, EGFR mutation (exon 19 deletions, exon 21 L858R point mutation, T790M, exon 20 insertion), ALK or ROS1 rearrangement, NTRK fusion, NRG1 fusion, BRAF V600E mutation, MET exon 14 skipping mutation, RET rearrangement or HER2 activating mutation.\n* Participant has received prior treatment with either docetaxel or a KRAS-targeting agent (including KRAS directed inhibitors, degraders, siRNA, vaccines and cellular therapies).\n* Participant requires treatment with concomitant drugs that are strong inhibitors or inducers of cytochrome P450 (CYP)3A or CYP2D6 or strong inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1) or organic anion transporting polypeptide 1B3 (OATP1B3).",{"count":658,"type":21},356,[98],"Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. The first treatment is usually chemotherapy, given with another treatment that targets specific proteins on cancer cells. If the cancer gets worse, the next main treatment is usually a medicine called docetaxel. This treatment doesn't stop most people's cancer from getting worse for very long. Other treatments are needed to improve outcomes in people with NSCLC.\n\nGenes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with NSCLC have a faulty KRAS gene in their tumor. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.\n\nSetidegrasib (ASP3082) is thought to remove some of the abnormal proteins made from the faulty KRAS gene. Before setidegrasib can become available as a treatment, studies need to be done.\n\nThis study is for people with NSCLC with a faulty KRAS gene in their tumor. In this study, some people will be given setidegrasib and some people will be given docetaxel. The main aims are to learn how long people who are given setidegrasib live with cancer without it getting worse, compared to people who are given docetaxel, and if they live for longer. Other aims are to check tumor response, symptoms, how the body processes setidegrasib, and its safety, compared with docetaxel.\n\nThe main aims of study are to learn how long people who are given setidegrasib live with cancer without it getting worse, compared to people who are given docetaxel and if people who are given setidegrasib live for longer compared to people who are given docetaxel.\n\nPeople in this study will be adults with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They have had no more than 2 previous treatments for their cancer. The key reasons people cannot take part are if they have different faulty genes in their tumor which can be targeted with other treatments, have symptomatic or untreated cancers that have spread from the lung into the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomeningeal disease), or they have recently had other active cancers that required treatment.\n\nIn this study, people will either receive setidegrasib or docetaxel. Whether people receive setidegrasib or docetaxel is decided by chance, not by the study doctor. Both study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly, they pass away. Some people on docetaxel may be able to switch to setidegrasib during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study. People will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After people's cancer becomes worse, clinic staff will telephone people every 12 weeks to check on their cancer.",[662],"Non-small Cell Lung Cancer (NSCLC)",[664,665,666,667,668],"Non-small cell lung cancer (NSCLC)","ASP3082","setidegrasib","KRAS G12D","Docetaxel",{"date":43,"type":46},{"date":671,"type":46},"2026-04-28",{"date":673,"type":21},"2030-06-30",{"name":675,"class":53},"Astellas Pharma Global Development, Inc.",8,{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":683,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":203,"enrollmentInfo":685,"targetDuration":4,"studyType":22,"phases":687,"briefSummary":688,"conditions":689,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":692,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":475},"100634906","phase-2-a-study-of-brenipatide-ly3537031-in-participants-with-irritable-bowel-syndrome-constipation-ibs-c-100634906","NCT07545772","A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-C","RENEW-IBS-C","Inclusion Criteria:\n\n* Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n\nExclusion Criteria:\n\n* Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality",{"count":686,"type":21},342,[24],"The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 35 weeks.",[690,691],"Irritable Bowel Syndrome","Constipation",{"date":43,"type":46},{"date":694,"type":46},"2026-04-29",{"date":696,"type":21},"2027-09",{"name":108,"class":53},{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":703,"acronym":704,"eligibilityCriteria":705,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":203,"enrollmentInfo":706,"targetDuration":4,"studyType":22,"phases":708,"briefSummary":709,"conditions":710,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":712,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":718},"100634905","phase-2-a-study-of-brenipatide-ly3537031-in-participants-with-irritable-bowel-syndrome-diarrhea-ibs-d-100634905","NCT07545759","A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D","RENEW-IBS-D","Inclusion Criteria:\n\n* Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and \\\u003C25% of bowel movements with BSFS Types 1 or 2\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n  * Have at least 4 days per week with a maximum BSFS ≥5 AND with at least 2 days of the 4 days per week with a maximum BSFS ≥6 during the 14 consecutive days prior to randomization\n* Have had no major changes in diet in the 4 weeks prior to screening\n\nExclusion Criteria:\n\n* Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality",{"count":707,"type":21},531,[24],"The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 35 weeks.",[690,711],"Diarrhea",{"date":43,"type":46},{"date":714,"type":46},"2026-05-06",{"date":716,"type":21},"2027-11",{"name":108,"class":53},89,""]