[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Australia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":704},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1998,0,25,[9,48,84,107,128,151,180,202,232,254,278,299,331,359,382,404,431,456,485,513,572,598,629,653,676],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054171","aquarius-pilot-study-to-evaluate-the-new-axonics-trial-system-100054171",false,"NCT07335484","Aquarius Pilot Study to Evaluate the New Axonics Trial System","Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)","Inclusion Criteria:\n\n* 18 years or older\n* Provides written informed consent prior to trial procedures\n* Primary indication of OAB (UUI\u002FUF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU\n\nExclusion Criteria:\n\n* Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits\n* Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function\n* Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)\n* Current symptomatic urinary tract infection (UTI)","ALL","18 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"NA","Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and\u002For fecal incontinence (FI).",[27,28,29,30],"Urinary Urge Incontinence (UUI)","Urinary Frequency (UF)","Fecal Incontinence (FI)","Overactive Bladder (OAB)",[32,33,34],"Peripheral nerve evaluation","External trial system","Pilot study","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-04-30",{"date":43,"type":21},"2026-12",{"name":45,"class":46},"Axonics, Inc.","INDUSTRY",2,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100053387","phase-3-a-study-evaluating-the-efficacy-and-safety-of-pegozafermin-in-participants-with-mash-and-fibrosis-enlighten-fibrosis-100053387","NCT06318169","A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)\n* Biopsy-confirmed MASH with fibrosis stage F2 or F3\n* Body mass index (BMI) at screening ≥25.0 kilograms (kg)\u002Fmeters squared (m\\^2) (≥23 kg\u002Fm\\^2 for Asian participants).\n\nKey Exclusion Criteria:\n\n* Chronic liver diseases other than MASH\n* Evidence of cirrhosis on screening liver biopsy\n* Have type 1 diabetes or poorly controlled type 2 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL)\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) or pioglitazone must be on stable dose for at least 6 months prior to Screening\n\nOther inclusion and exclusion criteria may apply.","80 Years",{"count":57,"type":21},1350,[59],"PHASE3","The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.",[62],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Fibrosis",[64,65,66,67,68,69,70,71,72,73,74,75],"Liver Diseases","Fatty Liver","Digestive System Diseases","Metabolic diseases","Metabolic Dysfunction-Associated Steatohepatitis","MASH","Steatohepatitis","Metabolic dysfunction-associated steatotic liver disease","MASLD","Nonalcoholic fatty liver disease","NAFLD","Fibrosis",{"date":38,"type":39},{"date":78,"type":39},"2024-03-13",{"date":80,"type":21},"2029-02",{"name":82,"class":46},"89bio, Inc.",361,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100054056","phase-2-podomount-basket-a-study-to-test-whether-bi-764198-helps-adults-and-adolescents-with-different-types-of-kidney-disease-100054056","NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","12 Years",{"count":93,"type":21},132,[95],"PHASE2","This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[98],"Proteinuric Kidney Diseases",{"date":38,"type":39},{"date":101,"type":39},"2026-03-23",{"date":103,"type":21},"2028-02-17",{"name":105,"class":46},"Boehringer Ingelheim",161,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100054317","phase-3-dareon-nec-1-a-study-in-people-with-advanced-extrapulmonary-neuroendocrine-cancer-epnec-to-compare-obrixtamig-plus-carboplatin-and-etoposide-treatment-with-standard-chemotherapy-100054317","NCT07544654","DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy","A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas","Inclusion Criteria:\n\n1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \\>20% or mitotic rate mitotic rate with number of mitoses \\>20 per 2 mm2, regardless of primary site (including site of unknown origin)\n2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue\n3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease\n4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg\u002Fm2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg\u002Fm2) prior to randomisation\n5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)\n6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay\n7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma\n3. Patients with neuroendocrine prostate cancer\n4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition\n5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)\n6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)\n8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and\u002For CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.",{"count":115,"type":21},390,[59],"This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).\n\nParticipants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.\n\nDuring the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.",[119],"Extrapulmonary Neuroendocrine Cancer (epNEC)","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":123,"type":21},"2026-07-07",{"date":125,"type":21},"2031-03-11",{"name":105,"class":46},165,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":135,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100054324","phase-3-a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100054324","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE",{"count":137,"type":21},1440,[59],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[141,142],"Prostate Cancer","Prostatic Neoplasms",{"date":38,"type":39},{"date":145,"type":39},"2025-05-13",{"date":147,"type":21},"2031-01-06",{"name":149,"class":46},"Merck Sharp & Dohme LLC",290,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":135,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100053507","phase-1-first-in-human-study-to-evaluate-azd8359-steap2-tce-in-participants-with-prostate-cancer-100053507","NCT07529717","First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer","Phase I\u002FII Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer","CRIUS-1","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer\n* Surgically or medically castrated with serum testosterone levels ≤ 50 ng\u002FdL (≤ 1.75 nmol\u002FL)\n* PSA value at screening should be ≥ 1ng\u002FmL\n* Evidence of disease progression within 6 months prior to screening\n* Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway inhibitor and at least one taxane regimen if amenable\n* Part B Participants should have received an androgen receptor pathway inhibitor for metastatic hormone sensitive prostate cancer or metastatic castration resistant prostate cancer (mCRPC). No prior taxane treatment for mCRPC is allowed for Module 1 and 2 Part B patients\n* Adequate organ function\n* Body weight ≥ 35 kg\n\nExclusion Criteria:\n\n* Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias\n* All prior treatment-related adverse events must have resolved to Grade ≤ 2\n* History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy\n* Active or prior documented autoimmune or inflammatory disorders within the past 3 years\n* Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer","100 Years",{"count":161,"type":21},42,[163,95],"PHASE1","This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels and dosing schedules of AZD8359 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD8359 doses in a larger group of participants (dose expansion).",[166],"Metastatic Prostate Cancer",[168,169,170,171],"Prostate","STEAP2","T Cell-engaging Antibody","CD8",{"date":38,"type":39},{"date":174,"type":39},"2026-05-18",{"date":176,"type":21},"2027-11-17",{"name":178,"class":46},"AstraZeneca",8,{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100053288","phase-1-a-clinical-trial-of-pr001-ly3884961-in-patients-with-peripheral-manifestations-of-gaucher-disease-proceed-100053288","NCT05487599","A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED)","An Open-label, Dose-Finding, Phase 1\u002F2 Study to Evaluate the Safety and Tolerability of a Single Intravenous Dose of LY3884961 in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED)","Inclusion Criteria:\n\n1. Age greater or equal to 18 years at the time of informed consent.\n2. Bi-allelic pathogenic GBA1 variants must be centrally confirmed.\n3. On ERT or SRT for at least 2 years and on a stable, maximum tolerated dose, for at least 3 months prior to screening.\n4. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n5. Females and males will be eligible for this study. Men and women of childbearing potential must use a highly effective method of contraception consistently and correctly for the duration of the study, including the long-term follow-up.\n6. Patients must agree to abstain from blood, tissue and organ donation; and must agree to abstain from tissue and organ donation for the duration of the study, including long-term follow-up.\n\nExclusion Criteria:\n\n1. Clinically significant neurological signs and symptoms and\u002For behavioral disturbances.\n2. Active and progressive bone disease expected to require surgical treatment in the next 6 months.\n3. History of total splenectomy or planned total splenectomy during the first 18 months of the study. (Partial splenectomy not exclusionary).\n4. Splenomegaly \\> 10 MN as evaluated by centrally read abdominal magnetic resonance imaging (MRI)\n5. Evidence of clinically significant liver disease, fragile liver, or history of exposure to hepatotoxins.\n6. Thrombocytopenia with platelet count \\\u003C 40 × 10\\^3 per μL.\n7. Severe hyperlipidemia (triglycerides \\> 1,000 mg\u002FdL).\n8. Current diagnosis of unstable or clinically significant cardiovascular conditions based on Investigator assessment.\n9. History of certain cancers within 5 years of Screening.\n10. Concomitant disease, condition or treatment which, in the opinion of the Investigator, would pose an unacceptable risk to the patient or interfere with the patient's ability to comply with study procedures or interfere with the conduct of the study.\n11. Women of childbearing potential, pregnant (i.e., positive serum pregnancy result at Screening and\u002For Check-in) or breastfeeding or intending to become pregnant during the course of the trial.\n12. Use of any GD-related chaperone therapy within 4 weeks prior to Screening or expected need to initiate chaperone therapy during at least the first 18 months of the study.\n13. Any type of prior gene or cell therapy.\n14. Use of systemic immunosuppressant or steroid therapy other than protocol-specified immunosuppression.\n15. Participation in another therapeutic investigational drug or device study within 3 months or 5 half-lives of the study agent, whichever is longer.\n16. Have an anti-AAV9 antibody titer of \\>1:40 as determined by central laboratory.\n17. Clinically significant abnormalities in laboratory test results at Screening.\n18. Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic)implants\u002Fcardiac pacemaker.",{"count":188,"type":21},15,[163,95],"Study J3Z-MC-OJAE is a Phase 1\u002F2, multicenter, open-label, dose-finding study of LY3884961 evaluating the safety and tolerability in adults with peripheral manifestations of GD.\n\nUp to 3 dose levels of LY3884961 will be assessed in 3 dose-finding cohorts of 3 patients. Following this, up to 6 patients may be enrolled in an expansion cohort.\n\nFor each enrolled patient, the study will be approximately 5 years in duration, including up to a 60-day screening period. During the first 18 months after dosing, subjects will be evaluated for the effects of LY3884961 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will be followed for an additional 42 months to monitor safety, immunogenicity, and selected biomarker and efficacy parameters.",[192,193],"Gaucher Disease","Gaucher Disease, Type 1",{"date":38,"type":39},{"date":196,"type":39},"2022-12-20",{"date":198,"type":21},"2032-08-30",{"name":200,"class":46},"Prevail Therapeutics",9,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100054019","phase-1-a-study-of-bgb-11417-in-participants-with-myeloid-malignancies-100054019","NCT04771130","A Study of BGB-11417 in Participants With Myeloid Malignancies","A Phase 1b\u002F2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:\n\n   * AML, nonacute promyelocytic leukemia\n   * MDS\n   * MDS\u002FMPN\n2. Eastern Cooperative Oncology Group performance status of 0 to 2.\n3. Adequate organ function defined as:\n\n   * Creatinine clearance ≥ 50 milliliters\u002Fminute (mL\u002Fmin) (or between 30 and 49 mL\u002Fmin in unfit AML cohort)\n   * Adequate liver function\n4. Life expectancy of \\> 12 weeks.\n5. Ability to comply with the requirements of the study.\n\nKey Exclusion Criteria:\n\n1. A diagnosis of acute promyelocytic leukemia.\n2. History of prior malignancy, with the exception of either a history of MDS or MDS\u002FMPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)\n3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n4. Prior therapy with a B-cell lymphoma-2 inhibitor\n5. Known central nervous system involvement by leukemia.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":210,"type":21},260,[163,95],"The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS\u002Fmyeloproliferative neoplasm (MPN) .",[214,215,216],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Myelodysplastic\u002FMyeloproliferative Neoplasm",[218,219,220,221,222,223],"BGB-11417","Azacitidine","Posaconazole","AML","MDS","MDS\u002FMPN",{"date":38,"type":39},{"date":226,"type":39},"2021-05-24",{"date":228,"type":21},"2028-02-08",{"name":230,"class":46},"BeOne Medicines",46,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100053586","phase-1-a-study-to-evaluate-the-effect-of-gdc-4198-alone-and-in-combination-with-giredestrant-versus-abemaciclib-and-giredestrant-in-participants-with-locally-advanced-or-metastatic-estrogen-receptor-positive-er-human-epidermal-growth-factor-receptor-negative-her2--breast-cancer-100053586","NCT07100106","A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer","A Phase Ib\u002FII Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4\u002F6 Inhibitor","MoonROSE","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic.\n* Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO\u002FCAP or ESMO guidelines.\n* Disease progression during or after treatment with an approved cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor and approved endocrine therapy (ET) in the locally advanced or metastatic setting.\n* Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy \\>= 6 months.\n\nExclusion Criteria:\n\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines.\n* Have received more than one-line of therapy for locally advanced or metastatic disease.\n* Have received prior chemotherapy for metastatic breast cancer.\n* Treatment with an approved oral ET within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4\u002F6 inhibitor within 21 days prior to initiation of study drug.\n* Malabsorption condition or other gastrointestinal (GI) conditions\u002Fsurgeries that the investigator assesses may significantly interfere with enteral absorption\n* History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death.\n* Known allergy or hypersensitivity to any component of the study treatments.",{"count":241,"type":21},285,[163,95],"The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.",[245],"Breast Cancer",{"date":38,"type":39},{"date":248,"type":39},"2025-10-07",{"date":250,"type":21},"2028-08-31",{"name":252,"class":46},"Genentech, Inc.",52,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100053708","phase-1-a-study-of-azd3470-a-prmt5-inhibitor-given-as-monotherapy-and-in-combination-in-patients-with-mtap-deficient-advancedmetastatic-solid-tumors-100053708","NCT06130553","A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced\u002FMetastatic Solid Tumors","PRIMROSE: A Modular Phase I\u002FIIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced\u002FMetastatic Solid Tumors That Are MTAP Deficient","PRIMROSE","Inclusion Criteria (All Modules) Participants are ≥ 18 years (or the legal age of consent in the jurisdiction) at the time of signing the informed consent form.\n\nParticipants are able to provide written informed consent and are willing and able to comply with study procedures.\n\nParticipants are willing to provide archival and\u002For newly obtained (baseline) tumor tissue for central testing, including required biomarker assessment(s) (and any module-specific biomarker requirements).\n\nParticipants have tumors meeting the protocol-defined MTAP-deficiency requirement, based on acceptable prior testing and\u002For central testing per protocol.\n\nParticipants have received prior systemic therapy appropriate for the tumor type and disease stage and have disease progression on or after prior therapy; participants must have had ≥ 1 prior line of systemic treatment in the recurrent\u002Fmetastatic (advanced) setting.\n\nParticipants have ECOG performance status 0-1. Participants have life expectancy ≥ 12 weeks, in the opinion of the Investigator.\n\nParticipants have measurable disease per RECIST v1.1. Participants have adequate organ and bone marrow function per protocol-defined laboratory\u002Fassessment criteria.\n\nParticipants have a treatment-free interval ≥ 3 weeks from prior anticancer therapy before starting study drug (with any additional protocol-defined washout requirements for certain therapies\u002Fprocedures).\n\nContraception use by men and women is consistent with local regulations and protocol-defined requirements.\n\nAdditional Inclusion Criteria (Module 2: Non-squamous NSCLC) Participants have histologically or cytologically confirmed non-squamous NSCLC, Stage IIIB\u002FIIIC not amenable to curative therapy or Stage IV.\n\nParticipants have documented radiographic extracranial disease progression while on or after the most recent treatment regimen for advanced\u002Fmetastatic NSCLC (CNS-only progression is not eligible).\n\nNSCLC of mixed histology is allowed if not predominantly squamous; no small cell or large cell neuroendocrine components.\n\nParticipants meet one of the following:\n\nTumor has a documented EGFR alteration eligible for EGFR-directed therapy (per protocol-defined criteria) and the participant has received prior systemic therapy appropriate for EGFR-altered advanced\u002Fmetastatic NSCLC (per protocol), OR Tumor is negative for EGFR alterations eligible for EGFR-directed therapy, has no other known actionable genomic alterations for which locally approved\u002Favailable targeted therapies exist (per protocol-defined criteria), meets any additional protocol-required biomarker criteria for this cohort (as applicable), and the participant has received prior systemic therapy appropriate for non-actionable-alteration advanced\u002Fmetastatic NSCLC (per protocol).\n\nExclusion Criteria (All Modules) Participants have spinal cord compression, or symptomatic and unstable brain metastases, leptomeningeal disease, or primary CNS malignancy. Participants with asymptomatic, radiographically stable brain metastases who do not require steroids (or who have completed definitive therapy and are neurologically stable off steroids, per protocol) may be eligible.\n\nParticipants have a history of allogeneic organ transplantation. Participants have any clinically significant abnormal laboratory finding or severe and uncontrolled medical condition that, in the Investigator's opinion, makes participation unsafe, including active infection requiring systemic treatment.\n\nParticipants have clinically significant cardiovascular disease or risk factors (including reduced LVEF, cardiomyopathy, clinically active cardiovascular disease, recent major ischemic events or revascularization procedures, uncontrolled angina, severe valvular disease, uncontrolled hypertension, clinically significant heart failure, or recent stroke\u002FTA clinically significant ECG abnormalities, prolonged QTc, or conditions\u002Fmedications that increase risk of QTc prolongation or arrhythmic events)..\n\nParticipants require therapeutic anticoagulation for treatment of acute thromboembolic events, per protocol.\n\nParticipants have active hepatitis B or hepatitis C infection (including detectable viral load, per protocol-defined testing).\n\nParticipants have known HIV infection. Participants have current ILD\u002Fpneumonitis, or a history of (non-infectious) ILD\u002Fpneumonitis requiring systemic steroids or supplemental oxygen, or suspected ILD\u002Fpneumonitis that cannot be ruled out by screening imaging.\n\nParticipants have active gastrointestinal disease, malabsorption, or other GI condition\u002Fsurgery that would significantly interfere with oral drug absorption or tolerability.\n\nParticipants have a history of another primary malignancy. Participants have unresolved clinically significant toxicity from prior anticancer therapy (typically Grade ≥ 2).\n\nParticipants have had prior treatment with a PRMT5 inhibitor Participants are pregnant, breastfeeding, or intend to become pregnant during study participation.\n\nAdditional Exclusion Criteria (Module 2 Only) Participants have inaccessible veins and\u002For inability to place required venous access (e.g., port), per Investigator judgment.\n\nParticipants have contraindication to required CNS imaging (brain MRI preferred or CT with contrast).\n\nParticipants have clinically significant corneal disease. Participants have known active tuberculosis infection, per clinical evaluation and local practice.\n\nParticipants have significant third-space fluid (e.g., pleural effusion\u002Fascites) not amenable to required repeated drainage, per Investigator judgment.\n\nParticipants have severe pulmonary function compromise due to intercurrent pulmonary illness (e.g., severe COPD\u002Fasthma\u002Frestrictive lung disease, recent pulmonary embolism), per protocol.\n\nParticipants have recent radiotherapy that does not meet protocol-defined washout requirements and\u002For ongoing radiation-related toxicities requiring corticosteroids.\n\nParticipants have had prior treatment with protocol-prohibited anticancer therapies.",{"count":263,"type":21},334,[163,95],"This is a first time in human (FTiH) Phase I\u002FIIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.",[267],"Advanced Solid Tumors That Are MTAP Deficient",[269,270],"solid tumor","MTAP deficient",{"date":38,"type":39},{"date":273,"type":39},"2024-01-18",{"date":275,"type":21},"2028-12-04",{"name":178,"class":46},21,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":287,"phases":4,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100054181","patient-retrospective-outcomes-pro-100054181","NCT01550575","Patient Retrospective Outcomes (PRO)","PRO","Key Inclusion Criteria:\n\n* Previously treated with or eligible for use with Boston Scientific Systems\n* 18 years of age or older at the start of Baseline",{"count":286,"type":21},15000,"OBSERVATIONAL","This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.",[290],"Chronic Pain",{"date":38,"type":39},{"date":293,"type":39},"2012-04-03",{"date":295,"type":21},"2030-12",{"name":297,"class":46},"Boston Scientific Corporation",144,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100053442","phase-3-a-study-to-evaluate-mezigdomide-bortezomib-and-dexamethasone-mezivd-versus-pomalidomide-bortezomib-and-dexamethasone-pvd-in-participants-with-relapsed-or-refractory-multiple-myeloma-rrmm-100053442","NCT05519085","A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","SUCCESSOR-1","Inclusion Criteria\n\n\\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.\n\ni) M-protein ≥ 0.5 grams per deciliter (g\u002FdL) by serum protein electrophoresis (sPEP) or.\n\nii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).\n\niii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n* Participants received 1 to 3 prior lines of antimyeloma therapy.\n* Participants achieved minimal response \\[MR\\] or better to at least 1 prior antimyeloma therapy.\n\nExclusion Criteria\n\n\\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.\n\ni) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.\n\nii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.\n\n* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.\n* Participant has had prior treatment with mezigdomide or pomalidomide.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":308,"type":21},810,[59],"The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.",[312],"Relapsed or Refractory Multiple Myeloma",[314,315,316,317,318,319,320,321,322],"Multiple myeloma","RRMM","MeziVd","PVd","CC92480","pomalidomide","bortezomib","dexamethasone","mezigdomide",{"date":38,"type":39},{"date":325,"type":39},"2022-09-20",{"date":327,"type":21},"2033-11-30",{"name":329,"class":46},"Celgene",266,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":347,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100053764","phase-3-a-study-of-vepugratinib-ly3866288-in-participants-with-cancer-in-the-urinary-tract-100053764","NCT07218380","A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration","FORAGER-2","Inclusion Criteria:\n\n* Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.\n* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.\n* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have adequate laboratory parameters\n\nExclusion Criteria:\n\n* Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).\n* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\\[CTCAE\\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.\n* Have ongoing sensory or motor neuropathy of Grade 2 or higher\n* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.\n* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.",{"count":340,"type":21},450,[59],"The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.\n\nVepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.\n\nStudy participation could last up to approximately 6 years.",[344,345,346],"Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Neoplasm Metastasis",[348,349,350],"FGFR3","Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma",{"date":38,"type":39},{"date":353,"type":39},"2025-12-12",{"date":355,"type":21},"2033-05",{"name":357,"class":46},"Eli Lilly and Company",286,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":381},"100053951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dnth103-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-captivate-100053951","NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.","75 Years",{"count":369,"type":21},256,[59],"The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[373],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":38,"type":39},{"date":376,"type":39},"2025-02-10",{"date":378,"type":21},"2030-12-31",{"name":380,"class":46},"Dianthus Therapeutics",180,{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":403},"100054053","phase-3-a-gaucher-disease-gene-therapy-trial-with-flt201-100054053","NCT07223944","A Gaucher Disease Gene Therapy Trial With FLT201","A Phase 3 Safety and Efficacy Trial of FLT201 Gene Therapy in Patients With Gaucher Disease Type 1","GALILEO-3","Key Inclusion Criteria:\n\n* Aged ≥18 years at time of screening.\n* Clinical diagnosis of Gaucher disease type 1\n* Stable hemoglobin concentration at baseline\n* Stable platelet count at baseline\n* Receiving ERT or SRT without interruption for at least 2 years\n\nKey Exclusion Criteria:\n\n* Diagnosed or suspected Gaucher disease type 2 or type 3\n* Positive for AAVS3 neutralizing antibodies.\n* Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study\n* Positive pregnancy test or lactating\n* History of hematopoietic stem cell transplant (HSCT)\u002Fbone marrow transplant or any solid organ transplant.\n* History of receiving any gene therapy or cell therapy.\n* History of total splenectomy. Note: Additional protocol defined Inclusion and Exclusion criteria apply",{"count":391,"type":21},45,[59],"This study is a Phase 3, non-randomized, multicenter, efficacy and safety study in adult patients with Gaucher disease Type 1, on stable treatment with enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for at least 2 years. The study aims to confirm the efficacy and safety of FLT201 in this population after discontinuation of ERT\u002FSRT.",[395],"Gaucher Disease Type 1",{"date":38,"type":39},{"date":398,"type":39},"2026-04-07",{"date":400,"type":21},"2032-10-01",{"name":402,"class":46},"Spur Therapeutics",33,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":412,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":430},"100053966","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-multiple-treatment-combinations-with-intravenous-mirvetuximab-soravtansine-in-adult-participants-with-ovarian-cancer-100053966","NCT07059845","A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer","FLORENZA","Inclusion Criteria:\n\nSubstudy 1\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n\n  2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.\n* Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available.\n\nSubstudy 2\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nSubstudy 3\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nExclusion Criteria:\n\nSubstudy 1\n\n* Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.\n* Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.\n* Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi).\n\nSubstudy 2\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.\n\nSubstudy 3\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.","FEMALE",{"count":414,"type":21},400,[95],"Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.\n\nMirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world.\n\nParticipants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 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, and scans.",[418],"Ovarian Cancer",[418,420,421,422],"Mirvetuximab Soravtansine","Bevacizumab","Carboplatin",{"date":38,"type":39},{"date":425,"type":39},"2025-11-13",{"date":427,"type":21},"2029-01",{"name":429,"class":46},"AbbVie",77,{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":367,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":455},"100053409","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-pegozafermin-in-participants-with-compensated-cirrhosis-due-to-mash-100053409","NCT06419374","A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).\n* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.\n* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.\n* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \\\u003C50.0 kilograms (kg)\u002Fmeters squared (m\\^2).\n\nKey Exclusion Criteria:\n\n* Liver disorder other than MASH.\n* History or evidence of hepatic decompensation.\n* History or evidence of hepatocellular carcinoma.\n* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.\n* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL).\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) must be on stable dose for at least 6 months prior to screening.\n\nOther protocol-defined inclusion and exclusion criteria may apply.",{"count":439,"type":21},762,[59],"The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \\[previously known as nonalcoholic steatohepatitis, NASH\\]).",[443],"Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis",[445,65,66,67,68,69,446,447,71,72,73,74,75,448],"Liver disease","Nonalcoholic steatohepatitis","NASH","Cirrhosis",{"date":38,"type":39},{"date":451,"type":39},"2024-05-24",{"date":453,"type":21},"2031-08",{"name":82,"class":46},317,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":463,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":287,"phases":4,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":484},"100053743","dominantly-inherited-alzheimer-network-dian-100053743","NCT00869817","Dominantly Inherited Alzheimer Network (DIAN)","DIAN","Inclusion Criteria:\n\n* Written informed consent obtained from participant and collateral source prior to any study-related procedures.\n* Aged 18 (inclusive) or older and the child of an affected individual (clinically or by testing) in a pedigree with a known mutation for ADAD.\n* Cognitively normal to very mild or mild cognitive impairment (CDR score range 0-1.0). Primary enrollment will focus on the recruitment of asymptomatic adult children who are more than 15 years younger than the estimated age of symptom onset. Enrollment of new participants with moderate cognitive impairment is allowed with the prior approval of the DIAN Coordinating Center.\n* Has two persons who are not their full-blooded siblings who can serve as collateral sources for the study.\n* Fluent in a language approved by the DIAN Coordinating Center at about the 6th grade level (international equivalent) or above.\n\nExclusion Criteria:\n\n* Under age 18\n* Medical or psychiatric illness that would interfere in completing initial and follow-up visits\n* Requires nursing home level care\n* Has no one who can serve as a study informant",true,{"count":465,"type":21},700,"The purpose of this study is to identify potential biomarkers that may predict the development of Alzheimer's disease in people who carry an Alzheimer's mutation.",[468],"Alzheimer's Disease",[470,471,472,473,474,475],"Alzheimer's disease","antecedent biomarkers","Amyloid Precursor Protein (APP) mutation","presenilin I (PS1) mutation","presenilin 2 (PS2) mutation","Autosomal Dominant Alzheimer's Disease",{"date":38,"type":39},{"date":478,"type":4},"2009-01",{"date":480,"type":21},"2027-07",{"name":482,"class":483},"Washington University School of Medicine","OTHER",26,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":492,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":512},"100053519","phase-2-study-to-evaluate-the-efficacy-safety-and-tolerability-of-pipe-791-in-subjects-with-idiopathic-pulmonary-fibrosis-100053519","NCT07284459","Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis","Key Inclusion Criteria:\n\n* Male or female ≥ 40 years of age at the time of Randomization.\n* A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS\u002FERS\u002FJRS\u002FALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.\n* Percent predicted (pp) FVC ≥ 40% on Screening spirometry.\n* Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently.\n\nKey Exclusion Criteria:\n\n* Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.\n* Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.\n* Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.\n* Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml\u002Fmin\u002F1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.\n* Female participants must not be of childbearing potential.\n\nAdditional inclusion and exclusion criteria apply.","40 Years",{"count":494,"type":21},324,[95],"This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.",[498],"Idiopathic Pulmonary Fibrosis",[498,500,501,502,503,504],"PIPE 791","Pulmonary Fibrosis","IPF","ILD","Interstitial lung disease",{"date":38,"type":39},{"date":507,"type":39},"2026-01-08",{"date":509,"type":21},"2028-06",{"name":511,"class":46},"Contineum Therapeutics",49,{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":533,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":571},"100053960","phase-1-intratumoral-n17350-in-advanced-solid-tumors-100053960","NCT07339176","Intratumoral N17350 in Advanced Solid Tumors","A Phase 1\u002F2 Open-Label, Dose Finding and Expansion Study to Investigate the Safety and Effectiveness and Determination of the Optimal Dose of N17350 Administered Intratumorally in Participants With Advanced Solid Tumors","OP-NEU-101","Inclusion Criteria:\n\n1. Age ≥18 years (or legal age of consent in the study jurisdiction).\n2. Able to provide written informed consent and willing\u002Fable to comply with study procedures, visits, and follow-up.\n3. Advanced solid tumor malignancy (excluding lymphoma and other hematologic malignancies), with disease that has progressed on, is intolerant of, or is ineligible for standard therapies known to provide clinical benefit, or for whom no standard therapy is available.\n4. ECOG performance status 0-1.\n5. Measurable disease per IT-RECIST (Parts A1\u002FA2) and RECIST v1.1 (Part A3), as applicable.\n6. At least one injectable tumor lesion, meeting superficial or visceral criteria and deemed safe\u002Faccessible for injection:\n\n   1. Superficial lesions: ≥10 mm in longest diameter (or multiple lesions each ≥5 mm with aggregate longest diameter ≥10 mm), and ≤80 mm, accessible for direct injection (± ultrasound guidance).\n   2. Visceral lesions: ≥10 mm and ≤50 mm in longest diameter, accessible for direct injection.\n   3. Injected lesions must not involve\u002Fencase major blood vessels or otherwise pose an unacceptable bleeding\u002Fvascular risk, per investigator assessment and imaging review (as applicable).\n   4. Expansion (Part A3): at least 1 measurable lesion and at least 1 additional injectable lesion suitable for injection.\n7. Adequate recovery from prior therapy: toxicities from prior anticancer treatment resolved to Grade ≤1 or baseline (except alopecia, controlled endocrine toxicities, or other stable toxicities as allowed per protocol\u002Fsponsor).\n8. Adequate organ function, including hepatic, renal, and coagulation parameters per protocol-defined thresholds.\n9. Adequate bone marrow function without transfusion support within 7 days prior to enrollment, per protocol-defined thresholds.\n10. Tumor tissue requirements: willingness to provide a pre-treatment tumor biopsy and on-study post-treatment biopsy, if an accessible lesion is available and safe for biopsy, and biopsy does not interfere with injection\u002Fresponse assessment; and\u002For availability of archival tumor tissue (obtained within 2 years prior to treatment), per protocol.\n11. Contraception requirements: participants of reproductive potential agree to use effective contraception and avoid pregnancy\u002Ffathering children from screening through 30 days after last dose; women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose, per protocol.\n\nExclusion Criteria:\n\n1. Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment.\n2. History of solid organ transplant.\n3. Alpha-1 antitrypsin deficiency.\n4. Hereditary or acquired bleeding disorder\u002Fcoagulation factor deficiency.\n5. Active autoimmune disease requiring systemic treatment within the past 6 months, except clinically stable autoimmune conditions in remission not requiring systemic therapy (per protocol).\n6. Baseline QTcF \\>480 ms.\n7. Pregnant or breastfeeding.\n8. Prior severe immune-mediated adverse event (imAE) from immunotherapy: ≥Grade 3 imAE within the past 16 weeks, any Grade 4 life-threatening imAE, or any neurologic\u002Focular AE of any grade (except controlled endocrine AEs on stable replacement therapy per protocol).\n9. Another active malignancy (current or within the past 2 years) other than the disease under study, except specified low-risk cancers treated with curative intent or under active surveillance (per protocol).\n10. Recent anticancer therapy: receipt of systemic anticancer therapy (including investigational agents) within 2 weeks prior to first dose (or 4 weeks for monoclonal antibodies\u002FADCs\u002Fother long half-life biologics), or within 5 half-lives, whichever is shorter.\n11. Recent radiotherapy within 2 weeks prior to first dose.\n12. Unresolved toxicity from prior anticancer therapy to \\>Grade 1 or not at baseline (except Grade ≤2 neuropathy and other allowed exceptions per protocol).\n13. Uncontrolled or unstable brain metastases (eligible only if neurologically stable for ≥4 weeks, and off steroids or on stable\u002Fdecreasing steroids ≤10 mg\u002Fday prednisone equivalent; carcinomatous meningitis excluded).\n14. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.\n15. Chronic viral infections not meeting protocol criteria:\n\n    1. HBV with detectable DNA unless on appropriate antiviral therapy\n    2. Active HCV with detectable HCV RNA (treated HCV permitted if RNA undetectable)\n    3. HIV infection with CD4+ count \\\u003C300\u002FμL, detectable viral load, or HIV-related illness within 6 months\n16. Use of systemic anticoagulants (e.g., warfarin, LMWH, DOACs) within 14 days prior to first dose.\n17. Chronic systemic corticosteroids \\>10 mg\u002Fday prednisone equivalent, or systemic immunosuppressive\u002Fanti-inflammatory medications within 4 weeks prior to first dose, except permitted topical\u002Finhaled\u002Flocal formulations or short courses for premedication per protocol.\n18. Known allergy\u002Fhypersensitivity to N17350 or any excipients.",{"count":522,"type":21},275,[163,95],"The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies.\n\nThe main questions it aims to answer are:\n\n1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?\n2. Are there any side effects for participants when taking N17350?\n3. What is the safest dose of N17350 and the dose that should be used for further study?\n4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo.\n\nParticipants will:\n\n1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks\n2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects\n3. Have imaging scans (such as CT or MRI) to measure tumors and assess response\n4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system",[526,527,528,529,530,531,532],"Neoplasms, Solid Tumor","Breast Neoplasms, Triple-Negative","Squamous Cell Carcinoma of Skin","Melanoma","Head and Neck Neoplasms","Carcinoma, Squamous Cell","Carcinoma, Non-Small-Cell Lung",[534,535,536,537,538,539,540,541,542,543,544,545,546,547,529,548,549,519,550,551,552,553,554,555,556,557,558,559,560,561,562,563],"N17350","Intratumoral injection","Intralesional injection","Dose escalation","Dose finding","Dose expansion","Phase 1","Open-label","Safety","Tolerability","Biomarkers","Advanced solid tumors","Triple-negative breast cancer","Cutaneous squamous cell carcinoma","Head and neck squamous cell carcinoma","Non-small cell lung cancer","Onchilles","Onchilles Pharma","ELANE","Phase 2","ELANE pathway","TNBC","cuSCC","HNSCC","SCCHN","metastatic","elastase","therapeutic elastase","neutrophil elastase","New cancer therapy",{"date":38,"type":39},{"date":566,"type":39},"2026-05-25",{"date":568,"type":21},"2029-11",{"name":570,"class":46},"Onchilles Pharma Inc",6,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":91,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":587,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":597},"100054201","phase-3-a-study-to-evaluate-the-safety-and-effectiveness-of-upadacitinib-tablets-in-adult-and-adolescent-participants-with-severe-alopecia-areata-100054201","NCT06012240","A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata","A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata","Up-AA","Inclusion Criteria:\n\n* Adult individuals must be \\\u003C 64 years old at Baseline Visit. Where permitted outside United States (US)\u002FEuropean Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.\n* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \\>= 50 scalp hair loss at Screening and Baseline.\n* Severe AA with no spontaneous scalp hair regrowth over the past 6 months.\n* Current episode of AA of less than 8 years.\n\nExclusion Criteria:\n\n* Current diagnosis of primarily diffuse type of AA.\n* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.\n* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.","63 Years",{"count":582,"type":21},1500,[59],"Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.\n\nUpadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.\n\nParticipants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.\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. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[586],"Alopecia Areata",[586,588,589,590],"Upadacitinib","Rinvoq","ABT-494",{"date":38,"type":39},{"date":593,"type":39},"2023-10-11",{"date":595,"type":21},"2030-04",{"name":429,"class":46},281,{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":22,"phases":607,"briefSummary":608,"conditions":609,"keywords":612,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100053250","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100053250","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":340,"type":21},[59],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[610,611],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[613,614,615,616,617,618,619,620],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":38,"type":39},{"date":623,"type":39},"2025-07-17",{"date":625,"type":21},"2029-12",{"name":627,"class":46},"Nuvalent Inc.",156,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":636,"maxAge":637,"enrollmentInfo":638,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":652},"100054157","phase-2-a-study-testing-the-combination-of-dasatinib-or-imatinib-to-chemotherapy-treatment-with-blinatumomab-for-children-adolescents-and-young-adults-with-philadelphia-chromosome-positive-ph-or-abl-class-philadelphia-chromosome-like-ph-like-b-cell-acute-lymphoblastic-leukemia-b-all-100054157","NCT06124157","A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)","An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patients must be \\> 365 days and \\\u003C 18 years (for AIEOP-BFM), \\> 365 days and \\\u003C 22 years (for Children's Oncology Group \\[COG\\]) and \\> 365 days and \\\u003C 46 years (for ALLTogether sites) at the time of enrollment\n* Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and\u002For dasatinib: ABL1, ABL2, CSF1R, and PDGFRB\n* Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment\n* Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and\u002For other standard cytotoxic chemotherapy\n* Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine\n* Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)\n* Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m2\n  * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard\n* For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34.2 micromoles\u002FL) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* \\* Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) OR\n\n  * Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) AND\n  * Corrected QT Interval, QTc \\\u003C 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\])\n\n    * Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment\n\nExclusion Criteria:\n\n* Known history of chronic myeloid leukemia (CML)\n* ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase\n* ALL developing after a previous cancer treated with cytotoxic chemotherapy\n* Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation\n* Down syndrome (trisomy 21)\n* Pregnancy and breast feeding\n\n  * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment\n  * Lactating females who plan to breastfeed their infants\n  * Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol\n\n    * NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer\n* Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib\n* Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block\n* Patients with known Charcot-Marie-Tooth disease\n* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement\n\n  * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved\n* HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","366 Days","46 Years",{"count":639,"type":21},222,[95],"This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes\u002Fcells\u002Fmolecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.",[643],"B Acute Lymphoblastic Leukemia",{"date":38,"type":39},{"date":646,"type":39},"2025-05-30",{"date":648,"type":21},"2030-12-01",{"name":650,"class":651},"National Cancer Institute (NCI)","NIH",154,{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":22,"phases":662,"briefSummary":663,"conditions":664,"keywords":666,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":675},"100053954","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-100053954","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":115,"type":21},[95],"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.",[665],"Metastatic Colorectal Cancer",[665,667,668],"AndroMETa-CRC-533","Telisotuzumab Adizutecan",{"date":38,"type":39},{"date":671,"type":39},"2025-04-24",{"date":673,"type":21},"2028-04",{"name":429,"class":46},56,{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":682,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":684,"enrollmentInfo":685,"targetDuration":4,"studyType":22,"phases":687,"briefSummary":688,"conditions":689,"keywords":690,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":697,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":703},"100054276","phase-2-a-study-of-novel-study-interventions-and-combinations-in-participants-with-colorectal-cancer-100054276","NCT06792695","A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer","A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)","CANTOR","Overall Inclusion Criteria:\n\n* Histopathologically confirmed colorectal adenocarcinoma.\n* Provision of FFPE tumor sample collected as per SoC.\n* Presence of measurable disease by RECIST 1.1 criteria.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks at the time of screening.\n\nSubstudy Inclusion Criteria:\n\n* No radiological evidence of liver metastasis.\n* No prior systemic therapy for mCRC, except for neoadjuvant\u002Fadjuvant chemotherapy where, \\> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease.\n* Known pMMR\u002FMSS status (only pMMR\u002FMSS mCRC allowed).\n* Adequate organ and bone marrow function\n* Body weight \\> 35 kg at screening and at randomization.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nOverall Exclusion Criteria:\n\n* Central nervous system metastases or spinal cord compression\n* Known history of severe allergy to any monoclonal antibody or study intervention.\n* Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.\n* History of another primary malignancy.\n\nSubstudy Exclusion Criteria:\n\n* Potentially resectable disease with multidisciplinary plan for radical surgery.\n* Active or prior documented autoimmune or inflammatory disorders or cardiac conditions.\n* Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks.\n* Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident.\n* History of abdominal or tracheoesophageal fistula, GI perforation and\u002For fistulae, or intraabdominal abscess within 6 months prior to randomization.\n* Prior exposure to immune mediated therapy.","130 Years",{"count":686,"type":21},80,[95],"The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).",[665],[691,692,693,694,695,696,682],"Metastatic disease","Immunotherapy","Liver metastasis","Mismatch-repair-proficient","Antibody targeting","Colorectal Cancer",{"date":38,"type":39},{"date":699,"type":39},"2025-03-12",{"date":701,"type":21},"2028-09-29",{"name":178,"class":46},76,""]