[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amgen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":686},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,52,0,25,[9,46,75,101,129,158,187,214,247,279,304,330,360,389,414,441,463,486,510,538,559,585,610,636,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652949","phase-3-phase-3-trial-of-tarlatamab-sc-vs-iv-in-extensive-stage-small-cell-lung-cancer-after-platinum-based-first-line-chemotherapy-es-sclc-100652949",false,"NCT07778316","Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)","A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)","DeLLphi-315","Inclusion Criteria:\n\n* Participant has provided informed consent prior to initiation of any study specific activities\u002Fprocedures.\n* Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.\n* Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.\n* Participants who progressed or recurred following 1 platinum-based regimen.\n* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.\n* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.\n* Minimum life expectancy of 12 weeks.\n* Adequate organ function.\n* History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.\n\nExclusion Criteria:\n\nDisease Related\n\n\\- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.\n\nOther Medical Conditions\n\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 6 months prior to first dose of study treatment.\n* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.\n* Current evidence or history of non-infectious pneumonitis\u002FILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.\n* History of other malignancy within the past 2 years, with exceptions defined in the protocol.\n* Presence or history of viral infection based on criteria per protocol.\n* History of solid organ transplantation.\n* Symptoms and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.\n* Known sensitivity or a contraindication to any of the products or components.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n\nPrior\u002FConcomitant Therapy\n\n* Prior systemic anticancer therapy within 30 days of enrolment\n* Prior history of severe or life-threatening events from any immune-mediated therapy.\n* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.\n* Live and live-attenuated vaccines within 28 days prior to the start of study treatment.\n* Receiving another anticancer therapy for a malignancy other than SCLC.\n* More than 1 prior line of anticancer therapy for SCLC.\n* Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.\n* Treatment in an alternative investigational trial within 28 days prior to enrolment.\n* History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.\n\nOther Exclusions\n\n* Participants unable to have SC injections administered in the abdomen or thigh.\n* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.\n* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.","ALL","18 Years","99 Years",{"count":22,"type":23},400,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.",[29],"Small Cell Lung Cancer",[31,32],"Tarlatamab","ES-SCLC","RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":23},"2026-08-31",{"date":41,"type":23},"2030-07-30",{"name":43,"class":44},"Amgen","INDUSTRY",2,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100633777","phase-1-study-of-tarlatamab--zl-1310---anti-programmed-death-ligand-1-anti-pd-l1-in-small-cell-lung-cancer-sclc-100633777","NCT07531095","Study of Tarlatamab + ZL-1310 +\u002F- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)","A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer","DeLLphi-313","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n* Participants with Histologically or cytologically confirmed SCLC:\n* For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.\n* For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.\n* For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.\n\nNote: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.\n* Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).\n\nExclusion Criteria:\n\n* Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.\n* History of interstitial lung disease (ILD)\u002Fpneumonitis.\n* Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.\n* Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.\n* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.\n* Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.\n* Enrollment in any tarlatamab clinical trial.",{"count":55,"type":23},160,[57],"PHASE1","The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and\u002For recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.",[29],[31,61,62,63,64,65,66,67],"ZL-1310","Durvalumab","SCLC","Anti-PD-L1","Extensive Stage Small Cell Lung Cancer","Programmed death protein-1 (PD-1)","Programmed death ligand 1 (PD-L1)",{"date":36,"type":37},{"date":70,"type":37},"2026-04-21",{"date":72,"type":23},"2031-05-21",{"name":43,"class":44},27,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100615851","phase-1-evaluation-of-xaluritamig-in-adults-adolescents-and-children-with-relapsed-or-refractory-ewing-sarcoma-ews-100615851","NCT07297979","Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)","A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Xaluritamig in Adult, Adolescent and Pediatric Participants With Relapsed or Refractory Ewing Sarcoma","Inclusion Criteria:\n\n1. Part 1: evaluable disease as defined by RECIST v1.1, as determined by the site investigator.\n\n   Part 2: measurable disease as defined by RECIST v1.1, as determined by the site investigator.\n2. Histologically or cytologically confirmed EWS with molecular evidence of an EWSR1 translocation with an E26 transformation-specific (ETS) family gene, eg, FLI1, ETS-related gene \\[ERG\\]) via next generation sequencing (based on local testing).\n3. Relapsed or refractory EWS following at least 1 line of chemotherapy (including treatment with an anthracycline and at least 1 alkylating agent).\n4. Performance status:\n\n   1. Karnofsky ≥ 70% for participants ≥ 16 years of age.\n   2. Lansky ≥ 70% for participants \\\u003C 16 years of age.\n5. Adequate organ function, defined as follows:\n\n   a. Hematological function: i. Absolute neutrophil count ≥ 1.0 x 109\u002FL, provided that:\n   * the participant has not received short-acting growth factor support within 7 days before screening assessment, and\n   * the participant has not received long-acting growth factor support within 14 days before screening assessment.\n\n   ii. Platelet count ≥ 75 x 109\u002FL, provided that:\n   * the participant has not received a platelet transfusion within 7 days before screening assessment, and\n   * the participant has not received a platelet stimulating agent within 14 days before screening assessment.\n\n     b. Renal function: i. Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 for participants ≥ 18 years of age.\n\n   ii. estimated glomerular filtration rate based on Schwartz (2009) calculation ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 for participants \\\u003C 18 years of age.\n\n   c. Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (or ≤ 5 x ULN for participants with liver metastases).\n\n   ii. Total bilirubin (TBL) ≤ 1.5 x ULN (unless related to Gilbert's or Meulengracht disease).\n\n   d. Pulmonary function: i. Baseline oxygen saturation \\> 92% in room air at rest and no oxygen supplementation.\n\n   e. Cardiac function: i. Left ventricular ejection fraction ≥ 50%. If left ventricular ejection fraction cannot be measured, then left ventricular fractional shortening ≥ 28%.\n6. Participants of childbearing potential must use protocol-specified contraception to prevent pregnancy during treatment and for an additional 6 months after the last dose of xaluritamig.\n\nExclusion Criteria:\n\n1. Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.\n2. History of other malignancy within the past 2 years, except for malignancy treated with curative intent with low risk for recurrence (approximately \\\u003C 10%) and with no known active disease present for \\>1 year before enrollment.\n3. Active autoimmune disease that has required systemic treatment (except physiologic adrenal hormone replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type 1 diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.\n4. Participants who received anti-cancer therapy administered within the following minimum washout periods prior to first dose of xaluritamig:\n\n   1. Cytotoxic chemotherapy: 21 days.\n   2. Small molecules including tyrosine kinase inhibitors: 7 days or 5 half-lives, whichever is shorter.\n   3. Monoclonal antibodies, immune checkpoint inhibitors, bispecific antibodies and other biologic agents: 28 days or 5 half-lives, whichever is shorter.\n   4. Cellular therapies including Chimeric Antigen Receptor T-cell therapy (CAR-T), adoptive T-cell therapy: 56 days.\n   5. Radiotherapy: 14 days for focal therapy, 28 days for large field therapy or involving \\> 30% of the bone marrow.\n   6. Stem cell transplant: 12 weeks for autologous, 6 months for allogeneic, with no active graft-versus-host disease.\n   7. Any other therapy or investigational agent: 28 days or 5 half-lives, whichever is longer.\n5. Requirement for chronic systemic corticosteroid therapy (prednisone dose \\> 10 mg\u002Fday \\[\\> 0.25 mg\u002Fkg\u002Fday if \\\u003C 40 kg\\] or equivalent) or any other immunosuppressive therapies (including anti-tumour necrosis factor α (TNFα) therapies) unless stopped (with adequate tapering) within 28 days before first dose of xaluritamig.\n6. Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant, donate eggs, or breastfeed while on trial until an additional 6 months after the last dose of trial intervention.\n7. Unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of xaluritamig.","2 Years",{"count":84,"type":23},50,[57],"The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric participants with relapsed or refractory EWS.",[88],"Ewing Sarcoma",[90,91,92,93],"Relapsed or refractory Ewing sarcoma","EWS","Xaluritamig","AMG 509",{"date":36,"type":37},{"date":96,"type":37},"2026-04-08",{"date":98,"type":23},"2030-05-26",{"name":43,"class":44},9,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":108,"minAge":19,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":24,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100609368","phase-3-a-study-of-xaluritamig-plus-abiraterone-versus-investigators-choice-in-participants-with-chemotherapy-nave-metastatic-castration-resistant-prostate-cancer-100609368","NCT07213674","A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n* Participant must have histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.\n* Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:\n\n  * Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng\u002FmL.\n  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.\n  * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).\n* Participants must have had prior orchiectomy and\u002For ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL).\n* Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.\n* Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\nDisease Related:\n\n* Participants with a history of central nervous system (CNS) metastases.\n* Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.\n\nPrior\u002FConcomitant Therapy:\n\n* Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Prior disease progression on or intolerance to abiraterone.\n* Prior treatment with any chemotherapy regimen in the mCRPC setting and\u002For \\> 6 cycles of docetaxel treatment in the mHSPC setting.\n* Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:\n\n  * Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.\n  * Androgen suppression therapy (eg, luteinizing hormone-releasing hormone\u002Fgonadotrophin releasing hormone \\[LHRH\u002FGnRH\\] analogue \\[agonist\u002Fantagonist\\]) is permitted.\n* Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.\n* Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.\n* Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.\n* Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.\n* Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.\n* Prior CD3-directed therapy.","MALE",{"count":110,"type":23},750,[26],"The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).",[114],"Metastatic Castration-resistant Prostate Cancer",[116,117,92,118,119,120,121],"Prostate Cancer","Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Abiraterone","Abiraterone Acetate","Docetaxel","Cabazitaxel",{"date":36,"type":37},{"date":124,"type":37},"2025-11-28",{"date":126,"type":23},"2032-08-30",{"name":43,"class":44},150,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":24,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100603399","phase-3-oceana-preevent---olpasiran-trials-of-cardiovascular-events-and-lipoproteina-reduction-to-prevent-first-major-cardiovascular-events-100603399","NCT07136012","OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events","A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)","Inclusion Criteria:\n\n* Age ≥50 years\n* Lp(a)≥ 200 nmol\u002FL during screening\n* Multiple atherosclerotic cardiovascular disease risk factors, and\u002For evidence of atherosclerosis\n\nExclusion Criteria:\n\n* Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)\n* Prior or planned arterial revascularization\n* History of major bleeding disorder","50 Years","105 Years",{"count":139,"type":23},11000,[26],"The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\\[a\\]).",[143],"Cardiovascular Disease",[145,146,147,148,149,150],"Olpasiran","AMG 890","Coronary heart disease","CHD","Myocardial infarction","Coronary revascularization",{"date":36,"type":37},{"date":153,"type":37},"2025-08-22",{"date":155,"type":23},"2031-10-20",{"name":43,"class":44},252,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":24,"phases":168,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100559950","phase-2-a-phase-2-master-protocol-assessing-inebilizumab-and-blinatumomab-in-autoimmune-diseases-100559950","NCT06570798","A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases","A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases","\\*Subprotocol A and B are no longer recruiting participants\\*\n\nInclusion Criteria:\n\n* Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification criteria.\n* Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or through documented history:\n\n  1. Antinuclear antibodies (ANA) ≥ 1:80\n  2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)\n  3. AntiSmith antibodies elevated to above normal (ie, positive results).\n* Subprotocol A and B (Subgroup 1): Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V LN (or pure Class V LN for Subprotocol B only) according to 2018 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria. The local biopsy report will be used.\n* Subprotocol A and B: SLE Disease Activity Index 2K ≥ 6.\n* Subprotocol A and B (Subgroup 1): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B Subgroup 1) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0 mg\u002Fmg.\n* Subprotocol B (Subgroup 2): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide.\n* Subprotocol B (Part B Subgroup 2): British Isles Lupus Assessment Group (BILAG)-2004 level A disease in 1 organ system or BILAG-2004 level B disease in ≥ 2 organ systems\n* Subprotocol B (Part B Subgroup 2): Physician Global Assessment (PGA) ≥ 1\n* Subprotocol A and B: If receiving any of the following medications, participants must be on these doses prior to Day 1:\n\n  1. Prednisone dose ≤ 20 mg\u002Fday (or its equivalent in other corticosteroid forms) and at a stable dose for 5 days\n  2. Hydroxychloroquine dose ≤ 400 mg\u002Fday and at a stable dose for 4 weeks. Other equivalent antimalarials (chloroquine, quinacrine) are also accepted at a stable dose for 4 weeks.\n  3. MMF dose ≤ 3 g\u002Fday or MPA dose ≤ 2160 mg\u002Fday and at a stable dose for 2 weeks.\n  4. AZA dose ≤ 2 mg\u002Fkg\u002Fday and at a stable dose for 2 weeks.\n  5. Methotrexate \\> 25 mg\u002Fweek and at a stable dose for 2 weeks\n  6. Leflunomide \\> 20 mg\u002Fday and at a stable dose for 2 weeks\n  7. Dapsone \\> 300 mg\u002Fday and at a stable dose for 2 weeks.\n* Subprotocol C (Part A and Part B): Diagnosis of RA according to the 2010 ACR\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria.\n* Subprotocol C (Part A and Part B): Moderate to severe disease activity as defined by DAS28-CRP \\> 3.2 with ≥ 3 swollen joints and ≥ 3 tender joints (based on 28 joint counts) at screening.\n* Subprotocol C (Part A and Part B): Refractory disease defined as:\n* Active disease despite having received treatment with:\n\n  1. at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD), AND\n  2. at least 2 biologic disease-modifying antirheumatic drugs (bDMARDs) of different mechanisms of action OR 1 bDMARD and at least 1 targeted synthetic disease-modifying antirheumatic drugs (tsDMARD).\n* Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should be defined as:\n\n  1. Participant having active disease despite a minimum of 12 weeks of treatment with a csDMARD, bDMARD, or tsDMARD.\n  2. Intolerance to treatment as defined by participant having experienced an adverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.\n* Subprotocol C (Part B): High sensitivity C-Reactive Protein (hsCRP) level ≥ upper limit of normal per the central laboratory at screening.\n\nExclusion Criteria:\n\n* Subprotocol A, B and C: Receipt of a live and\u002For live attenuated vaccine within 4 weeks prior to first dose of trial drug, during the treatment period, or until B-cell repletion after the end of the treatment period. Administration of inactivated (killed) vaccines is acceptable.\n* Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of \\\u003C 30 mL per minute per 1.73 m\\^2 of body surface area (calculated using the Modification of Diet in Renal Disease \\[MDRD\\] formula, with screening laboratory results for serum creatinine value).\n* Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease \\[ESRD\\]).\n* Subprotocol A and B: Any acute, severe lupus related flare during screening that needs immediate treatment.\n* Subprotocol A and B: A previous kidney transplant or planned transplant within trial treatment period.\n* Subprotocol A and B: History of or current renal diseases (Parts A and B, Subgroup 1) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).\n* Subprotocol A: Renal biopsy showing pure class V.\n* Subprotocol B: Active CNS Lupus within one year prior to screening.\n* Subprotocol B and C: History or presence of clinically relevant central nervous system (CNS) pathology or event such as seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.\n* Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to SLE, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).\n* Subprotocol C: Functional Class IV as defined by the ACR classification of functional status in RA.\n* Subprotocol A, B and C: Receipt of the following medications or treatments at any time prior to Day 1:\n\n  1. B-cell directed CAR T-cell and T-cell engager therapies\n  2. Total lymphoid irradiation\n  3. Bone marrow transplant\n  4. T-cell vaccination therapy\n  5. Natalizumab","75 Years",{"count":167,"type":23},220,[169],"PHASE2","The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).",[172,173],"Systemic Lupus Erythematosus","Active Refractory Rheumatoid Arthritis",[175,176,177,178,179],"Systemic lupus erythematosus","Inebilizumab","Blinatumomab","Active refractory rheumatoid arthritis","Rheumatoid arthritis",{"date":36,"type":37},{"date":182,"type":37},"2025-07-16",{"date":184,"type":23},"2028-08-06",{"name":43,"class":44},58,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":24,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100535501","phase-3-study-of-sotorasib-panitumumab-and-folfiri-versus-folfiri-with-or-without-bevacizumab-awwb-in-treatment-nave-participants-with-metastatic-colorectal-cancer-with-kras-pg12c-mutation-100535501","NCT06252649","Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","CodeBreaK 301","Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan",{"count":196,"type":23},450,[26],"The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.",[200],"Metastatic Colorectal Cancer",[202,203,204,205,206],"Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology",{"date":36,"type":37},{"date":209,"type":37},"2024-07-17",{"date":211,"type":23},"2032-04-25",{"name":43,"class":44},291,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":24,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100509970","phase-3-a-study-evaluating-sotorasib-platinum-doublet-combination-versus-pembrolizumab-platinum-doublet-combination-as-a-front-line-therapy-in-participants-with-stage-iv-or-advanced-stage-iiibc-nonsquamous-non-small-cell-lung-cancers-codebreak-202-100509970","NCT05920356","A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB\u002FC Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)","A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB\u002FC Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\n* No history of systemic anticancer therapy in metastatic\u002Fnon-curable settings\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n\nExclusion Criteria:\n\n* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology\n* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy\n* Symptomatic (treated or untreated) brain metastases\n* Gastrointestinal (GI) tract disease causing the inability to take oral medication\n* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina\n* Prior therapy with a KRAS G12C inhibitor","100 Years",{"count":110,"type":23},[26],"The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.",[226],"Non-Small Cell Lung Cancer (NSCLC)",[206,228,229,230,202,231,232,233,234,235,236,237,238,239],"Lung Cancer","PD-L1","KRAS p.G12C","Pembrolizumab","Carboplatin","Pemetrexed","CodeBreaK 202","NSCLC","PD-L1 Negative","AMG 510","LUMAKRAS ®","LUMYKRAS ®",{"date":36,"type":37},{"date":242,"type":37},"2023-11-16",{"date":244,"type":23},"2032-06-29",{"name":43,"class":44},414,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":108,"minAge":19,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":24,"phases":256,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100379512","phase-1-study-of-amg-509-in-participants-with-metastatic-castration-resistant-prostate-cancer-100379512","NCT04221542","Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Parts 1, 2, 5 and 7: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and\u002For enzalutamide, apalutamide, or darolutamide) and have failed at least 1 (but not more than 2) taxane regimens including for metastatic hormone-sensitive prostate cancer (mHSPC) (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Any NHT that has been administered and has been stopped for reasons other than progression will not be counted as an additional line of treatment.\n\n  1. Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.\n  2. Dose-expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.\n* Part 3: Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) given in any disease setting and who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen (unless taxane treatment was administered in HSPC setting). 0 1 prior PARP inhibitors or sipuleucel-T treatments are acceptable. Participants who received prior investigational therapy for the treatment of metastatic disease are not eligible.\n* Parts 4A, 4B and 7:\n\n  1. Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (given in any disease setting depending on the part), and no or 1 taxane regimen (for HSPC).\n  2. Dose-expansion phase: at least 1 prior NHT must have been given; 0-1 prior PARP inhibitors are acceptable.\n  3. 4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible). Participants may have had exposure to up to 2 NHTs with a similar mechanism of action (apalutamide, enzalutamide or darolutamide) in the non-mCRPC and mCRPC setting.\n* Dose-expansion phase: up to approximately 10 participants with prior exposure to abiraterone acetate may be enrolled into Part 4A expansion cohort.\n\n  d. 4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide\u002Fapalutamide or daralutamide are not eligible).\n* Part 6:\n\n  1. Prior disease progression on 1, and only 1, NHT (either enzalutamide, apalutamide, or darolutamide) is required. NOTE: Prior progression on or intolerance to abiraterone is not allowed.\n  2. No prior treatment with any chemotherapy regimen in the mCRPC setting; ≤ 6 cycles of docetaxel treatment in the mHSPC setting is allowed.\n  3. mCRPC with ≥ 1 RECIST v1.1 measurable lesion that is present on baseline computed tomography (CT) or magnetic resonance imaging (MRI).\n* All parts:\n* Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.\n* Total serum testosterone ≤ 50 ng\u002FdL or 1.7 nmol\u002FL.\n* Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:\n\n  1. PSA level ≥ 1 ng\u002FmL that has increased on at least 2 successive occasions at least 1 week apart.\n  2. Nodal or visceral progression as defined by RECIST v1.1 with PCGW3 modifications.\n  3. Appearance of 2 or more new lesions in bone scan.\n* Eastern Cooperative Oncology Group performance status of 0-1.\n* Life expectancy ≥ 3 months.\n* Adequate organ function, defined as follows:\n\n  1. Hematological function:\n\n     1. absolute neutrophil count ≥ 1 x 10\\^9\u002FL (without growth factor support within 7 days from screening assessment).\n     2. platelet count ≥ 75 x 10\\^9\u002FL (without platelet transfusion within 7 days from screening assessment).\n     3. hemoglobin ≥ 9 g\u002FdL (90 g\u002FL) (without blood transfusion within 7 days from screening assessment).\n  2. Renal function:\n\n     1\\. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation ≥ 30 ml\u002Fmin\u002F1.73 m\\^2.\n  3. Hepatic function:\n\n     1. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) (or \\\u003C 5 x ULN for participants with liver involvement).\n     2. total bilirubin (TBL) \\\u003C 1.5 x ULN (or \\\u003C 2 x ULN for participants with liver metastases).\n  4. Cardiac function:\n\n     1. left ventricular ejection fraction \\> 50% (2-D transthoracic echocardiogram \\[ECHO\\] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available).\n     2. Baseline electrocardiogram (ECG) QTcF ≤ 470 msec (average of triplicate values).\n  5. Pulmonary function:\n\n     1. baseline oxygen saturation \\> 92% on room air at rest and no oxygen supplementation.\n\nPart 3-Retreatment group:\n\n* Deriving benefit from initial treatment with AMG 509 as evidenced by one of the following:\n\n  1. confirmed PSA50 response.\n  2. radiographic stable disease\u002Fpartial response\u002Fcomplete response during 6 cycles of initial treatment with AMG 509 and without progression during the first 6 cycles.\n* No discontinuation for toxicity during the initial treatment with 6 cycles of AMG 509.\n* Progressive disease as defined in I106 within 12 months of final dose in their initial treatment with 6 cycles (EOT\\_1).\n* Willingness to have a fresh tumor biopsy prior to initiating the additional course of treatment, depending on safety and feasibility as assessed by investigator.\n\nKey Exclusion Criteria:\n\n* Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.\n* Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).\n* Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.\n* Prior major surgery within 4 weeks of first dose.\n* Participants with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration. Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Screening for chronic infectious conditions is not required.\n* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.\n* History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation. Participants with a recent history of venous thrombosis must be maintained on the same anti-coagulation therapy for a minimum of 28 days prior to first dose of study treatment.\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.\n* Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)\u002FGnRH analogue (agonist\u002Fantagonist).\n* Prior prostate specific membrane antigen (PSMA) radionuclide therapy within 2 months prior to AMG 509 unless participant received \\\u003C 2 cycles (Note: a participant cannot have received PSMA radionuclide therapy \\\u003C 35 days prior to enrollment if 1 cycle was given). Parts 3 and 4: prior PSMA radionuclide therapy is prohibited. Participants on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to enrollment are eligible (exception: part 3 retreatment).\n* Part 3-Retreatment only: Any anti-cancer therapy or immunotherapy, not including luteinizing hormone-releasing hormone\u002Fgonadotropin releasing hormone (LHRH\u002FGnRH) analogue (agonist\u002Fantagonist), and\u002For bisphosphonate or denosumab regimen after last dose of AMG 509 initial course of treatment.",{"count":255,"type":23},479,[57],"The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.",[116],[93,260,114,261,262,263,264,265,266,267,268,269,270,271],"mCRPC","Prostate cancer","PSMA","STEAP1","STEAP1 targeted therapy","Solid tumor","Immunotherapy","Immuno-oncology","Immunooncology","Bispecific T-Cell engager®","BiTE®","XmAb®",{"date":36,"type":37},{"date":274,"type":37},"2020-03-04",{"date":276,"type":23},"2032-03-21",{"name":43,"class":44},57,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":24,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":303},"100360147","phase-3-a-phase-3-study-of-etelcalcetide-in-children-with-secondary-hyperparathyroidism-receiving-hemodialysis-100360147","NCT03969329","A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis","Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to \u003C 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis","Inclusion Criteria:\n\n* Participant's legally acceptable representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and\u002For guidelines prior to any trial-specific activities\u002Fprocedures being initiated.\n* Male or female participants greater than or equal to 2 to less than 18 years of age at the time of enrollment.\n* Targeted dry weight greater than or equal to 7 kg at the time of screening Week -1.\n* Diagnosed with CKD and SHPT undergoing hemodialysis\u002Fhemodiafiltration TIW or four times a week (QIW) at the time of screening greater than or equal to 1 month.\n* Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values greater than 300 pg\u002FmL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening.\n* Serum corrected Ca value greater than or equal to 9.0 mg\u002FdL obtained from the central laboratory during screening.\n* Dialysate Ca level greater than or equal to 2.5 mEq\u002FL for at least 1 month prior to screening and throughout the duration of the trial.\n* participant receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable doses for the duration of the trial, except for adjustments allowed per protocol.\n* participant receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the trial, except for adjustments allowed per protocol.\n* Subject receiving Ca supplements must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the trial, except for adjustments allowed per protocol.\n* SHPT not due to vitamin D deficiency, per investigator assessment.\n\nExclusion Criteria:\n\n* Disease Related:\n* History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval.\n* Anticipated or scheduled parathyroidectomy during the trial period.\n* Anticipated or scheduled kidney transplant during the trial period.\n* Participant has received a parathyroidectomy within 6 months prior to enrollment.\n* Other Medical Conditions:\n* Current malignancy or history of other malignancy, except non-melanoma skin cancers within the last 5 years.\n* Prior\u002FConcomitant Therapy:\n* Use of concomitant medications that may prolong the QTc (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin). Refer to CredibleMeds.org for guidance. Certain medications may be allowed based on review by the Medical Monitor and require additional electrocardiogram (ECG) monitoring and potential electrolyte monitoring.\n* Receipt of cinacalcet therapy within 30 days prior to screening and through enrollment.\n* Any previous use of etelcalcetide prior to screening and through enrollment (Original protocol, Amendment 1, and Amendment 2 only).\n* Receipt of etelcalcetide therapy within 6 months prior to screening assessments and through enrollment (Amendment 3 and later only).\n* All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation.\n* Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to enrollment that are not established therapies for participants with renal disease or other conditions secondary to renal disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation. Paracetamol for analgesia will be allowed.\n* Prior\u002FConcurrent Clinical Trial Experience:\n* Currently receiving treatment in another investigational device or drug trial, or less than 30 days since ending treatment on another investigational device or drug trial(s). Other investigational procedures while participating in this trial are excluded.\n* Diagnostic Assessments During Screening:\n* Participant has significant abnormalities on the most recent central laboratory test during the screening period prior to enrollment per the Investigator including but not limited to the following: a. Serum transaminase (alanine aminotransferase \\[ALT\\] or serum glutamic pyruvic transaminase \\[SGPT\\], aspartate aminotransferase \\[AST\\], or serum glutamic oxaloacetic transaminase \\[SGOT\\]) greater than 1.5 times the upper limit of normal (ULN).\n* Corrected QT interval greater than 500 ms, using Bazett's formula.\n* Corrected QT interval greater than or equal to 450 to less than or equal to 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist.\n* Participant has a clinically significant ECG abnormality (eg, unstable arrhythmia) during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the trial evaluation.\n* Within the 3 Months Prior to Screening:\n* New onset or worsening of a pre-existing seizure disorder.\n* Participants on anti-convulsant medication must be on a stable and therapeutic dose for 3 months prior to screening (if blood level monitoring is clinically available, then the participant must have a therapeutic blood level within 1 week of enrollment).\n\nOther Exclusions:\n\n* Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of etelcalcetide. (Females of childbearing potential should only be included in the trial after a confirmed menstrual period and a negative highly sensitive serum pregnancy test within 7 days prior to the first dose of investigational product).\n* Female participants of childbearing potential unwilling to use 1 highly effective or acceptable method of effective contraception during treatment and for an additional 3 months after the last dose of investigational product.\n* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test.\n* Participant has known sensitivity to etelcalcetide or excipients to be administered during dosing.\n* Participant likely to not be available to complete all protocol-required trial visits or procedures, and\u002For to comply with all required trial procedures to the best of the participant and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) or unacceptable physical findings, that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the trial evaluation procedures or completion.\n* Participant has previously entered this trial or previously received treatment with etelcalcetide (Original protocol, Amendment 1 and Amendment 2 only).\n* Participant previously has entered this trial (Amendment 3 and later only).\n* Anemia, which in the opinion of the investigator makes it not advisable to undergo sequential blood draws.\n* History of unstable chronic heart failure within the last 1 year prior to screening.","17 Years",{"count":288,"type":23},24,[26],"Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to \\\u003C 18 years of age, with chronic kidney disease (CKD) on hemodialysis.",[292],"Secondary Hyperparathyroidism",[294,295,296],"Secondary hyperparathyroidism (sHPT)","Chronic kidney disease (CKD)","Paediatric",{"date":36,"type":37},{"date":299,"type":37},"2019-12-20",{"date":301,"type":23},"2027-06-30",{"name":43,"class":44},23,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":286,"enrollmentInfo":312,"targetDuration":4,"studyType":24,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100591985","phase-2-a-study-to-evaluate-the-pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-inebilizumab-in-children-with-generalized-myasthenia-gravis-gmg-100591985","NCT06987539","A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)","A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Generalized Myasthenia Gravis (gMG)","THYME","Inclusion Criteria\n\n* Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and\u002For guidelines before any study-specific activities\u002Fprocedures being initiated.\n* Age ≥ 2 to \\\u003C 18 years of age on the day of enrollment.\n* Diagnosis of gMG defined as:\n\n  * Positive serologic test for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody (Ab) titers as confirmed at screening (1 retest allowed), and\n  * At least 1 of the following:\n\n    * History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or\n    * History of positive anticholinesterase test (eg, edrophonium chloride test); or\n    * Participant demonstrated improvement in gMG signs on oral cholinesterase inhibitors, as assessed by the treating physician; or\n    * Clinical syndrome consistent with a diagnosis of gMG, and not otherwise explained by another condition.\n* Myasthenia Gravis Foundation of America Clinical Classification Class II, III, or IV at the time of screening.\n* Participants must be on:\n\n  * Corticosteroids only, with no dose increase within 4 weeks prior to screening, or\n  * One allowed non-steroidal immunosuppressive therapies (IST) (azathioprine, mycophenolate mofetil, or mycophenolic acid) with continuous use for at least 6 months prior to screening and no dose increase within 4 months prior to screening, or\n  * Combination of (1) corticosteroids with no dose increase within 4 weeks prior to screening and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to screening and no dose increase within 4 months prior to screening.\n\nTacrolimus is allowed in Japan only, with continued use for ≥ 6 months prior to screening and no dose increase within 4 months prior to screening.\n\n* Participants may enter the study on a stable dose of acetylcholinesterase inhibitors (pyridostigmine dose). The acetylcholinesterase inhibitor dose must have been stable for at least 2 weeks prior to enrollment.\n* Vital signs and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the investigator.\n\nExclusion Criteria\n\n* Employees of the Sponsor, contract research organization (CRO), site staff, and their family members.\n* Thymectomy within 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the treatment period.\n* Unresected thymoma- Participants with benign thymoma resected \\> 12 months prior to screening may enroll.\n* History of recurrent significant infections.\n* Known immunodeficiency disorder, including current infection or positive test for human immunodeficiency virus (HIV).\n* Positive test for chronic hepatitis B infection at screening.\n* History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV).\n* History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for TB was completed per local guidelines.\n* History of progressive multifocal leukoencephalopathy.\n* Participants diagnosed with congenital myasthenic syndromes.\n* Receipt of any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) or any experimental B-cell-depleting agent in the 6 months prior to screening.\n* Receipt of any other monoclonal antibody (mAb) or large molecule biologic, including but not limited to FcRn inhibitors, anti-TNF mAbs, anti-janus kinase (JAK) Stat mAbs, and complement inhibitors within 6 months prior to screening.\n* Receipt of the following medications or treatments at any time prior to randomization: alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, natalizumab.\n* Participants who are pregnant or breastfeeding or planning to get pregnant.",{"count":313,"type":23},15,[169],"The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.",[317],"Generalized Myasthenia Gravis",[317,176,319,320],"AMG 335","Uplizna","2026-08-18",{"date":323,"type":37},"2026-08-19",{"date":325,"type":37},"2026-07-21",{"date":327,"type":23},"2030-03-13",{"name":43,"class":44},4,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":136,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":24,"phases":339,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},"100642316","phase-3-a-study-to-evaluate-efficacy-safety-and-immunogenicity-with-abp-938-8-mg-versus-eylea-hd-aflibercept-in-participants-with-neovascular-age-related-macular-degeneration-100642316","NCT07614776","A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration","A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Men or women ≥ 50 years old, capable of giving signed informed consent\n* Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)\n* Total area of CNV (including both classic and occult components) \\> 50% of the total lesion area in the SE\n* The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE\n* Presence of intra and\u002For subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:\n\n* Total lesion size \\> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye\n* Scar, fibrosis, or atrophy involving the central subfield in the study eye\n* Scar or fibrosis involving \\> 50% of the total lesion in the study eye\n* Presence of retinal pigment epithelium tears or rips involving the macula in the study eye\n* History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study\n* Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study\n* Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with anti-glaucoma medication) in the study eye\n* History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye\n* Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization\n* Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening\n* Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF\u002Fanti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins\n* History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation\n* Other protocol-specified exclusion criteria",{"count":338,"type":23},304,[26],"The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)",[342,343],"Neovascular Age-related Macular Degeneration","nAMD",[345,346,347,348,349,350],"ABP 938","Aflibercept","neovascular age-related macular degeneration","Intravitreal","Randomized Controlled Trial","Double-masked","2026-08-14",{"date":353,"type":37},"2026-08-17",{"date":355,"type":37},"2026-05-27",{"date":357,"type":23},"2028-01-12",{"name":43,"class":44},51,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":368,"targetDuration":4,"studyType":24,"phases":370,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":278},"100610375","phase-3-maridebart-cafraglutide-versus-placebo-in-adult-participants-with-obstructive-sleep-apnea-not-on-positive-airway-pressure-pap-therapy-100610375","NCT07226765","Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)","MARITIME-OSA-2","Inclusion Criteria:\n\n* Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization.\n* Body Mass Index (BMI) of 27 kg\u002Fm\\^2 or more at the time of screening.\n* History of at least one unsuccessful attempt at weight loss through diet and exercise.\n* Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling\u002Funable to use PAP, and do not plan to use PAP therapy during the study.\n\nExclusion Criteria:\n\n* Individuals who have had any previous or planned upper airway surgery or major ear, nose or throat surgery for OSA.\n* Those with significant craniofacial abnormalities that may affect breathing at screening.\n* Participants diagnosed with Central or Mixed Sleep Apnea with proportion of mixed or central apneas\u002Fhypopneas ≥ 50%, and\u002For diagnosis of Cheyne Stokes Respiration.\n* Active device treatment of OSA or other treatments, that in the opinion of the investigator, may interfere with study outcomes.\n* Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.",{"count":369,"type":23},250,[26],"This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are not on PAP therapy and are living with overweight or obesity.",[373],"Obstructive Sleep Apnea",[375,376,377,378,379,380,381],"Obstructive sleep apnea","OSA","Overweight","Obesity","Maridebart Cafraglutide","AMG 133","MariTide","2026-08-13",{"date":351,"type":37},{"date":385,"type":37},"2025-11-25",{"date":387,"type":23},"2028-09-13",{"name":43,"class":44},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":221,"enrollmentInfo":396,"targetDuration":4,"studyType":24,"phases":398,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},"100521660","phase-4-a-study-to-evaluate-avacopan-in-participants-with-anca-associated-vasculitis-100521660","NCT06072482","A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis","A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Inclusion Criteria:\n\n* Participants has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where induction treatment with cyclophosphamide or rituximab is needed.\n* Age \\>\u002F= 18 years (or \\>\u002F= legal age within the country if it is older than 18 years).\n* Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.\n* At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, or at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.\n* eGFR \\>\u002F= 15 mL\u002Fmin\u002F1.73 m\\^2 (using Chronic Kidney Disease Epidemiology Collaboration equations).\n\nExclusion Criteria:\n\n* Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.\n* Any other known multisystem autoimmune disease that may confound study assessments and study conclusions including but not limited to eosinophilic granulomatosis with polyangiitis (GPA \\[Churg-Strauss\\]), systemic lupus erythematosus, immunoglobulin (Ig) A vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.\n* Any other medical condition requiring or expected to require continued use of immunosuppressive therapies, including corticosteroids that may cause confoundment with study assessments and study conclusions.\n* Received dialysis or plasma exchange within 16 weeks before Day 1 randomization.\n* Have had a kidney transplant.\n* Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or breast ductal carcinoma in situ) within the last 5 years before Day 1 randomization.\n* Acute or chronic, active hepatitis B virus or hepatitis C virus, or human immunodeficiency virus infection during screening.\n* Any known exposure to a case of active tuberculosis (TB) within the last 12 weeks before Day 1 randomization.\n* Positive test for active or latent TB during screening.\n* White blood cell count \\\u003C 3500\u002FµL, neutrophil count \\\u003C 1500\u002FµL, or lymphocyte count \\\u003C 500\u002Fµl. Note: Complete Blood Count can be repeated once in the screening period at the investigator discretion. In such instances, eligibility will be determined based on the repeat complete blood count.\n* Evidence of clinically significant hepatic disease including prior diagnosis of cirrhosis.\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \\>2.0 times the upper limit of normal (ULN).\n* Total bilirubin \\> 1.5 times the ULN. Note: A participant with documented Gilbert's syndrome with total bilirubin \\\u003C 2 x ULN may be eligible.\n* Any of the following within 6 weeks prior to Day 1 randomization: serious infection, infection requiring treatment with intravenous (IV) anti-infective agents, any other infection (including active infection, chronic infection, opportunistic infection, or history of recurrent infection) that in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. Oral or vaginal candidiasis and cutaneous or nail fungal infections do not constitute an exclusion.\n* Any of the following within 12 weeks prior to Day 1 randomization: myocardial infarction, stroke, unstable angina, symptomatic congestive heart failure requiring prescription medication, any other clinically significant cardiovascular disease that in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.\n* Received cyclophosphamide (CYC) within 12 weeks before signing the informed consent; if on azathioprine (AZA), mycophenolate, or methotrexate (MTX) at the time of screening, these drugs must be withdrawn before receiving CYC. Note: If induction therapy with CYC was started within 1 week before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or microscopic polyangiitis (MPA), the participant may be eligible, provided no CYC was received within 12 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with CYC.\n* Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone equivalent for more than 6 weeks continuously before signing of the informed consent.\n* Received RTX or other B-cell depleting therapies within 26 weeks before signing of the informed consent; if on AZA, mycophenolate, or MTX at the time of screening, these drugs must be withdrawn before receiving rituximab (RTX). Note: If induction therapy with RTX was started within 1 week before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or MPA, the participant may be eligible, provided no RTX was received within 26 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with RTX.\n* Received any of the following within 16 weeks before Day 1 randomization:\n* antitumor necrosis factor treatment\n* abatacept\n* alemtuzumab\n* IV Ig\n* belimumab\n* anti interleukin-6 agent (eg, tocilizumab, sarilumab).\n* Taking a strong or moderate inducer of the cytochrome P450 3A4 (CYP3A4) enzyme unless the strong or moderate CYP3A4 inducer can be changed to an alternative medicine at least 1 week before Day 1 randomization.\n* Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) before Day 1 randomization.\n* Previously received avacopan without clinical benefit per the Investigator's opinion or received avacopan within 60 days before Day 1 randomization.",{"count":397,"type":23},300,[399],"PHASE4","The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).",[402],"Antineutrophil Cytoplasmic Antibody-associated Vasculitis",[404,405,406],"Avacopan","ANCA-associated Vasculitis","AAV",{"date":351,"type":37},{"date":409,"type":37},"2024-02-07",{"date":411,"type":23},"2036-12-31",{"name":43,"class":44},83,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":24,"phases":425,"briefSummary":426,"conditions":427,"keywords":430,"overallStatus":432,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":440},"100638086","phase-3-a-trial-of-inebilizumab-in-participants-with-autoimmune-hepatitis-100638086","NCT07598825","A Trial of Inebilizumab in Participants With Autoimmune Hepatitis","A Phase 2\u002F3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis","MERCURY","Inclusion Criteria:\n\n* Signed informed consent.\n* Age ≥ 18 years or legal adult age within the country, whichever is older and \\\u003C 75 years at the time of signing the informed consent.\n* Participants must have either inadequate response to at least 9 months of SOC or are intolerant to SOC within 6 months of screening. Inadequate response to SOC treatment is defined as ALT ≥ 2 upper limit of normal (ULN) at screening after at least 9 months of SOC, including prednisone (or equivalent) \\> 5 mg\u002Fday and at least one conventional steroid sparing agent at guideline-concordant target or highest appropriate dose, that is azathioprine (AZA) or 6-mercaptopurine (6-MP) at appropriate weight-based dosing (typically up to 2 mg\u002Fkg\u002Fday AZA or 1 mg\u002Fkg\u002Fday 6-MP) or mycophenolate (MMF) up to 2 g\u002Fday, as judged appropriate by the investigator and documented in the medical record.\n\nIntolerance to SOC treatment is defined as any clinically significant adverse event related to treatment that results in discontinuation of the medication or prevents dose optimization necessary to achieve or maintain biochemical response, as determined by the Principal Investigator (PI). Intolerance applies to GCs, AZA, 6-MP, or MMF. Presence of one or more clinically significant adverse effects attributed to SOC include but not limited to side effects that, in the opinion of the investigator, compromise participant's safety or quality of life, exacerbate comorbid conditions, or render continued use medically inappropriate.\n\n* Participants with disease activity at screening as follows: ALT ≥ 2 x ULN to ≤ 7 x ULN. ALT ULN values will be gender specific.\n* Participant must have a biopsy proven definitive diagnosis of AIH according to simplified diagnostic criteria (score ≥ 7). Liver biopsy should be obtained within 90 days prior to randomization. Participants must have a mHAI score ≥ 5 in the biopsy.\n* Participant should be on:\n\n  * No increase in GC dose during the 28 days immediately preceding whichever biopsy is designated as the baseline sample-historical or screening-and the dose post biopsy must remain unchanged through the day of randomization AND\n  * Stable maximum tolerated doses of AZA or 6-MP for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons OR\n  * Stable maximum tolerated doses of MMF\u002Fmycophenolic acid (MPA) for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons.\n* Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.\n\nExclusion Criteria:\n\n* Diagnosis of definitive overlap autoimmune liver or rheumatologic syndrome with autoimmune hepatitis (eg, AIH + primary biliary cholangitis \\[PBC\\], AIH + primary sclerosing cholangitis \\[PSC\\], AIH related to Systemic Lupus Erythematosus, etc) where established overlap criteria are met.\n* Acute liver failure (ALF) at screening (e.g., acute hepatic dysfunction with coagulopathy and any degree of encephalopathy) in the investigator's judgment.\n* Participant has known history of:\n\n  * Allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis to any human gamma globulin therapy.\n  * Allergy to or intolerance of protocol-required treatment, including medications for prophylaxis of infusion reactions (antipyretic such as paracetamol\u002Facetaminophen or equivalent, diphenhydramine or equivalent, and methylprednisolone or equivalent).\n* Active malignancy or history of malignancy that was active within the last 10 years, except as follows:\n\n  * In situ carcinoma of the cervix treated with apparent success with curative therapy for \\> 12 months prior to screening\n  * Curatively treated breast ductal carcinoma in situ\n  * Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy for \\> 12 months prior to screening\n  * Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent \\> 3 years prior to screening and without known recurrence or current treatment\n  * Thyroid cancer for which complete surgical resection has been performed within 5 years with well-differentiated histology (papillary thyroid carcinoma or follicular thyroid carcinoma) and there is no evidence of active disease.\n* Known positive test for human immunodeficiency virus (HIV) infection. Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.\n* Presence or history of viral hepatitis infection:\n\n  * Positive test for, or prior treatment for, hepatitis B. A positive test for hepatitis B is detection of either:\n\n    * Positive for hepatitis B surface antigen (HBsAg) OR\n    * anti-HBc\n  * Participants with a history of or current hepatitis C virus (HCV) infection, even those considered to be cured.\n* Active tuberculosis (TB) or latent TB with no documented history of adequate treatment per local SOC.\n* Positive test for TB during screening is defined as positive QuantiFERON® test. At screening, all participants must be tested with an interferon-γ release assay (IGRA) (QuantiFERON®).\n* History of \\> 1 episode of herpes zoster (any grade) and\u002For any other definite or probable opportunistic infection in the 12 months prior to screening.\n* Estimated glomerular filtration rate \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2 using chronic kidney disease epidemiology (CKD-EPI) 2021 formula.\n* Blood tests at screening that meet any of the following criteria:\n\n  * Hemoglobin \\\u003C 7.5 g\u002FdL\n  * Neutrophils \\\u003C 1200\u002Fmm\\^3\n  * Platelets \\\u003C 150 x 10\\^9\u002FL\n  * international normalized ratio (INR) \\> 1.3\n  * cluster of differentiation 19 (CD19)+ B cells at screen \\\u003C 40 cells\u002FµL; an exclusionary value may be repeated.\n  * Serum albumin level \\\u003C 35 g\u002FL\n  * Direct bilirubin (BIL) in serum \\>ULN\n  * Total BIL ≥ 2.0 mg\u002FdL\n  * ALP \\> 1.5 x ULN\n  * AST \\> 7 x ULN Note: Participants with baseline cytopenia (where permitted) may be enrolled if, in the Investigator's judgment, the cytopenia derives from an alternative to AIH condition (eg, medication effect, nutritional deficiency, anemia of chronic disease etc).\n* Active, clinically significant infection at the time of randomization (investigational product administration may be delayed until recovery, if within screening window, otherwise participant may be rescreened).\n* History or evidence of uncontrolled alcohol use disorder (AUD), defined as participants who have a history of significant alcohol consumption, ie, consumption of \\>2 units\u002Fday for males and \\>1 unit\u002Fday for females, sustained for ≥ 3 consecutive months.\n* History of recurrent significant infections (eg, requiring hospitalization or IV antibiotics) within the past 12 months.\n* Major surgery within 8 weeks before screening.\n* Severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder, or any other condition that, in the opinion of the Investigator, would place the participant at unacceptable risk of complications, interfere with evaluation of the Investigational product or confound the interpretation of participant safety or trial results.\n* Known immunodeficiency disorder.\n* Participants with moderate-to-severe metabolic dysfunction-associated steatohepatitis (MASH) on screening\u002Fbaseline liver biopsy, defined by central pathology review as steatosis grade ≥ 2 with lobular inflammation ≥ 1, and hepatocellular ballooning ≥ 1.\n* Participants with decompensated cirrhosis, either historical or present at screening defined by:\n\n  * Histologic cirrhosis on screening or prior liver biopsy (fibrosis stage F4 \u002F Ishak 5-6), and\n  * Prior hepatic decompensation or Child-Pugh B-C.\n  * Child-Pugh category A at screening, without a history of prior hepatic decompensation (ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis \\[SBP\\], hepatorenal syndrome \\[HRS\\], acute-on-chronic liver failure, or progression to decompensated cirrhosis), is eligible.\n* Participant with a history of drug-induced liver injury (DILI), regardless of offending agent.\n* Receipt of any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, ianalumab) in the 6 months prior to screening.\n* Receipt of non-depleting B cell-directed therapy (eg, belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.\n* Receipt of tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab) within 6 months prior screening.\n* Receipt of immunosuppressive agents such as calcineurin inhibitors (tacrolimus, cyclosporin except eye drops), methotrexate, mammalian target of rapamycin inhibitors (eg, everolimus) within 6 weeks prior screening.\n* Receipt of any investigational agent \\\u003C 12 weeks or \\\u003C 5 half-lives of the drug (whichever is longer) prior to screening.\n* History of inability to be tapered off of GC therapy due to adrenal insufficiency or due to recurrent or prolonged systemic glucocorticoid therapy for any medical condition other than AIH (eg, severe steroid-dependent asthma) according to PI.\n* All vaccines are prohibited within 4 weeks before the first dose of trial treatment.\n\n  * Participants are recommended to be administered vaccines at least 4 weeks prior to dosing in accordance with local recommendations prior to enrollment to allow for adequate immune response.\n* Required regular use of medications with known hepatotoxicity.\n* Current use of:\n\n  * GCs (prednisone \\> 20 mg\u002Fday, or equivalent dose of other GCs)\n  * AZA \\> 2 mg\u002Fkg\u002Fday\n  * 6-MP \\> 1 mg\u002Fkg\u002Fday\n  * MMF \\> 2 g\u002Fday or MPA \\> 1440 mg\u002Fday.\n* Any concomitant immunosuppressive treatment, alone or in combination with GCs, except for AZA, 6-MP, MMF, and MPA.\n* Undetectable levels of 6-thioguanine nucleotides (6-TGN) or MPA during screening unless participants are not on AZA or MMF\u002FMPA due to intolerance per protocol.\n* No new Herbal and Dietary Supplements (HDS) products for 4 weeks prior to first dose of inebilizumab.\n* Currently receiving a trial intervention, or less than 30 days or 5 half-lives if known (whichever is later) since ending a trial intervention in another investigational device or drug trial.\n* Unable to safely undergo a liver biopsy.\n* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.\n* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.\n* Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant, donate eggs, or breastfeed while on trial until an additional 6 months after the last dose of inebilizumab (if applicable) with highest teratogenic risk.\n* Participants of childbearing potential with a positive pregnancy test assessed by serum pregnancy test at screening and a urine pregnancy test at Day 1 visit.\n* Participant unwilling to abstain from donating blood or plasma during the trial.\n\nIn order for participants to continue to OLP, they must:\n\n* Have completed the randomized controlled treatment period Week 78 visit and received all doses or not discontinued investigational product for any of the following reasons:\n\n  * Anaphylaxis or a serious hypersensitivity reaction that occurred within 7 days after IV dosing and cannot be attributed to another known allergen exposure.\n  * Any adverse events or significant laboratory abnormality that, in the opinion of the investigator, Amgen, or Data Monitoring Committee (DMC), warrants discontinuation of dosing.\n  * Any life-threatening (grade 4) infection.\n  * Any event of sepsis or febrile neutropenia.\n  * Any infection listed as either a definite or probable opportunistic infection.\n  * Any grade 3 infusion related reactions (IRR).\n  * Any grade 4 serious adverse events.\n  * Pregnancy or a decision to become pregnant.\n  * Malignancy.\n  * Absolute neutrophil count \\\u003C 800 cells\u002FµL confirmed by repeat testing.\n  * Determination that the participant was ineligible for trial participation and continuation of investigational product could pose a safety risk to the participant in the judgment of the investigator or the sponsor.\n  * Significant noncompliance with the trial protocol, as judged by the investigator or Amgen.\n* Receive dose 1 in the OLP within the window of 7 days after the randomized controlled treatment period Week 78 visit and only after the Week 78 biopsy has been completed.\n* Participants who meet protocol-defined early escape criteria and discontinue the RCP may enter the OLP, provided they have not discontinued investigational product for safety-related reasons that preclude further dosing.","74 Years",{"count":424,"type":23},180,[26],"The main objectives of this trial are to evaluate the safety and tolerability of inebilizumab in participants with autoimmune hepatitis (AIH) (Part 1) and to evaluate the efficacy of inebilizumab on AIH disease activity and glucocorticoid (GC) use in the management of AIH (Part 2).",[428,429],"Autoimmune Hepatitis","AIH",[431,429,176,319],"Autoimmune hepatitis","NOT_YET_RECRUITING","2026-08-12",{"date":351,"type":37},{"date":436,"type":23},"2026-09-07",{"date":438,"type":23},"2034-02-11",{"name":43,"class":44},12,{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":108,"minAge":19,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":24,"phases":450,"briefSummary":451,"conditions":452,"keywords":454,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":461,"locationsCount":462},"100630887","phase-1-trial-of-xaluritamig-in-adults-with-metastatic-castration-resistant-prostate-cancer-100630887","NCT07493512","Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer","A Phase 1b, Open-label Study of Xaluritamig (AMG 509) in Adults With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy imaging obtained within 28 days prior to enrollment.\n* Evidence of progressive disease, defined as 1 or more PCWG3 criteria:\n\n  * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL.\n  * Soft tissue progression defined as an increase ≥ 20% and an absolute increase of ≥ 5 mm in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions.\n  * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scintigraphy (as per the 2+2 PCWG3 criteria).\n* Prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n* Prior progression on at least one androgen receptor pathway inhibitor (androgen receptor pathway inhibitor \\[ARPI\\], enzalutamide, abiraterone, apalutamide, darolutamide).\n* Prior treatment with only one taxane therapy in the mCRPC setting. Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.\n\nExclusion Criteria:\n\n* History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.\n* History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.\n* History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free for \\>3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer.\n* Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.\n* Known positive test for human immunodeficiency virus.\n* Presence or history of viral hepatitis infection.\n* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of trial treatment with the following exceptions:\n\n  * Androgen-deprivation therapy with luteinizing hormone-releasing hormone\u002Fgonadotropin-releasing hormone (LHRH\u002FGnRH) analogue (agonist\u002Fantagonist) is allowed.\n  * ARPIs (enzalutamide, abiraterone, apalutamide, darolutamide) require a minimum washout of 2 weeks prior to the first dose of xaluritamig.\n  * Prior prostate-specific membrane antigen (PSMA) radionuclide therapy cannot be given within 3 months prior to first dose of xaluritamig unless participant received \\\u003C2 cycles of therapy, in which case participant cannot have received PSMA radionuclide therapy within 35 days prior to first dose.\n* Any prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Any prior cluster of differentiation 3 (CD3)-directed therapy.\n* Requirement for chronic systemic corticosteroid therapy (prednisone dose \\>10 mg\u002Fday or equivalent) or any other immunosuppressive therapies (including anti TNFα therapies).\n* Participation on any other xaluritamig trial, regardless of whether xaluritamig was administered.",{"count":449,"type":23},40,[57],"The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).",[453],"Metastatic Castration-resistant Prostate Cancer (mCRPC)",[92,93,260,116],"2026-08-05",{"date":457,"type":37},"2026-08-07",{"date":459,"type":37},"2026-04-28",{"date":41,"type":23},{"name":43,"class":44},11,{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":472,"briefSummary":473,"conditions":474,"keywords":476,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":483,"leadSponsor":485,"locationsCount":288},"100623983","phase-1-amg-436-as-monotherapy-and-combination-therapy-in-participants-with-msi-hdmmr-solid-tumors-100623983","NCT07403721","AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H\u002FdMMR Solid Tumors","A Phase 1\u002F1b Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 436 as Monotherapy and in Combination With Other Therapies in Participants With Microsatellite Instability-high (MSI-H)\u002FMismatch Repair Deficient (dMMR) Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).\n* Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing.\n* Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing.\n* Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).\n* Eastern Cooperative Oncology Group performance (ECOG) 0-1.\n* Adequate organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Participants with primary central nervous system (CNS) tumors.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Major surgery within 28 days of trial day 1.\n* Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 21 days (in this case, enrollment may be allowed with washout from prior therapy of \\\u003C 21 days.\n* Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose).\n* Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).",{"count":471,"type":23},464,[57],"The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and\u002For the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H\u002FdMMR solid tumors.",[475],"Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)",[477,478,479,480],"AMG 436","MSI-H","dMMR","Solid Tumors",{"date":457,"type":37},{"date":96,"type":37},{"date":484,"type":23},"2028-07-28",{"name":43,"class":44},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":509},"100622813","phase-3-a-double-blind-randomized-controlled-trial-to-investigate-the-efficacy-safety-and-pharmacokinetics-of-pegloticase-administration-via-subcutaneous-and-intravenous-routes-both-with-methotrexate-in-participants-with-uncontrolled-gout-100622813","NCT07388498","A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout","A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout","Inclusion Criteria\n\n* Participant has provided informed consent before initiation of any trial-specific activities\u002Fprocedures.\n* Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.\n* Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.\n* Participants with uncontrolled gout, as meeting the protocol defined criteria.\n\nExclusion Criteria\n\n* Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit).\n* Liver transaminase levels (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\> 1.25 x upper limit of normal (ULN) or albumin \\\u003C the lower limit of normal (LLN) at the screening visit.\n* Uncontrolled diabetes mellitus and\u002For hemoglobin A1c (HbA1c) \\> 8%.\n* Known intolerance to MTX.\n* Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug.\n* A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and\u002For non-steroidal anti-inflammatory drug and\u002For low-dose prednisone ≤ 10 mg\u002Fday or equivalent dose of other corticosteroid).\n* Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations \\\u003C 40 mL\u002Fmin\u002F1.73 m\\^2 or currently on dialysis.",{"count":494,"type":23},270,[26],"The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \\\u003C 6 mg\u002FdL for at least 80% of the time during Month 6.",[498],"Uncontrolled Gout",[498,500,501,502],"Pegloticase","KRYSTEXXA","Kadence",{"date":457,"type":37},{"date":505,"type":37},"2026-02-09",{"date":507,"type":23},"2028-06-18",{"name":43,"class":44},63,{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":18,"minAge":518,"maxAge":286,"enrollmentInfo":519,"targetDuration":4,"studyType":24,"phases":521,"briefSummary":522,"conditions":523,"keywords":525,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":537},"100424258","phase-3-apremilast-pediatric-study-in-children-with-active-juvenile-psoriatic-arthritis-100424258","NCT04804553","Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis","A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)","PEAPOD","Inclusion Criteria:\n\n* Male or Female participants 5 to \\\u003C 18 years of age at the time of randomization.\n* Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:\n\n  * Arthritis and psoriasis, OR\n  * Arthritis with at least 2 of the following:\n  * Dactylitis\n  * Nail pitting or onycholysis\n  * Psoriasis in a first-degree relative\n* Active disease: at least 3 active joints.\n* Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate \\[MTX\\] or biologic agents).\n\nExclusion Criteria:\n\n* Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:\n\n  * Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age\n  * Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative\n  * History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart\n  * Presence of systemic juvenile idiopathic arthritis (JIA).\n* Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.\n* Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).","5 Years",{"count":520,"type":23},60,[26],"The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.",[524],"Active Juvenile Psoriatic Arthritis",[526,527,528,529],"Apremilast","Otezla®","Juvenile psoriatic arthritis","Inflammatory disorders",{"date":531,"type":37},"2026-08-06",{"date":533,"type":37},"2022-03-17",{"date":535,"type":23},"2028-12-29",{"name":43,"class":44},45,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":546,"targetDuration":4,"studyType":24,"phases":547,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":558},"100610292","phase-3-maridebart-cafraglutide-versus-placebo-in-adult-participants-with-obstructive-sleep-apnea-on-positive-airway-pressure-therapy-100610292","NCT07225686","Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living With Overweight or Obesity","MARITIME-OSA-1","Inclusion Criteria:\n\n* AHI ≥ 15 on polysomnography at day 1 before randomization.\n* BMI ≥ 27 kg\u002Fm\\^2 at screening.\n* History of at least 1 unsuccessful attempt at weight loss by diet and exercise.\n* On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the trial.\n\nExclusion Criteria:\n\n* Had any previous or planned upper airway surgery or major ear, nose, or throat surgery for OSA.\n* Significant craniofacial abnormalities that may affect breathing at screening.\n* Diagnosis of Central or Mixed Sleep Apnea with proportion of mixed or central apneas\u002Fhypopneas ≥ 50%, and\u002For diagnosis of Cheyne Stokes Respiration.\n* Active device treatment of OSA other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes.\n* Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator.\n* Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.",{"count":369,"type":23},[26],"This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.",[378,373],[381,379,380,378],"2026-08-03",{"date":553,"type":37},"2026-08-04",{"date":555,"type":37},"2025-12-19",{"date":387,"type":23},{"name":43,"class":44},61,{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":566,"targetDuration":4,"studyType":24,"phases":568,"briefSummary":569,"conditions":570,"keywords":571,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":584},"100647039","phase-3-extension-trial-to-evaluate-the-long-term-efficacy-safety-and-tolerability-of-maridebart-cafraglutide-maritime-1-extension-100647039","NCT07684235","Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)","A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight","Inclusion Criteria:\n\n* Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Completed the parent trial (2010181)\n* Completed week 72 visit in parent trial\n* Did not permanently discontinue trial intervention in parent trial\n* Randomized within 7 Days of week 72 visit in the parent trial\n* Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention\n\nExclusion Criteria:\n\n* Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity\n* Body mass index ≤ 18.5 kilograms per meter square (kg\u002Fm\\^2)\n* Participant has known sensitivity to any of the products or components to be administered during dosing\n* History of ischemic optic neuropathy\n* Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ.\n* Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\\[s\\]) history of medullary thyroid cancer.\n* Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization\n* Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization.\n* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.\n* History or evidence of any other clinically significant disorder, condition, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.\n* Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or\n* Planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.\n* Major surgical procedures planned during the trial.\n* Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.\n* Investigative site personnel directly affiliated with the trial and\u002For their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).",{"count":567,"type":23},3200,[26],"The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).",[378,377],[377,572,378,573,574,381,575,576],"BMI","Maridebart cafraglutide","Chronic weight management","Extension","Long-Term","2026-08-01",{"date":553,"type":37},{"date":580,"type":37},"2026-07-23",{"date":582,"type":23},"2028-03-19",{"name":43,"class":44},31,{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":592,"sex":18,"minAge":19,"maxAge":165,"enrollmentInfo":593,"targetDuration":4,"studyType":24,"phases":595,"briefSummary":596,"conditions":597,"keywords":599,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":45},"100640678","phase-1-a-trial-evaluating-amg-127-in-healthy-participants-and-participants-with-type-2-diabetes-mellitus-100640678","NCT07590193","A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus","A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus","Inclusion Criteria for Part A and B\n\n* Participant must be 18-65 years of age\n* Participant must be overtly healthy\n\nInclusion Criteria for Part C\n\n* Participant must be 40-75 years of age\n* Confirmed diagnoses of T2DM\n\nExclusion Criteria for Part A and B\n\n* History of hypotension, syncope, or orthostatic intolerance\n* Systolic blood pressure \\>140 millimeters of mercury (mmHg) or diastolic blood pressure \\>90 mmHg\n\nExclusion Criteria for Part C\n\n* Hemoglobin A1c (HbA1c) \\>10% within the last 3 months\n* History of hypotension, syncope, or orthostatic intolerance\n* Systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg",true,{"count":594,"type":23},162,[57],"The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).",[598],"Diabetes Mellitus, Type 2",[600,601,602],"AMG 127","healthy participants","type 2 diabetes mellitus","2026-07-31",{"date":551,"type":37},{"date":606,"type":37},"2026-06-11",{"date":608,"type":23},"2027-10-02",{"name":43,"class":44},{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":592,"sex":18,"minAge":19,"maxAge":617,"enrollmentInfo":618,"targetDuration":4,"studyType":24,"phases":620,"briefSummary":621,"conditions":622,"keywords":624,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":632,"leadSponsor":634,"locationsCount":635},"100650205","phase-1-a-phase-1-trial-of-amg-691-in-healthy-chinese-and-japanese-volunteers-100650205","NCT07745907","A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 691 Administered in Healthy Chinese and Japanese Participants","Inclusion Criteria:\n\n* Healthy male or female participants, 18 to 60 years of age.\n* First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Japanese grandparents).\n* Body mass index (BMI) 18.0 to 30.0 kg\u002Fm\\^2 (inclusive) and body weight ≥40 kg.\n* In good general health based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.\n* Female participants must not be pregnant or breastfeeding.\n* Participants of reproductive potential must agree to follow protocol-specified contraception requirements.\n* Willing to maintain usual diet and physical activity regimen throughout study participation.\n\nExclusion Criteria:\n\n* Clinically significant medical condition, disease, or abnormal finding that could interfere with study participation or interpretation of results.\n* Clinically significant ECG abnormalities\n* Clinically significant abnormal blood pressure or pulse rate at screening\u002Fcheck-in.\n* History of malignancy (except adequately treated in situ cervical cancer or non-melanoma skin cancer \\>5 years before dosing).\n* Deep vein thrombosis or pulmonary embolism within 3 months prior to check-in.\n* History of hypersensitivity\u002Fanaphylaxis to biologic therapies, mammalian-derived products, or AMG 691 excipients.\n* Active, chronic, recurrent, or unresolved infection; history of severe infection requiring intravenous (IV) antibiotics within the past 3 years.\n* Positive or indeterminate QuantiFERON-TB Gold test.\n* Untreated or unresolved helminth parasitic infection.\n* History of immunodeficiency.\n* Receipt of live or live-attenuated vaccines within 12 weeks before check-in or planned during the study.\n* Estimated glomerular filtration rate (eGFR) \\\u003C70 mL\u002Fmin\u002F1.73 m\\^2.\n* Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or direct bilirubin \\>1.5 × Upper Limit Normal (ULN).\n* Positive screening tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.\n* Use of prohibited prescription, over-the-counter, herbal, vitamin, or dietary supplement products within 30 days (or 5 half-lives) before enrollment, unless approved by the investigator.\n* History of illicit drug use within 1 year, positive drug screen, or unwillingness to abstain from illicit drugs\u002Fcannabinoids during the study.\n* Use of tobacco or nicotine-containing products within 6 months prior to check-in.\n* History of alcohol abuse or excessive alcohol consumption.\n* History of non-suicidal self-injury within 5 years or unstable major depressive disorder\u002Fother severe psychiatric disorder within 2 years.\n* Participation in another investigational drug study within 90 days (or 5 half-lives) prior to check-in.\n* Previous exposure to AMG 691.\n* Recent donation of blood, plasma, or platelets.\n* Any participant considered unsuitable by the investigator or unwilling to comply with study restrictions.","60 Years",{"count":619,"type":23},28,[57],"The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants",[623],"Healthy Participants",[625,626,627,628],"AMG 691","Respiratory Tract Diseases","Asthma","Lung Diseases","2026-07-30",{"date":553,"type":37},{"date":457,"type":23},{"date":633,"type":23},"2027-03-31",{"name":43,"class":44},1,{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":4,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":108,"minAge":19,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":24,"phases":644,"briefSummary":645,"conditions":646,"keywords":647,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":100},"100563202","phase-1-evaluation-of-neoadjuvant-xaluritamig-in-localized-prostate-cancer-100563202","NCT06613100","Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer","A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, and Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n* Participants planned to undergo radical prostatectomy.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. Intermediate- or high-risk localized prostate cancer, defined as:\n\n  * Gleason score of 4+3 or higher AND initial PSA (iPSA) \\>10 OR\n  * Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND\u002FOR\n  * Positive locoregional lymph nodes as detected by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans OR ≤ 5 local lymph nodes on MRI can be enrolled.\n* Participants must have undergone a PSMA-PET (CT or MRI) scan within 3 months prior to screening as part of the standard of care (SOC).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Prior treatment for participant's prostate cancer.\n\n  \\- Exception: Participants intended for enrollment in cohort B may have received an oral GnRH antagonist up to 3 months prior to the start of screening.\n* Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans.\n* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.\n* Participants with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment:\n\n  \\- Participant has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.\n* Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3 months prior to the first dose of study treatment, respectively. Note: Participants with a history of venous thrombosis must be on stable anti-coagulation.\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association ≥ class II) within 12 months of first dose of xaluritamig with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement more than 6 months prior to first dose of xaluritamig.\n* Requirement for chronic systemic corticosteroid therapy unless stopped (with adequate tapering) within 7 days prior to dosing.\n* Currently receiving treatment in another investigational device or drug study, or less than 4 weeks (since ending treatment on another investigational device or drug study\\[ies\\]). Other investigational procedures and participation in observational research studies while participating in this study are excluded with the exception of investigational scans.",{"count":449,"type":23},[57],"The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered as monotherapy or in combination with an oral Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant setting followed by radical prostatectomy, and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered as monotherapy or in combination with an oral GnRH antagonist in the neoadjuvant setting.",[116],[92,648,649,116,650,266,651,263],"AMG509","Localized Prostate Cancer","Neoadjuvant Therapy","T-Cell Engager",{"date":603,"type":37},{"date":654,"type":37},"2024-11-25",{"date":656,"type":23},"2030-03-04",{"name":43,"class":44},{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":24,"phases":667,"briefSummary":668,"conditions":669,"keywords":671,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":685},"100600178","phase-1-amg-410-alone-and-in-combination-with-other-agents-in-participants-with-kras-altered-advanced-or-metastatic-solid-tumors-100600178","NCT07094113","AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors","A Phase 1\u002F1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years (or \\> legal age within the country if it is older than 18 years).\n2. Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT amplification assay.\n3. Participants must have no standard of care treatment options or have actively refused such therapy.\n4. Able to swallow and retain per oral administered study treatment.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n6. Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator.\n7. Adequate organ function.\n8. Archival (formalin-fixed, paraffin-embedded \\[FFPE\\]) tumor tissue or block collected within 5 years before screening must be available. Participants without archived tumor tissue may undergo tumor biopsy before AMG 410 dosing (Day1).\n\nExclusion Criteria:\n\n1. Untreated symptomatic central nervous system or leptomeningeal metastases.\n2. Uncontrolled pleural effusion and\u002For ascites.\n3. History of other malignancy within the past 5 years.\n4. Active systemic infection or symptoms that indicate an acute and\u002For uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment.\n5. History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).\n6. Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.\n7. History of solid organ transplant.\n8. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.\n9. Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n10. Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1.\n11. Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment.\n12. Major surgery within 28 days of first dose of study treatment.\n13. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.",{"count":666,"type":23},434,[57],"The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when administered alone or in combination with other agents in participants with advanced or metastatic solid tumors harboring KRAS alterations.\n\nThis is a dose-escalation study in which participants will be assigned to multiple dose levels (DLs) of AMG 410, either as monotherapy or in combination with other agents, followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose (MTD)-the highest dose with acceptable safety and manageable side effects-or the Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered advanced or metastatic solid tumors.",[670],"KRAS Altered Advanced or Metastatic Solid Tumors",[672,235,673,674,675,676,677],"Non-small cell lung cancer","Colorectal cancer","CRC","Pancreatic ductal adenocarcinoma","PDAC","AMG 410","2026-07-29",{"date":629,"type":37},{"date":681,"type":37},"2025-07-31",{"date":683,"type":23},"2031-04-20",{"name":43,"class":44},39,""]