[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EMD Serono Research & Development Institute, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":253},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,82,105,126,138,168,194,222],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053391","met-non-small-cell-cancer-registry-moment-100053391",false,"NCT05376891","Met Non Small Cell Cancer Registry (MOMENT)","Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)","Inclusion Criteria:\n\n* Participants who signed ICF\n* Participants with advanced stage (stages IIIB-IV) NSCLC (all histologies) and Confirmed METex14 skipping alterations (by valid assay)\n* Participants who are starting or are already being treated with systemic therapy\n\nExclusion Criteria:\n\n* Participants who are enrolled in a clinical trial","ALL",{"count":18,"type":19},700,"ESTIMATED","OBSERVATIONAL","The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time.\n\nThe registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14(METex14) participants treated with systemic therapy.",[23],"Cancer",[25,26],"Disease Registry","METex14 Skipping Alterations","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2022-10-04",{"date":35,"type":19},"2028-04-28",{"name":37,"class":38},"EMD Serono Research & Development Institute, Inc.","INDUSTRY",66,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":5},"100620253","phase-3-a-study-of-enpatoran-in-participants-with-cutaneous-manifestations-of-lupus-with-or-without-systemic-disease-elowen-2-100620253","NCT07355218","A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)","A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)","Inclusion Criteria\n\n* Vaccinations are up to date according to local guidelines\u002Frecommendations. Recombinant zoster vaccination is encouraged but not mandatory.\n* Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and\u002For Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).\n* Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.\n* Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and\u002For SCLE and\u002For ACLE.\n\nFor participants with SLE:\n\n* Participants with diagnosis of SLE and fulfill EULAR\u002FACR 2019 classification criteria.\n* Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening.\n* Participants with CLASI-A score \\>= 8 at Screening and Day 1 visits.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria\n\n* Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.\n* Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor\u002Fdesignee's opinion constitutes inappropriate risk or contraindication for participation.\n* Participants with drug-induced lupus (SLE or CLE).\n* Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).\n* Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\\>) 339 milligrams per millimole (mg\u002Fmmol), and\u002For estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL\u002Fmin\u002F1.73 m\\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.\n* Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.\n* Other protocol-defined exclusion criteria may apply.","18 Years","75 Years",{"count":50,"type":19},202,"INTERVENTIONAL",[53],"PHASE3","The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:\n\nStudy Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.\n\nIntervention Form: Film-coated tablet.",[56,57],"Systematic Lupus Erythematosus","Cutaneous Lupus Erythematosus",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73],"Toll-like Receptor 7","Toll-like Receptor 8","Adults","SLE","CLE","Lupus","Discoid lupus erythematosus","Subacute cutaneous lupus erythematosus","M5049","Enpatoran","Cutaneous manifestations","Lupus erythematosus","Acute cutaneous lupus erythematosus","Systemic lupus erythematosus","Interferon gene signature","2026-07-01",{"date":76,"type":31},"2026-07-02",{"date":78,"type":31},"2026-04-01",{"date":80,"type":19},"2029-05-25",{"name":37,"class":38},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":89,"targetDuration":4,"studyType":51,"phases":90,"briefSummary":54,"conditions":91,"keywords":94,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100618504","phase-3-a-study-of-enpatoran-in-participants-with-cutaneous-manifestations-of-lupus-with-or-without-systemic-disease-100618504","NCT07332481","A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease","A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)","ELOWEN-1",{"count":50,"type":19},[53],[92,93],"Systemic Lupus Erythematosus (SLE)","Cutaneous Lupus Erythematosus (CLE)",[59,60,61,62,63,64,95,96,67,68,69,70,97,73],"Discoid lupus erythematosus (DLE)","Subacute Cutaneous Lupus Erythematosus (SCLE)","Acute cutaneous lupus erythematosus (ACLE)",{"date":76,"type":31},{"date":100,"type":31},"2026-03-10",{"date":102,"type":19},"2029-05-24",{"name":37,"class":38},11,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":51,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100474909","phase-1-anti-ceacam5-adc-m9140-in-advanced-solid-tumors-proceade-crc-01-100474909","NCT05464030","Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)","A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)","Inclusion Criteria:\n\n* Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant\u002Frefractory to or progressed after standard systemic therapies for the advanced\u002Fmetastatic stage, if locally indicated and available to the participant. Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1\n* Participants with adequate hematologic, hepatic and renal function as defined in protocol\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm\u002Fhypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)\n* Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)\n* Participants with diarrhea (liquid stool) or ileus Grade \\> 1\n* Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and\u002For bowel obstruction\n* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] \\>= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of \\> 470 milliseconds (ms)\n* Cerebrovascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment)\n* Other protocol defined exclusion criteria could apply",{"count":113,"type":19},200,[115],"PHASE1","The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2)\n\nStudy details include:\n\n* Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2\n* M9140 is not available through an expanded access program",[118],"Colorectal Cancer",{"date":76,"type":31},{"date":121,"type":31},"2022-08-04",{"date":123,"type":19},"2026-10-23",{"name":37,"class":38},35,{"id":127,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":129,"keywords":130,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":136,"locationsCount":137},"100468216",{"count":18,"type":19},[23],[25,26],"2026-06-24",{"date":133,"type":31},"2026-06-25",{"date":33,"type":31},{"date":35,"type":19},{"name":37,"class":38},64,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":51,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100605752","phase-1-m0324-as-monotherapy-and-in-combination-with-pembrolizumab-or-chemotherapy-in-participants-with-selected-advanced-solid-tumors-100605752","NCT07166601","M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors","An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors","TITER","Inclusion Criteria:\n\nPart 1- M0324 Monotherapy:\n\n• Participants with certain advanced\u002Fmetastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator\n\nPart 2- M0324 Combination with Pembrolizumab:\n\n• Participants with certain advanced\u002Fmetastatic tumor types known to overexpress MUC-1 and the participants in the combination treatment involving M0324 and pembrolizumab must be intolerant or refractory to standard therapy and no other further standard therapy should be judged appropriate by the Investigator. In addition, the participants must have had prior treatment with immune checkpoint inhibitor(s) (ICIs) and must have experienced documented disease progression on or after ICIs.\n\nPart 3- M0324 Combination with mFOLFIRINOX:\n\n* Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with mFOLFIRINOX. Participants with prior Whipple surgery and\u002For adjuvant chemotherapy are not permitted\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Has a history of chronic diarrhea greater than or equal to (\\>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction\n* Participant has a history of malignancy within 3 years before the date of enrollment\n* Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure \\[New York Heart Association (NYHA) \\>= II\\] or a coronary revascularization procedure within 180 days of study entry\n* Life expectancy of less than 3 months\n* Other protocol defined exclusion criteria could apply",{"count":147,"type":19},77,[115],"The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).",[151],"Advanced Solid Tumor",[153,154,155,156,157,158],"Bispecific CD40 agonistic antibody","Mucin-1 (MUC-1)","pembrolizumab","mFOLFIRINOX","pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)","2026-06-22",{"date":161,"type":31},"2026-06-23",{"date":163,"type":31},"2025-10-10",{"date":165,"type":19},"2029-02-23",{"name":37,"class":38},5,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":51,"phases":177,"briefSummary":178,"conditions":179,"keywords":180,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":104},"100565417","phase-1-anti-gd2-adc-m3554-in-advanced-solid-tumors-100565417","NCT06641908","Anti-GD2 ADC M3554 in Advanced Solid Tumors","A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced\u002Fmetastatic setting.\n* Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention.\n* Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +\u002F- temozolomide, depending on the O\\^6-methylguanine-DNA methyltransferase \\[MGMT\\] status) and relapsing at least 3 months after the end of the radiotherapy treatment.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1\n* Participants with adequate hematologic, hepatic and renal function as defined in protocol\n* Other protocol defined inclusion criteria could apply\n\n  * Exclusion Criteria:\n* Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation\u002Fexpansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm\u002Fhypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years).\n* STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression\n* Other protocol defined exclusion criteria could apply",{"count":176,"type":19},52,[115],"The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.\n\nStudy details include:\n\nStudy Duration per participant: Approximately 4 months",[151],[181,182,183,184,185,186,187],"Glioblastoma","IDH-wildtype","Soft tissue sarcomas","GD2 prevalence","targeted therapy","TOP1 inhibitor","exatecan",{"date":161,"type":31},{"date":190,"type":31},"2024-11-08",{"date":192,"type":19},"2027-04-16",{"name":37,"class":38},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":51,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},"100635186","phase-3-a-study-of-precemtabart-tocentecan-with-or-without-bevacizumab-compared-to-trifluridinetipiracil-plus-bevacizumab-in-participants-with-previously-treated-metastatic-colorectal-cancer-proceade-crc-03-100635186","NCT07549412","A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine\u002FTipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine\u002FTipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","Inclusion Criteria:\n\n* Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.\n* Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting\n* Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1\n* Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations\n* Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0\n* Participant has a history of additional malignancy within 3 years before randomization\n* Participants with known brain metastases\n* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization\n* Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and\u002For bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments\n* Other protocol defined exclusion criteria may apply",{"count":202,"type":19},1020,[53],"This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride\u002Ftipiracil (FTD-TPI) plus bevacizumab.",[206],"Metastatic Colorectal Cancer",[208,209,210,211,212],"CEACAM5","Antibody-drug conjugate","Exatecan","M9140","Precem-TcT","2026-06-15",{"date":215,"type":31},"2026-06-16",{"date":217,"type":31},"2026-05-06",{"date":219,"type":19},"2029-10-16",{"name":37,"class":38},8,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":51,"phases":231,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":5},"100620645","phase-1-anti-ly6e-exatecan-adc-m7437-in-advanced-solid-tumors-100620645","NCT07360314","Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors","A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator.\n\nFor each tumor type, participants have received prior lines of therapy, where locally available:\n\n* Non-small cell lung cancer (nonsquamous or squamous)\n* Triple-negative breast cancer\n* Squamous cell carcinoma of head and neck\n* Pancreatic ductal adenocarcinoma\n* Gastric cancer\n* Epithelial ovarian cancer\n\n  * Participants with ECOG Performance Status (ECOG) less than and equal to (\\\u003C=) 1\n  * Participants must have blood, liver, and kidney function within safe levels.\n  * Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Participant has a history of another malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm\u002Fhyperplasia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years before the date of enrollment). History of hematopoietic allogenic transplantation.\n* Participants with known brain metastases, except those meeting both of the following criteria:\n\n  1. All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment.\n  2. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).\n* Participants with diarrhea (liquid stool) or ileus Grade more than (\\>) 1 within 1 week of Cycle1Day1.\n* Participants with active chronic inflammatory bowel disease and\u002For bowel obstruction.\n* Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1.\n* Other protocol defined exclusion criteria may apply.",{"count":230,"type":19},138,[115],"The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).",[234],"Advanced Solid Tumors",[236,237,238,239,240,241,242,243,244],"Ly6E expression","Topoisomerase I inhibitor (TOP1i)","NSCLC","Breast cancer","Gastric cancer","Head and neck squamous cell carcinoma","Ovarian cancer","Pancreatic ductal adenocarcinoma","Systemic antibody-drug conjugate therapy (ADC) therapy","2026-06-10",{"date":247,"type":31},"2026-06-11",{"date":249,"type":31},"2026-02-13",{"date":251,"type":19},"2029-03-28",{"name":37,"class":38},""]