[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658551":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":11,"studyPopulation":11,"armGroups":67,"interventions":80,"overallOfficials":11,"centralContacts":88,"locations":93,"responsibleParty":225,"collaborators":11,"id":227,"slug":228,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":11,"eligibilityCriteria":233,"healthyVolunteers":229,"sex":234,"minAge":235,"maxAge":11,"enrollmentInfo":236,"targetDuration":11,"studyType":239,"phases":240,"briefSummary":242,"conditions":243,"keywords":11,"overallStatus":245,"whyStopped":11,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Occurrence of dose-limiting toxicities (DLTs) during the primary DLT evaluation period (Dose escalation part A and B)",null,"During the first treatment cycle, up to 21 days",{"measure":14,"description":15,"timeFrame":16},"Objective response (OR)","defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (Part A2)","Up to 2 years",[18,20,22,24,26,28,31,34,38,41,44,47,50,53,55,58],{"measure":19,"description":11,"timeFrame":16},"Occurrence of treatment-emergent adverse events (AEs)",{"measure":21,"description":11,"timeFrame":16},"Occurrence of dose-limiting toxicities (DLTs)",{"measure":23,"description":11,"timeFrame":16},"Occurrence of drug-related AEs",{"measure":25,"description":11,"timeFrame":16},"Occurrence of treatment-emergent serious adverse events (SAEs)",{"measure":14,"description":27,"timeFrame":16},"defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (part A + B)",{"measure":29,"description":30,"timeFrame":16},"Duration of response (DoR)","based on RECIST v1.1, defined as the time from first confirmed CR or PR until the earliest of progressive disease (PD) or death among patients with an OR (part A2)",{"measure":32,"description":33,"timeFrame":16},"Progression-free survival (PFS)","defined as the time from first treatment administration until tumour progression according to RECIST v1.1 or death from any cause, whichever occurs first (part A2)",{"measure":35,"description":36,"timeFrame":37},"Progression-free survival (PFS) at 6 months (PFS6)","defined as being alive and without tumour progression at 6 months from first treatment administration (part A2)","At 6 months",{"measure":39,"description":40,"timeFrame":16},"Clinical Benefit (CB)","defined as achievement of BOR of CR or PR of any duration, or stable disease (SD) of at least 6 months according to RECIST v1.1 (part A2)",{"measure":42,"description":43,"timeFrame":16},"Disease control (DC)","based on RECIST v1.1, defined as the best overall response of CR, PR, or SD from the first administration of trial medication until the earliest of PD, death, last evaluable tumour assessment before the start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first",{"measure":45,"description":46,"timeFrame":16},"Immune objective response (iOR)","as determined by investigator's assessment according to iRECIST, defined as immune BOR (iBOR) of immune CR (iCR) or immune PR (iPR), determined from date of first administration until earliest of disease progression (immune unconfirmed progressive disease \\[iUPD\\] that is confirmed at next radiological assessment), death, last evaluable tumour assessment before start subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first",{"measure":48,"description":49,"timeFrame":16},"Immune DC (iDC)","based on iRECIST v1.1, defined as the best overall response of iCR, iPR or iSD from the first administration of trial medication until the earliest of iUPD (provided that iCPD is the next time point response, i.e. progression is confirmed at the next tumour assessment), death, last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first",{"measure":51,"description":11,"timeFrame":52},"Maximum measured concentration of the analyte in plasma (after the first dose in Cycle 1) (Cmax)","Up to Day 15 in cycle 1 (each cycle is 21 days)",{"measure":54,"description":11,"timeFrame":52},"Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose in Cycle 1 (AUCτ,1)",{"measure":56,"description":11,"timeFrame":57},"Maximum measured concentration of the analyte in plasma at steady state (after the first dose in Cycle 2) (Cmax,ss)","Up to Day 15 in cycle 2 (each cycle is 21 days)",{"measure":59,"description":11,"timeFrame":57},"Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (after the first dose in Cycle 2) (AUCτ,ss)",{"allocation":61,"interventionModel":62,"interventionModelDescription":11,"primaryPurpose":63,"observationalModel":11,"timePerspective":11,"maskingInfo":64},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":65,"maskingDescription":66,"whoMasked":11},"NONE","Open-label",[68,73,76],{"label":69,"type":70,"description":11,"interventionNames":71},"BI 3968621 dose escalation monotherapy (Part A)","EXPERIMENTAL",[72],"Drug: BI 3968621",{"label":74,"type":70,"description":11,"interventionNames":75},"BI 3968621 dose expansion monotherapy (Part A2)",[72],{"label":77,"type":70,"description":11,"interventionNames":78},"BI 3968621 + ezabenlimab dose escalation combination therapy (Part B)",[72,79],"Drug: ezabenlimab",[81,85],{"type":82,"name":83,"description":83,"armGroupLabels":84,"otherNames":11},"DRUG","BI 3968621",[77,69,74],{"type":82,"name":86,"description":86,"armGroupLabels":87,"otherNames":11},"ezabenlimab",[77],[89],{"name":5,"role":90,"phone":91,"phoneExt":11,"email":92},"CONTACT","018002430127","clintriage.rdg@boehringer-ingelheim.com",[94,111,123,135,147,159,174,189,199,214],{"facility":95,"status":11,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Florida Cancer Specialists-Sarasota-61670","Sarasota","Florida","34232","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-82.53065,27.33643,{"lat":105,"lon":104},[108],{"name":5,"role":90,"phone":109,"phoneExt":11,"email":110},"833-602-2368","unitedstates@bitrialsupport.com",{"facility":112,"status":11,"city":113,"state":114,"zip":115,"country":99,"countryCode":100,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Emory University","Atlanta","Georgia","30322",{"type":102,"coordinates":117},[118,119],-84.38798,33.749,{"lat":119,"lon":118},[122],{"name":5,"role":90,"phone":109,"phoneExt":11,"email":110},{"facility":124,"status":11,"city":125,"state":126,"zip":127,"country":99,"countryCode":100,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"type":102,"coordinates":129},[130,131],-75.16362,39.95238,{"lat":131,"lon":130},[134],{"name":5,"role":90,"phone":109,"phoneExt":11,"email":110},{"facility":136,"status":11,"city":137,"state":138,"zip":139,"country":99,"countryCode":100,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Sarah Cannon Research Institute-Nashville-48456","Nashville","Tennessee","37203",{"type":102,"coordinates":141},[142,143],-86.78444,36.16589,{"lat":143,"lon":142},[146],{"name":5,"role":90,"phone":109,"phoneExt":11,"email":110},{"facility":148,"status":11,"city":149,"state":150,"zip":151,"country":99,"countryCode":100,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":102,"coordinates":153},[154,155],-95.36327,29.76328,{"lat":155,"lon":154},[158],{"name":5,"role":90,"phone":109,"phoneExt":11,"email":110},{"facility":160,"status":11,"city":161,"state":11,"zip":162,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Universitair Ziekenhuis Gent","Ghent","9000","Belgium","BE",{"type":102,"coordinates":166},[167,168],3.71667,51.05,{"lat":168,"lon":167},[171],{"name":5,"role":90,"phone":172,"phoneExt":11,"email":173},"080049616","belgique@bitrialsupport.com",{"facility":175,"status":11,"city":176,"state":11,"zip":177,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Institut Gustave Roussy","Villejuif","94800","France","FR",{"type":102,"coordinates":181},[182,183],2.35992,48.7939,{"lat":183,"lon":182},[186],{"name":5,"role":90,"phone":187,"phoneExt":11,"email":188},"0805102354","france@bitrialsupport.com",{"facility":190,"status":11,"city":191,"state":11,"zip":192,"country":193,"countryCode":194,"cosmosGeoPoint":11,"geoPoint":11,"contacts":195},"Japanese Foundation for Cancer Research","Tokyo, Koto-ku","135-8550","Japan","JP",[196],{"name":5,"role":90,"phone":197,"phoneExt":11,"email":198},"05050508862","nippon@bitrialsupport.com",{"facility":200,"status":11,"city":201,"state":11,"zip":202,"country":203,"countryCode":204,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":102,"coordinates":206},[207,208],2.15899,41.38879,{"lat":208,"lon":207},[211],{"name":5,"role":90,"phone":212,"phoneExt":11,"email":213},"900876092","espana@bitrialsupport.com",{"facility":215,"status":11,"city":216,"state":11,"zip":217,"country":203,"countryCode":204,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Hospital Clinico De Valencia (INCLIVA)","Valencia","46010",{"type":102,"coordinates":219},[220,221],-0.37966,39.47391,{"lat":221,"lon":220},[224],{"name":5,"role":90,"phone":212,"phoneExt":11,"email":213},{"type":226,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658551","phase-1-a-study-to-test-different-doses-of-bi-3968621-when-given-alone-or-with-ezabenlimab-in-patients-with-advanced-cancer-100658551",false,"NCT07851103","A Study to Test Different Doses of BI 3968621 When Given Alone or With Ezabenlimab in Patients With Advanced Cancer","A First-in-human, Multicentre, Phase Ia Dose Escalation Study of BI 3968621 as Monotherapy and in Combination With Ezabenlimab to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumour Activity in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\n* Male and female participants ≥18 years of age and at least at the legal age of consent\n* Patients with a histologically confirmed diagnosis of advanced, unresectable, and\u002For metastatic solid tumours (any type). Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted approved treatment options known to prolong survival for their disease\n* At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy ≥3 months at the start of treatment in the opinion of the investigator\n* Patients with known brain metastases are eligible, provided they meet the protocol-defined criteria\n* Patients must have adequate organ function based on haematological, hepatic, renal, and coagulation parameters Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Previous or concomitant malignancies other than the one treated in this trial within the past 3 years (except effectively treated malignancy considered cured by local treatment, e.g. non melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ)\n* Patient with known leptomeningeal disease or spinal cord compression due to disease\n* Patients with hepatitis C infection or active hepatitis B infection (chronic or acute)\n* Patients with known history of Human immunodeficiency virus (HIV) infection who meet protocol-defined criteria\n* Patient with active autoimmune disease or a documented history of autoimmune disease, which requires systemic treatment (e.g. corticosteroids or immunosuppressive drugs)\n* Patient with a diagnosis of immunodeficiency other than HIV\n* Manifestation of malabsorption or any other condition that could affect oral absorption, distribution or metabolism of the study drug Further exclusion criteria apply.","ALL","18 Years",{"count":237,"type":238},90,"ESTIMATED","INTERVENTIONAL",[241],"PHASE1","This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body. The purpose of this study is to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab. Another purpose is to find out if taking these medicines can stop tumours from growing or make tumours shrink. In this study, BI 3968621 is given to people for the first time.\n\nThe study is done in 3 parts. The parts are called Part A, Part A2, and Part B. Participants get BI 3968621 alone or in combination with ezabenlimab depending on which part they are in. Part A is done to find the highest and the most suitable dose of BI 3968621 that people with advanced cancer can tolerate. Part A2 is done to find out if taking BI 3968621, at certain dose levels, can stop or slow down tumour growth in participants with kidney cancer. Part B is done to find out how BI 3968621 is tolerated when given with ezabenlimab. BI 3968621 is taken daily as tablets. Ezabenlimab is given as an infusion into a vein once every 3 weeks.\n\nParticipants can receive study treatment for up to 2 years if they benefit and can tolerate it. During this time, they visit the study site regularly. The number of visits depends on how participants respond to and tolerate the study treatment. Researchers look at the number of participants with certain severe health problems that happen within 3 weeks after the first study treatment. The study doctors check participants' health, take note of unwanted effects, take blood samples, and check how the cancer responds to study treatment.",[244],"Advanced Solid Tumour","NOT_YET_RECRUITING","2026-09-30",{"date":248,"type":249},"2026-10-01","ACTUAL",{"date":251,"type":238},"2026-10-26",{"date":253,"type":238},"2030-09-03",{"name":5,"class":6},10]