[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529810":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":58,"studyPopulation":58,"armGroups":62,"interventions":69,"overallOfficials":74,"centralContacts":78,"locations":84,"responsibleParty":149,"collaborators":58,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":58,"eligibilityCriteria":157,"healthyVolunteers":153,"sex":158,"minAge":159,"maxAge":58,"enrollmentInfo":160,"targetDuration":58,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":58,"overallStatus":87,"whyStopped":58,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":48},[9,13],{"measure":10,"description":11,"timeFrame":12},"Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)","Number of participants with DLTs will be reported. The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.","Up to first 21 days after administration of the first full treatment dose",{"measure":14,"description":15,"timeFrame":16},"Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity","An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.","Up to 2 years 9 months",[18,21,24,27,30,33,36,39,42,45],{"measure":19,"description":20,"timeFrame":16},"Part 1 and Part 2: Serum Concentration of JNJ-87890387","Serum concentration of JNJ-87890387 will be reported.",{"measure":22,"description":23,"timeFrame":16},"Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387","Cmax is defined as maximum observed serum concentration of JNJ-87890387.",{"measure":25,"description":26,"timeFrame":16},"Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387","Tmax is defined as the time to reach maximum observed serum concentration of JNJ-87890387.",{"measure":28,"description":29,"timeFrame":16},"Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387","AUC(t1-t2) is defined as area under the serum concentration versus time curve from time t1 to time t2 of JNJ-87890387.",{"measure":31,"description":32,"timeFrame":16},"Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387","AUC(0-tau) is defined as area under the serum concentration versus time curve from time 0 to time tau of JNJ-87890387.",{"measure":34,"description":35,"timeFrame":16},"Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387","Cmin is defined as the minimum observed serum concentration of JNJ-87890387.",{"measure":37,"description":38,"timeFrame":16},"Part 1 and Part 2: Accumulation Ratio of JNJ-87890387","Accumulation ratio of JNJ-87890387 will be reported. The AR is the accumulation ratio calculated as Cmax or AUC after multiple doses divided by Cmax or AUC after the first dose, respectively.",{"measure":40,"description":41,"timeFrame":16},"Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies","Number of participants with presence of anti-JNJ-87890387 antibodies will be reported.",{"measure":43,"description":44,"timeFrame":16},"Part 1 and Part 2: Objective Response Rate (ORR)","ORR is defined as the percentage of participants with a best response of complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) maintained for at least 4 weeks.",{"measure":46,"description":47,"timeFrame":16},"Part 1 and Part 2: Duration of Response (DOR)","DOR is defined as the duration from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST v. 1.1, or death due to any cause, whichever occurs first.",[49,52],{"measure":50,"description":51,"timeFrame":16},"Part 1 and Part 2: Time to Response (TTR)","TTR is defined for the responders as the time from the date of the first dose of JNJ-87890387 to the date of the first documented response.",{"measure":53,"description":54,"timeFrame":16},"Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate","CA 125 response rate is defined as the proportion of participants with ovarian cancer who achieved a partial response or complete response according to the Gynecologic Cancer Intergroup (GCIG) response criteria for CA 125, maintained for at least 4 weeks. A CA 125 response is defined as at least 50 percentage (%) reduction in CA 125 levels from a pretreatment sample which must be confirmed and maintained for at least 28 days.",{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":58,"timePerspective":58,"maskingInfo":60},"NA","SEQUENTIAL",null,"TREATMENT",{"masking":61,"maskingDescription":58,"whoMasked":58},"NONE",[63],{"label":64,"type":65,"description":66,"interventionNames":67},"JNJ-87890387","EXPERIMENTAL","In Part 1 (Dose escalation) participants will receive JNJ-87890387. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. In Part 2 (Dose expansion), participants will receive JNJ-87890387 at the RP2D regimen(s) determined in Part 1.",[68],"Drug: JNJ-87890387",[70],{"type":71,"name":64,"description":72,"armGroupLabels":73,"otherNames":58},"DRUG","JNJ-87890387 will be administered.",[64],[75],{"name":76,"affiliation":5,"role":77},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[79],{"name":80,"role":81,"phone":82,"phoneExt":58,"email":83},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[85,99,109,120,129,140],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":58},"Start Midwest","RECRUITING","Grand Rapids","Michigan","49546","United States","US",{"type":94,"coordinates":95},"Point",[96,97],-85.66809,42.96336,{"lat":97,"lon":96},{"facility":100,"status":87,"city":101,"state":102,"zip":103,"country":91,"countryCode":92,"cosmosGeoPoint":104,"geoPoint":108,"contacts":58},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"type":94,"coordinates":105},[106,107],-86.78444,36.16589,{"lat":107,"lon":106},{"facility":110,"status":87,"city":111,"state":58,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":58},"Centre Leon Berard","Lyon","69008","France","FR",{"type":94,"coordinates":116},[117,118],4.84789,45.74906,{"lat":118,"lon":117},{"facility":121,"status":87,"city":122,"state":58,"zip":123,"country":113,"countryCode":114,"cosmosGeoPoint":124,"geoPoint":128,"contacts":58},"Institut Gustave Roussy","Villejuif","94805",{"type":94,"coordinates":125},[126,127],2.35992,48.7939,{"lat":127,"lon":126},{"facility":130,"status":87,"city":131,"state":58,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":139,"contacts":58},"Hosp Univ Vall D Hebron","Barcelona","08035","Spain","ES",{"type":94,"coordinates":136},[137,138],2.15899,41.38879,{"lat":138,"lon":137},{"facility":141,"status":87,"city":142,"state":58,"zip":143,"country":133,"countryCode":134,"cosmosGeoPoint":144,"geoPoint":148,"contacts":58},"Hosp. Univ. 12 de Octubre","Madrid","28041",{"type":94,"coordinates":145},[146,147],-3.70256,40.4165,{"lat":147,"lon":146},{"type":150,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100529810","phase-1-a-study-of-jnj-87890387-for-advanced-solid-tumors-100529810",false,"NCT06178614","A Study of JNJ-87890387 for Advanced Solid Tumors","A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase\u002FPhosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed, metastatic, or unresectable solid tumor of one of the following types: a) Renal cell cancer (RCC)-clear cell or papillary carcinoma; b) Endometrioid ovarian cancer c) Endometrioid uterine carcinoma; d) Colorectal adenocarcinoma (CRC); e) Lung adenocarcinoma\n* Have measurable or evaluable disease: Part 1- Either measurable or evaluable disease; Part 2- At least 1 measurable lesion per RECIST v1.1. Participants with ovarian cancer without a measurable lesion must have disease evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or have cancer antigen (CA) 125 greater than (\\>) 2\\*upper limit of normal (ULN) during screening\n* All participants in Part 1 and Part 2 must consent to provide an archived tumor tissue sample at screening\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening\n* Be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\nExclusion Criteria:\n\n* Active Central Nervous System (CNS) involvement with the exception of locally treated brain metastases that are clinically stable and asymptomatic for \\> 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \\[\\\u003C=\\]10 milligrams \\[mg\\] prednisone or equivalent) for at least 2 weeks prior to start of study treatment\n* Toxicity from prior anticancer therapy that has not resolved to Grade \\\u003C=1 (except alopecia, vitiligo, Grade \\\u003C=2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)\n* History of Grade greater than or equal to (\\>=) 2 immune-related AE(s) with prior immunotherapy that led to discontinuation of previous immunotherapy with the exception of Grade 2 and Grade 3 immune-related AEs that responded to treatment and that did not recur following rechallenge. Endocrinopathies that are stable on hormone replacement therapy or that have resolved are allowed.\n* History of solid organ or hematologic stem cell transplantation\n* Any episode of partial or complete bowel obstruction requiring hospitalization within 30 days prior to first dose of study treatment","ALL","18 Years",{"count":161,"type":162},200,"ESTIMATED","INTERVENTIONAL",[165],"PHASE1","The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).",[168,169],"Neoplasms","Advanced Solid Tumors","2026-09-24",{"date":172,"type":173},"2026-09-25","ACTUAL",{"date":175,"type":173},"2023-12-14",{"date":177,"type":162},"2029-02-07",{"name":5,"class":6},6]