[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614341":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":76,"overallOfficials":88,"centralContacts":92,"locations":98,"responsibleParty":350,"collaborators":32,"id":352,"slug":353,"hasResults":354,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":32,"eligibilityCriteria":358,"healthyVolunteers":354,"sex":359,"minAge":360,"maxAge":32,"enrollmentInfo":361,"targetDuration":32,"studyType":364,"phases":365,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":101,"whyStopped":32,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":381},{"fullName":5,"class":6},"AbbVie","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Adverse Events (AE)","An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment.","Up to Approximately 3 Years",{"measure":14,"description":15,"timeFrame":12},"Overall Response (as assessed by the investigator)","Overall response is defined as participants achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by the investigator.",[17,20,23,26,29],{"measure":18,"description":19,"timeFrame":12},"Overall Response (as assessed by independent central review)","Overall response is defined as participants achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by independent central review (ICR).",{"measure":21,"description":22,"timeFrame":12},"Duration of Response (DOR)","DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST Version 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.",{"measure":24,"description":25,"timeFrame":12},"Progression-free survival (PFS)","PFS is defined as time from first study treatment to a documented disease progression according to RECIST Version 1.1 (or other assessment criteria), as determined by the investigator, or death due to any cause, whichever occurs earlier.",{"measure":27,"description":28,"timeFrame":12},"Overall Survival (OS)","OS is defined as time from first study treatment to death due to any cause.",{"measure":30,"description":31,"timeFrame":12},"Disease Control Rate","Disease Control Rate is defined as the percentage of participants with best overall response (BOR) of stable disease (SD), PR or better per investigator review according to RECIST version 1.1 criteria.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40,46,50,54,58,63,67,72],{"label":41,"type":42,"description":43,"interventionNames":44},"Part 1: ABBV-901 Dose Escalation","EXPERIMENTAL","Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.",[45],"Drug: ABBV-901",{"label":47,"type":42,"description":48,"interventionNames":49},"Part 2: ABBV-901 Optimization Dose A","Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.",[45],{"label":51,"type":42,"description":52,"interventionNames":53},"Part 2: ABBV-901 Optimization Dose B","Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.",[45],{"label":55,"type":42,"description":56,"interventionNames":57},"Part 2: ABBV-901 Optimization Dose C","Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.",[45],{"label":59,"type":42,"description":60,"interventionNames":61},"Part 3: ABBV-901 + Bevacizumab Escalation","Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.",[45,62],"Drug: Bevacizumab",{"label":64,"type":42,"description":65,"interventionNames":66},"Part 4: ABBV-901 + Bevacizumab Expansion","Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.",[45,62],{"label":68,"type":42,"description":69,"interventionNames":70},"Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation","Participants will receive escalating doses of ABBV-901 in combination with Carboplatin \\& Bevacizumab, as part of the approximately 3 year study duration.",[45,62,71],"Drug: Carboplatin",{"label":73,"type":42,"description":74,"interventionNames":75},"Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion","Participants will receive the recommended doses for expansion doses of ABBV-901 in combination with Carboplatin \\& Bevacizumab, as part of the approximately 3 year study duration.",[45,62,71],[77,82,85],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":32},"DRUG","ABBV-901","Intravenous (IV)",[41,47,51,55,59,64,68,73],{"type":78,"name":83,"description":80,"armGroupLabels":84,"otherNames":32},"Bevacizumab",[59,64,68,73],{"type":78,"name":86,"description":80,"armGroupLabels":87,"otherNames":32},"Carboplatin",[68,73],[89],{"name":90,"affiliation":5,"role":91},"ABBVIE INC.","STUDY_DIRECTOR",[93],{"name":94,"role":95,"phone":96,"phoneExt":32,"email":97},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[99,113,122,132,142,152,162,172,182,194,204,213,225,235,247,256,265,272,282,287,298,307,319,327,333,344],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":32},"City of Hope National Medical Center \u002FID# 281381","RECRUITING","Duarte","California","91010","United States","US",{"type":108,"coordinates":109},"Point",[110,111],-117.97729,34.13945,{"lat":111,"lon":110},{"facility":114,"status":101,"city":115,"state":103,"zip":116,"country":105,"countryCode":106,"cosmosGeoPoint":117,"geoPoint":121,"contacts":32},"City of Hope - Orange County Lennar Foundation Cancer Center \u002FID# 280914","Irvine","92618",{"type":108,"coordinates":118},[119,120],-117.82311,33.66946,{"lat":120,"lon":119},{"facility":123,"status":101,"city":124,"state":125,"zip":126,"country":105,"countryCode":106,"cosmosGeoPoint":127,"geoPoint":131,"contacts":32},"Sarah Cannon Research Institute at HealthONE \u002FID# 278785","Denver","Colorado","80218",{"type":108,"coordinates":128},[129,130],-104.9847,39.73915,{"lat":130,"lon":129},{"facility":133,"status":101,"city":134,"state":135,"zip":136,"country":105,"countryCode":106,"cosmosGeoPoint":137,"geoPoint":141,"contacts":32},"University of Chicago Medical Center \u002FID# 278295","Chicago","Illinois","60637",{"type":108,"coordinates":138},[139,140],-87.65005,41.85003,{"lat":140,"lon":139},{"facility":143,"status":101,"city":144,"state":145,"zip":146,"country":105,"countryCode":106,"cosmosGeoPoint":147,"geoPoint":151,"contacts":32},"University Of Nebraska Medical Center \u002FID# 281020","Omaha","Nebraska","68198",{"type":108,"coordinates":148},[149,150],-95.94043,41.25626,{"lat":150,"lon":149},{"facility":153,"status":101,"city":154,"state":155,"zip":156,"country":105,"countryCode":106,"cosmosGeoPoint":157,"geoPoint":161,"contacts":32},"NEXT Oncology - San Antonio \u002FID# 278606","San Antonio","Texas","78229",{"type":108,"coordinates":158},[159,160],-98.49363,29.42412,{"lat":160,"lon":159},{"facility":163,"status":101,"city":164,"state":165,"zip":166,"country":105,"countryCode":106,"cosmosGeoPoint":167,"geoPoint":171,"contacts":32},"Start Mountain Region \u002FID# 278609","West Valley City","Utah","84119",{"type":108,"coordinates":168},[169,170],-112.00105,40.69161,{"lat":170,"lon":169},{"facility":173,"status":101,"city":174,"state":175,"zip":176,"country":105,"countryCode":106,"cosmosGeoPoint":177,"geoPoint":181,"contacts":32},"Next Virginia \u002FID# 278607","Fairfax","Virginia","22031",{"type":108,"coordinates":178},[179,180],-77.30637,38.84622,{"lat":180,"lon":179},{"facility":183,"status":101,"city":184,"state":185,"zip":186,"country":187,"countryCode":188,"cosmosGeoPoint":189,"geoPoint":193,"contacts":32},"Blacktown Hospital \u002FID# 282426","Blacktown","New South Wales","2148","Australia","AU",{"type":108,"coordinates":190},[191,192],150.91667,-33.76667,{"lat":192,"lon":191},{"facility":195,"status":101,"city":196,"state":197,"zip":198,"country":187,"countryCode":188,"cosmosGeoPoint":199,"geoPoint":203,"contacts":32},"Monash Health - Monash Medical Centre - Clayton \u002FID# 281468","Clayton","Victoria","3168",{"type":108,"coordinates":200},[201,202],145.11667,-37.91667,{"lat":202,"lon":201},{"facility":205,"status":101,"city":206,"state":197,"zip":207,"country":187,"countryCode":188,"cosmosGeoPoint":208,"geoPoint":212,"contacts":32},"Peter MacCallum Cancer Centre. \u002FID# 281751","Melbourne","3000",{"type":108,"coordinates":209},[210,211],144.96332,-37.814,{"lat":211,"lon":210},{"facility":214,"status":101,"city":215,"state":216,"zip":217,"country":218,"countryCode":219,"cosmosGeoPoint":220,"geoPoint":224,"contacts":32},"Institut De Cancerologie De L'Ouest - Site Rene Gauducheau \u002FID# 280684","Saint-Herblain","Pays de la Loire Region","44805","France","FR",{"type":108,"coordinates":221},[222,223],-1.651,47.21154,{"lat":223,"lon":222},{"facility":226,"status":101,"city":227,"state":228,"zip":229,"country":218,"countryCode":219,"cosmosGeoPoint":230,"geoPoint":234,"contacts":32},"Centre Leon Berard \u002FID# 280575","Lyon","Rhone","69373",{"type":108,"coordinates":231},[232,233],4.84789,45.74906,{"lat":233,"lon":232},{"facility":236,"status":101,"city":237,"state":238,"zip":239,"country":240,"countryCode":241,"cosmosGeoPoint":242,"geoPoint":246,"contacts":32},"The Chaim Sheba Medical Center \u002FID# 278416","Ramat Gan","Tel Aviv","5265601","Israel","IL",{"type":108,"coordinates":243},[244,245],34.81065,32.08227,{"lat":245,"lon":244},{"facility":248,"status":101,"city":249,"state":32,"zip":250,"country":240,"countryCode":241,"cosmosGeoPoint":251,"geoPoint":255,"contacts":32},"Rambam Health Care Campus \u002FID# 278418","Haifa","3109601",{"type":108,"coordinates":252},[253,254],34.99928,32.81303,{"lat":254,"lon":253},{"facility":257,"status":101,"city":258,"state":32,"zip":259,"country":240,"countryCode":241,"cosmosGeoPoint":260,"geoPoint":264,"contacts":32},"Hadassah Medical Center-Hebrew University \u002FID# 278420","Jerusalem","91120",{"type":108,"coordinates":261},[262,263],35.21633,31.76904,{"lat":263,"lon":262},{"facility":266,"status":101,"city":267,"state":268,"zip":269,"country":270,"countryCode":271,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"National Cancer Center Hospital East \u002FID# 278604","Kashiwa-shi","Chiba","277-8577","Japan","JP",{"facility":273,"status":101,"city":274,"state":275,"zip":276,"country":270,"countryCode":271,"cosmosGeoPoint":277,"geoPoint":281,"contacts":32},"Saitama Medical University International Medical Center \u002FID# 278437","Hidaka","Saitama","350-1298",{"type":108,"coordinates":278},[279,280],139.36233,35.91664,{"lat":280,"lon":279},{"facility":283,"status":101,"city":284,"state":285,"zip":286,"country":270,"countryCode":271,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"Shizuoka Cancer Center \u002FID# 278538","Sunto-gun","Shizuoka","411-8777",{"facility":288,"status":101,"city":289,"state":32,"zip":290,"country":291,"countryCode":292,"cosmosGeoPoint":293,"geoPoint":297,"contacts":32},"Unidade Local de Saude de Santa Maria \u002FID# 280296","Lisbon","1649-035","Portugal","PT",{"type":108,"coordinates":294},[295,296],-9.1498,38.72509,{"lat":296,"lon":295},{"facility":299,"status":101,"city":300,"state":32,"zip":301,"country":291,"countryCode":292,"cosmosGeoPoint":302,"geoPoint":306,"contacts":32},"Instituto Portugues de Oncologia do Porto Francisco Gentil \u002FID# 280293","Porto","4200-072",{"type":108,"coordinates":303},[304,305],-8.61097,41.1485,{"lat":305,"lon":304},{"facility":308,"status":101,"city":309,"state":310,"zip":311,"country":312,"countryCode":313,"cosmosGeoPoint":314,"geoPoint":318,"contacts":32},"Hospital Universitario Puerta de Hierro - Majadahonda \u002FID# 280459","Majadahonda","Madrid","28222","Spain","ES",{"type":108,"coordinates":315},[316,317],-3.87182,40.47353,{"lat":317,"lon":316},{"facility":320,"status":101,"city":310,"state":32,"zip":321,"country":312,"countryCode":313,"cosmosGeoPoint":322,"geoPoint":326,"contacts":32},"Hospital Universitario Fundacion Jimenez Diaz \u002FID# 280440","28040",{"type":108,"coordinates":323},[324,325],-3.70256,40.4165,{"lat":325,"lon":324},{"facility":328,"status":101,"city":310,"state":32,"zip":329,"country":312,"countryCode":313,"cosmosGeoPoint":330,"geoPoint":332,"contacts":32},"Hospital Universitario HM Sanchinarro \u002FID# 280439","28050",{"type":108,"coordinates":331},[324,325],{"lat":325,"lon":324},{"facility":334,"status":101,"city":335,"state":32,"zip":336,"country":337,"countryCode":338,"cosmosGeoPoint":339,"geoPoint":343,"contacts":32},"National Taiwan University Hospital \u002FID# 280701","Taipei","100","Taiwan","TW",{"type":108,"coordinates":340},[341,342],121.52639,25.05306,{"lat":342,"lon":341},{"facility":345,"status":101,"city":335,"state":32,"zip":346,"country":337,"countryCode":338,"cosmosGeoPoint":347,"geoPoint":349,"contacts":32},"Taipei Veterans General Hospital \u002FID# 281349","112",{"type":108,"coordinates":348},[341,342],{"lat":342,"lon":341},{"type":351,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100614341","phase-1-a-study-to-assess-adverse-events-change-in-disease-activity-and-how-intravenous-iv-abbv901-moves-through-the-body-alone-or-in-combination-with-bevacizumab-in-adult-participants-with-ovarian-cancer-100614341",false,"NCT07278336","A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Other Anticancer Drugs in Adult Participants With Ovarian Cancer","A Phase 1 First-in-Human, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-901 as a Monotherapy and in Combination in Adult Subjects With Ovarian Cancer","Inclusion Criteria:\n\n* Diagnosis of an advanced or unresectable malignant high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC), fallopian tube or primary peritoneal cancer by histology (World Health Organization \\[WHO\\] criteria).\n* Participants enrolled in backfill (Part 1) must provide consent to paired fresh biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion.\n\nFor Parts 1-4:\n\n\\- Participants must be considered platinum resistant or platinum ineligible. Platinum resistant disease is defined as radiographic progression within 6 months (up to 182 days) after the last dose of the most recent platinum therapy).\n\nFor Parts 5-6:\n\n\\- Participants will have platinum-sensitive disease defined as radiographic progression \\> 6 months from last dose of platinum-based chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.\n\nExclusion Criteria:\n\n* Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, mucinous, carcinosarcoma or sarcomatous histology, mixed tumors or low grade\u002Fborderline ovarian tumor.\n* Participants with platinum refractory disease.\n* Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor.\n* Prior history of Grade \\>= 2 interstitial lung disease (ILD) or pneumonitis.\n* Prior history of Grade 2 \\>= 2 ILD or pneumonitis or any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan.\n\nFor Parts 3-6:\n\n* History of Grade 3\u002F4 adverse events that, in the opinion of the investigator, are attributed to bevacizumab.\n* History of clinically significant cardiac disease including CHF Class II or higher NYHA; active coronary artery disease, MI within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted).\n* Echocardiogram with ejection fraction \\\u003C= 50% and no other clinically significant cardiac abnormalities that in the opinion of the investigator, would increase the participants susceptibility to cardiac toxicity.\n\nFor Parts 5-6:\n\n\\- Participants who had prior allergic reaction to platinum containing compound.","ALL","18 Years",{"count":362,"type":363},285,"ESTIMATED","INTERVENTIONAL",[366],"PHASE1","Ovarian cancer (OC) is a lethal disease. The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABBV901, alone or in combination with other anticancer drugs, in participants with ovarian cancer.\n\nABBV901 is an investigational drug for the treatment of ovarian cancer. This study has 6 parts where participants will receive ABBV-901, alone or in combination with other anticancer therapies. Around 285 participants will be enrolled in the study at approximately 45 sites around the world.\n\nIn part 1, participants will receive escalating doses of intravenous (IV) ABBV-901 alone. In part 2, participants will receive 1 of 3 doses of IV ABBV-901 alone to determine the optimized dose. In part 3, participants will receive escalating doses of IV ABBV-901 in combination with IV bevacizumab. In part 4, participants will receive recommended doses for expansion of IV ABBV-901 combination with IV bevacizumab. in Part 5, participants will receive escalating doses of IV ABBV-901 in combination with IV carboplatin and IV bevacizumab and in part 6, participants will receive recommended doses for expansion of IV ABBV-901 combination with IV carboplatin and IV bevacizumab. The total study duration will be approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[369],"Ovarian Cancer",[369,371,79,83],"Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers","2026-10-07",{"date":374,"type":375},"2026-10-09","ACTUAL",{"date":377,"type":375},"2025-11-27",{"date":379,"type":363},"2029-01",{"name":5,"class":6},26]