[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534062":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":53,"centralContacts":57,"locations":62,"responsibleParty":410,"collaborators":46,"id":412,"slug":46,"hasResults":413,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":46,"eligibilityCriteria":417,"healthyVolunteers":413,"sex":418,"minAge":419,"maxAge":46,"enrollmentInfo":420,"targetDuration":46,"studyType":423,"phases":424,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":65,"whyStopped":46,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",[8,14,18,23,27,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a: Part A (Monotherapy Dose Escalation)","EXPERIMENTAL","BG-C9074 monotherapy dose escalation",[13],"Drug: BG-C9074",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1a: Part B (Monotherapy Safety Expansion)","BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase 1a: Part C (Combination Therapy Dose Escalation)","BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE).",[13,22],"Drug: Tislelizumab",{"label":24,"type":10,"description":25,"interventionNames":26},"Phase 1a: Part D (Japan Cohort)","A separate cohort in Japan will evaluate the safety of BG-C9074 monotherapy in Japanese participants with select solid tumors",[13],{"label":28,"type":10,"description":29,"interventionNames":30},"Phase 1b: Monotherapy Dose Expansion","The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 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infusion",[9,15,19,24,36,32,28],null,{"type":42,"name":48,"description":44,"armGroupLabels":49,"otherNames":46},"Tislelizumab",[19,32],{"type":42,"name":51,"description":44,"armGroupLabels":52,"otherNames":46},"Bevacizumab",[36],[54],{"name":55,"affiliation":5,"role":56},"Study Director","STUDY_DIRECTOR",[58],{"name":55,"role":59,"phone":60,"phoneExt":46,"email":61},"CONTACT","1.877.828.5568","clinicaltrials@beonemed.com",[63,77,87,97,107,117,129,138,147,157,167,176,185,195,206,215,224,228,237,246,252,264,274,284,294,304,310,320,329,335,345,354,363,373,383,393,405],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":46},"Usc Norris Comprehensive Cancer Center (Nccc)","RECRUITING","Los Angeles","California","90089-1019","United 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Hopkins","Baltimore","Maryland","21287",{"type":72,"coordinates":103},[104,105],-76.61219,39.29038,{"lat":105,"lon":104},{"facility":108,"status":65,"city":109,"state":110,"zip":111,"country":69,"countryCode":70,"cosmosGeoPoint":112,"geoPoint":116,"contacts":46},"James Cancer Hospital and Solove Research Institute","Columbus","Ohio","43210-1240",{"type":72,"coordinates":113},[114,115],-82.99879,39.96118,{"lat":115,"lon":114},{"facility":118,"status":65,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":46},"Blacktown Cancer and Haematology Centre","Blacktown","New South Wales","NSW 2148","Australia","AU",{"type":72,"coordinates":125},[126,127],150.91667,-33.76667,{"lat":127,"lon":126},{"facility":130,"status":65,"city":131,"state":120,"zip":132,"country":122,"countryCode":123,"cosmosGeoPoint":133,"geoPoint":137,"contacts":46},"Macquarie University","North Ryde","NSW 2109",{"type":72,"coordinates":134},[135,136],151.12436,-33.79677,{"lat":136,"lon":135},{"facility":139,"status":65,"city":140,"state":120,"zip":141,"country":122,"countryCode":123,"cosmosGeoPoint":142,"geoPoint":146,"contacts":46},"Cancer Care Wollongong","Wollongong","NSW 2500",{"type":72,"coordinates":143},[144,145],150.89345,-34.424,{"lat":145,"lon":144},{"facility":148,"status":65,"city":149,"state":150,"zip":151,"country":122,"countryCode":123,"cosmosGeoPoint":152,"geoPoint":156,"contacts":46},"Princess Alexandra Hospital","Woolloongabba","Queensland","QLD 4102",{"type":72,"coordinates":153},[154,155],153.03655,-27.48855,{"lat":155,"lon":154},{"facility":158,"status":65,"city":159,"state":160,"zip":161,"country":122,"countryCode":123,"cosmosGeoPoint":162,"geoPoint":166,"contacts":46},"Monash Health","Clayton","Victoria","VIC 3168",{"type":72,"coordinates":163},[164,165],145.11667,-37.91667,{"lat":165,"lon":164},{"facility":168,"status":65,"city":169,"state":160,"zip":170,"country":122,"countryCode":123,"cosmosGeoPoint":171,"geoPoint":175,"contacts":46},"Cabrini Hospital Malvern","Malvern","VIC 3144",{"type":72,"coordinates":172},[173,174],145.02811,-37.86259,{"lat":174,"lon":173},{"facility":177,"status":65,"city":178,"state":160,"zip":179,"country":122,"countryCode":123,"cosmosGeoPoint":180,"geoPoint":184,"contacts":46},"Peter Maccallum Cancer Centre","Melbourne","VIC 3000",{"type":72,"coordinates":181},[182,183],144.96332,-37.814,{"lat":183,"lon":182},{"facility":186,"status":65,"city":187,"state":188,"zip":189,"country":122,"countryCode":123,"cosmosGeoPoint":190,"geoPoint":194,"contacts":46},"Linear Clinical Research","Nedlands","Western Australia","WA 6009",{"type":72,"coordinates":191},[192,193],115.8073,-31.98184,{"lat":193,"lon":192},{"facility":196,"status":65,"city":197,"state":46,"zip":198,"country":199,"countryCode":200,"cosmosGeoPoint":201,"geoPoint":205,"contacts":46},"Hospital Sirio Libanes Brasilia","Brasília","70200-730","Brazil","BR",{"type":72,"coordinates":202},[203,204],-47.92972,-15.77972,{"lat":204,"lon":203},{"facility":207,"status":65,"city":208,"state":46,"zip":209,"country":199,"countryCode":200,"cosmosGeoPoint":210,"geoPoint":214,"contacts":46},"Liga Norte Riograndene Contra O Cancer","Natal","59062-000",{"type":72,"coordinates":211},[212,213],-35.20944,-5.795,{"lat":213,"lon":212},{"facility":216,"status":65,"city":217,"state":46,"zip":218,"country":199,"countryCode":200,"cosmosGeoPoint":219,"geoPoint":223,"contacts":46},"Hospital Sao Lucas Da Pucrs","Porto Alegre","90610-000",{"type":72,"coordinates":220},[221,222],-51.23019,-30.03283,{"lat":222,"lon":221},{"facility":225,"status":65,"city":226,"state":46,"zip":227,"country":199,"countryCode":200,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"Instituto Nacional de Cancer Hospital Do Cancer Ii","Rio de Janerio","20220-410",{"facility":229,"status":65,"city":230,"state":46,"zip":231,"country":199,"countryCode":200,"cosmosGeoPoint":232,"geoPoint":236,"contacts":46},"Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto","São José do Rio Preto","15090-000",{"type":72,"coordinates":233},[234,235],-49.37944,-20.81972,{"lat":235,"lon":234},{"facility":238,"status":65,"city":239,"state":46,"zip":240,"country":199,"countryCode":200,"cosmosGeoPoint":241,"geoPoint":245,"contacts":46},"Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira","São 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Technology","Wuhan","Hubei","430022",{"type":72,"coordinates":300},[301,302],114.26667,30.58333,{"lat":302,"lon":301},{"facility":305,"status":65,"city":296,"state":297,"zip":306,"country":257,"countryCode":258,"cosmosGeoPoint":307,"geoPoint":309,"contacts":46},"Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology","430030",{"type":72,"coordinates":308},[301,302],{"lat":302,"lon":301},{"facility":311,"status":65,"city":312,"state":313,"zip":314,"country":257,"countryCode":258,"cosmosGeoPoint":315,"geoPoint":319,"contacts":46},"The Second Hospital of Dalian Medical University","Dalian","Liaoning","116023",{"type":72,"coordinates":316},[317,318],121.60222,38.91222,{"lat":318,"lon":317},{"facility":321,"status":65,"city":322,"state":313,"zip":323,"country":257,"countryCode":258,"cosmosGeoPoint":324,"geoPoint":328,"contacts":46},"Shengjing Hospital of China Medical University","Shenyang","110004",{"type":72,"coordinates":325},[326,327],123.43278,41.79222,{"lat":327,"lon":326},{"facility":330,"status":65,"city":322,"state":313,"zip":331,"country":257,"countryCode":258,"cosmosGeoPoint":332,"geoPoint":334,"contacts":46},"Liaoning Cancer Hospital and Institute","110042",{"type":72,"coordinates":333},[326,327],{"lat":327,"lon":326},{"facility":336,"status":65,"city":337,"state":338,"zip":339,"country":257,"countryCode":258,"cosmosGeoPoint":340,"geoPoint":344,"contacts":46},"Qilu Hospital of Shandong University","Jinan","Shandong","250000",{"type":72,"coordinates":341},[342,343],116.99722,36.66833,{"lat":343,"lon":342},{"facility":346,"status":65,"city":347,"state":338,"zip":348,"country":257,"countryCode":258,"cosmosGeoPoint":349,"geoPoint":353,"contacts":46},"Affiliated Hospital of Jining Medical University","Jining","272000",{"type":72,"coordinates":350},[351,352],116.58139,35.405,{"lat":352,"lon":351},{"facility":355,"status":65,"city":356,"state":338,"zip":357,"country":257,"countryCode":258,"cosmosGeoPoint":358,"geoPoint":362,"contacts":46},"Weifang Peoples Hospital","Weifang","261000",{"type":72,"coordinates":359},[360,361],119.10194,36.71,{"lat":361,"lon":360},{"facility":364,"status":65,"city":365,"state":366,"zip":367,"country":257,"countryCode":258,"cosmosGeoPoint":368,"geoPoint":372,"contacts":46},"Obstetrics and Gynecology Hospital of Fudan University","Shanghai","Shanghai Municipality","200011",{"type":72,"coordinates":369},[370,371],121.45806,31.22222,{"lat":371,"lon":370},{"facility":374,"status":65,"city":375,"state":376,"zip":377,"country":257,"countryCode":258,"cosmosGeoPoint":378,"geoPoint":382,"contacts":46},"Tianjin Medical University Cancer Institute and Hospital","Tianjin","Tianjin Municipality","300060",{"type":72,"coordinates":379},[380,381],117.17667,39.14222,{"lat":381,"lon":380},{"facility":384,"status":65,"city":385,"state":386,"zip":387,"country":257,"countryCode":258,"cosmosGeoPoint":388,"geoPoint":392,"contacts":46},"Zhejiang Cancer Hospital","Hangzhou","Zhejiang","310022",{"type":72,"coordinates":389},[390,391],120.16142,30.29365,{"lat":391,"lon":390},{"facility":394,"status":65,"city":395,"state":396,"zip":397,"country":398,"countryCode":399,"cosmosGeoPoint":400,"geoPoint":404,"contacts":46},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577","Japan","JP",{"type":72,"coordinates":401},[402,403],139.97732,35.86224,{"lat":403,"lon":402},{"facility":406,"status":65,"city":407,"state":408,"zip":409,"country":398,"countryCode":399,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"Cancer Institute Hospital of Jfcr","Kotoku","Tokyo","135-8550",{"type":411,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100534062",false,"NCT06233942","Phase 1a\u002F1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors","Phase 1a\u002F1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n3. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy and whose cancer is not amenable to therapy with curative intent, and for whom further treatment is not available or not tolerated. Enrollment will be limited to participants with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) breast cancer, cholangiocarcinoma (CCA), endometrial cancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited to participants with HR+\u002FHER2- breast cancer, TNBC, endometrial cancer, or ovarian cancer.\n4. ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)\n5. Able to provide an archived tumor tissue sample.\n6. Adequate bone marrow and organ function.\n7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).\n8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).\n\nExclusion Criteria:\n\n1. Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.\n2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n3. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \\\u003C 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.\n5. Uncontrolled diabetes.\n6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":421,"type":422},308,"ESTIMATED","INTERVENTIONAL",[425],"PHASE1","This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.",[428],"Advanced Solid Tumor",[43,48,430,431,432],"Advanced Solid Tumors","first-in-human","B7H4","2026-06-04",{"date":435,"type":436},"2026-06-05","ACTUAL",{"date":438,"type":436},"2024-04-12",{"date":440,"type":422},"2028-05-15",{"name":5,"class":6},37]