[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624838":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":38,"studyPopulation":38,"armGroups":68,"interventions":88,"overallOfficials":99,"centralContacts":103,"locations":108,"responsibleParty":238,"collaborators":38,"id":240,"slug":38,"hasResults":241,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":38,"eligibilityCriteria":245,"healthyVolunteers":241,"sex":246,"minAge":247,"maxAge":38,"enrollmentInfo":248,"targetDuration":38,"studyType":251,"phases":252,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":111,"whyStopped":38,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":38},[9,13,17,20,23],{"measure":10,"description":11,"timeFrame":12},"Phase 1a: Number of Participants Experiencing Adverse Events (AEs)","Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results.","Up to approximately 24 months",{"measure":14,"description":15,"timeFrame":16},"Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy","MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.","Up to approximately 10 months",{"measure":18,"description":19,"timeFrame":16},"Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])","The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available.",{"measure":21,"description":22,"timeFrame":12},"Phase 1b: Recommended Phase 2 Dose (RP2D)","RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available.",{"measure":24,"description":25,"timeFrame":12},"Phase 1b: Overall Response Rate (ORR)","ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).",[27,30,33,36,40,42,44,46,48,51,54,57,60],{"measure":28,"description":29,"timeFrame":12},"Phase 1a: ORR","ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).",{"measure":31,"description":32,"timeFrame":12},"Phase 1a and 1b: Duration of Response (DOR)","DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first.",{"measure":34,"description":35,"timeFrame":12},"Phase 1a and 1b: Disease Control Rate (DCR)","DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease.",{"measure":37,"description":38,"timeFrame":39},"Phase 1a: Plasma Concentration of BG-C0979",null,"Up to approximately 3 months",{"measure":41,"description":38,"timeFrame":39},"Phase 1a: Area Under the Concentration-Time Curve (AUC) for BG-C0979",{"measure":43,"description":38,"timeFrame":39},"Phase 1a: Maximum Observed Concentration (Cmax) of BG-C0979",{"measure":45,"description":38,"timeFrame":39},"Phase 1a: Time to Maximum Concentration (Tmax) of BG-C0979",{"measure":47,"description":38,"timeFrame":12},"Phase 1a and 1b: Number of Participants with Anti-Drug Antibodies (ADAs)",{"measure":49,"description":50,"timeFrame":12},"Phase 1b: Number of Participants Experiencing Adverse Events (AEs)","Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results.",{"measure":52,"description":53,"timeFrame":12},"Phase 1b: Progression-Free Survival","PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first.",{"measure":55,"description":56,"timeFrame":12},"Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC","rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first.",{"measure":58,"description":59,"timeFrame":12},"Prostate-Specific Antigen (PSA) Response for Participants with CRPC","PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.",{"measure":61,"description":38,"timeFrame":39},"Phase 1b: Plasma Concentration of BG-C0979, Alone and in Combination with Tislelizumab",{"allocation":63,"interventionModel":64,"interventionModelDescription":38,"primaryPurpose":65,"observationalModel":38,"timePerspective":38,"maskingInfo":66},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":67,"maskingDescription":38,"whoMasked":38},"NONE",[69,75,79,83],{"label":70,"type":71,"description":72,"interventionNames":73},"Phase 1a: Monotherapy Dose Escalation","EXPERIMENTAL","Participants will receive increasing doses of BG-C0979 as monotherapy.",[74],"Drug: BG-C0979",{"label":76,"type":71,"description":77,"interventionNames":78},"Phase 1a: Monotherapy Safety Expansion","Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion.",[74],{"label":80,"type":71,"description":81,"interventionNames":82},"Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion","Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a.",[74],{"label":84,"type":71,"description":85,"interventionNames":86},"Phase 1b, Part B: Combination Therapy Expansion","Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.",[74,87],"Drug: Tislelizumab",[89,94],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":38},"DRUG","BG-C0979","Administered by intravenous infusion.",[70,76,80,84],{"type":90,"name":95,"description":92,"armGroupLabels":96,"otherNames":97},"Tislelizumab",[84],[98],"BGB-A317",[100],{"name":101,"affiliation":5,"role":102},"Study Director","STUDY_DIRECTOR",[104],{"name":101,"role":105,"phone":106,"phoneExt":38,"email":107},"CONTACT","8778285568","clinicaltrials@beonemed.com",[109,123,133,145,154,164,174,186,196,206,217,223,232],{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":38},"John Theurer Cancer Center Hackensack University Medical Center","RECRUITING","Hackensack","New Jersey","07601","United States","US",{"type":118,"coordinates":119},"Point",[120,121],-74.04347,40.88593,{"lat":121,"lon":120},{"facility":124,"status":111,"city":125,"state":126,"zip":127,"country":115,"countryCode":116,"cosmosGeoPoint":128,"geoPoint":132,"contacts":38},"Next Oncology San Antonio","San Antonio","Texas","78229",{"type":118,"coordinates":129},[130,131],-98.49363,29.42412,{"lat":131,"lon":130},{"facility":134,"status":111,"city":135,"state":136,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":144,"contacts":38},"Northern Beaches Hospital","Frenchs Forest","New South Wales","NSW 2086","Australia","AU",{"type":118,"coordinates":141},[142,143],151.22322,-33.74821,{"lat":143,"lon":142},{"facility":146,"status":111,"city":147,"state":136,"zip":148,"country":138,"countryCode":139,"cosmosGeoPoint":149,"geoPoint":153,"contacts":38},"Liverpool Hospital","Liverpool","NSW 2170",{"type":118,"coordinates":150},[151,152],150.92588,-33.91938,{"lat":152,"lon":151},{"facility":155,"status":111,"city":156,"state":157,"zip":158,"country":138,"countryCode":139,"cosmosGeoPoint":159,"geoPoint":163,"contacts":38},"Icon Cancer Centre South Brisbane","South Brisbane","Queensland","QLD 4101",{"type":118,"coordinates":160},[161,162],153.02049,-27.48034,{"lat":162,"lon":161},{"facility":165,"status":111,"city":166,"state":167,"zip":168,"country":138,"countryCode":139,"cosmosGeoPoint":169,"geoPoint":173,"contacts":38},"Cabrini Hospital Malvern","Malvern","Victoria","VIC 3144",{"type":118,"coordinates":170},[171,172],145.02811,-37.86259,{"lat":172,"lon":171},{"facility":175,"status":111,"city":176,"state":177,"zip":178,"country":179,"countryCode":180,"cosmosGeoPoint":181,"geoPoint":185,"contacts":38},"Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)","Chongqing","Chongqing Municipality","400037","China","CN",{"type":118,"coordinates":182},[183,184],106.55771,29.56026,{"lat":184,"lon":183},{"facility":187,"status":111,"city":188,"state":189,"zip":190,"country":179,"countryCode":180,"cosmosGeoPoint":191,"geoPoint":195,"contacts":38},"Mengchao Hepatobiliary Hospital of Fujian Medical University","Fuzhou","Fujian","350028",{"type":118,"coordinates":192},[193,194],119.30611,26.06139,{"lat":194,"lon":193},{"facility":197,"status":111,"city":198,"state":199,"zip":200,"country":179,"countryCode":180,"cosmosGeoPoint":201,"geoPoint":205,"contacts":38},"Yichang Central Peoples Hospital","Yichang","Hubei","443003",{"type":118,"coordinates":202},[203,204],111.28472,30.71444,{"lat":204,"lon":203},{"facility":207,"status":111,"city":208,"state":38,"zip":209,"country":210,"countryCode":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":38},"Hospital Universitario Vall Dhebron","Barcelona","08035","Spain","ES",{"type":118,"coordinates":213},[214,215],2.15899,41.38879,{"lat":215,"lon":214},{"facility":218,"status":111,"city":208,"state":38,"zip":219,"country":210,"countryCode":211,"cosmosGeoPoint":220,"geoPoint":222,"contacts":38},"Hospital Clinic de Barcelona","08036",{"type":118,"coordinates":221},[214,215],{"lat":215,"lon":214},{"facility":224,"status":111,"city":225,"state":38,"zip":226,"country":210,"countryCode":211,"cosmosGeoPoint":227,"geoPoint":231,"contacts":38},"Hospital Universitario Fundacion Jimenez Diaz","Madrid","28040",{"type":118,"coordinates":228},[229,230],-3.70256,40.4165,{"lat":230,"lon":229},{"facility":233,"status":111,"city":225,"state":38,"zip":234,"country":210,"countryCode":211,"cosmosGeoPoint":235,"geoPoint":237,"contacts":38},"Next Oncology Madrid","28223",{"type":118,"coordinates":236},[229,230],{"lat":230,"lon":229},{"type":239,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100624838",false,"NCT07414836","A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors","A Multicenter, Open-Label, Phase 1a\u002Fb First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.\n* Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.\n* Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.\n* Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Participants must have adequate organ function.\n\nExclusion Criteria:\n\n* Prior treatment with any ADAM9-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 inhibitor as payload.\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":249,"type":250},84,"ESTIMATED","INTERVENTIONAL",[253],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).",[256],"Advanced Solid Tumor",[258,259],"ADAM9 (disintegrin and metalloproteinase 9)","antibody-drug conjugate","2026-06-17",{"date":262,"type":263},"2026-06-18","ACTUAL",{"date":265,"type":263},"2026-04-13",{"date":267,"type":250},"2029-04-30",{"name":5,"class":6},13]