[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07226349":3,"trial-entities:NCT07226349":314,"trial-summary:NCT07226349":318},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":49,"secondary_outcomes":64,"sex":114,"minimum_age":115,"maximum_age":116,"healthy_volunteers":15,"eligibility_criteria":117,"std_ages":131,"locations":134,"central_contacts":303,"overall_officials":309,"references":312,"see_also_links":313},"NCT07226349","BG-75098-101","A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors","A Phase 1a\u002F1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors","RECRUITING","2028-11-01","2026-09","2026-09-11","2025-12-11","BeOne Medicines","INDUSTRY",false,"The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.","This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.",[19],"Advanced Solid Tumor",[21,22,23,24],"Cyclin-Dependent Kinase 2- Targeted Protein Degrader","CDK2","CDK4","CDK4 inhibitor","INTERVENTIONAL","TREATMENT",[28],"PHASE1",{"count":30,"type":31},105,"ESTIMATED",[33,42,45],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","BG-75098","Administered orally.",[38,39,40,41],"Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy","Phase 1a, Part B: Dose Escalation, BG-75098 Combination","Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination","Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy",{"type":34,"name":43,"description":36,"armGroupLabels":44},"BGB-43395",[39,40],{"type":34,"name":46,"description":47,"armGroupLabels":48},"Fulvestrant","Administered by intramuscular injection.",[39,40],[50,54,58,61],{"measure":51,"description":52,"timeFrame":53},"Phase 1a: Number of Participants with Adverse Events (AEs)","Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria.","From first dose to 30 days after last dose, up to approximately 12 months",{"measure":55,"description":56,"timeFrame":57},"Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098","MTD is determined based on a target for dose-limiting toxicities. MAD is defined as the maximum administered dose, and it is used when MTD is not reached.","Up to approximately 2 years",{"measure":59,"description":60,"timeFrame":57},"Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-75098 as Monotherapy and in Combination with BGB-43395 and Fulvestrant","The RDFE(s) will be determined from safety, tolerability, pharmacokinetic, pharmacodynamic biomarker(s), preliminary antitumor activity, and any other relevant data that are obtained from the dose escalation phase.",{"measure":62,"description":63,"timeFrame":57},"Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator","ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.",[65,68,71,74,77,79,81,84,87,89,92,95,97,99,101,104,106,108,110,112],{"measure":66,"description":67,"timeFrame":57},"Phase 1a: ORR as Assessed by the Investigator","ORR is defined as the percentage of participants with best overall response of CR or PR, as assessed by the investigator using RECIST v1.1.",{"measure":69,"description":70,"timeFrame":57},"Phase 1a: Duration of Response (DOR) as Assessed by the Investigator","DOR is defined as the time from the first confirmed objective response assessed by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.",{"measure":72,"description":73,"timeFrame":57},"Phase 1a: Time to Response (TTR) as Assessed by the Investigator","TTR is defined as the time from treatment initiation to the first determination of overall response assessed by the investigator using RECIST v1.1.",{"measure":75,"description":76,"timeFrame":57},"Phase 1a: Progression-Free Survival (PFS) as Assessed by the Investigator","PFS is defined as the time from the date of the first dose of study treatment to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.",{"measure":78,"description":70,"timeFrame":57},"Phase 1b: DOR as Assessed by the Investigator",{"measure":80,"description":73,"timeFrame":57},"Phase 1b: TTR as Assessed by the Investigator",{"measure":82,"description":83,"timeFrame":57},"Phase 1b: Disease Control Rate (DCR)","DCR is defined as the percentage of participants with a best overall response, of CR, PR, or stable disease assessed by the investigator using RECIST v1.1.",{"measure":85,"description":86,"timeFrame":57},"Phase 1b: Clinical Benefit Rate (CBR)","CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks.",{"measure":88,"description":76,"timeFrame":57},"Phase 1b: PFS",{"measure":90,"description":91,"timeFrame":57},"Phase 1b: Number of Participants with AEs","Number of participants with TEAEs and SAEs, including physical examination findings, electrocardiogram results, and laboratory values.",{"measure":93,"timeFrame":94},"Observed Plasma Maximum Concentration (Cmax) of BG-75098","Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)",{"measure":96,"timeFrame":94},"Observed Plasma Trough Concentration (Ctrough) of BG-75098",{"measure":98,"timeFrame":94},"Area Under the Concentration-Time Curve (AUC) of BG-75098",{"measure":100,"timeFrame":94},"Terminal Half-Life (t1\u002F2) of BG-75098",{"measure":102,"timeFrame":103},"Phase 1b: Plasma Concentrations of BG-75098","Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days)",{"measure":105,"timeFrame":94},"Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395",{"measure":107,"timeFrame":94},"Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395",{"measure":109,"timeFrame":94},"Phase 1a: Area Under the Concentration-Time Curve (AUC) of BGB-43395",{"measure":111,"timeFrame":94},"Phase 1a: Terminal Half-Life (t1\u002F2) of BGB-43395",{"measure":113,"timeFrame":103},"Plasma Concentrations of BGB-43395","ALL","18 Years",null,{"inclusion":118,"exclusion":126,"raw_text":130},[119,120,121,122,123,124,125],"Participants must have measurable disease as assessed by RECIST v1.1.","Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.","Participants must have adequate organ function.","Dose Escalation Part A: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors potentially associated with cyclin-dependent kinase 2 (CDK2) dependency. Participants should have received prior treatment with available standard-of-care (SOC) systemic therapies for advanced\u002Fmetastatic disease, or for whom standard therapy is not available or not tolerated.","Dose Escalation Part B: Patients with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who have received ≥ 1 prior line of systemic therapy in the metastatic setting.","Dose Expansion Cohort 1: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable CDK4\u002F6 inhibitor-progressed solid tumors.","Dose Expansion Cohort 2: Participants with advanced solid tumors. Participants with primary platinum refractory disease are not eligible. Participants should have received ≥ 1 line of platinum-containing chemotherapy and ≤ 4 prior therapeutic regimens in the advanced\u002Fmetastatic setting.",[127,128,129],"For all cohorts: Prior therapy selectively targeting CDK2 inhibition or degradation.","For combination cohorts: Prior therapy selectively targeting CDK4. Prior CDK4\u002F6 inhibitor standard of care therapy is permitted and required in local regions where it is approved and available.","Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.","Inclusion Criteria:\n\n* Participants must have measurable disease 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* Dose Escalation Part A: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors potentially associated with cyclin-dependent kinase 2 (CDK2) dependency. Participants should have received prior treatment with available standard-of-care (SOC) systemic therapies for advanced\u002Fmetastatic disease, or for whom standard therapy is not available or not tolerated.\n* Dose Escalation Part B: Patients with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who have received ≥ 1 prior line of systemic therapy in the metastatic setting.\n* Dose Expansion Cohort 1: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable CDK4\u002F6 inhibitor-progressed solid tumors.\n* Dose Expansion Cohort 2: Participants with advanced solid tumors. Participants with primary platinum refractory disease are not eligible. Participants should have received ≥ 1 line of platinum-containing chemotherapy and ≤ 4 prior therapeutic regimens in the advanced\u002Fmetastatic setting.\n\nExclusion Criteria:\n\n* For all cohorts: Prior therapy selectively targeting CDK2 inhibition or degradation.\n* For combination cohorts: Prior therapy selectively targeting CDK4. Prior CDK4\u002F6 inhibitor standard of care therapy is permitted and required in local regions where it is approved and available.\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",[132,133],"ADULT","OLDER_ADULT",[135,144,152,160,168,176,180,188,197,204,212,220,227,235,244,252,260,268,272,280,288,295],{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":140,"geoPoint":141},"University of Alabama At Birmingham Hospital","Birmingham","Alabama","35294-0004","United States",{"lat":142,"lon":143},33.52066,-86.80249,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":140,"geoPoint":149},"Yale Cancer Center","New Haven","Connecticut","06510",{"lat":150,"lon":151},41.30815,-72.92816,{"facility":153,"status":8,"city":154,"state":155,"zip":156,"country":140,"geoPoint":157},"Sidney Kimmel Comprehensive Cancer At Johns Hopkins","Baltimore","Maryland","21287",{"lat":158,"lon":159},39.29038,-76.61219,{"facility":161,"status":8,"city":162,"state":163,"zip":164,"country":140,"geoPoint":165},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":166,"lon":167},42.35843,-71.05977,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":140,"geoPoint":173},"The University of Texas Md Anderson Cancer Center","Houston","Texas","77030-4009",{"lat":174,"lon":175},29.76328,-95.36327,{"facility":177,"status":8,"city":170,"state":171,"zip":178,"country":140,"geoPoint":179},"Next Oncology Houston","77054",{"lat":174,"lon":175},{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":140,"geoPoint":185},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226-3522",{"lat":186,"lon":187},43.0389,-87.90647,{"facility":189,"status":8,"city":190,"state":191,"zip":192,"country":193,"geoPoint":194},"Blacktown Cancer and Haematology Centre","Blacktown","New South Wales","NSW 2148","Australia",{"lat":195,"lon":196},-33.76667,150.91667,{"facility":198,"status":8,"city":199,"state":191,"zip":200,"country":193,"geoPoint":201},"Genesiscare St Leonards","St Leonards","NSW 2065",{"lat":202,"lon":203},-33.82344,151.19836,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":193,"geoPoint":209},"Icon Cancer Centre Wesley","Auchenflower","Queensland","QLD 4066",{"lat":210,"lon":211},-27.47443,152.99213,{"facility":213,"status":8,"city":214,"state":215,"zip":216,"country":193,"geoPoint":217},"Cabrini Hospital Malvern","Malvern","Victoria","VIC 3144",{"lat":218,"lon":219},-37.86259,145.02811,{"facility":221,"status":8,"city":222,"state":215,"zip":223,"country":193,"geoPoint":224},"Peter Maccallum Cancer Centre","Melbourne","VIC 3000",{"lat":225,"lon":226},-37.814,144.96332,{"facility":228,"status":8,"city":229,"state":230,"zip":231,"country":193,"geoPoint":232},"One Clinical Research","Nedlands","Western Australia","WA 6009",{"lat":233,"lon":234},-31.98184,115.8073,{"facility":236,"status":8,"city":237,"state":238,"zip":239,"country":240,"geoPoint":241},"Cancer Hospital Chinese Academy of Medical Sciences","Beijing","Beijing Municipality","100021","China",{"lat":242,"lon":243},39.9075,116.39723,{"facility":245,"status":8,"city":246,"state":247,"zip":248,"country":240,"geoPoint":249},"Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)","Guangzhou","Guangdong","510245",{"lat":250,"lon":251},23.11667,113.25,{"facility":253,"status":8,"city":254,"state":255,"zip":256,"country":240,"geoPoint":257},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang","150000",{"lat":258,"lon":259},45.75,126.65,{"facility":261,"status":8,"city":262,"state":263,"zip":264,"country":240,"geoPoint":265},"Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology","Wuhan","Hubei","430030",{"lat":266,"lon":267},30.58333,114.26667,{"facility":269,"status":8,"city":262,"state":263,"zip":270,"country":240,"geoPoint":271},"Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch","430048",{"lat":266,"lon":267},{"facility":273,"status":8,"city":274,"state":275,"zip":276,"country":240,"geoPoint":277},"Jiangsu Province Hospital Longjiang Branch","Nanjing","Jiangsu","210036",{"lat":278,"lon":279},32.06167,118.77778,{"facility":281,"status":8,"city":282,"state":283,"zip":284,"country":240,"geoPoint":285},"Qilu Hospital of Shandong University","Jinan","Shandong","250000",{"lat":286,"lon":287},36.66833,116.99722,{"facility":289,"status":8,"city":290,"state":283,"zip":291,"country":240,"geoPoint":292},"Weifang Peoples Hospital","Weifang","261000",{"lat":293,"lon":294},36.71,119.10194,{"facility":296,"status":8,"city":297,"zip":298,"country":299,"geoPoint":300},"Rigshospitalet","Copenhagen","2100","Denmark",{"lat":301,"lon":302},55.67594,12.56553,[304],{"name":305,"role":306,"phone":307,"email":308},"Study Director","CONTACT","8778285568","clinicaltrials@beonemed.com",[310],{"name":305,"affiliation":13,"role":311},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":315,"biomarkers":317},[316],"Solid Neoplasm",[],{"nct_id":4,"found":319,"summary":320,"prompt_version":330},true,{"design":321,"status":322,"heading":323,"summary":324,"follow_up":325,"word_count":326,"commitments":327,"compensation":328,"drugs_mentioned":329},"This is an interventional study planning to enroll 105 participants. It will be conducted in two parts: a dose escalation phase (Phase 1a) and a dose expansion phase (Phase 1b).","completed","A Study of BG-75098 for Advanced Solid Tumors","This study is testing BG-75098, alone and with BGB-43395 and fulvestrant, in adults with advanced solid tumors. The purpose is to understand how safe these treatments are, how well your body handles them, and if they show early signs of shrinking tumors. Researchers are looking at how BG-75098 affects CDK and CDK4. You might be able to join if you have advanced, metastatic, or unresectable solid tumors that can be measured, have a good general health status (ECOG 0 or 1), and healthy organ function. The study aims to find the safest and most effective dose of BG-75098. The current status of this study is unclear.","Your safety will be monitored from the first dose to 30 days after your last dose, for up to approximately 12 months. The maximum tolerated dose and recommended dose will be assessed for up to approximately 2 years.",106,"Not specified in the trial record.","Not stated in the trial record.",[35,43,46],"v2"]