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Hospital","Kuching","93586",{"type":131,"coordinates":591},[592,593],110.33333,1.55,{"lat":593,"lon":592},{"facility":596,"status":124,"city":597,"state":46,"zip":598,"country":570,"countryCode":571,"cosmosGeoPoint":599,"geoPoint":603,"contacts":46},"National Cancer Institute (Institut Kanser Negara)","Putrajaya","62250",{"type":131,"coordinates":600},[601,602],101.69112,2.93527,{"lat":602,"lon":601},{"facility":605,"status":124,"city":606,"state":46,"zip":607,"country":608,"countryCode":609,"cosmosGeoPoint":610,"geoPoint":614,"contacts":46},"The Institute of Oncology, Arensia Exploratory Medicine","Chisinau","2025","Moldova","MD",{"type":131,"coordinates":611},[612,613],28.85938,47.00902,{"lat":613,"lon":612},{"facility":616,"status":124,"city":617,"state":46,"zip":618,"country":619,"countryCode":620,"cosmosGeoPoint":621,"geoPoint":625,"contacts":46},"Harbour Cancer and Wellness","Auckland","1023","New Zealand","NZ",{"type":131,"coordinates":622},[623,624],174.76349,-36.84853,{"lat":624,"lon":623},{"facility":627,"status":124,"city":628,"state":629,"zip":630,"country":631,"countryCode":46,"cosmosGeoPoint":632,"geoPoint":636,"contacts":46},"Seoul National University Bundang Hospital","Seongnam-si","Gyeonggi-do","13620","South Korea",{"type":131,"coordinates":633},[634,635],127.13778,37.43861,{"lat":635,"lon":634},{"facility":638,"status":124,"city":639,"state":640,"zip":641,"country":631,"countryCode":46,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"Gachon University Gil Medical Center","NamdongGu","Incheon Gwang'Yeogsi","21565",{"facility":643,"status":124,"city":644,"state":645,"zip":646,"country":631,"countryCode":46,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"Samsung Medical Center","GangnamGu","Seoul Teugbyeolsi","06351",{"facility":648,"status":124,"city":649,"state":645,"zip":650,"country":631,"countryCode":46,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"The Catholic University of Korea, Seoul St Marys Hospital","SeochoGu","06591",{"facility":652,"status":124,"city":653,"state":645,"zip":654,"country":631,"countryCode":46,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"Severance Hospital Yonsei University Health System","SeodaemunGu","03722",{"facility":656,"status":124,"city":657,"state":645,"zip":658,"country":631,"countryCode":46,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"Korea University Anam Hospital","SeongbukGu","02841",{"facility":660,"status":124,"city":661,"state":645,"zip":662,"country":631,"countryCode":46,"cosmosGeoPoint":663,"geoPoint":667,"contacts":46},"Seoul National University Hospital","Seoul","03080",{"type":131,"coordinates":664},[665,666],126.9784,37.566,{"lat":666,"lon":665},{"facility":669,"status":124,"city":670,"state":645,"zip":671,"country":631,"countryCode":46,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"Asan Medical Center","SongpaGu","05505",{"facility":673,"status":674,"city":675,"state":46,"zip":676,"country":677,"countryCode":678,"cosmosGeoPoint":46,"geoPoint":46,"contacts":46},"Srinagarind Hospital (Khon Kaen University)","ACTIVE_NOT_RECRUITING","Muang","40002","Thailand","TH",{"type":680,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326",false,"NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 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).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":691,"type":692},399,"ESTIMATED","INTERVENTIONAL",[695],"PHASE1","This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[698,699,700,701,702,703,704,705,706],"Advanced Solid Tumor","Advanced Breast Cancer","Metastatic Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","HER2-negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[708,709,710,711,712,705,94,713],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","non-small cell lung cancer","2026-08-18",{"date":716,"type":717},"2026-08-19","ACTUAL",{"date":719,"type":717},"2023-12-01",{"date":721,"type":692},"2028-11",{"name":5,"class":6},62]