[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BeOne Medicines\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":656},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,57,85,112,134,157,192,229,251,276,298,327,348,370,393,415,444,466,489,509,531,552,577,597,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100564854","phase-1-a-study-to-investigate-safety-and-effectiveness-of-bgb-16673-in-combination-with-other-agents-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100564854",false,"NCT06634589","A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1b\u002F2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies","Key Inclusion Criteria:\n\n* Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF\n* Confirmed diagnosis of a R\u002FR B-cell malignancy\n* Protocol-defined measurable disease\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab\n* Substudies 1, 3, and 4 Inclusion Criterion:\n\n  * Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL\u002Fmin\n* Substudy 2 Inclusion Criteria:\n\n  * Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression\n  * Adequate renal function as indicated by eGFR of ≥ 30 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Treatment-naive B-cell malignancies\n* Unable to comply with the requirements of the protocol\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively\n* Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening\n* Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period\n* Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of tacabrutideg, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab\n* Substudy 1 Exclusion Criterion:\n\n  * Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen)\n* Substudy 2 Exclusion Criterion:\n\n  * Participants who discontinued prior zanubrutinib treatment due to intolerance\n* Substudies 3 and 4 Exclusion Criteria:\n\n  * Prior exposure to a CD20 x CD3 T-cell engager antibody treatment\n  * All participants with a prior allogeneic stem cell transplant\n  * Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with tacabrutideg in combination with other agents in participants with relapsed or refractory (R\u002FR) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.",[28,29,30,31],"B-cell Malignancy","Relapsed Cancer","Refractory Cancer","B-cell Lymphoma",[33,34,35,36,37,38,39,40,41,42,43],"R\u002FR B-Cell Malignancies","relapsed or refractory B-Cell Malignancies","B-Cell malignancy","BGB-16673","sonrotoclax","zanubrutinib","B-cell lymphoma","Bruton Tyrosine Kinase (BTK)","Mosunetuzumab","Glofitamab","tacabrutideg","RECRUITING","2026-08-20",{"date":47,"type":48},"2026-08-21","ACTUAL",{"date":50,"type":48},"2024-11-27",{"date":52,"type":21},"2029-12-02",{"name":54,"class":55},"BeOne Medicines","INDUSTRY",50,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":66,"type":21},645,[24,25],"Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[28,70,71,72,73,74,75,76,77],"Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma",{"date":47,"type":48},{"date":80,"type":48},"2021-09-13",{"date":82,"type":21},"2029-11",{"name":54,"class":55},115,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100630820","phase-3-bgb-43395-plus-letrozole-versus-cdk46i-plus-letrozole-for-patients-with-advanced-or-metastatic-hrher2--breast-cancer-who-have-not-received-prior-treatment-for-advanced-or-metastatic-disease-100630820","NCT07492641","BGB-43395 Plus Letrozole Versus CDK4\u002F6i Plus Letrozole for Patients With Advanced or Metastatic HR+\u002FHER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease","An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4\u002F6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+\u002FHER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease","KANDELA-302","Inclusion Criteria:\n\n* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.\n* Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Participants who have received prior systemic treatment in the advanced or metastatic setting.\n* Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":94,"type":21},1056,[96],"PHASE3","The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.",[99],"HR+\u002FHER2- Breast Cancer",[101,102],"CDK4 inhibitor","CDK4\u002F6 inhibitor","2026-08-18",{"date":105,"type":48},"2026-08-19",{"date":107,"type":48},"2026-05-22",{"date":109,"type":21},"2037-08-07",{"name":54,"class":55},108,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100614256","phase-3-a-study-to-investigate-sonrotoclax-bgb-11417-plus-zanubrutinib-bgb-3111-compared-with-venetoclax-plus-acalabrutinib-in-adults-with-previously-untreated-chronic-lymphocytic-leukemia-100614256","NCT07277231","A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia","A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia","Inclusion Criteria:\n\n* Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment\n* Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n* Measurable disease by Computer Tomography\u002FMagnetic Resonance Imaging\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Previous systemic treatment for CLL\n* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n* Known central nervous system involvement\n* History of confirmed progressive multifocal leukoencephalopathy (PML)\n* Uncontrolled hypertension or clinically significant cardiovascular disease\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":120,"type":21},500,[96],"The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).",[74],[125,126],"B-cell Lymphoma-2 Inhibitor","Bruton Tyrosine Kinase Inhibitor",{"date":105,"type":48},{"date":129,"type":48},"2026-01-22",{"date":131,"type":21},"2031-11",{"name":54,"class":55},105,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100610343","phase-1-a-study-of-bg-75098-alone-and-in-combination-with-other-agents-in-adults-with-advanced-solid-tumors-100610343","NCT07226349","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","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.",{"count":133,"type":21},[24],"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.",[145],"Advanced Solid Tumor",[147,148,149,101],"Cyclin-Dependent Kinase 2- Targeted Protein Degrader","CDK2","CDK4",{"date":105,"type":48},{"date":152,"type":48},"2025-12-11",{"date":154,"type":21},"2028-11-01",{"name":54,"class":55},22,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":177,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","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.",{"count":165,"type":21},399,[24],"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.",[145,169,170,171,172,173,174,175,176],"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",[178,179,180,181,182,175,183,184],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer",{"date":105,"type":48},{"date":187,"type":48},"2023-12-01",{"date":189,"type":21},"2028-11",{"name":54,"class":55},62,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":218,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100652162","phase-1-a-study-of-sonrotoclax-bgb-11417-in-children-with-relapsed-or-refractory-acute-myeloid-leukemia-and-b-cell-acute-lymphoblastic-leukemia-100652162","NCT07770698","A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia","A Phase 1\u002F2a, Open-Label, Dose Finding and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sonrotoclax (BGB-11417) in Combination With Other Agents in Pediatric Patients Aged 6 Months to 17 Years, With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia","Key Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for participation:\n\n1. Have a performance status of Lansky ≥50 for participants ≤16 years of age or Karnofsky ≥50 for participants \\>16 years of age.\n2. Have adequate renal function, defined as an estimated or measured glomerular filtration rate (GFR) ≥60 mL\u002Fmin.\n3. Have adequate hepatic function, defined as:\n\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C2.5 × the institutional upper limit of normal (ULN)\n   * Total bilirubin ≤1.5 × the institutional ULN.\n4. Have minimum cardiac function as defined in the study protocol.\n\nAcute Myeloid Leukemia (AML)-Specific Inclusion Criteria\n\n1. Have a histologically confirmed diagnosis of acute myeloid leukemia (AML) that is relapsed or refractory (R\u002FR) after ≥2 prior lines of systemic therapy.\n2. Have ≥5% blasts in a bone marrow aspirate or biopsy sample, as assessed by morphology. Participants with extramedullary, non-central nervous system (CNS) disease are eligible.\n\nB-Cell Precursor Acute Lymphoblastic Leukemia (ALL)-Specific Inclusion Criteria\n\n1. Have a histologically confirmed diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) that is R\u002FR after ≥2 prior lines of systemic therapy, including at least 1 line of blinatumomab-based therapy.\n2. Have ≥5% blasts in a bone marrow aspirate or biopsy sample, as assessed by morphology.\n3. Have leukemic blasts expressing cluster of differentiation 22 (CD22) on the cell surface, as assessed by flow cytometry of a bone marrow aspirate.\n\nKey Exclusion Criteria\n\nParticipants will be excluded from participation if any of the following apply:\n\n1. Have central nervous system (CNS) 2 or CNS 3 disease at screening.\n2. Have toxicity from prior anticancer therapy that has not recovered to ≤Grade 1, as defined by the applicable toxicity grading criteria.\n3. Have a history of prior allogeneic stem cell transplantation \\\u003C90 days from enrollment or if if ≥ 90 days from enrollment, with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent.\n\nAML-Specific Exclusion Criteria\n\n1. Have a diagnosis of acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).\n2. Have AML with fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), as determined by local assessment.\n\nALL-Specific Exclusion Criteria\n\n1. Have Philadelphia chromosome-positive (Ph+) ALL with a breakpoint cluster region::Abelson murine leukemia viral oncogene homolog 1 (BCR::ABL1) fusion.\n2. Have received prior therapy with a B-cell lymphoma 2 (BCL-2) inhibitor.\n\nNote: Other eligibility criteria may apply.","6 Months","17 Years",{"count":202,"type":21},30,[24,25],"The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment or has not responded to treatment. The study will also learn how the body processes sonrotoclax when it is given with other medicines. The main questions it aims to answer are:\n\n* Is sonrotoclax safe and well tolerated when given with other anti-cancer medicines?\n* How does the body absorb, process, and remove sonrotoclax?\n* Does treatment with sonrotoclax, in combination with other medicines, help reduce or eliminate leukemia?\n\nResearchers will give sonrotoclax together with other anti-cancer medicines to participants with relapsed or refractory AML or ALL. Participants will:\n\n* Take sonrotoclax in combination with other anti-cancer medicines\n* Have regular clinic visits for physical exams, blood tests, heart monitoring, and other safety assessments.\n* Provide blood samples to measure how the body processes sonrotoclax.\n* Have tests to evaluate how their leukemia responds to treatment.\n* Continue treatment as long as it is helping and side effects remain manageable, according to the study plan.",[206,207,208,209,210,211,212,213,214,215,216,217],"Relapsed Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","B-cell Acute Lymphoblastic Leukemia","Pediatric Cancer","Pediatric ALL, Relapsed","Pediatric ALL","Pediatric ALL, B Cell","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Pediatric AML","R\u002FR AML","R\u002FR B-cell ALL",[217,216,215,214,213,212,211,210,209,206,207,219,220],"Sonrotoclax","Pediatric","NOT_YET_RECRUITING","2026-08-17",{"date":103,"type":48},{"date":225,"type":21},"2026-10",{"date":227,"type":21},"2031-09",{"name":54,"class":55},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100640438","an-investigational-study-of-bg-75202-alone-and-in-combination-with-other-agents-in-patients-with-myeloid-malignancies-100640438","NCT07619287","An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Patients With Myeloid Malignancies","A Phase 1a\u002F1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BG-75202, Alone and in Combination With Other Agents, in Patients With Myeloid Malignancies","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), inclusive, at the time of signing the Informed consent form (ICF).\n* Patients must have a confirmed diagnosis of myeloid malignancies based on 2016 World Health Organization criteria, and meet the following categories:\n\n  * Relapsed\u002Frefractory; myeloid malignancies after ≥1 prior systemic therapy, per ELN; 2022 criteria; patients with actionable genetic alteration must have previously received targeted therapies unless contraindicated, unavailable\u002Finaccessible, or declined by patient.\n* Patients must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n\nExclusion Criteria:\n\n* Prior exposure to KAT6A\u002FB inhibitors\u002Fdegraders.\n* A diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia.\n* Known central nervous system involvement by leukemia\n* Use of antileukemic therapies without sufficient washout period\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":237,"type":21},118,[24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of BG-75202 (KAT6A\u002FB inhibitor) alone and in combination with other agents in patients with myeloid malignancies.",[241],"Myeloid Malignancy",[243],"KAT6 inhibitor",{"date":103,"type":48},{"date":246,"type":48},"2026-06-23",{"date":248,"type":21},"2028-09-30",{"name":54,"class":55},13,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100573185","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-sonrotoclax-plus-zanubrutinib-compared-with-placebo-plus-zanubrutinib-in-adults-with-relapsedrefractory-mantle-cell-lymphoma-celestial-rrmcl-100573185","NCT06742996","A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed\u002FRefractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)","A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)\n* Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis\n* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator\n* Relapsed or refractory disease after the last line of therapy\n* Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)\n* Prior therapy with BTK degraders\n* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.\n* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug\n* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug\n* Known central nervous system involvement by lymphoma\n* Clinically significant cardiovascular disease\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":259,"type":21},300,[96],"The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed\u002Frefractory (R\u002FR) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.",[76,263],"B Cell Lymphoma",[265,266,267,37,268],"mantle cell lymphoma","MCL","relapsed\u002Frefractory mantle cell lymphoma","BGB-11417",{"date":105,"type":48},{"date":271,"type":48},"2025-03-05",{"date":273,"type":21},"2032-03-30",{"name":54,"class":55},155,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"100610029","phase-1-an-investigational-study-of-bg-75202-alone-and-in-combination-with-other-therapeutic-agents-in-adults-with-advanced-solid-tumors-100610029","NCT07222267","An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors","A Phase 1a\u002F1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and\u002For without available standard of care therapies.\n* Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced\u002F metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload).\n* Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitors are not approved and\u002For not available as the first-line treatment and who are CDK4\u002F6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease.\n* Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior exposure to KAT6A\u002FB or KAT7 inhibitors\u002Fdegraders.\n* Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n* Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":284,"type":21},86,[24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A\u002FB inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.",[288,145],"Breast Cancer",[243],"2026-08-13",{"date":292,"type":48},"2026-08-14",{"date":152,"type":48},{"date":295,"type":21},"2037-01-13",{"name":54,"class":55},31,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":305,"sex":17,"minAge":18,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100647695","a-study-to-investigate-the-relative-bioavailability-of-2-tablet-formulations-and-the-effect-of-food-on-the-pharmacokinetics-of-bgb-58067-in-healthy-participants-100647695","NCT07712640","A Study to Investigate the Relative Bioavailability of 2 Tablet Formulations and the Effect of Food on the Pharmacokinetics of BGB-58067 in Healthy Participants","A Phase 1, Single Dose, Open-label, Randomized 4-Period, 4-Sequence Crossover Study to Assess the Relative Bioavailability of Two Tablet Formulations of BGB-58067 and the Effect of Food on the Pharmacokinetics of a Single Oral Dose of BGB-58067 Administered Simultaneously to Healthy Adult Participants","Inclusion Criteria:\n\n* Participants must be 18 to 65 years of age, inclusive, at the time of signing the ICF.\n* Participants who are overtly healthy, as determined by the investigator or delegate through medical evaluation\n* Female participants must be of non-childbearing potential. Note: A woman is considered childbearing potential (ie, fertile, following menarche and until becoming postmenopausal) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy\n* Nonsterile male participants must be willing to use condom and refrain from sperm donation for the duration of the study and for 90 days after the last dose of BGB-58067.An additional highly effective method of birth control must be used for the duration of the study and for 90 days after the last dose of BGB-58067. A sterile man is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Men with known \"low sperm counts\" (consistent with \"subfertility\") are not to be considered sterile for purposes of this study\n\nExclusion Criteria:\n\n* Presence or history of relevant seasonal allergies requiring treatment, drug and\u002For food allergies (ie, allergy to any study drug or excipients, or any significant food allergy that could preclude a standard diet in the study site). Hay fever is allowed unless it is active (ie, No clinically meaningful allergy symptoms at screening and pre-dose, no requirement for pharmacologic therapy, and stable condition without anticipated flare during the PK assessment period).\n* History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric (including SIB) disorder, or severe cutaneous adverse reactions such as Stevens-Johnson Syndrome, as judged by the investigator or delegate.\n* Participants with a history of cholecystectomy or gall stones.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",true,"65 Years",{"count":308,"type":21},32,[24],"This study is being done to understand how the body processes 2 different tablet formulations of the study drug (BGB-58067) and how food intake influences the processing of the study drug by the body.",[312],"Healthy Volunteers",[314,315,316,317],"Relative bioavailability","Food effect","Tablets formulation","Healthy volunteer","2026-08-06",{"date":320,"type":48},"2026-08-10",{"date":322,"type":48},"2026-07-21",{"date":324,"type":21},"2028-07-01",{"name":54,"class":55},1,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":305,"sex":17,"minAge":18,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100624673","a-study-to-evaluate-the-safety-of-bg-a3004-in-healthy-participants-and-patients-with-immune-mediated-skin-diseases-100624673","NCT07412691","A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases","A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases","Inclusion Criteria\n\n* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 180 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug.\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 180 days after the last dose of study drug.\n\nPart A (SAD) specific Inclusion criteria\n\n* Healthy participants as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.\n* Body mass index (BMI) of 19 to 28 kg\u002Fm\\^2\n\nPart B (MAD) specific inclusion criteria:\n\n* Must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.\n* Body mass index (BMI) of 18 to 32 kg\u002Fm\\^2\n* Patients with alopecia areata (AA), clinical diagnosis of AA with no other etiology of hair loss. Severity of Alopecia Tool (SALT) ≥ 25 and \\\u003C 95 at screening and randomization.\n* Patients with cutaneous lichen planus (CLP), clinical and histological features of LP with predominant cutaneous involvement. Investigator's Global Assessment (IGA) score of 3 or 4 at screening and randomization.\n* Patients with nonsegmental vitiligo (NSV), documented clinical diagnosis of NSV for at least 3 months. Facial-Vitiligo Area Scoring Index (F-VASI) ≥ 0.5 and Total body-VASI ≥ 3 at screening and randomization.\n\nExclusion Criteria:\n\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of the study drug or drugs of the same class.\n* Participants who are unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.\n* Participants with any malignancy ≤ 5 years before randomization, except for any locally recurring cancer that has been treated curatively\n* Participants who were administered a live vaccine ≤ 28 days before randomization.\n* Female participants who are pregnant or are breastfeeding.\n* History of Tuberculosis or active, latent, or inadequately treated infection\n* A known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predispose the participant to infections.\n* Known infection with hepatitis B virus \\[presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody( HBcAb)\\], or presence of hepatitis C virus antibody (HCV Ab)\n* Have a history of any lymphoproliferative disorder (such as Epstein Barr Virus-related lymphoproliferative disorder, as reported in some participants on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.\n* Have an active infection or a history of infection within 6 months before the first dose of study drug that required hospitalization, or parenteral antimicrobial therapy, or have a history of opportunistic infection or a chronic or recurrent infectious disease that, in the opinion of the investigator, makes them unsuitable for this study.\n* Have or have had symptomatic herpes zoster or herpes simplex within 12 weeks, more than 1 episode of local herpes zoster, or a history (single episode) of disseminated zoster.\n* Acute disease state (e.g., asthma attack, nausea, vomiting, fever, or diarrhea) within 7 days prior to the first dose of study drug.\n\nPart B(MAD) specific exclusion criteria:\n\n* Previous use of any Janus Kinase (JAK) inhibitor for any disease indication at any time.\n* Treatment with systemic immunomodulatory medications within 4 weeks or 5 half-lives (if known), whichever is longer prior to randomization, including immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine); corticosteroids administered orally, intravenously, or intramuscularly; chloroquine derivatives; and oral phosphodiesterase-4 (PDE4) inhibitors (e.g., apremilast).\n* Phototherapy (UV or laser therapy) or cryotherapy within 4 weeks prior to randomization.\n* For AA patients, AA that affects more than scalp hair, e.g., eyebrow, eyelash, body hair.\n* For CLP patients, Patients whose LP is a predominantly bullous variant.\n* For NSV patients, Participants who have no pigmented hair within any of the vitiligo areas on the face.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","60 Years",{"count":336,"type":21},98,[24],"This is the first-in-human study of BG-A3004. The study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of BG-A3004 after single and multiple doses administered in different dose levels in healthy participants (Part A) and patients with immune-mediated skin diseases (Part B), respectively.\n\nStudy details include:\n\n* The study duration will be approximately 3 years.\n* The treatment duration will be 1 dose for Part A and 4 doses for Part B.\n* Safety follow-up period is 168 days after the last dose",[340],"Skin Diseases",{"date":320,"type":48},{"date":343,"type":48},"2026-03-19",{"date":345,"type":21},"2028-08-08",{"name":54,"class":55},11,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":369},"100596280","phase-3-a-study-to-investigate-tislelizumab-administered-as-subcutaneous-injection-versus-intravenous-infusion-plus-chemotherapy-in-patients-with-unresectable-or-metastatic-gastric-or-gastroesophageal-junction-adenocarcinoma-100596280","NCT07043400","A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed, locally advanced unresectable or metastatic gastric\u002F gastroesophageal junction (GEJ) adenocarcinoma.\n* No previous systemic therapy for locally advanced unresectable or metastatic gastric\u002FGEJ cancer.\n* At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.\n* Must be able to provide tumor tissues for biomarker assessment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.\n* Adequate organ function.\n* Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab.\n* Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab.\n\nExclusion Criteria:\n\n* Squamous cell or undifferentiated or other histological type gastric cancer (GC)\n* Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization.\n* Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).\n* Active autoimmune diseases or history of autoimmune diseases that may relapse.\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and\u002For diuretics within 7 days prior to randomization\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":356,"type":21},351,[96],"This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.",[360,361],"Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",{"date":363,"type":48},"2026-08-07",{"date":365,"type":48},"2025-08-27",{"date":367,"type":21},"2028-04-22",{"name":54,"class":55},95,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":392},"100588628","a-study-to-investigate-progression-free-survival-with-sonrotoclax-plus-obinutuzumab-or-sonrotoclax-plus-rituximab-compared-with-venetoclax-plus-rituximab-treatment-in-patients-with-relapsed-andor-refractory-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-celestial-rrcll-100588628","NCT06943872","A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and\u002For Refractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CELESTIAL-RRCLL)","A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL\u002FSLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria\n* Received one or more prior therapies for CLL\u002FSLL. For each line of therapy, participants must have received at least 2 cycles of the therapy\n* Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known active prolymphocytic leukemia or currently suspected Richter's transformation\n* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug\n* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent\n* Known central nervous system involvement by CLL\u002FSLL\n* Severe or debilitating pulmonary disease\n* Clinically significant cardiovascular disease\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":378,"type":21},630,[96],"The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and\u002For refractory (R\u002FR) chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R\u002FR CLL\u002FSLL. The safety of these treatments will also be assessed.",[74,75],[383,384,385],"B-cell lymphoma 2 inhibitor (BCL-2i)","CLL-RR1","German CLL Study Group",{"date":320,"type":48},{"date":388,"type":48},"2025-06-11",{"date":390,"type":21},"2031-12",{"name":54,"class":55},195,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":414},"100581158","phase-3-a-study-of-bgb-16673-compared-to-investigators-choice-in-participants-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-previously-exposed-to-both-bruton-tyrosine-kinase-btk-and-b-cell-leukemialymphoma-2-protein-bcl2-inhibitors-100581158","NCT06846671","A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia\u002FLymphoma 2 Protein (BCL2) Inhibitors","A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors","CaDAnCe-302","Inclusion Criteria:\n\n1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.\n2. Previously received treatment for CLL\u002FSLL with both a BTKi and a BCL2i.\n3. Participants with SLL must have measurable disease by computer tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n5. Adequate liver function\n6. Adequate blood clotting function\n\nExclusion Criteria:\n\n1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months\n3. Known central nervous system involvement\n4. Prior exposure to any BTK protein degraders\n5. Active fungal, bacterial and\u002For viral infection requiring parenteral systemic therapy\n6. Clinically significant cardiovascular disease\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":402,"type":21},250,[96],"The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \\[for CLL only\\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).",[406,74],"CLL",[406],{"date":363,"type":48},{"date":410,"type":48},"2025-04-10",{"date":412,"type":21},"2030-02-14",{"name":54,"class":55},127,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":428,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":443},"100577852","a-study-of-bgb-b455-in-adults-with-advanced-or-metastatic-solid-tumors-100577852","NCT06803680","A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors","A Phase 1, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B455 in Patients With Selected Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer) will be enrolled in dose escalation cohorts, starting from Protocol Amendment 3.0.\n* Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.\n* Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.\n* ≥ 1 measurable lesion as assessed by RECIST v1.1.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese \\[or other country\\] patent medicines, ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).\n* Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).\n* Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\n* Any major surgical procedure ≤ 28 days before the first dose of study drug(s).\n* History of prior ≥ Grade 3 cytokine release syndrome (CRS).\n* Participants with toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":423,"type":21},90,[24],"The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.\n\nThe main questions it aims to answer are:\n\n* What is the recommended dosing for BGB-B455?\n* What medical problems do participants have when taking BGB-B455?\n\nThe study has two parts:\n\n* Phase 1a: dose escalation and safety expansion\n* Phase 1b: dose expansion",[145,427],"Metastatic Solid Tumor",[429,430,431,432,433,434,435,436],"Claudin-6","CLDN6+","advanced or metastatic solid tumor","CD3","BsAb","bispecific antibody","CD3-BsAb","CLDN",{"date":320,"type":48},{"date":439,"type":48},"2025-03-18",{"date":441,"type":21},"2028-04-29",{"name":54,"class":55},12,{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":465},"100569664","a-study-to-investigate-the-safety-of-novel-dose-ramp-up-schedules-when-initiating-sonrotoclax-in-participants-treated-for-blood-cancers-100569664","NCT06697184","A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.","A Phase 1\u002F2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.","Inclusion Criteria:\n\n1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.\n2. Adequate organ function and no very recent transfusion or blood growth factor\n3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.\n\n   Only for participants with Chronic Lymphocytic Leukemia (CLL):\n4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease\n5. At least 1 measurable lesion based on computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.\n\n   Only for participants with Mantle cell lymphoma (MCL):\n6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).\n7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.\n8. Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter.\n\nExclusion Criteria:\n\n1. Participants unable to comply with the requirements of the protocol\n2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n3. Positive HIV serology (HIVAb) status unless certain conditions are met.\n4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment\n5. Prior systemic treatment for the CLL\n6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment\n7. Prior exposure to a BCL-2 inhibitor\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":452,"type":21},258,[24,25],"The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.",[74,406,76,266],[457,458],"CLL previously untreated","Hematological Malignancies",{"date":320,"type":48},{"date":461,"type":48},"2025-01-23",{"date":463,"type":21},"2032-11-30",{"name":54,"class":55},17,{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":488,"locationsCount":202},"100562102","phase-1-study-of-bg-t187-alone-and-in-combination-with-other-therapeutic-agents-in-participants-with-advanced-solid-tumors-100562102","NCT06598800","Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors","A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents 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. Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n4. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC).\n5. ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.\n6. Adequate organ function.\n\nExclusion Criteria:\n\n1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.\n2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.\n3. Any malignancy ≤ 3 years before the first dose of study drug(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 (ILD) or noninfectious pneumonitis requiring steroids or other immune suppressive agents ≤ 2 years before the first dose of the study drug, or with current ILD\u002Fnoninfectious pneumonitis, or where suspected ILD\u002Fnoninfectious pneumonitis cannot be ruled out by imaging during screening.\n5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).\n6. Active hepatitis C.\n7. Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":474,"type":21},153,[24],"This is a first-in-human (FIH), Phase 1a\u002F1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.",[145],[479,480,481,482,483],"Advanced Solid Tumors","First-in-human","BG-T187","EGFR","c-MET",{"date":363,"type":48},{"date":486,"type":48},"2024-10-18",{"date":248,"type":21},{"name":54,"class":55},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":508},"100437233","phase-1-a-phase-1b2-study-of-sonrotoclax-bgb-11417-as-monotherapy-and-in-various-combinations-with-dexamethasone-plus-carfilzomib-dexamethasone-plus-daratumumab-and-dexamethasone-plus-pomalidomide-in-multiple-myeloma-100437233","NCT04973605","A Phase 1b\u002F2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma","A Phase 1b\u002F2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone, Dexamethasone\u002FCarfilzomib, Dexamethasone\u002FDaratumumab, and Dexamethasone\u002FPomalidomide in Patients With Relapsed\u002FRefractory Multiple Myeloma and t(11;14)","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n2. A confirmed diagnosis of multiple myeloma (must have an M-component in serum and\u002For urine)\n3. Measurable disease defined as:\n\n   i. M-spike ≥ 500mg\u002FdL, or ii. Urine protein M-spike of ≥ 200 mg\u002Fday, or iii. Serum free light chains ≥ 10 mg\u002FdL, and an abnormal κ:λ ratio\n4. Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.\n\n   i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.\n\n   ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.\n   1. In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.\n   2. Participants in Part 2 Cohorts 3, 4, and 5 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory by the investigator.\n   3. Participants in Part 2 Cohorts 6 and 7 should have relapsed or progressive disease and have had 1 to 3 prior lines of therapy and previously treated with a proteasome inhibitor and an IMiD\n5. Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory\n\n   a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.\n6. Adequate organ function defined as:\n\n   1. Hemoglobin ≥ 8.0 g\u002FdL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)\n   2. Platelet count ≥ 75,000\u002FμL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions\n   3. Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 within 7 days before first dose of study treatment\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin must be \\\u003C 3 x ULN for patients with Gilbert's syndrome)\n\nExclusion Criteria:\n\n1. Participant has any of the following conditions:\n\n   1. Non secretory MM (Serum free light chains \\\u003C 10 mg\u002FdL)\n   2. Solitary plasmacytoma\n   3. Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or \\> 2.0 x 109\u002FL circulating plasma cells by standard differential)\n   4. Waldenström macroglobulinemia (WM)\n   5. Amyloidosis.\n   6. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome\n   7. Chronic respiratory disease that requires continuous oxygen\n2. Significant cardiovascular disease, including but not limited to:\n\n   1. Myocardial infarction ≤ 6 months before screening\n   2. Ejection fraction ≤ 50%\n   3. Unstable angina≤ 3 months before screening\n   4. New York Heart Association Class III or IV congestive heart failure\n   5. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n   6. Heart rate-corrected QT interval \\> 480 milliseconds based on Fridericia's formula\n   7. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n   8. Uncontrolled hypertension at screening, defined as systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg by ≥ 2 consecutive measurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2 activity (eg, venetoclax)\n3. Known infection with human immunodeficiency virus (HIV)\n4. Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:\n\n   1. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity \\\u003C 20 IU\u002FmL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation.\n   2. Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity \\\u003C 15 IU\u002FmL).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":497,"type":21},246,[24,25],"The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed\u002Frefractory (R\u002FR) multiple myeloma (MM) and chromosomal translocation t(11;14).\n\nThe study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.",[501],"Relapsed\u002FRefractory Multiple Myeloma",{"date":363,"type":48},{"date":504,"type":48},"2021-09-16",{"date":506,"type":21},"2026-11",{"name":54,"class":55},83,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":518,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":465},"100624838","phase-1-a-first-in-human-study-of-bg-c0979-in-adults-with-advanced-solid-tumors-100624838","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 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":517,"type":21},84,[24],"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).",[145],[522,523],"ADAM9 (disintegrin and metalloproteinase 9)","antibody-drug conjugate","2026-08-05",{"date":318,"type":48},{"date":527,"type":48},"2026-04-13",{"date":529,"type":21},"2029-04-30",{"name":54,"class":55},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":539,"briefSummary":540,"conditions":541,"keywords":542,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":551},"100590881","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-bgb-16673-compared-to-pirtobrutinib-in-adults-with-relapsedrefractory-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-100590881","NCT06973187","A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria\n* Previously received treatment for CLL\u002FSLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.\n* Participants with SLL must have measurable disease by computed tomography\u002Fmagnetic resonance imaging, defined as ≥ 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.\n\nExclusion Criteria:\n\n* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.\n* History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug\n* Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).\n* Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL\u002FSLL\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":120,"type":21},[96],"The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R\u002FR) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).",[74,75],[543,544],"Noncovalent Bruton tyrosine kinase inhibitor","Bruton tyrosine kinase-targeted protein degrader",{"date":318,"type":48},{"date":547,"type":48},"2025-09-04",{"date":549,"type":21},"2028-04-17",{"name":54,"class":55},204,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":576},"100561923","phase-1-a-study-of-bg-c477-in-participants-with-advanced-solid-tumors-100561923","NCT06596473","A Study of BG-C477 in Participants With Advanced Solid Tumors","A Multicenter, Open-Label, Phase 1a\u002Fb First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must sign the informed consent form (ICF) and be capable of giving written informed consent\n* Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy\n* Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator\n* Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy\n* Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease\n* ≥ 1 measurable lesion as assessed by RECIST v1.1\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477, for ≥ 6 months after the last dose of chemotherapy, and for ≥ 4 months after the last dose of tislelizumab,whichever comes later\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, for ≥ 3 months after chemotherapy, and for ≥ 4 months after the last dose of tislelizumab, whichever comes later.\n\nExclusion Criteria:\n\n* Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload\n* History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":560,"type":21},310,[24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.",[479],[565,566,567],"BG-C477","advanced solid tumors","CEA ADC","2026-07-31",{"date":570,"type":48},"2026-08-03",{"date":572,"type":48},"2024-10-03",{"date":574,"type":21},"2027-12-31",{"name":54,"class":55},58,{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":4},"100650127","phase-1-a-first-in-human-study-investigating-bg-85738-alone-or-in-combination-with-other-antitumor-agents-in-patients-with-advanced-or-metastatic-solid-tumors-with-rat-sarcoma-virus-ras-mutations-100650127","NCT07746141","A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-85738, Alone or in Combination With Other Antitumor Agents, in Patients With Advanced or Metastatic Solid Tumors With RAS Mutations","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if they meet all the following criteria:\n\n* Participants must sign the informed consent form and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Participants must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older), at the time of signing the ICF.\n* Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors and meet study part and cohort-specific criteria\n* Participants must have evidence of a RAS mutation defined as a nonsynonymous mutation in Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), or Harvey rat sarcoma viral oncogene homolog (HRAS) at codons 12, 13, or 61 (G12, G13, or Q61), based on testing of either tumor tissue or liquid biopsy (blood or plasma) as determined by the local laboratory\n\nExclusion Criteria:\n\nParticipants are excluded from the study if they meet any of the following criteria:\n\n* Participants who have prior RAS-targeted therapy, including, but not limited to, KRAS mutation-specific inhibitors (with the exception of participants with NSCLC and colorectal cancer who received a G12C inhibitor), pan-KRAS inhibitors, and pan-RAS inhibitors.\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment.\n* Participants who are unable to comply with the requirements of the protocol.\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastases\n* Participants with any malignancy ≤ 3 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).\n* Participants with active hepatitis C.\n* Participants with medical history of untreated Human Immunodeficiency Virus infection.\n\nNote: Other protocol defined criteria may apply.",{"count":585,"type":21},100,[24],"The purpose of this study is to test if the BG-85738 is safe and if it works in patients with advanced solid tumors with RAS mutations when it is given on its own and in combination.",[589,145,427],"RAS Mutation","2026-07-30",{"date":592,"type":48},"2026-08-04",{"date":594,"type":21},"2026-09-04",{"date":248,"type":21},{"name":54,"class":55},{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":22,"phases":605,"briefSummary":606,"conditions":607,"keywords":610,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":4},"100649327","phase-2-a-study-investigating-alternate-schedules-of-tislelizumab-plus-chemotherapy-in-japanese-patients-with-first-line-advanced-escc-100649327","NCT07733180","A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC","A Phase 2 Study of Tislelizumab Administered With Alternative Dosing Schedules Plus Chemotherapy as First-line Treatment in Japanese Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Able to provide written informed consent by the participant or by the participants' legally acceptable representative and can understand and agree to comply with the requirements of the study\n* Histologically confirmed, unresectable locally advanced, recurrent or metastatic ESCC not amenable to curative approaches such as definitive chemoradiation or surgery.\n* No previous systemic therapy for unresectable locally advanced, recurrent or metastatic ESCC\n* At least 1 measurable lesion per RECIST v1.1 as determined by investigator\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1\n* Adequate organ function as indicated by the laboratory values ≤ 14 days prior to the first dose of study drugs\n* Females of childbearing potential must have a negative urine or serum pregnancy test≤ 7 days prior to the first dose of study drugs and be willing to use a highly effective method of birth control for the duration of the study until at least 120 days after the last dose of tislelizumab. Further contraception requirements after completing chemotherapy should follow the approved product labeling for each specific cytotoxic agent\n\nExclusion Criteria:\n\n* Participants who are unable to comply with the requirements of the protocol\n* Participants with evidence of esophageal or gastroesophageal perforation or fistula ( esophageal\u002Fbronchial or esophageal\u002Faorta), or complete esophageal obstruction not amenable to treatment within 6 months prior to the first dose of study drugs\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention) and\u002For diuretics within 7 days prior to the first dose of study drugs (the cytological confirmation of any effusion is permitted)\n* Have an estimated life expectancy \\\u003C 3 months, per the judgment of the investigator\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Prior therapy with anti-programmed death protein-1 (anti-PD-1), anti-programmed death protein ligand-1(anti-PD-L1), anti-programmed death protein ligand- 2 (anti-PD-L2), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":202,"type":21},[25],"The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of tislelizumab administered once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in combination with chemotherapy as first-line treatment in Japanese participants with previously untreated, unresectable locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC).",[608,609],"Advanced Esophageal Squamous Cell Carcinoma","Metastatic Esophageal Squamous Cell Carcinoma",[611,612,613,614],"ESCC","Metastatic esophageal squamous cell carcinoma","Advanced esophageal squamous cell carcinoma","Japanese population","2026-07-28",{"date":617,"type":48},"2026-07-29",{"date":619,"type":21},"2026-08-31",{"date":621,"type":21},"2028-02-28",{"name":54,"class":55},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":633,"conditions":634,"keywords":640,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":655},"100548972","phase-1-a-phase-1-study-of-bgb-b2033-alone-or-in-combination-with-tislelizumab-with-or-without-bevacizumab-in-participants-with-advanced-or-metastatic-solid-tumors-100548972","NCT06427941","A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors","A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:\n\n   1. Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach.\n   2. Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC with AFP \\> 20 ng\u002FmL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay based on local or central testing.\n   3. Germ cell tumors: Histologically confirmed germ cell tumors including extragonadal yolk sac tumors (e.g., located in the mediastinum, vagina, brain, retroperitoneum), and non-dysgerminomas for which no further curative systemic treatment options exist.\n   4. Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC): Histologically confirmed GPC3-positive squamous NSCLC with prior exposure to a checkpoint inhibitor (CPI).\n2. At least one evaluable lesion for dose escalation, and\n3. At least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n5. Adequate organ function as defined in the protocol.\n6. Provision of tumor tissue samples is required for specified parts of the study.\n\nKey Exclusion Criteria:\n\n1. Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).\n2. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n3. Active autoimmune disease or a history of autoimmune disease with potential for relapse.\n4. Any malignancy diagnosed ≤ 2 years before the first dose of study drug(s), except: The cancer type under investigation in this study, or Locally recurring malignancies previously treated with curative intent.\n5. Requirement for systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of study drug(s).\n6. Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol.\n\nNote: Additional protocol-defined inclusion and exclusion criteria may apply.",{"count":631,"type":21},392,[24],"This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors\u002Fnon-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC).",[635,636,637,638,639],"Metastatic Hepatocellular Carcinoma","Local Advanced Hepatocellular Carcinoma","Alpha-fetoprotein (AFP)-Producing Gastric Cancer","Extragonadal Yolk Sac Tumors","Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer",[641,642,643,644,645,646,647,648],"GPC-3","GPC3-positive squamous non-small cell lung cancer","BGB-B2033","tislelizumab","hepatocellular carcinoma","alpha-fetoprotein (AFP)-producing gastric cancer","extragonadal yolk sac tumors","Bevacizumab",{"date":617,"type":48},{"date":651,"type":48},"2024-07-23",{"date":653,"type":21},"2028-05-30",{"name":54,"class":55},48,""]