[{"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:":597},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,51,78,102,126,149,172,193,216,227,252,263,287,311,333,355,377,404,432,457,481,504,528,552,574],{"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":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100054019","phase-1-a-study-of-bgb-11417-in-participants-with-myeloid-malignancies-100054019",false,"NCT04771130","A Study of BGB-11417 in Participants With Myeloid Malignancies","A Phase 1b\u002F2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:\n\n   * AML, nonacute promyelocytic leukemia\n   * MDS\n   * MDS\u002FMPN\n2. Eastern Cooperative Oncology Group performance status of 0 to 2.\n3. Adequate organ function defined as:\n\n   * Creatinine clearance ≥ 50 milliliters\u002Fminute (mL\u002Fmin) (or between 30 and 49 mL\u002Fmin in unfit AML cohort)\n   * Adequate liver function\n4. Life expectancy of \\> 12 weeks.\n5. Ability to comply with the requirements of the study.\n\nKey Exclusion Criteria:\n\n1. A diagnosis of acute promyelocytic leukemia.\n2. History of prior malignancy, with the exception of either a history of MDS or MDS\u002FMPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)\n3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n4. Prior therapy with a B-cell lymphoma-2 inhibitor\n5. Known central nervous system involvement by leukemia.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS\u002Fmyeloproliferative neoplasm (MPN) .",[28,29,30],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Myelodysplastic\u002FMyeloproliferative Neoplasm",[32,33,34,35,36,37],"BGB-11417","Azacitidine","Posaconazole","AML","MDS","MDS\u002FMPN","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2021-05-24",{"date":46,"type":21},"2028-02-08",{"name":48,"class":49},"BeOne Medicines","INDUSTRY",46,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100053834","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-100053834","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":59,"type":21},300,[61],"PHASE3","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.",[64,65],"Mantle Cell Lymphoma","B Cell Lymphoma",[67,68,69,70,32],"mantle cell lymphoma","MCL","relapsed\u002Frefractory mantle cell lymphoma","sonrotoclax",{"date":41,"type":42},{"date":73,"type":42},"2025-03-05",{"date":75,"type":21},"2032-03-30",{"name":48,"class":49},155,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100053849","phase-1-an-investigational-study-of-bgb-58067-as-a-single-agent-and-in-combination-with-anticancer-agents-in-participants-with-advanced-solid-tumors-100053849","NCT06589596","An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors","A Phase 1a\u002Fb Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must sign the ICF and be capable of giving written informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70\n* Life expectancy ≥ 3 months\n* Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue\n* Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing\n* Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after receiving standard systemic therapy or radiotherapy, or for whom standard systemic therapy is not available or tolerated, or would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor\n* Active leptomeningeal disease or symptomatic spinal cord compression\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage\n* Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively\n* Significantly impaired pulmonary function\n* Clinically significant infections\n* Serologically active hepatitis B or C infection\n* Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria\n* High cardiovascular risk factors\n* QTcF \\> 470 ms based on the screening triplicate 12-lead ECG records and\u002For a history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome)\n* Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized\n* Participants who are unable to swallow or with disease\u002Fprocedure significantly affecting gastrointestinal function\n* Female participants who are pregnant or are breastfeeding\n* Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":86,"type":21},525,[24],"This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.",[90],"Advanced Solid Tumor",[92,93,94],"advanced solid tumor","BGB-58067","MTAP deficiency",{"date":41,"type":42},{"date":97,"type":42},"2025-01-10",{"date":99,"type":21},"2027-09-30",{"name":48,"class":49},96,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100640438","phase-1-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":110,"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.",[114],"Myeloid Malignancy",[116],"KAT6 inhibitor","2026-06-26",{"date":119,"type":42},"2026-06-30",{"date":121,"type":42},"2026-06-23",{"date":123,"type":21},"2028-09-30",{"name":48,"class":49},1,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":125},"100641634","a-study-to-investigate-treatment-patterns-and-effectiveness-of-tislelizumab-in-european-patients-with-resectable-or-advanced-non-small-cell-lung-cancer-nsclc-and-small-cell-lung-cancer-sclc-100641634","NCT07652736","A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC)","A Real-World Evaluation of Tislelizumab Treatment Patterns and Effectiveness in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer and Small Cell Lung Cancer","TITANS","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if they meet all the following criteria:\n\n  1. Participants or their legal representative must sign written inform consent form (ICF)\n  2. Participants receive tislelizumab as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the SmPC, within the approved indications in the 4 cohorts described.\n\nNote: The decision to treat the patient with a tislelizumab-based regimen, as per its authorized indication, must have been made by the treating physician prior to and independent of the patient's consideration for participation in this study.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if they meet any of the following criteria:\n\n  1. Participants who are unable to understand all implications of study participation.\n  2. Participants who have contraindications for treatment with tislelizumab in the investigator's opinion or have any contraindication as listed in the SmPC of tislelizumab.\n  3. Participants who are deemed ineligible according to the investigator's opinion and the SmPC of tislelizumab.",{"count":135,"type":21},440,"OBSERVATIONAL","The purpose of this study is to collect real-world data on treatment patterns and clinical outcomes in European patients receiving tislelizumab in routine clinical practice",[139,140],"Advanced Non-Small Cell Lung Cancer","Extensive-Stage Small Cell Lung Cancer","2026-06-22",{"date":143,"type":42},"2026-06-25",{"date":145,"type":42},"2026-06-05",{"date":147,"type":21},"2030-11-17",{"name":48,"class":49},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100635579","phase-2-a-study-to-evaluate-efficacy-and-safety-of-tislelizumab-plus-chemotherapy-for-locally-advanced-unresectable-or-metastatic-gastric-or-gastroesophageal-adenocarcinoma-and-esophageal-squamous-cell-carcinoma-in-racial-and-ethnic-minority-patients-in-the-united-states-100635579","NCT07554521","A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States","An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients","Inclusion Criteria:\n\n* Self-identifies as a member of racial and\u002For ethnic minority populations as defined by the Food and Drug Administration (FDA), such as Black or African American, Hispanic or Latino, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander\n* Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC\u002FGEA) or esophageal squamous cell carcinoma (ESCC)\n* No previous systemic therapy for locally advanced unresectable or metastatic GAC\u002FGEA or ESCC\n* At least 1 measurable lesion per RECIST v1.1 as determined by investigator assessment\n* Patients must have positive tumor programmed death-ligand 1 (PD-L1) expression. Documented PD-L1 results are acceptable\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1\n* Adequate organ function as indicated by the following laboratory values ≤ 14 days prior to study treatment\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 and ≥ 180 days after the last dose of chemotherapy, and have a negative urine or serum pregnancy test ≤ 7 days prior to study treatment\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 and ≥ 180 days after the last dose of chemotherapy\n\nExclusion Criteria:\n\n* Patient has squamous cell or undifferentiated or other histological type gastric cancer\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 study treatment.\n* Patients with evidence of esophageal\u002Fbronchial or esophageal\u002Faorta fistula, or complete esophageal obstruction not amenable to treatment.\n* Diagnosed with GAC\u002FGEA with positive human epidermal growth factor receptor 2 (HER2). Results of the tumor HER2 testing must be known prior to study treatment\n* Active autoimmune diseases or history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and may proceed to further screening:\n\n  1. Controlled Type I diabetes\n  2. Hypothyroidism (provided it is managed with hormone replacement therapy only)\n  3. Controlled celiac disease\n  4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)\n  5. Any other disease that is not expected to recur in the absence of external triggering factors\n* Any active malignancy ≤ 2 years before study treatment, with the exception of the specific cancer under investigation in this trial or 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* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and\u002For diuretics within 7 days prior to study treatment (the cytological confirmation of any effusion is permitted)\n* Have clinically significant bleeding (Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2) from the GI tract within 1 month prior to study treatment\n* Have a history of gastrointestinal (GI) perforation (CTCAE ≥ Grade 2) and\u002For fistulae (including prior gastric fistula operation) within 6 months prior to study treatment\n* Have a clinically significant bowel obstruction (CTCAE ≥ Grade 2)\n* Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before study treatment.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":157,"type":21},30,[25],"The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC\u002FGEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.",[161,162,163],"Advanced Unresectable Gastric Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Advanced Gastroesophageal Adenocarcinoma","2026-06-18",{"date":141,"type":42},{"date":167,"type":42},"2026-04-30",{"date":169,"type":21},"2031-12-31",{"name":48,"class":49},2,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"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":180,"type":21},351,[61],"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.",[184,185],"Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",{"date":141,"type":42},{"date":188,"type":42},"2025-08-27",{"date":190,"type":21},"2028-04-22",{"name":48,"class":49},94,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},"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":202,"type":21},250,[61],"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).",[206,207],"CLL","Chronic Lymphocytic Leukemia",[206],{"date":141,"type":42},{"date":211,"type":42},"2025-04-10",{"date":213,"type":21},"2030-02-14",{"name":48,"class":49},120,{"id":217,"slug":4,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":62,"conditions":220,"keywords":221,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":224,"leadSponsor":225,"locationsCount":226},"100573185",{"count":59,"type":21},[61],[64,65],[67,68,69,70,32],{"date":141,"type":42},{"date":73,"type":42},{"date":75,"type":21},{"name":48,"class":49},152,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},"100564162","phase-1-a-first-in-human-fih-study-of-bg-c137-an-anti-fibroblast-growth-factor-receptor-2b-fgfr2b-antibody-drug-conjugate-in-participants-with-advanced-solid-tumors-100564162","NCT06625593","A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors","A Phase 1a\u002Fb, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced or metastatic solid tumors.\n2. Life expectancy of ≥ 3 months.\n3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Combo Dose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who have received at least 1 or 2 prior lines of systemic therapy, which included a fluoropyrimidine and\u002For a platinum in the advanced or metastatic setting\n4. Tumors with FGFR2b expression\u002F or FGFR2 gene amplification. Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and other biomarker assessments.\n5. ≥ 1 measurable lesion per RECIST v1.1.\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n7. Adequate organ function as determined per protocol.\n\nExclusion Criteria:\n\n1. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.\n2. Active or chronic corneal disorder, history of corneal transplantation, corneal keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n4. Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives \\[whichever is shorter\\] for chemotherapy, ADCs, or investigational therapy) before first dose of study drug(s).\n5. Toxicities due to prior therapy that have not recovered.\n6. Any malignancy ≤ 2 years before 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.\n7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest \\\u003C 92%, or requirement for supplemental oxygen at baseline.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":235,"type":21},168,[24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).",[90],[240,90,241,242,243,244],"BG-C137","First-in-human","FGFR2b","ADC","Fibroblast growth factor receptor 2b",{"date":141,"type":42},{"date":247,"type":42},"2024-12-09",{"date":249,"type":21},"2026-12-31",{"name":48,"class":49},53,{"id":253,"slug":4,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":88,"conditions":256,"keywords":257,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":260,"leadSponsor":261,"locationsCount":262},"100561394",{"count":86,"type":21},[24],[90],[92,93,94],{"date":141,"type":42},{"date":97,"type":42},{"date":99,"type":21},{"name":48,"class":49},92,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"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":271,"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.",[275],"Advanced Solid Tumors",[277,278,279],"BG-C477","advanced solid tumors","CEA ADC",{"date":141,"type":42},{"date":282,"type":42},"2024-10-03",{"date":284,"type":21},"2027-12-31",{"name":48,"class":49},54,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":157},"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":296,"type":21},1056,[61],"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.",[300],"HR+\u002FHER2- Breast Cancer",[302,303],"CDK4 inhibitor","CDK4\u002F6 inhibitor","2026-06-17",{"date":164,"type":42},{"date":307,"type":42},"2026-05-22",{"date":309,"type":21},"2037-08-07",{"name":48,"class":49},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"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-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 inhibitor as payload.\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":319,"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).",[90],[324,325],"ADAM9 (disintegrin and metalloproteinase 9)","antibody-drug conjugate",{"date":164,"type":42},{"date":328,"type":42},"2026-04-13",{"date":330,"type":21},"2029-04-30",{"name":48,"class":49},13,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":354},"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":341,"type":21},500,[61],"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).",[207],[346,347],"B-cell Lymphoma-2 Inhibitor","Bruton Tyrosine Kinase Inhibitor",{"date":164,"type":42},{"date":350,"type":42},"2026-01-22",{"date":352,"type":21},"2031-11",{"name":48,"class":49},77,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":376},"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":341,"type":21},[61],"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).",[207,366],"Small Lymphocytic Lymphoma",[368,369],"Noncovalent Bruton tyrosine kinase inhibitor","Bruton tyrosine kinase-targeted protein degrader",{"date":164,"type":42},{"date":372,"type":42},"2025-09-04",{"date":374,"type":21},"2028-04-17",{"name":48,"class":49},167,{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":391,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"100574257","phase-1-bgb-21447-bcl-2-inhibitor-combinations-for-adults-with-hormone-receptor-positive-hrhuman-epidermal-growth-factor-receptor-2-negative-her2--metastatic-breast-cancer-100574257","NCT06756932","BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)\u002FHuman Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer","A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+\u002FHER2- Metastatic Breast Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed HR+\u002FHER2- metastatic breast cancer. Part 1A and 1B: Participants must have received ≥ 1 prior line(s) of treatment for advanced\u002Fmetastatic disease, including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting. Part 2: Participants must have received 1-3 prior line(s) of treatment for advanced\u002Fmetastatic disease, including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Female participants will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal.\n* Male participants may be required to use GnRH agonists when being treated with fulvestrant at the discretion of the investigator.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n* Female participants of childbearing potential and nonsterile male participants with female partners of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for 7 days after the last dose of BGB-21447, 6 months after the last dose of BGB-43395, and 2 years after the last dose of fulvestrant.\n* Food effect substudy only: Participants who are able and willing to fast overnight (≥ 10 hours) and consume a high-fat meal.\n\nExclusion Criteria:\n\n* Prior Bcl-2 inhibitor exposure. For triplet combination cohorts only: Prior therapy selectively targeting CDK4.\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, treated papillary thyroid carcinoma, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* For Part 1B: Uncontrolled diabetes.\n* History of hepatitis B or active Hepatitis C infection\n* China Only: Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \\> 500 IU\u002Fml (or \\> 2500 copies\u002Fml) at screening.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":215,"type":21},[24],"This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia\u002Flymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+\u002FHER2- metastatic breast cancer.",[388,389,390],"Hormone-receptor-positive Breast Cancer","HER2-negative Breast Cancer","Metastatic Breast Cancer",[392,393,394,395,396],"BGB-21447","BGB-43395","metastatic breast cancer","Bcl-2i","CDK4i",{"date":141,"type":42},{"date":399,"type":42},"2025-02-04",{"date":401,"type":21},"2027-07-30",{"name":48,"class":49},14,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":419,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100447009","phase-3-a-study-of-zanubrutinib-plus-anti-cd20-versus-lenalidomide-plus-rituximab-in-participants-with-relapsedrefractory-follicular-or-marginal-zone-lymphoma-100447009","NCT05100862","A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed\u002FRefractory Follicular or Marginal Zone Lymphoma","A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed\u002FRefractory Follicular or Marginal Zone Lymphoma","MAHOGANY","Key Inclusion Criteria:\n\n* Histologically confirmed grade 1-3a FL or MZL\n* Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy\n* Need for systemic therapy for FL or MZL\n* Measurable disease by computed tomography or magnetic resonance imaging\n* Adequate bone marrow, liver and renal function\n\nKey Exclusion Criteria:\n\n* Transformation to aggressive lymphoma\n* Requiring ongoing need for corticosteroid treatment\n* Clinically significant cardiovascular disease\n* Prior malignancy within the past 2 years\n* Active fungal, bacterial, and\u002For viral infection that requires systemic therapy\n* Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (\\\u003C 24 months)\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":413,"type":21},780,[61],"The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\\^2) in participants with relapsed\u002Frefractory (R\u002FR) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET\u002FCT), and to compare the efficacy of zanubrutinib plus rituximab versus R\\^2 in participants with R\u002FR marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.",[417,418],"Relapsed\u002FRefractory Follicular Lymphoma","Marginal Zone Lymphoma",[420,421,422,423,424],"Zanubrutinib","BGB-3111","Rituximab","Lenalidomide","Obinutuzumab",{"date":164,"type":42},{"date":427,"type":42},"2022-03-10",{"date":429,"type":21},"2030-06",{"name":48,"class":49},277,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":456},"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 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":441,"type":21},645,[24,25],"Study consists of two main parts to explore BGB-16673 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)",[445,418,446,447,448,207,366,64,449],"B-cell Malignancy","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Diffuse Large B Cell Lymphoma",{"date":164,"type":42},{"date":452,"type":42},"2021-09-13",{"date":454,"type":21},"2029-11",{"name":48,"class":49},127,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":464,"sex":17,"minAge":18,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":125},"100641483","phase-1-a-study-to-investigate-the-effect-of-the-cyp3a-inducer-phenytoin-and-the-cyp3a-inhibitor-itraconazole-on-the-pharmacokinetics-of-bgb-58067-in-healthy-participants-100641483","NCT07590102","A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants","An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants","Inclusion Criteria:\n\n* Participants 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 and in this protocol\n* Participants must be willing and able to comply with all study requirements.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, clinical laboratory assessments, vital sign measurements,12-lead electrocardiogram (ECG), and physical examination at screening and check-in as determined by the investigator, with additional requirements as follows:\n\n  a. Body Mass Index (BMI) of 18.0 to 32.0 kg\u002Fm2 inclusive.\n* Female participants must be of no childbearing potential. Note: A female participant is considered of 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 3 months after the last dose of BGB-58067. An additional highly effective method of birth control is highly recommended for the duration of the study and for 3 months 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* Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients\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 not an exclusion criterion unless it is active\n* Significant serious skin disease as judged by the investigator, including rash, food allergy, eczema, psoriasis, or urticaria\n* History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory, or gastrointestinal (GI) disease; neurological or psychiatric (including suicidal ideation or behavior) disorder; or severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), as judged by the investigator.\n* Participants with a history of cholecystectomy or gall stones\n* Poor venous access that limits phlebotomy\n* Positive highly sensitive serum pregnancy test at screening, and positive highly sensitive urine test at admission.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",true,"65 Years",{"count":157,"type":21},[24],"This study is being done to understand how the body processes the study drug (BGB-58067) when it is taken together with other medicines.\n\nBGB-58067 is mainly broken down in the body by a liver enzyme called CYP3A. Some medicines can affect how this enzyme works. For example, certain medicines can increase the production of the enzyme (called inducers), while others can block or inhibit its activity (called inhibitors). This may change how much of the study drug is present in the bloodstream.\n\nIn this study, we will give BGB-58067 together with two commonly used medicines:\n\n* Part A: Phenytoin (inducer), which can increase the production of the enzyme, and\n* Part B: Itraconazole (inhibitor), which can inhibit the activity of the enzyme.",[470],"Healthy Volunteers",[93,472,473],"Pharmacokinetics","Drug-Drug Interaction (DDI)","2026-06-16",{"date":304,"type":42},{"date":477,"type":21},"2026-06-04",{"date":479,"type":21},"2026-09-30",{"name":48,"class":49},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":493,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":503},"100569664","phase-1-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":489,"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.",[207,206,64,68],[494,495],"CLL previously untreated","Hematological Malignancies",{"date":497,"type":42},"2026-06-08",{"date":499,"type":42},"2025-01-23",{"date":501,"type":21},"2032-11-30",{"name":48,"class":49},17,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":527},"100534062","phase-1-phase-1a1b-first-in-human-study-of-bg-c9074-alone-and-in-combination-with-other-anticancer-therapies-in-patients-with-advanced-solid-tumors-100534062","NCT06233942","Phase 1a\u002F1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors","Phase 1a\u002F1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n3. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy and whose cancer is not amenable to therapy with curative intent, and for whom further treatment is not available or not tolerated. Enrollment will be limited to participants with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) breast cancer, cholangiocarcinoma (CCA), endometrial cancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited to participants with HR+\u002FHER2- breast cancer, TNBC, endometrial cancer, or ovarian cancer.\n4. ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)\n5. Able to provide an archived tumor tissue sample.\n6. Adequate bone marrow and organ function.\n7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).\n8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).\n\nExclusion Criteria:\n\n1. Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.\n2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n3. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \\\u003C 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.\n5. Uncontrolled diabetes.\n6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":512,"type":21},308,[24],"This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.",[90],[517,518,275,519,520],"BG-C9074","Tislelizumab","first-in-human","B7H4",{"date":145,"type":42},{"date":523,"type":42},"2024-04-12",{"date":525,"type":21},"2028-05-15",{"name":48,"class":49},37,{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":540,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":551},"100588628","phase-3-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":536,"type":21},630,[61],"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.",[207,366],[541,542,543],"B-cell lymphoma 2 inhibitor (BCL-2i)","CLL-RR1","German CLL Study Group","2026-06-03",{"date":477,"type":42},{"date":547,"type":42},"2025-06-11",{"date":549,"type":21},"2031-12",{"name":48,"class":49},173,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":464,"sex":17,"minAge":18,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":563,"conditions":564,"keywords":565,"overallStatus":567,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":571,"leadSponsor":573,"locationsCount":4},"100640210","phase-1-a-study-to-investigate-the-relative-bioavailability-and-food-effect-of-tablet-for-oral-suspension-of-sonrotoclax-in-healthy-adults-100640210","NCT07628881","A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy Adults","A Phase 1, Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Participants to Evaluate Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax","Inclusion Criteria:\n\n* Participants 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 and in this protocol.\n* Participants who are overtly healthy as determined by no clinically significant findings from medical history, clinical laboratory assessments, vital sign measurements, 12-lead electrocardiogram (ECG), and physical examination at screening and check-in as determined by the Investigator, with additional requirements as follows:\n* Body mass index (BMI) of 18.0 to 32.0 kg\u002Fm2 inclusive.\n* An absolute B-cell count of \\> 150 cells per microliter (cells\u002FμL). If the B-cell count is \\\u003C 150 cells\u002FμL, the assessment will be repeated. If the repeat value is \\> 150 cells\u002FμL, the participant may be enrolled after consultation with the medical monitor.\n* Female participants of non-childbearing potential who meet any of the following criteria:\n* Surgically sterile (ie, through tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy).\n* Postmenopausal, defined as: with no spontaneous menses for ≥ 12 months in the absence of prior chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone (FSH) in the postmenopausal range.\n* Male participants are eligible if vasectomized or if they agree to the use of barrier contraception with other highly effective methods if sexually active with women of childbearing potential, during study treatment and for at least 7 days after the last dose of study treatment\n\nExclusion Criteria:\n\n* Significant medical history or conditions: significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator or designee.\n* Investigator discretion: participants who, in the opinion of the Investigator or designee, should not participate in the study for any other reason.\n* Hypersensitivity or allergies: history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the Investigator or designee.\n* Stomach or intestinal surgery: history of gastrointestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).\n* Surgery or trauma: major surgical procedure or significant traumatic injury within 3 months prior to check-in or anticipation of the need for major surgery during the study.\n* Medications affecting drug metabolism: use or intent to use any medications\u002Fproducts known to alter drug absorption, metabolism, or elimination processes, including St.John's wort, moderate\u002Fstrong CYP3A inhibitors or inducers, or P-glycoprotein (P-gp)\u002Fbreast cancer resistance protein (BCRP) inhibitors, within 30 days prior to dosing\n* Infections: evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeks prior to the first dose of study treatment, as determined by the Investigator (or designee).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","60 Years",{"count":561,"type":21},12,[24],"The purpose of this study is to evaluate whether blood levels of sonrotoclax after administration of a tablet for oral suspension are similar to those observed with the current sonrotoclax tablet. In addition, this study evaluates the effect of food on the absorption of sonrotoclax after administration of the tablet for oral suspension and the resulting blood levels of sonrotoclax.",[470],[32,566],"Sonrotoclax","NOT_YET_RECRUITING","2026-06-01",{"date":145,"type":42},{"date":164,"type":21},{"date":572,"type":21},"2026-09-27",{"name":48,"class":49},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":586,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":596},"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":582,"type":21},105,[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.",[90],[587,588,589,302],"Cyclin-Dependent Kinase 2- Targeted Protein Degrader","CDK2","CDK4",{"date":544,"type":42},{"date":592,"type":42},"2025-12-11",{"date":594,"type":21},"2028-11-01",{"name":48,"class":49},21,""]