[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ascentage Pharma Group Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":617},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,41,70,97,122,146,172,202,227,251,274,295,327,348,373,396,422,443,467,490,512,532,558,580,601],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100524119","phase-3-global-trial-in-apg2575-for-patients-with-cllsll-100524119",false,"NCT06104566","Global Trial in APG2575 for Patients With CLL\u002FSLL","A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (GLORA Study)","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients that have documented CLL\u002FSLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months\n3. ECOG Performance Status grade 0-2\n4. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:\n\n   * Absolute neutrophil count ≥ 1.0 × 109\u002FL\n   * Platelet counts ≥ 75 × 109\u002FL; in cases of thrombocytopenia\n   * Total hemoglobin ≥ 9 g\u002FdL,\n5. Adequate renal function\n\n   * Creatinine clearance must be \\> 50 ml\u002Fmin directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)\u002F(72 x creatinine), for women x 0.85) or an equally accurate method.\n   * For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml\u002Fmin may be eligible if a repeat estimate after adequate hydration is \\> 50 ml\u002Fmin.\n6. Adequate liver function as indicated by:\n\n   * Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome\n   * Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value\n   * Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,\n   * International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.\n7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements","ALL","18 Years","99 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL\u002FSLL patients who previously treated with BTK inhibitors",[27],"CLL\u002FSLL","RECRUITING","2026-06-16",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":34,"type":32},"2023-12-20",{"date":36,"type":21},"2027-10-31",{"name":38,"class":39},"Ascentage Pharma Group Inc.","INDUSTRY",135,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100400967","phase-1-study-of-lisaftoclax-apg-2575-single-agent-and-combination-with-therapy-in-patients-relapsedrefractory-aml-100400967","NCT04501120","Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed\u002FRefractory AML","A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed\u002FRefractory AML","Inclusion Criteria:\n\nSubjects who meet each of the following inclusion criteria are eligible to participate in this study:\n\n1. In accordance with the World Health Organization (WHO) 2016 diagnostic criteria for relapsed or refractory acute myeloid leukemia (AML), Mixed phenotype acute leukemia(MPAL), Chronic myelomonocytic leukemia (CMML), Higher-risk myelodysplastic syndrome (HR-MDS) , Blastic plasmacytoid dendritic cell neoplasm (BPDCN) and naïve AML ineligible for treatment with a standard chemotherapy due to age or comorbidities.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2 (0 to 3 for participants \\>= 60 to 74 years of age who are evaluated as ineligible for treatment with standard chemotherapy).\n3. Subjects can accept oral administration of Lisaftoclax (APG-2575).\n4. Life expectancy ≥ 3 months.\n5. Adequate renal and liver function.\n6. Males, female patients of childbearing potential (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take contraception which the investigator considers effective during treatment and at least three months after the last dose of study drug.\n7. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).\n8. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria are not to be enrolled in this study:\n\n1. Patients diagnosed with acute promyelocytic leukemia or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML patients.\n2. The persistent toxicities caused by previous chemotherapy or radiotherapy has not been restored to lower than grade 2 by CTCAE 5.0 (except for alopecia).\n3. Known leukemia infiltration of the central nervous system.\n4. Symptomatic active fungal, bacterial and\u002For viral infections.\n5. Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy, autologous hematopoietic stem cell transplantation within 12 months.\n6. Within 14 days before the first dose of study drug, received chemotherapy (hydroxyurea is permitted more than 24 hours before the first dose of study drug), radiotherapy, surgery, immunotherapy, targeted therapy, biological therapy or any investigational treatment.\n7. Within 7 days before the first dose of study drug, received a strong and\u002For moderate CYP3A inducer and\u002For Inhibitor.\n8. At the discretion of the investigator, gastrointestinal diseases that affect the absorption of Lisaftoclax (APG-2575).\n9. Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.",{"count":49,"type":21},682,[51,52],"PHASE1","PHASE2","The purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT\u002FAZA in patients with relapsed\u002Frefractory AML and related myeloid malignancies.",[55,56],"Relapsed\u002FRefractory Acute Myeloid Leukaemia","Myeloid Malignancy",[58,59,56,60],"Acute Myeloid Leukaemia (AML)","Bcl-2 Inhibitor","Lisaftoclax (APG-2575)","2026-04-27",{"date":63,"type":32},"2026-04-29",{"date":65,"type":32},"2020-09-28",{"date":67,"type":21},"2029-09",{"name":38,"class":39},12,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100520042","phase-3-a-study-of-olverembatinib-in-patients-with-newly-diagnosed-ph-all-polaris-1-100520042","NCT06051409","A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)","A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL","Inclusion Criteria:\n\n1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)\n2. Expected survival of at least 3 months\n3. ECOG ≤ 2\n4. Adequate organ function\n\nExclusion Criteria:\n\n1. A history of chronic myeloid leukemia (CML)\n2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly\n3. Previous or current clinical CNS diseases\n4. Autoimmune diseases that may involve the CNS\n5. Use of therapeutic doses of anticoagulants and\u002For antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed\n6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug\n7. Uncontrolled heart diseases\n8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism\n9. Use of prohibited drugs\n10. Disease or medical condition that is unstable or may affect its safety or compliance with the study\n11. Use of medications known to cause prolonged QT interval\n12. Active infections requiring systemic treatment\n13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer\n14. Contraindications to the use of glucocorticoids\n15. Bleeding disorders unrelated to ALL\n16. Plan to undergo major surgery\n17. Allergy to drug ingredients, excipients, or their analogues in the study\n18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period\n19. Other malignant tumors within 2 years\n20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study",{"count":78,"type":21},350,[24],"A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).",[82,83],"Ph+ ALL","Leukemia, Lymphoblastic, Acute, Philadelphia-Positive",[82,85,86,87],"Olverembatinib","Acute lymphoblastic leukemia","Bcr-Abl Tyrosine Kinase","2026-04-24",{"date":90,"type":32},"2026-04-30",{"date":92,"type":32},"2023-08-31",{"date":94,"type":21},"2029-06-30",{"name":38,"class":39},90,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100498694","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-apg-5918-100498694","NCT05773586","A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.","A Phase 1, Ascending Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of APG-5918 in Healthy Volunteers and Patients With Anemia.","Inclusion Criteria:\n\n1. Healthy Subjects:\n\n1\\. Age: 18 to 55 years. 2. Body Mass Index (BMI): 18-28 kg\u002Fm² (inclusive). 3. Hemoglobin value: 120 g\u002FL-160 g\u002FL (inclusive). 4. Normal body iron stores. 2. Anemic Subjects:\n\n1. Age: ≥ 18 years.\n2. Including beta-thalassemia and other related anemias, with screening Hb ≤ 100.0 g\u002FL.\n3. Body weight ≥ 40 kg.\n4. Serum folate and vitamin B12 levels above the lower limit of normal (LLN).\n5. ALT, AST ≤ 2×ULN, and direct (unconjugated) total bilirubin (DBIL) ≤ 2×ULN. Higher levels may be accepted after excluding other diseases based on investigator judgment.\n6. No active or chronic bleeding.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n\n3\\. For female subjects of childbearing potential, a negative blood or urine pregnancy test within 7 days prior to the first dose.\n\n4\\. Subjects and their partners must voluntarily agree to use effective contraceptive measures as required by the protocol during the treatment period and for at least 3 months after the last dose of study drug.\n\n5\\. Ability to understand and voluntarily sign a written informed consent form, which must be signed before any trial-specific procedures are performed.\n\nExclusion Criteria -\n\n1\\. Healthy Subjects:\n\n1. History of any disease or clinical condition that, in the investigator's opinion, may confound the study results or pose additional risk to the subject with administration of the study drug.\n2. ALT or AST \\> 2×ULN, or TBIL \\> 1.5×ULN at screening.\n3. Undergone surgery (excluding minor cosmetic or dental procedures) within 3 months prior to screening.\n4. Blood donation or blood loss exceeding 400 mL within 3 months prior to screening, or planned donation of blood or blood components during the study period.\n5. Use of another investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing, or current participation in a prospective study of an investigational product or medical device.\n6. History of substance abuse within 6 months prior to screening.\n7. Positive alcohol breath test.\n\n2\\. Anemic Subjects:\n\n1. Presence of clinically significant or uncontrolled ongoing autoimmune disease.\n2. Severe cardiac disease.\n3. Severe renal disease, defined as estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m², or dependence on dialysis.\n4. Active malignancy, history of cancer, or presence of a known or suspected familial cancer syndrome in linealrelatives.\n5. A history of persistent hemolysis or hemolytic syndrome due to causes other than the study diseases.\n6. A history of thrombosis or newly developed thrombus within 4 weeks prior to screening.\n7. Receipt of intravenous iron supplementation within 28 days prior to first dosing.\n8. Any active infection requiring systemic antibiotic therapy (including oral, intravenous, or intraperitoneal administration) within 14 days prior to first dosing.\n9. A history of organ transplantation.\n10. Any condition that may affect drug absorption.\n11. Participation in another clinical study and still using another investigational products, or without completion of a washout period of at least 5 half-lives within 4 weeks prior to first dosing.\n12. Receipt of cytotoxic agents, high-dose systemic corticosteroids, immunosuppressive agents, or anticoagulant therapy such as warfarin within 28 days prior to first dosing.\n\n3\\. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody at screening.\n\n4\\. A history of regular alcohol consumption within 6 months prior to screening, defined as an average daily intake of ≥30 grams (for males) or ≥20 grams (for females) of ethanol.\n\n5\\. Standard 12-lead ECG with QTcB \\> 450 ms for males or QTcB \\> 470 ms for females.\n\n6\\. Female subjects who are pregnant, planning to become pregnant, or breastfeeding; or male subjects whose partners are planning to become pregnant.\n\n7\\. Any subject deemed unsuitable for participation in this study based on the investigator's judgment.",true,{"count":106,"type":21},105,[51],"The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.",[110],"Anemia",[112,110],"APG-5918","2026-04-12",{"date":115,"type":32},"2026-04-15",{"date":117,"type":32},"2023-03-13",{"date":119,"type":21},"2028-07-15",{"name":38,"class":39},2,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100331374","phase-1-a-study-of-hqp1351-in-patients-with-gist-or-other-solid-tumors-100331374","NCT03594422","A Study of HQP1351 in Patients With GIST or Other Solid Tumors","A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.","Inclusion Criteria:\n\n1. Male or not pregnant or lactating women, age≥12years.\n2. Advanced and\u002For metastatic GIST or other solid tumors, confirmed by histology and\u002For cytology. GIST patients must be primary resistant to imatinib (tumor progresses within 6 months first-line imatinib treatment, or succinate dehydrogenase B (SDHB) deficient confirmed by immunohistochemistry, or NF1 mutation), OR imatinib or imatinib and at least one other TKI treatment failure (after imatinib or other TKI treatment for more than 6 months, tumor progress again after achieving tumor remission or stability).\n3. ECOG≤ 2.\n4. Estimated survival at least 3 months.\n5. Adequate hematologic and bone marrow functions.\n6. Adequate renal and liver function.\n7. Heart function index:\n\n   * Troponin(I\u002FT) ≤ Upper Limit of Normal;\n   * Ejection fraction \\>40%;\n   * QTc interval ≤ 450 ms in male or ≤ 470 ms in female.\n8. Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour prior to the first dose of investigational product.\n9. Willing to use contraception by a method that is deemed effective by the investigator by Subject and their partners throughout the treatment period and for at least 30 days following the last dose of study drug.\n10. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).\n11. Willing and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\n1. Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half- time before first dose of HQP1351.\n2. Received any TKIs within 14 days before first dose of HQP1351.\n3. Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.\n4. Have not recovered (\\> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.\n5. Malabsorption syndrome or other diseases that affect the absorption of oral drugs.\n6. Cardiovascular diseases of clinical significance, uncontrollable or active, including but not limited to: history of myocardial infarction; unstable history of angina pectoris; a history of congestive heart failure or lower left ventricular ejection fraction (LVEF) than normal limit within 6 months; the history of atrial arrhythmias was judged by the researchers to have important clinical significance; history of ventricular arrhythmias, etc.\n7. Hypertension was still poorly controlled after medication treatment (SBP \\> 140 mmHg and\u002For DBP \\> 90 mmHg).\n8. Concurrent use any medication led to prolong QT interval.\n9. Pulmonary mean arterial pressure\\>35 mmHg by ECHO.\n10. Significant severe cardiovascular conditions during previous TKI treatment.\n11. Uncontrollable hypertriglyceridemia.\n12. Performed major surgery (except for intravenous catheterization or bone marrow biopsy) within 14 days of first dose of HQP1351.\n13. Arterial thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, TIA), or venous thrombosis events or pulmonary embolism within 6 months before the first dose of HQP1351 or deep vein thrombosis within 3 months before the first dose of HQP1351.\n14. Brain metastasis.\n15. Had other primary malignant tumors in the last three years (exception of the tumors being cured for 5 years or more, or complete removal of non-melanoma skin cancer or successful treatment of carcinoma in situ, or the controlled prostate cancer).\n16. Had active, symptomatic infections (including known infections of HIV, viral hepatitis (A, B, or C)). If there is no history of infection, screening is not required.\n17. Subjects who are known to be allergic to pharmaceutical ingredients or their analogs.\n18. Pregnancy or lactation, or expect to be pregnant during the study period.\n19. According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may jeopardize the safety or safety assessment of the subject.\n20. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.","12 Years",{"count":131,"type":21},100,[51],"This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK\u002FPD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.",[135,136],"Gastrointestinal Stromal Tumor (GIST)","Solid Tumor, Adult","2026-04-06",{"date":139,"type":32},"2026-04-09",{"date":141,"type":32},"2018-07-11",{"date":143,"type":21},"2028-12",{"name":38,"class":39},6,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100450590","phase-2-study-of-apg-2575-in-patients-with-relapsedrefractory-cllsll-100450590","NCT05147467","Study of APG-2575 in Patients With Relapsed\u002FRefractory CLL\u002FSLL","A Single-arm, Pivotal Registration Phase II Study of the Efficacy and Safety of APG-2575 Monotherapy in Relapsed or Refractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\nSubjects who meet each of the following inclusion criteria are eligible to participate in this study:\n\n1. Age ≥18 years old.\n2. Pathologically confirmed CLL\u002FSLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL.\n3. Expected survival is at least 12 weeks.\n4. Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2.\n6. Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures).\n7. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria are not to be enrolled in this study:\n\n1. Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 24 months.\n2. Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.\n3. Received Bcl-2 inhibitor treatment.\n4. Invasive NHL transformation or central nervous system (CNS) involvement has occurred.\n5. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.\n6. Within 2 years before entering the study, the subject had a history of active malignant tumors other than CLL \u002F SLL, except that:\n\n   * Fully treated cervical carcinoma in situ;\n   * Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n   * Confinement and resection of previously cured malignancies (or other treatment).\n7. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.",{"count":154,"type":21},75,[52],"The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed\u002Frefractory CLL\u002FSLL.",[158,159],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma",[158,159,161,162],"APG-2575","Lisaftoclax","2026-03-24",{"date":165,"type":32},"2026-03-27",{"date":167,"type":32},"2021-12-28",{"date":169,"type":21},"2027-12",{"name":38,"class":39},11,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":191,"overallStatus":193,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":121},"100625607","phase-1-a-study-of-apg-3288-in-relapsedrefractory-blood-cancers-100625607","NCT07424833","A Study of APG-3288 in Relapsed\u002FRefractory Blood Cancers","A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of APG-3288 in Patients With Relapsed\u002FRefractory Hematological Malignancies","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) status ≤ 1 in Part 1 (dose escalation), and ≤ 2 in Part 2 (dose expansion).\n* Part 1 (Dose Escalation): histologically or cytologically confirmed diagnosis of R\u002FR CLL\u002FSLL, DLBCL (including Richter Transformation), MCL, WM, MZL, or FL.\n* Prior systemic therapy: at least 2 prior lines of systemic therapy (including BTK inhibitor for approved indications) and who have failed or are not eligible for available therapies with established clinical benefit.\n* Measurable disease per response criteria specific to the malignant condition.\n* Adequate organ and bone marrow function.\n\nKey Exclusion Criteria:\n\n* Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, with the exception of hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels).\n* Any investigational therapy within 14 days prior to the first dose of study drug or within 5 half-lives of the respective investigational drug (whichever is shorter).\n* Persistent toxicities from prior radiotherapy, targeted therapy, immunotherapy, or chemotherapy agents that have not recovered to Grade \\\u003C2 (except for alopecia or vitiligo).\n* Symptomatic brain metastases due to tumor involvement of the central nervous system (CNS). Patients with CNS tumors who have been treated, are asymptomatic, and who have discontinued steroids (for the treatment of CNS tumors) for \\> 28 days may be enrolled.\n* Use of therapeutic-dose anticoagulants or antiplatelet agents. (Use of low-dose anticoagulants to maintain central venous catheter patency is permitted)\n* Biological growth factors within 7 days prior to the first dose of study drug.\n* Patients who, in the investigator's judgment, have not adequately recovered from prior surgery, or have undergone major surgery within 28 days prior to enrollment, or minor surgery within 14 days prior to enrollment.\n* Significant cardiac disease defined as:\n\n  1. New York Heart Association class III or IV cardiac disease, including pre-existing uncontrolled, clinically-significant arrhythmia, congestive heart failure, or cardiomyopathy.\n  2. Unstable angina, myocardial infarction, or a coronary revascularization procedure within ≤ 3 months prior to initiation of study treatment.\n  3. History of left ventricular ejection fraction \\\u003C 50%.\n  4. Poorly controlled hypertension, or history of poor compliance with antihypertensive drug regimens.\n* Clinically active and uncontrolled symptomatic infection; well-controlled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection may be considered for enrollment.\n* Autoimmune diseases, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.\n* Concurrent use of QT-prolonging medications or history of torsades de pointes.\n* Concurrent malignancy other than the one being treated in this study with the exception of the following: cured malignancy without recurrence within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of any type.\n* Any severe and\u002For uncontrolled medical condition that, in the investigator's opinion, may compromise the individual's safety or the evaluation of study results.\n* Prior treatment with: BTK degrader treatment or allogeneic stem cell transplant",{"count":180,"type":21},180,[51],"This is a Phase I, multicenter, open-label, two-stage study of APG-3288 monotherapy, aiming to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of APG-3288 administered orally once daily in patients with relapsed\u002Frefractory (R\u002FR) hematologic malignancies.",[184,185,186,187,188,189,190],"Relapsed\u002FRefractory Hematological Malignancies","Relapsed\u002FRefractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Leukemia (CLL\u002FSLL","Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma (DLBCL; Including Richter Transformation)","Relapsed\u002FRefractory Mantle Cell Lymphoma (MCL)","Relapsed\u002FRefractory Waldenström Macroglobulinemia (WM)","Relapsed\u002FRefractory Marginal Zone Lymphoma (MZL)","Relapsed\u002FRefractory Follicular Lymphoma (FL)",[184,192],"APG-3288","NOT_YET_RECRUITING","2026-02-19",{"date":196,"type":32},"2026-02-20",{"date":198,"type":21},"2026-03",{"date":200,"type":21},"2031-12",{"name":38,"class":39},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":104,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100614630","phase-1-pharmacokinetics-of-olverembatinib-in-participants-with-hepatic-impairment-100614630","NCT07282093","Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment","An Open-Label, Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of Olverembatinib","Inclusion Criteria:\n\n1. The participant voluntarily joins the study, signs the Informed Consent Form, and demonstrates good compliance.\n2. Body Mass Index (BMI) between 18 and 30 kg\u002Fm² (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.\n3. The investigator judges the participant suitable to participate in this study based on physical examination, vital signs, laboratory tests, and 12-lead electrocardiogram (ECG) examination.\n4. Female participants of childbearing potential must agree to use effective contraception during the study and for 3 months after the study ends; must have a negative serum pregnancy test within 7 days prior to study enrollment; and must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 3 months after the study ends.\n5. Additional Criteria for Participants with hepatic impairment Only:\n\n1\\. Chronic hepatic impairment due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other causes.\n\n2\\. Hepatic impairment classified as Child-Pugh Class A, B, or C. 3. Coagulation function: INR ≤ 2.5 without intervention with procoagulant drugs (after a 2-week washout period). Hematology: Neutrophils ≥ 1.0 × 10⁹\u002FL, Hemoglobin ≥ 70 g\u002FL, Platelets ≥ 30 × 10⁹\u002FL. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5 times the Upper Limit of Normal (ULN); Total Bilirubin ≤ 5 × ULN.\n\n4\\. Stable treatment for hepatic impairment, complications, and other concomitant diseases prior to study drug administration, with no need for dosage adjustment. Treatment for hepatic impairment must have been stable for at least 4 weeks.\n\nExclusion Criteria:\n\n1. Drug-induced liver injury.\n2. Any of the following conditions: history of liver transplantation; presence of acute or worsening liver injury due to any cause; liver failure; concurrent Grade 3\u002F4 hepatic encephalopathy; active hepatocellular carcinoma lesions; severe esophageal or gastric varices or history of rupture and bleeding; severe\u002Flate-stage ascites or pleural effusion requiring paracentesis\u002Fthoracentesis and albumin supplementation; hepatorenal syndrome; or any other condition deemed by the investigator as unsuitable for study participation.\n3. History of cholestasis, biliary tract infection, or other diseases affecting bile excretion within 3 months prior to screening.\n4. Esophageal or gastric variceal bleeding due to portal hypertension within 3 months prior to screening, or history of portosystemic shunt surgery (including Transjugular Intrahepatic Portosystemic Shunt - TIPS) within 6 months prior to screening.\n5. History of significant allergy or intolerance to any drug, food, or other substance.\n6. History of any clinically significant disease in the neurological, cardiovascular, digestive, respiratory, urinary, endocrine, hematological, immune systems, or any other disease or condition that the investigator believes may affect the trial results.\n7. History of surgery that may affect drug absorption, distribution, metabolism, or excretion, or plans for surgery or other reasons requiring hospitalization during the expected study period.\n8. Uncontrolled bacterial, viral, parasitic, or fungal infection requiring treatment at the time of screening (except Hepatitis B), or history of severe active infection within 1 month prior to screening.\n9. Positive Human Immunodeficiency Virus (HIV) antigen\u002Fantibody test at screening. For participants with normal hepatic function: Positive Treponema pallidum antibody. For hepatically impaired participants: Active syphilis.\n10. Use of systemic medications with known potential hepatotoxicity for 7 consecutive days or more within 14 days prior to study drug administration.\n11. Use of traditional Chinese medicine (herbal medicines, proprietary Chinese medicines), dietary supplements, or vitamins within 14 days prior to study drug administration.\n12. Systemic use of moderate or potent CYP3A4 inhibitors (e.g., itraconazole, fluconazole) or moderate or potent CYP3A4 inducers within 14 days prior to study drug administration.\n13. Positive urine drug screen or alcohol breath test at screening.\n14. Excessive alcohol intake (averaging more than 14 units of alcohol per week) within 3 months prior to screening, or inability to abstain from alcohol during the trial period.\n15. Consumption of grapefruit\u002Fjuice, foods or beverages rich in methylxanthines, engagement in strenuous exercise, or presence of other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to study drug administration, and inability to abstain from these during the hospitalization period.\n16. Participation in other investigational drug or medical device clinical trials within 3 months prior to the first dose of the study drug, or participation in 3 or more drug or medical device clinical trials within the past year. If the half-life of the other investigational drug is long, a longer interval is required, at least 5 times the half-life of that drug.\n17. Blood donation (or blood loss) ≥ 400 mL, or receipt of blood transfusion or blood products within 3 months prior to screening.\n18. History of needle or blood phobia, difficulty with blood collection, or intolerance to venipuncture.\n19. Unwillingness or inability to comply with the study procedures outlined in the protocol, or any other reason considered by the investigator as unsuitable for participation in this clinical study.\n20. Additional Criteria for Participants with Normal Hepatic Function Only:\n\n1). For participants with normal hepatic function: History of hepatitis, Hepatitis B, or Hepatitis C. History of hepatic impairment, or findings during screening physical examination or laboratory tests suggesting existing or potential hepatic impairment; Positive Hepatitis B Surface Antigen (HBsAg) or positive anti-HCV antibody.","75 Years",{"count":211,"type":21},48,[51],"This is a non-randomized, open-label, parallel, single-dose study to evaluate the pharmacokinetic profile of olverembatinib in participants with normal or impaired liver function.",[215,85],"Pharmacokinetic",[217],"olverembatinib","2025-12-21",{"date":220,"type":32},"2025-12-23",{"date":222,"type":32},"2025-11-11",{"date":224,"type":21},"2026-10-31",{"name":38,"class":39},1,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":234,"minAge":17,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":226},"100530145","phase-1-a-study-of-apg-2575-in-patients-with-mild-to-moderate-systemic-lupus-erythematosus-100530145","NCT06182969","A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.","A Randomized, Double-blind, Placebo-controlled Phase I\u002FII Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.","Inclusion Criteria:\n\n* 1\\. Diagnosis of systemic lupus erythematosus for at least 6 months.\n* 2\\. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.\n* 3\\. SLEDIA-2000 score: 4-12\n* 4.Other than systemic lupus erythematosus, subject should be in general good health.\n\nExclusion Criteria:\n\n* 1\\. Severe systemic lupus erythematosus.\n* 2\\. Significant autoimmune disease other than lupus.\n* 3\\. Significant, uncontrolled or unstable disease in any organ.","FEMALE","65 Years",{"count":237,"type":21},40,[51,52],"To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).",[241],"SLE",[241,161],"2025-12-14",{"date":245,"type":32},"2025-12-16",{"date":247,"type":32},"2024-08-09",{"date":249,"type":21},"2026-12",{"name":38,"class":39},{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":145},"100546004","phase-3-a-pivotal-study-of-apg-2575-lisaftoclax-combined-with-azacitidine-in-the-treatment-of-acute-myeloid-leukemia-100546004","NCT06389292","A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia","A Global, Multicenter, Randomized, Double-blind, Phase 3 Pivotal Registrational Clinical Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (GLORA-3)","Inclusion Criteria:\n\n1. Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.\n2. Life expectancy of ≥3 months.\n3. Be able to accept oral administration.\n4. Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and \\\u003C70 years with ECOG score of 0-3.\n5. Adequate kidney function.\n6. White blood cell ≤ 30×10\\^9\u002FL.\n7. Adequate liver function.\n8. Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.\n9. Be able to understand and voluntarily sign written informed consent.\n10. Patients must be willing and able to complete study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.\n2. Active leukemic infiltration of the central nervous system.\n3. Active infection that is uncontrolled and requires systemic treatment.\n4. Use of strong inducers of CYP3A4 within 7 days prior to the first dose of the investigational drug, and\u002For use of moderate to strong inhibitors of CYP3A4 within 7 days or 3-5 half-lives (whichever is longer) prior to the first dose of the investigational drug.\n5. Previous treatment for hematologic disorders.\n6. Patients who has a cardiovascular disability status of New York Heart Association Class \\> 2.\n7. Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.\n8. Patients had a history of other malignancies prior to study initiation.\n9. Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.",{"count":259,"type":21},486,[24],"A global, multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.",[263],"Acute Myeloid Leukemia",[265,162],"APG -2575","2025-11-20",{"date":268,"type":32},"2025-11-25",{"date":270,"type":32},"2024-06-11",{"date":272,"type":21},"2029-03-26",{"name":38,"class":39},{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":121},"100565379","phase-3-lisaftoclax-apg-2575-combined-with-azacytidine-aza-in-the-treatment-of-patients-with-higher-risk-myelodysplastic-syndrome-glora-4-100565379","NCT06641414","Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).","A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).","Inclusion Criteria:\n\n1. Newly diagnosed higher-risk MDS.\n2. ECOG score of ≤2.\n3. Expected survival ≥ 3 months.\n4. Adequate organ function.\n5. Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.\n6. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.\n7. Subjects are able to complete study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.\n2. Have undergone hematopoietic stem cell transplantation.\n3. Uncontrolled active infection\n4. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.\n5. MDS or other conditions that cannot be administered enterally.\n6. Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.",{"count":282,"type":21},490,[24],"A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.",[286],"Higher-risk Myelodysplastic Syndrome",[286,162],"2025-11-18",{"date":266,"type":32},{"date":291,"type":32},"2025-01-22",{"date":293,"type":21},"2029-12",{"name":38,"class":39},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":312,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100382468","phase-1-study-of-hqp1351-in-subjects-with-refractory-cml-and-ph-all-100382468","NCT04260022","Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL","A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)","Inclusion Criteria:\n\n* For HQP1351 monotherapy, patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, with or without T315I mutation\n* For Cohort D, patients with Ph+ BCP ALL or CML LBP must be resistant or intolerant to at least one second or later generation TKI, such as dasatinib, nilotinib, bosutinib and ponatinib, despite optimal supportive care\n* For HQP1351 monotherapy only: Be previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib, dasatinib, nilotinib, bosutinib, and asciminib. For patients with a T315I mutation, number of pretreated TKIs is not restricted.\n\n  1. The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for patients in CP, AP, BP, and Ph+ ALL, and apply also to second-line treatment, when first-line treatment was changed for intolerance. The patients must meet at least one criterion:\n\n     1. Three months after the initiation of therapy: non-complete hematologic response (CHR) and\u002For Ph+ \\>95%\n     2. Six months after the initiation of therapy: BCR-ABL1\\>10% and\u002For Ph+ \\>35%\n     3. Twelve months after the initiation of therapy: BCR-ABL1\\>1% and\u002For Ph+ \\>0%\n     4. Then, and at any time after the initiation of therapy: Loss of CHR, or loss of complete cytogenetic response (CCyR), or confirmed loss of major molecular response (MMR) (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), mutations, clonal chromosome abnormalities in Ph+ cells (CCA\u002FPh+)\n  2. The definition of resistance to second-line TKI treatment\n\n     a) For CML CP patients: the patients must meet at least one criterion as follows:\n\n     i.) Three months after the initiation of therapy: No CHR or Ph+ \\>95% or new mutations\n\n     ii.) Six months after the initiation of therapy: BCR-ABL1\\>10% and\u002For Ph+ \\>65% and\u002For new mutations\n\n     iii.) Twelve months after the initiation of therapy: BCR-ABL1\\>1% and\u002For Ph+ \\>35% and\u002For new mutations\n\n     iv.) Then, and at any time after the initiation of therapy: Loss of CHR or loss of CCyR, new mutations, confirmed loss of MMR (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), clonal chromosome abnormalities in Ph+ cells (CCA\u002FPh+)\n\n     b) For CML AP patients: the patients must meet at least one criterion as follows:\n\n     i.) Three months after the initiation of therapy: failure to achieve a major hematologic response (MaHR)\n\n     ii.) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 4 weeks\n\n     iii.) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR\n\n     c) For CML BP and Ph+ ALL patients: the patients must meet at least one criterion as follows:\n\n     i) One month after the initiation of therapy: failure to achieve a MaHR\n\n     ii) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 1 week\n\n     iii) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR\n  3. Intolerance to TKIs is defined as:\n\n     1. Non-hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP\u002FBP or Ph+ ALL patients\n     2. Hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, that is recurrent after unresponsive after optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP\u002FBP or Ph+ ALL patients\n* Patients providing written informed consent before initiation of any study-related activities\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Minimum life expectancy of 3 months or more\n* Patients with adequate organ function as defined below:\n\n  1. Creatinine \\\u003C 2 × upper limit of normal (ULN); or, creatinine \\> 2 × ULN, with 24h glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin (Cockcroft-Gault)\n  2. Serum albumin ≥ 3.0 g\u002FdL\n  3. Total bilirubin \\\u003C 1.5 × ULN\n  4. Aspartate aminotransferase (AST \\[Serum glutamic oxaloacetic transaminase (SGOT)\\]) and alanine aminotransferase (ALT \\[serum glutamate-pyruvate transaminase (SGPT)\\]) \\\u003C 3 × ULN for institution (\\\u003C5×ULN if liver involvement with leukemia)\n  5. Serum amylase and lipase ≤ 1.5 × ULN\n  6. Prothrombin time (PT) ≤ 1.5 × ULN\n* Heart function: Left ventricular ejection fraction (LVEF) \\> 50%\n* Normal QT interval corrected Fridericia (QTcF) interval on screening electrocardiogram (ECG) evaluation: male ≤450ms, female ≤470ms\n* For females of childbearing potential, a negative pregnancy test must be established before enrollment. And the eligible female and male patients with childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study\n* Ability to comply with study procedures, in the Investigator's opinion\n\nExclusion Criteria:\n\n* Received TKI therapy within 5 half-lives or 7 days prior to first dose of HQP1351, whichever is shorter, or any adverse events (AEs) (except alopecia and pigmentation) not recovered to CTCAE v5.0 grade 0-1 due to any other treatments\n* Received other therapies as follows:\n\n  1. For CP and AP patients, received hydroxyurea or anagrelide within 24 hours prior to the first dose of HQP1351; or, interferon, immunotherapy or cytarabine within 14 days prior to the first dose of HQP1351; or, any other radiotherapy, cytotoxic chemotherapy or investigational therapy within 28 days prior to receiving the first dose of HQP1351\n  2. For BP patients, received chemotherapy within 7 days prior to the first dose of HQP1351\n  3. For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of HQP1351, or received chemotherapy within 7 days prior to the first dose of HQP1351\n  4. Patients who are currently receiving treatment with a medication that has the potential to interact with HQP1351\n  5. Patients who had been treated with HQP1351\n  6. Patients requiring immunosuppressive therapy other than short time of steroid\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs\n* Patients with cardiovascular diseases, including uncontrolled high blood pressure (HBP) (that is blood pressure \\>140\u002F90mmHg.); or, receiving drugs that can cause prolonged QT interval. Patients with well controlled HBP can be considered to be included. (\"well controlled HBP\" is defined as: HBP can be ≤ 140\u002F90mmHg with antihypertensive treatment). Those requiring 3 or more antihypertensive medications should be discussed with the medical monitor.\n* Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  1. Any history of myocardial infarction (MI) within 6 months or unstable angina within 3 months\n  2. Any history of cerebrovascular accident within 1 year, or transient ischemic attack (TIA) within 3 months\n  3. Any history of peripheral vascular infarction, including visceral infarction within 6 months\n  4. Congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] class III or IV) within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment\n  5. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia\n  6. Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 3 months prior to enrollment. Patients who have experienced a venous thromboembolic event should only be eligible if the condition is well controlled with optimal intervention (as determined by the treating physician). Continued prophylactic anticoagulation is acceptable.\n  7. Patients with revascularization procedures including cardiac bypass within the 6 months and stenting within the past 3 months should be excluded.\n* Have history of autologous or allogeneic stem cell transplant, or with active graft-versus-host disease (GVHD), or active immune suppression in recent 6 months prior to informed consent date or active immune suppression in recent 6 months prior to informed consent date\n* CML CP patients with CCyR\n* Patients who have a significant bleeding disorder unrelated to CML or Ph+ ALL\n* Patients who had a major surgery within 4 weeks prior to study entry or have not recovered from side effects of such surgery which the Investigator considers not appropriate for enrollment\n* Cytologically confirmed central nervous system (CNS) involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment)\n* Patients with another primary malignancy within 1 year of study entry. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.\n* Have ongoing or active infection, including known history of immunodeficiency virus (HIV) or HIV antibody positive, hepatitis B virus (HBV) or HBsAg positive, hepatitis C virus (HCV). Patients who have positive HCV antibody must have an undetectable HCV viral load.\n* Patients with COVID-19 who now present with positive swab\n* Patients who have poorly controlled diabetes, defined as HbA1C values of \\> 7.5%. Patients with pre-existing, well-controlled diabetes are not excluded.\n* Known allergy to any components in the study drug\n* Pregnant or lactating\n* Patients who have any conditions or illness that, according to the opinions of the investigator or the medical monitor, would comprise patient safety or interfere with the evaluation of safety and efficacy to the study drug",{"count":303,"type":21},242,[51],"A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.",[307,308,309,310,311],"Leukemia, Myeloid, Chronic","Myeloid Leukemia","Chronic Myeloid Leukemia","Philadelphia Positive Acute Lymphoblastic Leukemia","B Cell Precursor Type Acute Leukemia",[313,314,315,316,317],"T315I mutation","Chronic Phase","Accelerated Phase","Blast Phase","Lymphoid blast phase","2025-11-04",{"date":320,"type":32},"2025-11-05",{"date":322,"type":32},"2020-01-09",{"date":324,"type":21},"2030-03-31",{"name":38,"class":39},9,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":226},"100400600","phase-2-a-study-evaluating-apg-115-as-a-single-agent-or-in-combination-with-apg-2575-in-subjects-with-rr-t-pll-and-nhl-100400600","NCT04496349","A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R\u002FR T-PLL and NHL","A Phase IIa Study Evaluating the Pharmacokinetics, Safety and Efficacy of APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With Relapsed\u002FRefractory T-Cell Prolymphocytic Leukemia (R\u002FR T-PLL) or Non-Hodgkin's Lymphoma (NHL).","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Patients with relapsed\u002Frefractory T-PLL who have active disease and have received at least one prior therapy; Patients with histologically confirmed diagnosis of NHL, NHL Patients must be either relapsed, refractory, intolerant, or are considered ineligible for therapies known to provide clinical benefit;\n3. Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting APG-115 and\u002For APG-2575. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.\n4. Absolute neutrophil count (ANC) ≥ 500\u002Fmm˄3; hemoglobin ≥ 60 g\u002FL; platelet count ≥ 30,000\u002Fmm˄3\n5. Patients with adequate organ function;\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n7. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his\u002Fher legally authorized representative is required prior to their enrollment on the protocol.\n\nExclusion Criteria:\n\n1. Patient previously treated with a murine double minute 2 (MDM2) inhibitor.\n2. Known active, uncontrolled central nervous system (CNS) malignancy\n3. Patients require graft versus host therapy, or require continued treatment with systemic immunosuppressive agents (calcineurin inhibitors within 4 weeks prior to the first dose of study drug).\n4. Patients who have any conditions or illness that, according to the opinions of the Investigators or the medical monitor, would compromise patient safety or interfere with the evaluation of safety and efficacy to the study drug(s).\n5. Patients who have used strong CYP2C8 inhibitors, or moderate or strong CYP3A4 inhibitors or inducers within washout period of 14 days or 7 half-lives before the first administration of study drugs, whichever is longer.",{"count":335,"type":21},78,[52],"The goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.",[339,340],"T-Prolymphocytic Leukemia","Non-Hodgkins Lymphoma","2025-11-03",{"date":318,"type":32},{"date":344,"type":32},"2021-07-12",{"date":346,"type":21},"2027-05-31",{"name":38,"class":39},{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":326},"100356134","phase-1-apg-2449-in-patients-with-advanced-solid-tumors-100356134","NCT03917043","APG-2449 in Patients With Advanced Solid Tumors","A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Dose exploration stage: non-small cell lung cancer diagnosed by histology and\u002For cytology and positive for ALK\u002FROS1 gene fusion (molecular diagnosis confirmed by the investigator) and malignant pleural mesothelioma, esophageal cancer and ovarian cancer. Kind of patients with advanced tumors.\n\n   Expansion stage: cohort 1, patients with non-small cell lung cancer who have progressed or are intolerant to TKI therapy, including patients with second-generation ALK TKI, or either ROS1 TKI, or third-generation ALK inhibitor (lorlatinib, etc.) with pFAK expression (pFAK expression is subject to central laboratory results) of about 10 or above; Cohort 2, TKI-naïve patients with ALK\u002FROS1 fusion gene positive NSCLC. The molecular diagnosis results of the above patients can be confirmed by the investigator.\n2. ECOG Performance Status ≤ 1.\n3. Expectation of life ≥ 3 months.\n4. According to RECIST version 1.1, there is at least 1 measurable lesion.\n5. Adequate hematologic and bone marrow functions.\n6. Adequate renal and liver function.\n7. Normal cardiac function.\n8. Brain metastases with clinically controlled neurologic symptoms.\n9. Serum pregnancy test results of women of childbearing age were negative within 7 days before taking the first dose of study drug.\n10. Men, women of childbearing age (postmenopausal women must have been menopausal for at least 12 months before they can be considered infertile) and their partners voluntarily take the study drug for at least 30 days after signing the informed consent form and taking the study drug as deemed effective by the investigator Contraceptive measures\n11. Ability to understand and willingness to sign a written informed consent form\n12. Subjects must be willing and able to complete the research procedures and follow-up inspections.\n13. Subjects are required to provide fresh (for recurrent subjects only) or archived tumor tissue samples from within 28 days prior to treatment. If none of these specimens are available, they may be included after consultation with the sponsor.\n14. Subjects should provide fresh biopsy tumor tissue specimens prior to treatment.\n\nExclusion Criteria:\n\n1. Receiving concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy); or any investigational therapy within 28 days prior to the first dose of study drug.\n2. Receiving TKI therapy within 8 days prior to the first dose of study drug.\n3. Continuance of toxicities due to prior therapy that do not recover (CTCAE V5.0 Grade\\> 1).\n4. Has difficulty in swallowing, absorbing barrier, or other diseases blocking APG-2449' taken.\n5. Obvious cardiovascular disease history.\n6. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.\n7. Active symptomatic fungal, bacterial and\u002For viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C).\n8. Known allergies to study drug ingredients or their analogs.\n9. Female subjects who are pregnant or breastfeeding, or expecting to become pregnant during the study period.\n10. According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may endanger its safety or interfere with the safety assessment of the study drug.\n11. Subjects who have used CYP3A4, CYP2C9, or CYP2C19 moderately potent inhibitors or moderately potent inducers 1 week before receiving the study drug for the first time.\n12. Subjects who used CYP3A4 substrates and narrow treatment window 1 week before the first study drug.",{"count":356,"type":21},165,[51],"APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-2449 is intended for the treatment of patients with advanced solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and\u002For recommended phase 2 dose (RP2D), several phase Ib\u002FII studies will be implemented accordingly.",[360,361,362,363,364],"Advanced Solid Cancer","Non Small Cell Lung Cancer","Esophageal Cancer","Ovarian Cancer","Malignant Pleural Mesothelioma","2025-06-16",{"date":367,"type":32},"2025-06-18",{"date":369,"type":32},"2019-05-27",{"date":371,"type":21},"2028-01",{"name":38,"class":39},{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":226},"100548662","phase-3-study-of-olverembatinib-hqp1351-in-patients-with-cp-cml-100548662","NCT06423911","Study of Olverembatinib (HQP1351) in Patients With CP-CML","This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia","POLARIS-2","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria.\n\n1. Age ≥ 18 years old.\n2. Diagnosis of CML-CP\n3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.\n5. Written informed consent obtained prior to any screening procedures.\n6. Patients with adequate organ functions\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria.\n\n1. For Part A only: T315I mutation at any time prior to starting study treatment.\n2. Active infection that requires systemic drug therapy\n3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs\n4. Previous treatment with or known \u002F suspected hypersensitivity to olverembatinib or any of its excipients.\n5. Previous treatment with or known \u002F suspected hypersensitivity to bosutinib or any of its excipients.\n6. Pregnant or nursing (lactating) women.",{"count":382,"type":21},285,[24],"A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)",[309,386,387],"CML","CML, Chronic Phase","2025-05-29",{"date":390,"type":32},"2025-06-03",{"date":392,"type":32},"2024-02-05",{"date":394,"type":21},"2026-02",{"name":38,"class":39},{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100400459","phase-1-study-of-apg2575-single-agent-and-combination-therapy-in-patients-with-relapsedrefractory-cllsll-100400459","NCT04494503","Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed\u002FRefractory CLL\u002FSLL","A Phase Ib\u002FII Study of the Safety, Pharmacokinetic, Pharmacodynamic and Efficacy of APG-2575 Single Agent and in Combination With Other Therapeutic Agents in Patients With Relapsed\u002FRefractory CLL\u002FSLL","Inclusion Criteria:\n\nSubjects who meet each of the following inclusion criteria are eligible to participate in this study:\n\n1. Age ≥18 years old.\n2. Diagnosis as relapsed\u002Frefractory chronic lymphocytic leukemia\u002F small lymphocytic lymphoma according to the IWCLL NCI-WG guidelines revised in 2008.\n3. Through radiological assessment, subjects with a lymph node length ≥ 10 cm require prior approval from the sponsor before enrollment.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1.\n5. QTcF interval ≤450ms in males, and ≤470ms in females.\n6. Adequate bone marrow function independent of growth factor and transfusion.\n7. Adequate renal and liver function.\n8. Willingness by males, female patients of child bearing potential, and their partners to use contraception by effective methods throughout the treatment period and for at least three months following the last dose of study drug.\n9. Pregnancy test results of serum samples obtained within 14 days before the first study drug administration in fertile female subjects were negative; If the serum pregnancy test results obtained are\\> 7 days from the first administration, urine sample obtained before the first study dose of study drug must be negative.\n10. Male subjects must avoid sperm donation throughout the treatment period and for at least three months following the last dose of study drug.\n11. Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures).\n12. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria are not to be enrolled in this study:\n\n1. Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy within 24 months or autologous hematopoietic stem cell transplantation within 12 months.\n2. Monoclonal antibody therapy against CLL was adopted within 4 weeks prior to the first dose of the study drug.\n3. Receive any of the following treatments within 14 days or 5x half-life before the first dose of study drug, or clinically significant adverse reactions \u002F toxicities due to previous treatments have not recovered to ≤ Grade 1: Anti-tumor therapies include chemotherapy, radiotherapy, anti-tumor steroid treatment, anti-tumor Chinese medicine treatment; investigational treatment, including targeted small molecule drugs.\n4. Use the following drugs within 14 days before the first dose of study drug: moderately potent CYP3A inhibitors such as fluconazole, ketoconazole and clarithromycin; moderately potent CYP3A inducers such as rifampin, carbamazepine, phenytoin And St. John's wort.\n5. Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.\n6. Received Bcl-2 inhibitor treatment.\n7. Invasive NHL transformation or central nervous system (CNS) involvement. has occurred.\n8. Cardiovascular disease of grade ≥2 (New York Heart Association Class).\n9. A significant history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular or liver disease. The investigator believes that participating in this study will have an adverse effect on him \u002F her. For subjects requiring intervention for any of the above diseases in the past 6 months, the investigator and the sponsor must discuss.\n10. Warfarin or other anticoagulants is required.\n11. Known to be allergic to study drug ingredients or their analogues.\n12. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.\n13. Within 3 years before entering the study, the subject had a history of active malignant tumors other than CLL \u002F SLL, except that:\n\n    * Fully treated cervical carcinoma in situ;\n    * Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n    * confinement and resection of previously cured malignancies (or other treatment).\n14. Has malabsorption syndrome or other conditions that are not suitable for enteral administration.\n15. Uncontrolled other clinically significant symptoms, including but not limited to: uncontrolled systemic infections (viruses, bacteria, or fungi), including but not limited to known hepatitis B virus (HBV) surface antigens and DNA positive(HBV-DNA≥2000copies\u002FmL or ≥500IU\u002FmL); Hepatitis C virus (HCV) antibody positive or RNA positive; human immunodeficiency virus (HIV) antibody positive; Febrile neutropenia occured within 1 week before administration.\n16. Primary active autoimmune diseases and connective tissue diseases, such as active and uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP).\n17. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.",{"count":404,"type":21},123,[51,52],"The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed\u002Frefractory CLL\u002FSLL.",[158,159],[161,409,410,411,412],"rituximab","ibrutinib","chronic lymphocytic leukemia(CLL)","small lymphocytic lymphoma(SLL)","2025-04-15",{"date":415,"type":32},"2025-04-16",{"date":417,"type":32},"2020-08-31",{"date":419,"type":21},"2025-12",{"name":38,"class":39},18,{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":326},"100379072","phase-1-study-of-apg-2575-as-a-single-agent-or-in-combination-with-other-therapeutic-agents-for-cllsll-100379072","NCT04215809","Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL\u002FSLL","APG-2575CU101, A Phase Ib Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents in Patients With Relapsed and\u002For Refractory Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","Inclusion Criteria:\n\n1. ≥18 years of age.\n2. Histologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) according to the 2018 international workshop (IW) CLL criteria who must have relapsed or be refractory to at least one prior therapy for CLL\u002FSLL and require treatment by 2018 IWCLL criteria. In addition, lisaftoclax (600 mg) plus acalabrutinib combination cohort may include patients who are: (1) treatment-naïve, or (2) refractory to venetoclax.\n3. Eastern Cooperative Oncology Group (ECOG) ≤ 2.\n4. Patient must have objectively documented evidence of disease progression prior to study entry such as: escalating lymphocytes count with an increase \\> 50% over a period of two months or doubling time in less than 6 months; enlarging adenopathy or splenomegaly; increasing cytopenias; clinical B symptoms -night sweats, fatigue, \\> 1% weight loss in 6 months, fevers \\> 100.50F for ≥ one month without infection.\n5. Adequate bone marrow function independent of growth factor:\n\n   1. Absolute neutrophil count (ANC) ≥1.0× 109\u002FL in patient without bone marrow involvement. This criterion does not apply to patients with bone marrow involvement by CLL\u002FSLL.\n   2. Platelets count ≥30 x 109\u002FL (entry platelet count must be independent of transfusion within 7 days of first dose of lisaftoclax).\n6. Adequate renal and hepatic function as indicated by:\n\n   1. Serum creatinine ≤1.5×upper limit of normal (ULN); if serum creatinine is \\>1.5×ULN, creatinine clearance must be ≥ 50 mL\u002Fmin, calculated using the Cockcroft and Gault formula(140-Age)x mas (kg)\u002F(72x creatinine mg\u002FdL); multiply by 0.85 if female (Cockcroft 1976).\n   2. Total bilirubin ≤1.5 x ULN, except patients with known Gilbert's syndrome.\n   3. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C2.5 x ULN, Alkaline phosphatase\\\u003C2.5×ULN.\n   4. International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤1.5×ULN unless the patient is receiving anticoagulant therapy as long as PT or APTT is within therapeutic range of intended use of anticoagulants.\n7. Females of childbearing potential (i.e., not postmenopausal for at least 2 years or surgically sterile) must have negative results for pregnancy test performed:\n\n   1. At screening on a serum sample obtained within 14 days prior to the first lisaftoclax administration;\n   2. Prior to dosing on a urine sample obtained on the first day of lisaftoclax administration, if it has been \\>7 days since obtaining the serum pregnancy test results.\n8. Females of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing lisaftoclax:\n\n   1. Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable;\n   2. Surgically sterile partner(s); acceptable sterility surgeries are: vasectomy, bilateral tubal ligation, bilateral oophorectomy or hysterectomy\n   3. Intrauterine device (IUD);\n   4. Double-barrier method (contraceptive sponge, diaphragm or cervical cap with spermicidal fellies or cream AND a condom);\n   5. Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 3 months prior to lisaftoclax administration. If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to lisaftoclax administration.\n9. Male patients must refrain from sperm donation, from initial lisaftoclax administration until 90 days after the last dose of lisaftoclax.\n10. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).\n11. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\n1. Patient has undergone allogeneic stem cell transplant \\\u003C 90 days.\n2. Patient has active graft-versus-host disease or require immunosuppressive therapy.\n3. Patient has undergone CAR-T cell therapy \\\u003C 30 days.\n4. Richter's Syndrome (patients with previously treated Richter's syndrome will be permitted if they are in remission).\n5. Prior anti-BCL-2 treatment (except patients who discontinued treatment for reasons other than disease progression and patients in the lisaftoclax plus acalabrutinib cohort).\n6. For the acalabrutinib and lisaftoclax combination cohort: (1) Patients who discontinued due to acalabrutinib toxicity (Note: Patients who received a BTK inhibitor therapy may participate whether, or not, they progressed following BTK inhibitor treatment). (2) Patients who require treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, etc.) at study entry. (Patients receiving proton pump inhibitors who switch to H2 receptor antagonists or antacids are eligible for enrollment to this study arm.) (3) Patients who require or are receiving anticoagulation therapy with warfarin or equivalent vitamin K antagonists within 7 days of first dose of the study drug(s).\n7. Active pathogen infections including human immunodeficiency virus syndrome (HIV) infection.\n8. Active hepatitis B infection, as defined seropositivity for Hep B surface antigen (HBsAg) or known active Hepatitis C infection as determined by Hepatitis C antibody with elevated liver enzymes as defined in the inclusion criteria or any other evidence of active Hepatitis C such as currently on treatment; or active COVID-19 infection. (Patients who have received COVID-19 vaccination will be considered as eligible for the study).\n9. Has known central nervous system (CNS) involvement.\n10. Prior malignancy that required treatment and has shown recurrence within 2 years of screening (except for non-melanoma skin cancer or adequately treated carcinoma in situ of cervix or breast). Cancer treated within 2 years with curative intent and without recurrence as well as prostate cancer on active surveillance are allowed.\n11. Concurrent treatment with any other investigational agent, received biologics (≤28 days), or small molecule targeted therapies (≤5 half-life) or other anti-cancer therapies (including chemotherapy) ≤14 days of first dose of lisaftoclax.\n12. Patient is pregnant or breast feeding.\n13. Has received the following within 7 days prior to the first dose of lisaftoclax:\n\n    1. Steroid therapy at a dose greater than prednisone 20 mg daily (or equivalent) for anti-neoplastic intent\n    2. CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin\n    3. Potent CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.\n14. Radiation within 14 days of study entry.\n15. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ grade 1 or baseline, except alopecia or neuropathy.\n16. Failure to recover adequately, as judged by the Investigator, from prior surgical procedures. For example, patients with active wound healing; patients who have had major surgery within 28 days from 1st dose of lisaftoclax.\n17. Has a cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain.\n18. Unstable angina or myocardial infarction within 3 months of enrollment.\n19. QTc interval\\> 480ms (Bazett or Fredericia formulae) or other remarkable abnormal ECG findings, including second-degree type II atrioventricular block, third-degree atrioventricular block or bradycardia (ventricular rate of less than 50 beats per minute).\n20. Unable to swallow capsules or have gastrointestinal conditions that could affect the absorption of lisaftoclax in the opinion of the Investigator.\n21. Uncontrolled concurrent illness including, but not limited to: uncontrolled diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with the study requirements.\n22. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.","85 Years",{"count":431,"type":21},144,[51],"Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) \u002F recommended phase 2 dose (RP2D) of lisaftoclax.",[27],"2025-04-08",{"date":437,"type":32},"2025-04-10",{"date":439,"type":32},"2020-03-02",{"date":441,"type":21},"2027-06-30",{"name":38,"class":39},{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":226},"100568887","phase-1-apg-2449-monotherapy-or-in-combination-with-pld-in-patients-with-platinum-resistant-recurrent-oc-or-advanced-st-100568887","NCT06687070","APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST","A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APG-2449 Monotherapy or in Combination With Anticancer Agents in Patients With Platinum-resistant Recurrent Ovarian Cancer or Advanced Solid Tumors","Inclusion Criteria:\n\n1. Part A: No gender limitation. Patients with histologically and\u002For cytologically confirmed ALK\u002FROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.\n\n   Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.\n2. At least one measurable tumor lesion.\n3. ECOG score is 0\\~1.\n4. Life expectancy of ≥3 months.\n5. AE caused by previous treatment must recover to ≤ grade 1.\n6. Sufficient bone marrow, liver, kidney and coagulation function.\n7. Female patients must be in a non-pregnant and non-lactating state.\n8. Able to understand and willing to sign informed consent.\n9. Patients are required to provide fresh or archived tumor tissue samples prior to treatment.\n\nExclusion Criteria:\n\n1. Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose.\n2. Received systemic antitumor drugs, including investigational drugs.\n3. Received radiotherapy within 14 days before first dose.\n4. Previous treatment with FAK inhibitors.\n5. Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose.\n6. Known active central nervous system (CNS) metastases and\u002For cancerous meningitis.\n7. Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose.\n8. Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose.\n9. Malabsorption syndrome, or inability to take medications orally.\n10. Severe gastrointestinal disease.\n11. Any serious or uncontrolled systemic disease; Various chronic active infections.\n12. Allergy to APG-2449 or PLD and its drug components.\n13. Previous cumulative doses of anthracyclines ≥550 mg\u002Fm\\^2.\n14. Patients using a moderately potent CYP3A4, CYP2C9, or CYP2C19 inhibitor\u002Finducer or P-gp inhibitor within a week before first dose. Patients using CYP3A4 substrates and the drugs of a narrow treatment window within a week before first dose.\n15. Other factors that, in the investigator's judgment, should prevent the patient from entering the study.",{"count":451,"type":21},50,[51],"An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.",[455,456],"Platinum-resistant Recurrent Ovarian Cancer","Advanced Solid Tumor",[458],"APG-2449","2025-02-24",{"date":461,"type":32},"2025-02-26",{"date":463,"type":32},"2024-12-17",{"date":465,"type":21},"2027-05",{"name":38,"class":39},{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":129,"maxAge":17,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":480,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"100493142","phase-1-apg-115-alone-or-in-combination-with-apg-2575-in-children-with-recurrent-or-refractory-neuroblastoma-or-solid-tumors-100493142","NCT05701306","APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors","A Phase I Clinical Study of APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors","Inclusion Criteria:\n\n1. Recurrent or refractory neuroblastoma or solid tumor.\n2. Physical state score ≥ 50.\n3. Expected survival ≥ 3 months.\n4. There are target lesions (neuroblastoma) or measurable lesions (other solid tumors).\n5. Have adequate organ function.\n6. Fresh or archived tumor tissue samples should be provided prior to treatment. If none of these specimens are available, inclusion may be made after consultation with the sponsor.\n7. Fertile women (≥14 years of age or having menarche) must have a negative serum pregnancy test at the time of the screening visit and must not be breastfeeding or planning to become pregnant during the study period.\n8. A potentially fertile male subject (who has spermatoses) or female subject (ibid.) must agree to use effective contraception during the trial period and for 3 months after the trial ends (or is prematurely discontinued).\n9. Informed consent must be obtained before carrying out any study procedure specified in the test. For child subjects, the consent of the subject and one of the parent\u002Flegal guardian must be obtained.\n10. The ability to swallow research drugs.\n\nExclusion Criteria:\n\n1. Systemic antitumor therapy, including biotherapy, chemotherapy, surgery, radiotherapy, immunotherapy, and other investigational drug therapy (other than placebo), was received within 21 days prior to the first treatment with the study drug.\n2. Small-molecule targeted drug therapy was administered 14 days before the first treatment of the study drug or within a known five-half-life period, whichever is shorter.\n3. Patients who, according to the investigators' judgment, did not recover sufficiently after surgical treatment. Patients who underwent major surgery within 28 days before receiving the study drug for the first time.\n4. Adverse events due to previous antitumor therapy (except grade 2 peripheral neurotoxicity and alopecia that the investigators judged to be of no safety risk) have not recovered (severity higher than grade 1 according to CTCAE version 5.0).\n5. Patients with active brain tumors or brain metastases.\n6. Active gastrointestinal diseases (e.g. Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption syndromes that may affect drug absorption.\n7. A known hemorrhagic predisposition\u002Fdisease, such as a history of non-chemotherapy-induced thrombocytopenic bleeding within 1 year before first receiving the study drug; Have active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AIHA), or a history of platelet transfusion failure (within 1 year before first receiving the study drug); Severe gastrointestinal bleeding occurred within 3 months.\n8. Clinically significant cardiovascular disease, cardiomyopathy, myocardial infarction or history within 6 months prior to administration.\n9. Symptomatic active fungal, bacterial, and\u002For viral infections requiring systemic treatment.\n10. Unexplained fever \\> 38.5℃ within 2 weeks prior to initial administration (subjects with tumor-related fever, as determined by the investigator, could be enrolled).\n11. Received MDM2 inhibitors or BCL-2 inhibitors.\n12. Any other circumstances or conditions that the investigator considers the patient inappropriate for participation in the study.",{"count":131,"type":21},[51],"An open, non-randomized Phase I trial of dose-escalation and cohorts expansion to evaluate the safety, pharmacokinetic profile and initial efficacy of APG-115 alone or in combination with APG-2575 in the treatment of recurrent or refractory pediatric neuroblastoma or solid tumors.",[478,479],"Neuroblastoma","Solid Tumor",[478,479,481],"APG-115",{"date":483,"type":32},"2025-02-25",{"date":485,"type":32},"2023-02-28",{"date":487,"type":21},"2027-12-31",{"name":38,"class":39},3,{"id":491,"slug":492,"hasResults":11,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":489},"100422773","phase-1-apg-115-in-combination-with-pd-1-inhibitor-in-patients-with-advanced-liposarcoma-or-advanced-solid-tumors-100422773","NCT04785196","APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors","A Phase Ib\u002FII Study of APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Other Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent;\n2. ECOG PS 0-1;\n3. Phase Ib: Histologically confirmed, advanced liposarcoma or advanced solid tumor patients who failed standard of care therapy; Phase II: Histologically confirmed, advanced liposarcoma with TP53 wide-type and MDM2 Amplification;\n4. The expected survival period is more than 12 weeks;\n5. Measurable disease on CT or MRI by RECIST 1.1.\n6. Adequate bone marrow and organ function as indicated by: the following laboratory values without continuous supportive treatment (such as blood transfusion, coagulation factors and\u002For platelet infusion, red\u002Fwhite blood cell growth factor administration, or albumin infusion)\n\n   1. ANC≥1.5 x 10\\^9\u002F L;\n   2. PLT≥100 x 10\\^9\u002F L;\n   3. Hgb≥90 g\u002FL;\n   4. Alb≥30 g\u002FL;\n   5. AST and AST ≤3 \\* ULN (for hepatic metastases, ALT and AST≤5\\*ULN);\n   6. Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 50ml \u002F min.\n\nExclusion Criteria:\n\n1. Patients who have previously been treated with MDM2-p53 inhibitor;\n2. Known hypersensitivity reaction to PD-(L)1 inhibitors, or any prior ≥ Grade 3 irAE;\n3. Prior treatment consisted of any kinds of immunotherapies, like PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, OX-40 et.al( for phase II);\n4. Has known active central nervous (CNS) metastases and\u002For carcinomatous meningitis;\n5. Has any active or history of autoimmune disease;\n6. Active infection or unexplained fever \\> 38.5 ° C two weeks before first dose;\n7. Patients with any severe and\u002For uncontrolled diseases, including: hypertension and uncontrollable levels of normal anti-hypertensive medication; clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, or coronary artery bypass surgery, congestive heart failure (New York Heart Association (NYHA) ) \\> 2);active or uncontrolled serious infection (≥CTCAE 5.0 Level 2 infection);objective evidence of previous or current history of pulmonary disease; moderate to severe hepatic impairment (Child-Pugh score ≥ 10 points); moderate to severe renal impairment or psychiatric illness\u002Fsocial circumstances that may affect study compliance;\n8. Poorly controlled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females).",{"count":498,"type":21},95,[51,52],"Part 1 is a phase Ib standard \"3 + 3\" design, will be employed to determine the MTD of APG-115 by assessing the DLT of APG-115 in combination with PD-1 inhibitor(toripalimab) in advanced solid tumors.\n\nPart 2 is a Simon two-stage phase II study design. At RP2D of APG-115 in combination with toripalimab in advanced liposarcoma, approximately 34 patients will be treated with the combination until disease progression, unacceptable toxicity, or another discontinuation criterion is met.",[502,456],"Liposarcoma",[481,504,502,505],"Toripalimab","Advanced solid tumors",{"date":461,"type":32},{"date":508,"type":32},"2021-05-26",{"date":510,"type":21},"2027-01",{"name":38,"class":39},{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":16,"minAge":129,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":520,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":531,"locationsCount":226},"100565298","phase-3-a-study-of-olverembatinib-in-sdh-deficient-gist-100565298","NCT06640361","A Study of Olverembatinib in SDH-deficient GIST.","A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator.\n2. Must have at least one measurable target lesion.\n3. ECOG≤ 2.\n4. Expected survival of at least 3 months.\n5. Adequate organ function.\n6. Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dose of study drug.\n7. Males, women of childbearing potential, as well as their partners, voluntarily take effective contraceptive measures as specified in the protocol from the time of signing the informed consent form until at least 30 days after the last dose of study drug.\n8. Prior to initiation of any screening or study-specific procedures, the patient or his\u002Fher guardian is able to understand and voluntarily sign an informed consent form approved by the Ethics Committee in writing, voluntarily and able to complete the study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. Received antitumor cytotoxic chemotherapy, radiotherapy, biologic drug therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life prior to the first dose.\n2. Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.\n3. Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.\n4. Adverse events due to prior treatment have not recovered (\\> NCI CTCAE v5.0 Grade 1).\n5. Absorption disorder syndrome or other conditions that affect the absorption of oral medications.\n6. With clinically significant, uncontrolled or active cardiovascular disease or thrombotic disease.\n7. Poorly controlled hypertension after hypertension medication.\n8. Severe cardiovascular and cerebrovascular diseases during previous use of TKIs.\n9. Uncontrolled Hyperlipidemia.\n10. Major surgery, open biopsy, or major traumatic injury within 14 days prior to initiation of study drug.\n11. With brain metastases.\n12. Other malignancies within 2 years.\n13. Uncontrolled systemic active fungal, bacterial, and\u002For viral infections.\n14. Female patients who are pregnant or lactating, or female patients who are expecting to become pregnant within the period of this study.\n15. Any symptoms or disease of the patient, in the judgment of the investigator or sponsor, that may jeopardize their safety or interfere with the safety evaluation of the investigational drug.",{"count":237,"type":21},[24],"An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.",[523],"GIST",[85,523],"2024-12-23",{"date":527,"type":32},"2024-12-27",{"date":529,"type":32},"2024-11-11",{"date":94,"type":21},{"name":38,"class":39},{"id":533,"slug":534,"hasResults":11,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":546,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":557},"100383658","phase-1-a-phase-ib-study-of-apg-115-single-agent-or-in-combination-with-azacitidine-or-cytarabine-in-patients-with-aml-and-mds-100383658","NCT04275518","A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.","A Phase Ib Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of APG-115 as a Single Agent or in Combination With Azacitidine or Cytarabine in Patients With Relapse\u002FRefractory AML and Relapsed\u002FProgressed High\u002FVery High Risk MDS","Inclusion Criteria:\n\n1. Patients with a diagnosis of histologically confirmed relapsed or refractory (R\u002FR) acute myeloid leukemia by WHO classification or relapsed\u002Fprogressed high\u002Fvery high risk MDS (score≥4.5) according to IPSS-R risk stratification\n2. Age \\>\u002F= 18 years.\n3. Adequate organ function\n4. Subject must have a projected life expectancy of at least 12 weeks.\n5. ECOG performance status of 0-1.\n6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n7. Subject has a white blood cell count\\\u003C 50 × 109\u002FL. Note: Hydroxyurea is permitted to meet this criterion.\n\nExclusion Criteria:\n\n1. Subject has acute promyelocytic leukemia.\n2. Patients must not have had leukemia biotherapy 4 weeks prior to starting investigational drug, or less than 5 half-lives small molecular targeted drug therapy, or 28 days any anti-cancer therapy (whichever is longer)\n3. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n4. Active infection requiring systemic antibiotic\u002Fantifungal medication, known clinically active hepatitis B or C, or HIV infection.\n5. Participants who have received allogeneic HSCT, or autologous HSCT within 12 months.\n6. Patients with active, uncontrolled CNS leukemia will not be eligible.\n7. Any prior systemic MDM2-p53 inhibitor treatment\n8. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.\n9. Subject has a history of other malignancies within 2 years prior to study entry, with the exception of:\n\n   * Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;\n   * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n   * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intention: requires discussion with sponsor.",{"count":540,"type":21},102,[51],"Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (blasts) in the bone marrow and circulation.\n\nAPG-115 is a potent and orally active small-molecule MDM2 inhibitor, it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines. APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models.\n\nThis is a phase 1b, open-label, three-stages study that will initially evaluate the safety and PK\u002FPD profile of APG-115 as a single agent, followed by a combination of APG-115 + azacytidine or cytarabine in R\u002FR AML or MDS subjects.\n\nPatients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first. Patients who continue to be benefit after 6 cycles' treatment will receive additional cycles of treatment until progression of disease, unacceptable toxicity is observed or administrative discontinuation. (As long as it is proven safe).",[544,545],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndromes (MDS)",[481,547,548],"AML","MDS","2024-10-10",{"date":551,"type":32},"2024-10-15",{"date":553,"type":32},"2020-07-06",{"date":555,"type":21},"2025-12-31",{"name":38,"class":39},14,{"id":559,"slug":560,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":579},"100327008","early-phase-1-apg-2575-study-of-safety-tolerability-pkpd-in-patients-with-hematologic-malignancies-100327008","NCT03537482","APG-2575 Study of Safety, Tolerability ,PK\u002FPD in Patients With Hematologic Malignancies","A Phase I Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Property of Orally Administered APG-2575 in Patients With Hematologic Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years old.\n2. Histologically confirmed diagnosis of either one of the B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, lymphoplasmacytic lymphoma, and non-Hodgkin's lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid leukemia\n3. Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. In addition,\n\n   a. AML Patients will be eligible if they have failed standard induction regimen, are not considered candidate for further chemotherapy or stem cell transplantation or have primary refractory AML.\n4. Life expectancy ≥ 3 months.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation ; 0-2 in dose expansion.\n6. QTc interval ≤450ms in males, and ≤470ms in females.\n7. Adequate bone marrow function independent of growth factor:\n8. Absolute neutrophil count (ANC) ≥1.0 X 109\u002FL.\n9. Hemoglobin ≥ 8.0 g\u002FdL.\n10. Platelets count ≥ 30 X 109\u002FL (entry platelet count must be independent of transfusion within 7 days of first dose).\n11. Adequate renal and liver function as indicated by:\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria are not to be enrolled in this study:\n\n1. Prior history of allogeneic cell transplant.\n2. Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma\u002Fleukemia.\n3. Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.\n4. Received biologic (\\\u003C 28 days), small molecule targeted therapies (\\\u003C 5 half-life) or other anti-cancer therapy within 21 days of study entry.\n5. Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry.\n6. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator.\n7. Has known active central nervous system (CNS) involvement.\n8. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.\n9. Concurrent treatment with an investigational agent, 14 days for small molecular agents and\u002For 28 days for biologics treatment prior to the first dose of therapy.\n10. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.\n11. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.\n12. Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.\n13. Active infection requiring systemic antibiotic\u002F antifungal medication, known clinically active hepatitis B or C infection, or on antiretroviral therapy for HIV disease.",{"count":96,"type":21},[567],"EARLY_PHASE1","This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage.",[570],"Hematologic Malignancies","2024-08-16",{"date":573,"type":32},"2024-08-19",{"date":575,"type":32},"2018-08-07",{"date":577,"type":21},"2025-02-15",{"name":38,"class":39},5,{"id":581,"slug":582,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":589,"briefSummary":590,"conditions":591,"keywords":592,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":145},"100540639","phase-3-a-global-study-of-lisaftoclax-apg-2575-combined-with-acalabrutinib-versus-immunochemotherapy-for-newly-diagnosed-cllsll-100540639","NCT06319456","A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL\u002FSLL.","A Global Multicenter, Open Label, Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib Versus Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (GLORA-2).","1. CLL\u002FSLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment.\n2. With a measurable disease.\n3. ECOG score 0-2.\n4. QTcF interval: ≤450ms in males, ≤470ms in females.\n5. Adequate bone marrow function independent of growth factor support.\n6. Adequate liver, kidney and coagulation function.\n7. Males and females of childbearing potential, and their partners voluntarily use effective contraceptive measures throughout the treatment and for at least three months after the last dose of the study drug. Male patients must avoid donation from the first dose of the study drug to three months after the last dose of the study drug.\n8. Female patients of childbearing potential have negative serum pregnancy test results within 14 days prior to the first dose of the study drug.\n9. Patients must be able to understand and voluntarily sign an informed consent form approved by the Ethics Committee (EC) before commencing any screening or study specific procedures.\n10. Must be willing and able to complete research procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. Any previous CLL specific treatment.\n2. Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within 28 days prior to the first dose of the study drug or who receive a minor surgery (excluding biopsy) within 14 days prior to the initiation of the study.\n3. Presence of significant cardiovascular disease within 6 months prior to study entry.\n4. A history of significant kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease, which will have an adverse effect on the patient if he\u002Fshe participates in the study, at the discretion of the investigator.\n5. Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.\n6. Known to have hypersensitivity to the drug ingredient or its analogues.\n7. Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose.\n8. Patients who have history of other active malignant tumor other than CLL\u002FSLL within 3 years before study entry.\n9. With a malabsorption syndrome or other conditions unsuitable for enteral administration.\n10. Other clinically significant uncontrolled symptoms.\n11. With primary active autoimmune disease and connective tissue disease.\n12. Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.",{"count":588,"type":21},344,[24],"This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL\u002FSLL.",[27],[27,162,161],"2024-05-28",{"date":595,"type":32},"2024-05-29",{"date":597,"type":32},"2024-04-07",{"date":599,"type":21},"2028-08",{"name":38,"class":39},{"id":602,"slug":603,"hasResults":11,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":4,"targetDuration":4,"studyType":608,"phases":4,"briefSummary":609,"conditions":4,"keywords":610,"overallStatus":612,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":616,"locationsCount":4},"100484953","named-patient-program-for-olverembatinib-hqp1351-100484953","NCT05594758","Named Patient Program for Olverembatinib (HQP1351)","Named Patient Program for Providing Access to Olverembatinib (HQP1351) to Countries Where the Drug is Not Available","Inclusion Criteria:\n\n• Patients who are suitable to receive Olverembatinib and for whom there is reasonable expectation that Olverembatinib may provide clinical benefit based on the medical judgment of their prescribing physician.\n\nExclusion Criteria:\n\n* Existing risks of serious Arterial occlusive events (AOE), including myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and recent revascularization procedures\n* Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis\n* Existing serious heart conditions, including acute\u002Fchronic heart failure, coronary artery disease\n* Existing conditions of severe liver malfunction\n* Existing conditions of severe myelosuppression\n* Existing conditions of severe hemorrhage\n* Pregnant or baby feeding","EXPANDED_ACCESS","This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions where the drug is not available.",[611],"Named Patient Program","AVAILABLE","2024-02-06",{"date":615,"type":32},"2024-02-07",{"name":38,"class":39},""]