[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"olverembatinib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:olverembatinib":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100606696","phase-2-phase-ii-study-of-the-combination-of-subcutaneous-blinatumomab-and-olverembatinib-in-patients-with-philadelphia-chromosome-ph-positive-andor-bcrabl1-positive-acute-lymphoblastic-leukemia-all-100606696",false,"NCT07178912","Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and\u002For BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)","Eligibility Criteria\n\n* Diagnosis of one of the following:\n\n  o Participants ≥18 years of age with newly diagnosed or relapsed\u002Frefractory Ph-positive and\u002For BCR::ABL1-positive ALL (includes Participants initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. Participants with newly diagnosed disease could have received one or two courses of chemotherapy with or without other TKIs and still eligible (Participants with lymphoid accelerated or blast phase CML will be evaluated separately).\n* Performance status ≤2 (ECOG Scale).\n* Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n  * Total serum bilirubin \\\u003C2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN.\n* Adequate pancreatic function as defined by serum lipase and amylase \\\u003C1.5 x ULN.\n* For females of childbearing potential, a negative urine pregnancy test must be documented.\n* Female Participants who:\n\n  * Are postmenopausal for at least 1 year before the screening visit, OR\n  * Are surgically sterile, OR\n  * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n* Male Participants, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n  * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n  * Agree to completely abstain from heterosexual intercourse.\n* Adequate cardiac function as assessed clinically by history and physical examination.\n* Signed informed consent.\n\nExclusion Criteria\n\n* Active serious infection not controlled by oral or IV antibiotics.\n* Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nActive grade III-V cardiac failure as defined by the New York Heart Association criteria.\n\n* Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  * Myocardial infarction, stroke, or revascularization within 3 months\n  * Unstable angina or transient ischemic attack\n  * Congestive heart failure prior to enrollment, or left ventricular ejection fraction less than lower limit of normal per local institutional standards prior to enrollment\n  * Diagnosed or suspected congenital long QT syndrome\n  * Clinically significant atrial or ventricular arrhythmias (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician\n  * Prolonged QTc interval on pre-entry electrocardiogram (\\>470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n  * Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated thrombosis will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility\n  * Uncontrolled hypertension (diastolic blood pressure \\>90 mmHg, systolic \\>140 mmHg). Participants with hypertension should be under treatment on study entry for blood pressure control.\n* History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Participants with active CNS leukemia will not be excluded.\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.\n* Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days before study entry, unless full recovery from side effects has occurred or Participant has rapidly progressive disease judged to be life-threatening by the investigator.\n* Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n* History of significant bleeding disorder unrelated to cancer, including:\n\n  * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n  * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).\n* Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.","ALL","18 Years",{"count":18,"type":19},60,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.",[25,26,27,28,29],"Phase II Clinical Trial","Blinatumomab","Olverembatinib","Lymphoblastic Leukemia","Philadelphia Chromosome Positive","NOT_YET_RECRUITING","2026-04-29",{"date":33,"type":34},"2026-05-05","ACTUAL",{"date":36,"type":19},"2026-08-27",{"date":38,"type":19},"2033-09-30",{"name":40,"class":41},"M.D. Anderson Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":42},"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.",true,"75 Years",{"count":53,"type":19},48,[55],"PHASE1","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.",[58,27],"Pharmacokinetic",[60],"olverembatinib","RECRUITING","2025-12-21",{"date":64,"type":34},"2025-12-23",{"date":66,"type":34},"2025-11-11",{"date":68,"type":19},"2026-10-31",{"name":70,"class":71},"Ascentage Pharma Group Inc.","INDUSTRY"]