[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eilean Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100633689","phase-1-study-of-ze74-0282-for-patients-with-jak2-v617f-positive-blood-cancers-100633689",false,"NCT07529951","Study of ZE74-0282 for Patients With JAK2 V617F Positive Blood Cancers","A Dose Finding Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ZE74-0282 in Select JAK2 V617F Mutated Hematologic Disorders","Inclusion Criteria:\n\n1. Patient is ≥18 years of age at the time of obtaining informed consent.\n2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n3. Patient has histological confirmation JAK2 V617F mutated hematologic diagnosis with later confirmation using ipsogen® JAK2 RGQ PCR Kit) with prior therapy or who have declined them.\n4. All AEs related to prior therapies (chemotherapy\u002Fsystemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline except for:\n\n   1. Alopecia (Grade ≤2)\n   2. Sensory neuropathy (Grade ≤2)\n   3. Other AEs that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the patient.\n5. Adequate hematologic function including\n6. Organ function\u002Freserve as per the following laboratory criteria:\n\n   1. Hepatic: Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin \\\u003C 2 x ULN (except for patients with known or suspected Gilbert's syndrome and with direct bilirubin within normal range) for the local laboratory. If due to disease, higher values may be approved after discussion with medical monitor.\n   2. Renal: Adequate renal function as defined by calculated creatinine clearance \\>45 mL\u002Fmin for the local laboratory.\n7. Baseline corrected QT interval by Fredericia (QTcF) \\\u003C 470 ms. Patients with right, left, or partial bundle branch blocks or pacemaker that may confound interpretation of this reading are not excluded from this provided they lack history of primary arrhythmic events and are cleared by cardiology for enrollment in the trial.\n8. Pregnancy:\n\n   1. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening (not applicable to patients who are unable to become pregnant, including those with bilateral oophorectomy and\u002For hysterectomy). The test must be performed within 72 hours before Day 1 of treatment.\n   2. Women of non-child-bearing potential must have at least 12 continuous months of natural (spontaneous) amenorrhea and an appropriate clinical profile (e.g., age appropriate or history of vasomotor symptoms) or have had surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) \\>42 days prior to screening.\n9. Contraception and Gamete Donation:\n\n   1. Male patients with a WOCBP partner must use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 120 days following the last dose of the study treatment. They must also refrain from sperm donation from screening visit until 120 days following the last dose of study treatment.\n   2. Women of child-bearing potential must use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 120 days following the last dose of the study treatment. They must also refrain from ova donation from screening visit until 120 days following the last dose of study treatment.\n10. Written informed consent must be obtained according to local guidelines and signed and dated by the patient prior to the performance of any study specific procedures, sampling, or analyses.\n\nExclusion Criteria:\n\n1. Clinical signs\u002Fsymptoms of leukostasis or thrombophilia require urgent therapy (phereses).\n2. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.\n3. Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.\n4. Patients who have received an investigational agent (for any indication) \\\u003C14 days prior the first dose of ZE74-0282; an investigational agent is one for which there is no approved indication by the United States (US) FDA or by the applicable regulatory authority in the country where the study is being conducted. Additionally, the first dose of ZE74-0282 should not occur before the shorter of 28 days or a period of 5 half-lives of the investigational drug; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment.\n5. Systemic antineoplastic or radiotherapy \\\u003C14 days prior to the first day of ZE74-0282 administration (Hydroxyurea is allowed prior to study to control counts and may be given during study until completion of cycle 2.\n6. Female patients who are pregnant, lactating, or planning to become pregnant or initiate breastfeeding.\n7. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the study.\n8. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities, stroke or transient ischemic attack within 6 months prior to enrollment (Troponin (regular or high sensitivity) leak alone not included if no residual dysfunction),\n9. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n10. Patients with uncontrolled infection requiring parenteral therapy shall not be enrolled until infection is treated and brought under control (to minimum of requirement of oral antibiotics).\n11. Currently participating in or has planned participation in a study of another investigational agent or device.\n12. Active prior or concurrent malignancy. Such patients for whom the natural history of the malignancy or its treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational schedule are eligible for this study, if approved in writing by the sponsor. Examples of such malignancies include basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and early-stage prostate cancer undergoing watchful waiting. Patients with a completely treated prior malignancy and no evidence of disease for \\>2 years prior to the first dose of ZE74-0282 are eligible.\n13. Patient for whom MRI OR CT imaging of spleen can not be performed on the same imaging platform throughout the study","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will test an experimental drug called ZE74-0282 in people with certain blood disorders caused by a specific mutation called JAK2 V617F. The main goals are to find the right dose level, to see how safe and tolerable different doses are, how the drug moves through the body, and whether it shows early signs of anti-tumor activity. Participants will receive ZE74-0282 in one of several dose groups. The study is open-label, meaning both the doctor and the participant know which treatment is given. It will take place at multiple centers across different countries. Blood tests and regular check-ups will be done to monitor side effects and measure the effect on the disease.",[26,27],"Polycythemia Vera (PV)","Myelofibrosis (MF)",[29,30,31],"JAK2 V617F mutations","polycythemia vera","myelofibrosis","NOT_YET_RECRUITING","2026-04-08",{"date":35,"type":36},"2026-04-14","ACTUAL",{"date":38,"type":20},"2026-05-15",{"date":40,"type":20},"2028-12-30",{"name":42,"class":43},"Eilean Therapeutics","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100633242","phase-1-study-of-ze94-0605-in-patients-with-advanced-solid-tumors-with-dose-expansion-cohorts-100633242","NCT07524140","Study of ZE94-0605 in Patients With Advanced Solid Tumors, With Dose Expansion Cohorts.","Phase 1 Study of ZE94-0605 in Solid Tumors Who Have Exhausted All Treatment Options and Then With Expansion Into Two Dose Cohorts in Select Solid Tumor Patients","Inclusion Criteria:\n\n1. Phase 1 Escalation cohort:\n\n   Patients ≥ 18 with pathologically confirmed, advanced and unresectable or metastatic solid tumor refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\n   Phase 1 Expansion cohort:\n\n   Patients ≥ 18 with pathologically confirmed, advanced and unresectable or metastatic solid tumor refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition or who have declined it who have CCNE1 amplification.\n2. ECOG performance status of 0-1.\n3. Adequate end-organ function as defined by: Creatinine clearance \\>60 ml\u002Fmin, AST\u002FALT \\\u003C3x upper limit of normal, total bilirubin \\\u003C1.5x upper limit of normal (except for patients with Gilbert's disease).\n4. Absolute Neutrophil Count (ANC) must be 1.5 x 109\u002FL or greater, platelets 100 x 109\u002FL or greater.\n5. For female patients of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for 30 days following the last dose of either study drug.\n6. For male patients of childbearing potential having intercourse with females of childbearing potential, the willingness to abstain from heterosexual intercourse or use a protocol recommended method of contraception from the start of study treatment throughout the study treatment period and for 90 days following the last dose of either study drug. Males must also refrain from sperm donation from the start of study treatment throughout the study treatment period and for 90 days following the last dose of either dose of study drug.\n7. Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures and study restrictions.\n\nExclusion Criteria:\n\n1. History of alternative malignancy except for the following: adequately treated local basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease or any other cancer that has been in complete remission without treatment for ≥ 2 years prior to enrollment or that has life expectancy of 24 months and does not require therapy that confounds interpretation of data from this study. Cases where this occurs must be discussed with the medical monitor before screening for enrollment.\n2. Known active Hepatitis C, Hepatitis B, or HIV.\n3. Pregnancy or breast feeding.\n4. Concurrent participation in an investigational drug trial with therapeutic intent defined as prior study therapy within 14 days prior to study treatment.\n5. Inability to tolerate oral medications including symptomatic disease significantly affecting gastrointestinal function such as inflammatory bowel disease or resection of stomach or small bowel.\n6. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by the United States (US) FDA.\n7. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the trial.\n8. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, New York Heart Association (NYHA) Class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n9. Patients with QTc greater than or equal to 470ms unless patient has a pacemaker. Patients with an incomplete or complete right\u002Fleft bundle branch block may participate if cleared by a cardiology evaluation for enrollment.",{"count":19,"type":20},[23],"Phase 1 Study of ZE94-0605 in solid tumors who have exhausted all treatment options and then with expansion into two dose cohorts in select solid tumor patients.",[55,56,57],"Solid Tumor Malignancies","Solid Cancer","Metastatic Solid Tumor",[59,57],"CDK2 inhibitor","2026-04-06",{"date":62,"type":36},"2026-04-13",{"date":64,"type":20},"2026-04",{"date":66,"type":20},"2028-05",{"name":42,"class":43},""]