[{"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:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100649554","phase-1-a-first-in-human-study-of-ze66-0205-in-healthy-volunteers-100649554",false,"NCT07735728","A First-in-Human Study of ZE66-0205 in Healthy Volunteers","A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE66-0205 in Healthy Volunteers","Inclusion Criteria:\n\n* Written informed consent provided before any study-related activities; able to understand the nature, purpose, risks, and possible adverse effects of the study.\n* Male or female, 18 to 55 years of age, inclusive, at Screening.\n* Body mass index 18.0 to 32.0 kg\u002Fm², inclusive, and body weight no more than 100 kg at Screening.\n* Medically healthy in the opinion of the Investigator or delegate based on medical history and absence of clinically significant abnormalities, including: no clinically relevant physical-examination findings; systolic blood pressure 90 to 160 mmHg and diastolic blood pressure 50 to 95 mmHg after at least 5 minutes of rest; pulse rate 40 to 100 beats\u002Fminute after at least 5 minutes of rest; tympanic body temperature 35.5°C to 37.7°C; and electrocardiogram without clinically significant abnormalities, including QTcF less than 450 msec for males and less than 470 msec for females.\n* Female participants must be of non-childbearing potential (surgically sterilised at least 6 weeks before Screening or postmenopausal with confirmatory follicle-stimulating hormone level) or, if of childbearing potential, must have negative pregnancy tests at Screening and Day -1, agree not to become pregnant or donate ova until at least 30 days after the last dose, and use protocol-defined adequate contraception during this period unless exclusively in a same-sex relationship or abstinent as a committed lifestyle.\n* Male participants must agree not to donate sperm until at least 90 days after the last dose. When engaging in sexual intercourse with a female partner who could become pregnant, the participant must use a condom together with a protocol-defined highly effective method of contraception until at least 90 days after the last dose. When engaging in sexual intercourse with a female partner who is not of childbearing potential or with a same-sex partner, the participant must use a condom until at least 5 days after the last dose.\n* Suitable venous access for blood sampling.\n* Willing and able to comply with all study assessments, schedule requirements, and restrictions.\n\nExclusion Criteria:\n\n* History of anaphylaxis or another significant allergy that, in the opinion of the Investigator or delegate, could interfere with study participation.\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease or disorder, including any clinically relevant acute illness within the previous 3 months.\n* Surgery or hospitalization within 3 months before Screening, or planned surgery during the study.\n* History of malignant disease within the previous 10 years, except surgically resected squamous-cell or basal-cell skin carcinoma with histopathologically confirmed clear margins.\n* Clinically relevant immunosuppression, including immunodeficiency conditions such as common variable hypogammaglobulinemia.\n* History of risk factors for torsade de pointes, including family history of long QT syndrome or sudden cardiac death, or a known arrhythmia.\n* Gastrointestinal, hepatic (including Gilbert syndrome), renal, or other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Gamma-glutamyl transferase, total bilirubin, alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase greater than 1.5 times the upper limit of normal, unless an isolated elevation is considered a normal variant by the Investigator or delegate and is not accompanied by clinical signs.\n* Estimated creatinine clearance below 60 mL\u002Fmin using the Cockcroft-Gault formula or serum creatinine greater than 1.5 times the upper limit of normal.\n* History of or positive Screening test for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibodies.\n* Positive urine drug-of-abuse test, carbon monoxide breath test, or alcohol breath test at Screening or Day -1.\n* Regular smoking of more than 5 cigarettes per week or equivalent, including tobacco, nicotine replacement therapy, e-cigarettes, or marijuana. Casual smokers may be eligible only if all protocol requirements are met.\n* Pregnant or breastfeeding female, or female planning to breastfeed from Screening until 3 months after the last dose or 5 half-lives, whichever is longer.\n* Unable to swallow oral medication.\n* Use of prescription medication, including oral contraceptives, within 14 days or 5 half-lives, whichever is longer, before the first dose; or use of over-the-counter medication within 7 days or 5 half-lives, whichever is longer, before the first dose, except protocol-permitted paracetamol.\n* Current infection requiring a systemically absorbed antibiotic, antifungal, antiparasitic, or antiviral medication within 10 days before the first dose.\n* Receipt of an inactivated vaccination within 14 days or a live vaccination within 30 days before the first dose, or planned vaccination during the study.\n* Use of systemic immunosuppressive or immunomodulating medication within 28 days or 5 half-lives, whichever is longer, before dosing or during the study.\n* Blood or plasma donation within 30 days before the first dose; loss of more than 500 mL of whole blood within 30 days before the first dose; or receipt of a blood transfusion within 1 year before the first dose.\n* Participation in a clinical study of an investigational drug or device within 30 days or 5 half-lives of the investigational drug, whichever is longer, before Screening.\n* Any other condition or prior therapy that, in the opinion of the Investigator or delegate, makes the participant unsuitable for the study, including inability to cooperate fully or likely noncompliance with study requirements.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This first-in-human study will evaluate ZE66-0205 in healthy adults. The main purpose is to assess the safety and tolerability of single oral doses and, if evaluated, two doses given on Day 1. The study will also assess how ZE66-0205 is absorbed, distributed, and eliminated from the body and how it affects MALT1 levels in blood cells. Participants will be assigned by chance to receive ZE66-0205 or placebo in sequential ascending-dose cohorts.",[28],"Healthy Volunteers (HV)",[30,31,32,33,34,35,36,37,38],"ZE66-0205","MALT1","MALT1 degrader","proteolysis-targeting chimera","PROTAC","first-in-human","single ascending dose","pharmacokinetics","pharmacodynamics","NOT_YET_RECRUITING","2026-08-12",{"date":42,"type":43},"2026-08-14","ACTUAL",{"date":45,"type":22},"2026-08-15",{"date":47,"type":22},"2027-08-15",{"name":49,"class":50},"Eilean Therapeutics","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":5},"100633242","phase-1-a-first-in-human-study-of-ze94-0605-in-patients-with-advanced-solid-tumors-100633242","NCT07524140","A First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors","A Phase 1, First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nPhase 1a Dose-Escalation Cohorts:\n\n1. Age 18 years or older with a pathologically confirmed, advanced, unresectable or metastatic solid tumor that is refractory to, or intolerant of, available existing therapy or therapies known to provide clinical benefit for the condition, if available, and with measurable disease.\n\n   Phase 1b Dose-Expansion Cohorts:\n2. Age 18 years or older with a pathologically confirmed, advanced, unresectable or metastatic solid tumor that is refractory to, or intolerant of, available existing therapy or therapies known to provide clinical benefit for the condition, if available, or who has declined such therapy; presence of CCNE1 amplification; and measurable disease.\n\n   Common Eligibility Criteria:\n3. Eastern Cooperative Oncology Group performance status of 0 or 1.\n4. Adequate end-organ function, defined as creatinine clearance greater than 60 mL\u002Fmin, aspartate aminotransferase and alanine aminotransferase less than 3 times the upper limit of normal, and total bilirubin less than 1.5 times the upper limit of normal, except for participants with Gilbert's disease.\n5. Absolute neutrophil count at least 1.5 × 10\\^9\u002FL and platelet count at least 100 × 10\\^9\u002FL.\n6. Female participants of childbearing potential must be willing to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from screening throughout study treatment and for 90 days after the last dose of ZE94-0605.\n7. Male participants of reproductive potential who have intercourse with females of childbearing potential must be willing to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the start of study treatment throughout study treatment and for 90 days after the last dose of ZE94-0605. Male participants must also refrain from sperm donation during this period.\n8. Willingness to comply with scheduled visits, the drug-administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions.\n\nExclusion Criteria:\n\n1. History of another malignancy, except 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 another cancer that has been in complete remission without treatment for at least 2 years before enrollment or has a life expectancy of 24 months and does not require therapy that would confound interpretation of this study. Such cases must be discussed with the Medical Monitor before screening.\n2. Known active hepatitis C, hepatitis B, or human immunodeficiency virus infection.\n3. Pregnancy or breastfeeding.\n4. Concurrent participation in an investigational-drug trial with therapeutic intent, defined as receipt of prior study therapy within 14 days before study treatment.\n5. Inability to tolerate oral medication, including symptomatic disease that significantly affects gastrointestinal function, such as inflammatory bowel disease or resection of the stomach or small bowel.\n6. Receipt of an investigational agent for any indication within 5 half-lives of the agent. If the half-life is unknown, the participant must wait 1 week before the first dose of study treatment. An investigational agent is one for which there is no approved indication from the U.S. Food and Drug Administration.\n7. Psychological, familial, social, or geographic factors; another significant medical condition; or a laboratory abnormality that precludes informed consent or protocol compliance, may hamper adherence to study treatment or follow-up, or would confound interpretation of study results.\n8. Uncontrolled intercurrent illness, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, New York Heart Association Class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction-system abnormalities. Participants with medical comorbidities that would preclude safety evaluation of ZE94-0605 must not be enrolled.\n9. QT interval corrected using Fridericia's formula (QTcF) greater than or equal to 470 milliseconds, unless the participant has a pacemaker. Participants with an incomplete or complete right or left bundle branch block may participate if cleared for enrollment by a cardiology evaluation.",{"count":60,"type":22},60,[25],"ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor. This multicenter, open-label, first-in-human Phase 1 study will evaluate ZE94-0605 in adults with advanced, unresectable or metastatic solid tumors. Phase 1a will use sequential dose escalation to determine the maximally tolerated dose and biologically effective dose. Phase 1b will randomize participants with CCNE1 amplification, or another prospectively specified molecular feature, between two dose levels to select the recommended Phase 2 dose.",[64,65],"Advanced Solid Tumor Cancer","Metastatic Solid Tumor",[67,68,69,70,71,72,73,74,75,76],"ZE94-0605","Selective CDK2 inhibitor","CCNE1 amplification","Cyclin E1","First-in-human","Dose escalation","Dose optimization","Recommended Phase 2 dose","Project Optimus","Brain-penetrant CDK2 inhibitor","RECRUITING","2026-07-28",{"date":80,"type":43},"2026-07-29",{"date":82,"type":43},"2026-06-25",{"date":84,"type":22},"2028-05",{"name":49,"class":50},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100633689","phase-1-study-of-ze74-0282-for-patients-with-jak2-v617f-positive-blood-cancers-100633689","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",{"count":60,"type":22},[25],"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.",[97,98],"Polycythemia Vera (PV)","Myelofibrosis (MF)",[100,101,102],"JAK2 V617F mutations","polycythemia vera","myelofibrosis","2026-04-08",{"date":105,"type":43},"2026-04-14",{"date":107,"type":22},"2026-05-15",{"date":109,"type":22},"2028-12-30",{"name":49,"class":50},""]