[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ellipses Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,72,96],{"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":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100473302","phase-1-a-study-of-ep0031-lunbotinib-in-patients-with-advanced-ret-altered-malignancies-100473302",false,"NCT05443126","A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies","A Modular, Open-label, Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0031 in Patients With Advanced RET-altered Malignancies","Inclusion Criteria:\n\nApplicable to all participants:\n\n1. Must be ≥18 years of age, with documented RET-altered NSCLC\n2. Participants should be well informed and consented about alternative treatment options including approved RET-targeted therapies\n3. ECOG performance status of 0 or 1 and life expectancy \\>3 months at screening\n4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures\n5. Measurable disease defined by RECIST v1.1\n6. Must have locally advanced or metastatic NSCLC with RET fusion who are eligible to receive platinum-based doublet chemotherapy.\n7. First line patients: Must not have received a Selective RET inhibitor or chemotherapy. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation\u002Fchemoradiation with or without regimens including immunotherapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior. Palliative radiotherapy for symptom management (eg, bone metastases) is permitted up to 2 weeks prior to treatment start.\n\nExclusion Criteria:\n\nParticipants with any of the following will not be included in the study:\n\n1. Any known major driver gene alterations other than RET.\n2. Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.\n3. Active infection requiring systemic antibiotic, antifungal, or antiviral medication\n4. Severe or uncontrolled medical condition or psychiatric condition\n5. Chronic glomerulonephritis or renal transplant\n6. Participants with active hepatitis B infection or active hepatitis C\n7. Participants with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 months\n8. Receipt of any strong inhibitor or inducer of CYP3A4\n9. Impaired hepatic or renal function, inadequate bone marrow reserve or organ function\n10. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade III-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months\n11. Uncontrolled hypertension\n12. Corneal ulceration or untreated keratitis at screening","ALL","18 Years",{"count":19,"type":20},265,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The aim of this study is to assess the safety, side effects and effectiveness of EP0031 (Lunbotinib) in patients with advanced RET-altered non-small cell lung cancer (NSCLC) in monotherapy and in combination with standard of care (SOC) chemotherapy.",[27],"NSCLC",[29,27,30,31,32,33,34],"selective RET-inhibitor","RET","EP0031","A400","Chemotherapy","lunbotinib","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2022-09-30",{"date":43,"type":20},"2028-03",{"name":45,"class":46},"Ellipses Pharma","INDUSTRY",52,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100407137","phase-1-study-to-evaluate-the-safety-and-tolerability-of-ep0042-100407137","NCT04581512","Study to Evaluate the Safety and Tolerability of EP0042","A Modular, Multipart, Multi-arm, Open-label, Phase I\u002FIIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination With Anti-cancer Treatments in Patients With Advanced Malignancies","General\n\n1. Male or female patients aged ≥ 18 years of age, at the time of informed consent, with histological or cytological confirmation of AML\n2. Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumor tissue\n3. Ability to swallow and retain oral medication\n4. Sufficient life expectancy to allow the patient to complete at least 1 cycle (28 days) of the treatment period.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at screening\n6. In the opinion of the investigator, all other relevant medical conditions must be well-managed and stable for at least 28 days prior to first administration of study drug\n7. Patients with pathologically confirmed\u002Fdocumented AML or MDS, as defined by the 2022 European LeukaemiaNet (ELN) recommendations, or CMML, as defined by World Health Organization (WHO) criteria, who have relapsed from or are refractory to previous therapy and have failed all (or are not eligible for\u002Fintolerant to) available approved therapies for their disease.\n8. Patients with relapsed\u002Frefractory FLT3 WT AML.\n9. Previous exposure to venetoclax, hypomethylating agent and\u002For FLT3 inhibitors (gilteritinib, midostaurin, quizartinib, sorafenib) is allowed for relapsed\u002Frefractory AML patients.\n10. Mutation status of patients must be known at trial entry.\n11. Female patients should either be of non-child-bearing potential or must agree to use highly effective methods of contraception from Screening until 6 months following administration of the last dose of study drug\n12. Male patients must use double barrier contraception from enrolment through treatment and for 6 months following administration of the last dose of study drug\n\n5.2 Core Exclusion Criteria\n\nPatients with any of the following will not be included in the study:\n\nDisease Under Study and Prior Anticancer Treatment\n\n1. Suspected brain and\u002For leptomeningeal metastases that are symptomatic or untreated or that require current therapy\n2. Acute promyelocytic leukemia (FAB:M3)\n3. Systemic anti-cancer therapy for the disease under study within 2 weeks of the first dose of study treatment. If the previous anti-cancer therapy has a very long half-life and may interact with EP0042, e.g. a strong CYP3A4 inhibitor, the washout period may need to be increased for safety reasons but will be no longer than 3 weeks (Concomitant hydroxyurea is acceptable and will be permitted throughout the screening period and during first 6 cycles of study treatment)\n4. Ongoing toxic manifestations of previous treatments that have not reduced to at least CTCAE Grade 1. Exceptions to this are alopecia or certain Grade 2 treatment related toxicities, which in the opinion of the Investigator should not exclude the patient.\n5. Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks\n\n   Laboratory Parameters\n6. Patient with any out-of-range laboratory values defined as shown below.\n\n   • Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \\\u003C 50 mL\u002F min\n7. Inadequate liver function as demonstrated by\n\n   * total serum bilirubin ≥ 1.5 times the upper limits of normal range (ULN) or\n   * ALT ≥3 times the ULN or\n   * AST ≥3 times the ULN or\n   * AST or ALT ≥5 times the ULN in the presence of liver involvement by leukemia",{"count":56,"type":20},70,[23,24],"A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).",[60,61,62],"Acute Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndromes","2026-06-18",{"date":65,"type":39},"2026-06-22",{"date":67,"type":39},"2020-11-02",{"date":69,"type":20},"2027-12",{"name":45,"class":46},6,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":79,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100483291","phase-1-phase-12-study-to-evaluate-ep0062-as-monotherapy-and-in-combination-in-patients-with-advanced-or-metastatic-arher-2-er-breast-cancer-100483291","NCT05573126","Phase 1\u002F2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer","A Modular, Open-Label, Multi-Centre Phase 1\u002F2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 as Monotherapy and in Combination in Patients With Relapsed Locally Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer","Inclusion Criteria:\n\n1. Women 18 years or older at the time of informed consent\n2. Histologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced breast adenocarcinoma as defined by the American Joint Committee on Cancer\u002FUnion for International Cancer Control\u002FTumour Node Metastases (AJCC\u002FUICC TNM) staging classification (8th Ed, 2017) and where no conventional therapy is available or considered appropriate by the Investigator or is declined by the patient\n3. Availability of archival tumour sample (formalin-fixed, paraffin-embedded block(s) or slides from a primary tumour or biopsy of a metastatic tumour lesion or lesions); in the absence of an archival tumour sample, or if only archival bone tissue is available, a fresh biopsy will need to be collected\n4. Biopsy-proven AR+ and ER+ breast cancer\n\n   * For Module A, AR+ breast cancer is defined as ≥ 10% AR nuclei staining by central immunohistochemistry (IHC) using the Ventana assay\n   * For Modules B and C, AR+ breast cancer is defined as ≥ 30% AR nuclei staining by central IHC using the Ventana assay\n5. HER2-negative breast cancer, defined as negative by fluorescence in situ hybridisation (FISH) or IHC score of 0 or 1+. If IHC is equivocal at 2+, a negative FISH test (HER2\u002FAmplification of the centromeric region of chromosome 17)CEP17 ratio of \\\u003C2.0) is required\n6. Postmenopausal, as defined by at least one of the following:\n\n   1. Age over 60 years\n   2. Amenorrhea \\> 12 months at the time of informed consent and an intact uterus, with follicle-stimulating hormone (FSH) and oestradiol in the postmenopausal ranges (as per local practice)\n   3. FSH and oestradiol in the postmenopausal ranges (as per local practice) in women aged \\\u003C55 years who have undergone hysterectomy\n   4. Prior bilateral oophorectomy\n7. Module B arm 1: patients who have progressed on ≤ 2 prior lines of endocrine therapy, including a prior CDK4\u002F6 inhibitor.\n8. Module B arm 2: patients who have progressed on ≤ 2 prior lines of endocrine therapy in advanced\u002Fmetastatic setting, including prior CDK4\u002F6 inhibitor\n9. Module B arm 3: patients who have progressed on treatment with a prior CDK4\u002F6 inhibitor plus an aromatase inhibitor as initial therapy or recurrence on\u002Fafter treatment with a CDK4\u002F6 inhibitor plus endocrine therapy in the adjuvant setting.\n\nExclusion Criteria:\n\nPatients with any of the following will not be included in the study:\n\n1. Prior anti-cancer or investigational drug treatment within the following time windows:\n\n   * Any chemotherapy within 21 days prior to the first dose of study drug\n   * Any non-chemotherapy investigational anti-cancer drug \\\u003C 5 half-lives (28 days for biologics) or \\\u003C 14 days for small-molecule therapeutics or if half-life is not known\n   * Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug\n   * Fulvestrant or other investigational Selective Estrogen Receptor Degraders (SERDs) within 21 days prior to first dose of study drug\n2. Currently taking testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, testosterone-like agents (e.g., dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens\n3. Radiation therapy within 14 days prior to the first dose of study drug and scheduled to have radiation therapy during participation in this study. Short courses of palliative radiation therapy during the study might be allowed following discussion with and approval by the Medical Monitor. Palliative radiotherapy within 6 weeks prior to first dose of study drug is permitted\n4. Unresolved or unstable serious toxic side effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except fatigue, alopecia, and Grade 2 chemotherapy-induced neuropathy\n5. Confirmed Corrected QT Interval by Fridericia (QTcF) \\> 470 ms on screening ECG, or history of torsades de pointes (TdP), or history of congenital long QT syndrome, or immediate family history of long QT syndrome, unexplained sudden death at a young age, or sudden cardiac death\n6. Any other clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third-degree heart block); rate-controlled atrial fibrillation is permitted\n7. Concomitant medications that prolong the corrected QT interval and\u002For increase the risk for TdP that cannot be discontinued or substituted with another drug within 5 half-lives or 14 days before the first dose of study drug, whichever is longer\n8. Congestive heart failure Grades II-IV according to the New York Heart Association at the time of screening\n9. Myocardial infarction or unstable angina within the previous 6 months\n10. Patients receiving medications that are known to be strong inhibitors or inducers of CYP3A4 within 5 half-lives or 14 days, whichever is longer, before the first dose of study drug\n11. Prior treatment with selected combination agent","FEMALE",{"count":81,"type":20},95,[23,24],"The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer",[85,86,87],"Hormone Receptor-positive Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","Metastatic Breast Cancer","2026-06-17",{"date":65,"type":39},{"date":91,"type":39},"2023-01-11",{"date":93,"type":20},"2028-02",{"name":45,"class":46},14,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100595286","phase-1-a-study-to-evaluate-the-safety-and-tolerability-of-ep0089-100595286","NCT07030478","A Study to Evaluate the Safety and Tolerability of EP0089","A Phase I\u002FIIa Study to Evaluate the Safety and Tolerability of Monoclonal Antibody EP0089 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\nApplicable to all patients:\n\n1. Must be ≥18 years of age (≥19 in South Korea) with documented recurrent, metastatic or unresectable solid tumours for whom no standard therapy exists or standard therapy has failed\n2. ECOG performance status of 0 or 1 and life expectancy \\>3 months at screening\n3. Ability to understand and provide written informed consent\n4. Must be willing to comply with necessary contraceptive methods as required\n5. Willing and able to comply with the scheduled study treatment plan, laboratory tests, and other study procedures.\n6. Adequate hepatic, haematological and renal function as assessed by protocol-defined criteria.\n7. Additional cohort\u002Fdisease specific criteria apply\n8. Measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n1. Known active CNS metastases and\u002For leptomeningeal disease and\u002For carcinomatous meningitis.\n2. Recent major surgery\n3. Recent live or live-attenuated vaccine ≤ 30 days prior to the first dose\n4. Current active, or history of, autoimmune disease that requires or required systemic treatment (ie, with disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to starting study treatment.\n5. Prior severe hypersensitivity reaction to mAbs\n6. Previous \\> Grade 2 peripheral neuropathy.\n7. Significant neurological condition eg stroke, transient ischaemic attack (in the last 12 months), epilepsy, head trauma, brain surgery or prior history of any significant psychiatric disorder\n\n9\\. Current active, or history of, autoimmune disease that requires or required continuous treatment within 2 years prior to starting study treatment\n\n10\\. Receiving chronic systemic steroid therapy (\\> 10 mg \u002Fday of prednisone or equivalent) or any other form of immunosuppressive therapy ≤ 7 days prior the first dose of study drug. Topical or inhaled steroids are permitted.\n\n11\\. Any prior immune-mediated or immune-related adverse events related to treatment with immune-modulatory agents that caused permanent discontinuation of the agent, that were ≥ Grade 3 in severity or in the opinion of the Investigator would otherwise jeopardise patient safety in this study.\n\n12\\. One or more clinically significant (ie, active) cardiovascular diseases, myocardial infarction, or unstable angina (≤ 6 months prior to first administration of study drug)",{"count":104,"type":20},190,[23,24],"This is a first-in-human (FIH), first-in-class, Phase I\u002FIIa, open-label study designed to evaluate the safety and tolerability of EP0089 (study drug). Study drug will initially be given via intravenous (IV) infusion once every 2 weeks (Q2W), with one treatment cycle defined as 14 days. The study will enroll patients with advanced solid tumours for whom no standard therapy exists or for whom standard therapy has failed. An independent Safety Monitoring Committee (SMC) will review safety data at regular intervals to ensure participant safety and support dose escalation decisions.",[108,109],"Solid Cancers","Solid Tumours","NOT_YET_RECRUITING","2025-06-12",{"date":113,"type":39},"2025-06-22",{"date":115,"type":20},"2025-09",{"date":117,"type":20},"2029-06",{"name":45,"class":46},""]