[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stelexis BioSciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"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},"100610758",false,"NCT07231744","Study of STLX-2012 in Healthy Volunteers","A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of STLX-2012 in Healthy Volunteers","Inclusion Criteria:\n\n* Male or female participants aged 18-55 years old, inclusive, at Screening.\n* Body mass index of 18-32 kg\u002Fm\\^2, inclusive\n* Healthy as determined by the investigator\n* Adequate hepatic and renal function\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n* Male participants and females of childbearing potential must agree to use an effective method of contraception for 30 days after the last dose of STLX-2012\n\nExclusion Criteria:\n\n* Pregnant or lactating female.\n* Positive urine drug screen or alcohol breath test\n* Neutropenia, defined as neutrophil count \\\u003C2.0 x 10\\^9\u002FL\n* History of allergic reaction requiring treatment or anaphylactic reactions to any therapeutic drug.\n* Previous treatment with an IL-1RAP monoclonal antibody\n* History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (excluding mild seasonal allergies)",true,"ALL","18 Years","55 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.",[27],"Healthy Participants","NOT_YET_RECRUITING","2026-04-21",{"date":31,"type":32},"2026-04-22","ACTUAL",{"date":34,"type":21},"2026-10",{"date":36,"type":21},"2027-02",{"name":38,"class":39},"Stelexis BioSciences","INDUSTRY",1,{"id":42,"slug":4,"hasResults":10,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100557103","NCT06533761","Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed\u002FRefractory AML","A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.\n\nExclusion Criteria:\n\n* Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.\n* Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).\n* Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \\>72 hours prior to treatment\n* WBC count \\>25 × 10\\^9\u002FL measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).\n* Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.",{"count":48,"type":21},125,[24],"This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed\u002Frefractory (r\u002Fr) acute myeloid leukemia (AML) or r\u002Fr higher-risk myelodysplastic syndromes (HR-MDS).\n\nThe study consists of 2 parts:\n\n* Part 1: Dose Escalation (DE) in both monotherapy and in combination.\n* Part 2: Dose Optimization",[52,53],"AML, Adult","MDS","RECRUITING","2025-10-20",{"date":57,"type":32},"2025-10-22",{"date":59,"type":32},"2025-04-28",{"date":61,"type":21},"2028-03-15",{"name":38,"class":39},13,""]