[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"LARKSPUR BIOSCIENCES, INC.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053380","phase-1-a-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-lrk-4189-alone-and-in-combination-in-patients-with-solid-tumors-100053380",false,"NCT07498725","A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors","A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination With mFOLFOX6 or FOLFIRI in Patients With Solid Tumors","Inclusion Criteria:\n\n* Willing and able to sign the study consent form and take part in all required study visits, tests, and procedures.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have a locally advanced or metastatic cancer that cannot be removed with surgery and has gotten worse despite treatment.\n* Cancer can be measured on scans, such as CT or MRI.\n* Willing to have tumor biopsies, meaning small samples of your tumor will be collected during the study.\n* Heart rhythm test (ECG) shows a normal result within safe limits.\n* Blood test results at screening are within an acceptable and stable range.\n* If you are a woman, you are not able to become pregnant, or you agree not to become pregnant during the study and to use approved birth control methods.\n* If you are a man, you agree not to donate sperm during the study. If you have sex with a partner who could become pregnant, you agree to use approved birth control methods during the study.\n\nExclusion Criteria:\n\n* Unable to swallow the study medication or your body cannot absorb it.\n* Have had a serious allergic reaction to LRK-4189 or any of its ingredients.\n* Have needed a fluid drainage procedure from the chest or abdomen within the past 6 weeks.\n* Have active cancer in the brain or spinal fluid, or brain tumors that require steroid treatment.\n* Currently receiving another cancer treatment.\n* Have an active HIV, hepatitis B, or hepatitis C infection with detectable virus levels.\n* Have an active infection that requires treatment through a vein (IV).\n* Taking certain medications that strongly interact with the study drug and cannot stop them at least 14 days before starting the study.\n* Pregnant or breastfeeding or planning to become pregnant or father a child during the study.\n* Cannot safely receive the standard chemotherapy that would be used with this study.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189.\n\nThe main questions it aims to answer are:\n\nIs LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors?\n\nParticipants will:\n\n* Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years.\n* Visit the clinic once every week for checkups and tests.",[27],"Neoplasms","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-07-07",{"date":36,"type":20},"2029-06",{"name":38,"class":39},"LARKSPUR BIOSCIENCES, INC.","INDUSTRY",3,{"id":42,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":43,"targetDuration":4,"studyType":21,"phases":44,"briefSummary":25,"conditions":45,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":53,"locationsCount":5},"100631288",{"count":19,"type":20},[23,24],[27],"NOT_YET_RECRUITING","2026-03-23",{"date":49,"type":32},"2026-03-27",{"date":51,"type":20},"2026-05",{"date":36,"type":20},{"name":38,"class":39},""]