[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631288":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":11,"centralContacts":44,"locations":50,"responsibleParty":78,"collaborators":11,"id":80,"slug":11,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":11,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":11,"enrollmentInfo":88,"targetDuration":11,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":11,"overallStatus":98,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"LARKSPUR BIOSCIENCES, INC.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1\u002F1b escalation","EXPERIMENTAL",null,[13],"Drug: LRK-4189 escalation",{"label":15,"type":10,"description":11,"interventionNames":16},"Part 2 expansion",[17],"Drug: LRK-4189 expansion",{"label":19,"type":10,"description":11,"interventionNames":20},"Part 2b expansion",[17,21],"Drug: Chemo",{"label":23,"type":10,"description":11,"interventionNames":24},"Part 3 optimization",[25],"Drug: LRK-4189 optimization",[27,32,36,40],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","LRK-4189 escalation","LRK-4189 at various doses",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"LRK-4189 expansion","LRK-4189 MTD",[15,19],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"LRK-4189 optimization","LRK-4189 2 distinct doses",[23],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Chemo","Standard of care",[19],[45],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"CEO","CONTACT","6176931232","trialinfo@larkspur.bio",[51,66],{"facility":52,"status":11,"city":53,"state":11,"zip":11,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Centre Antoine Lacassagne","Nice","France","FR",{"type":57,"coordinates":58},"Point",[59,60],7.26608,43.70313,{"lat":60,"lon":59},[63],{"name":64,"role":47,"phone":48,"phoneExt":11,"email":65},"Sr. Director, Program Management","clinicaltrials@larkspur.bio",{"facility":67,"status":11,"city":68,"state":11,"zip":11,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Western General Hospital","Edinburgh","United Kingdom","UK",{"type":57,"coordinates":72},[73,74],-3.19648,55.95206,{"lat":74,"lon":73},[77],{"name":64,"role":47,"phone":48,"phoneExt":11,"email":65},{"type":79,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100631288",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":89,"type":90},120,"ESTIMATED","INTERVENTIONAL",[93,94],"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.",[97],"Neoplasms","NOT_YET_RECRUITING","2026-03-23",{"date":101,"type":102},"2026-03-27","ACTUAL",{"date":104,"type":90},"2026-05",{"date":106,"type":90},"2029-06",{"name":5,"class":6},2]