[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631288":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":19,"interventions":37,"overallOfficials":11,"centralContacts":55,"locations":61,"responsibleParty":89,"collaborators":11,"id":91,"slug":11,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":11,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":11,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":103,"briefSummary":106,"conditions":107,"keywords":11,"overallStatus":109,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"LARKSPUR BIOSCIENCES, INC.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluation of treatment-related adverse events and\u002For toxicity, presented by dose, regimen and tumor type",null,"From enrollment to the end of the first treatment cycle (each cycle is 21 days)",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":11},"NONE",[20,25,29,33],{"label":21,"type":22,"description":11,"interventionNames":23},"Part 1\u002F1b escalation","EXPERIMENTAL",[24],"Drug: LRK-4189 escalation",{"label":26,"type":22,"description":11,"interventionNames":27},"Part 2 expansion",[28],"Drug: LRK-4189 expansion",{"label":30,"type":22,"description":11,"interventionNames":31},"Part 2b expansion",[28,32],"Drug: Chemo",{"label":34,"type":22,"description":11,"interventionNames":35},"Part 3 optimization",[36],"Drug: LRK-4189 optimization",[38,43,47,51],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"DRUG","LRK-4189 escalation","LRK-4189 at various doses",[21],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":11},"LRK-4189 expansion","LRK-4189 MTD",[26,30],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"LRK-4189 optimization","LRK-4189 2 distinct doses",[34],{"type":39,"name":52,"description":53,"armGroupLabels":54,"otherNames":11},"Chemo","Standard of care",[30],[56],{"name":57,"role":58,"phone":59,"phoneExt":11,"email":60},"CEO","CONTACT","6176931232","trialinfo@larkspur.bio",[62,77],{"facility":63,"status":11,"city":64,"state":11,"zip":11,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Centre Antoine Lacassagne","Nice","France","FR",{"type":68,"coordinates":69},"Point",[70,71],7.26608,43.70313,{"lat":71,"lon":70},[74],{"name":75,"role":58,"phone":59,"phoneExt":11,"email":76},"Sr. Director, Program Management","clinicaltrials@larkspur.bio",{"facility":78,"status":11,"city":79,"state":11,"zip":11,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Western General Hospital","Edinburgh","United Kingdom","UK",{"type":68,"coordinates":83},[84,85],-3.19648,55.95206,{"lat":85,"lon":84},[88],{"name":75,"role":58,"phone":59,"phoneExt":11,"email":76},{"type":90,"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":100,"type":101},120,"ESTIMATED","INTERVENTIONAL",[104,105],"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.",[108],"Neoplasms","NOT_YET_RECRUITING","2026-03-23",{"date":112,"type":113},"2026-03-27","ACTUAL",{"date":115,"type":101},"2026-05",{"date":117,"type":101},"2029-06",{"name":5,"class":6},2]