[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06244771":3,"trial-entities:NCT06244771":418,"trial-summary:NCT06244771":426},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":36,"interventions":39,"primary_outcomes":45,"secondary_outcomes":54,"sex":88,"minimum_age":89,"maximum_age":17,"healthy_volunteers":90,"eligibility_criteria":91,"std_ages":105,"locations":108,"central_contacts":408,"overall_officials":413,"references":416,"see_also_links":417},"NCT06244771","FMC-376-CL101","A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors","An Open-Label, Phase 1\u002F2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants With KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors","RECRUITING","2028-04","2026-03","2026-03-18","2024-02-12","Frontier Medicines Corporation","INDUSTRY",true,"The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.",null,[19,20,21,22,23,24,25,26],"Advanced Solid Tumors With KRAS G12C Mutations","Solid Tumor, Adult","Unresectable Solid Tumor","Metastatic Solid Tumor","Non Small Cell Lung Cancer","Colorectal Cancer","KRAS G12C","Pancreatic Cancer",[28,29,30],"Lung Cancer","KRAS","G12C","INTERVENTIONAL","TREATMENT",[34,35],"PHASE1","PHASE2",{"count":37,"type":38},403,"ESTIMATED",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DRUG","FMC-376","Oral Capsule Daily",[42],[46,50],{"measure":47,"description":48,"timeFrame":49},"Dose Limiting Toxicities","Number of participants with Dose Limiting Toxicities (DLTs)","Up to 21 Days",{"measure":51,"description":52,"timeFrame":53},"Adverse Events (AEs)","Number of participants with treatment-emergent adverse events (TEAEs)","Approximately 24 Months",[55,58,61,64,67,70,73,76,79,82,84,86],{"measure":56,"description":57,"timeFrame":53},"Maximum Observed Plasma Concentration (Cmax) of FMC-376","Cmax",{"measure":59,"description":60,"timeFrame":53},"Time to Reach Maximum Blood Concentration (Tmax) of FMC-376","Tmax",{"measure":62,"description":63,"timeFrame":53},"Minimum Observed Plasma Concentration (Cmin) of FMC-376","Cmin",{"measure":65,"description":66,"timeFrame":53},"Elimination Half-life (t1\u002F2) of FMC-376","t1\u002F2",{"measure":68,"description":69,"timeFrame":53},"Area Under Blood Concentration-Time Curve (AUC) of FMC-376","AUC",{"measure":71,"description":72,"timeFrame":53},"Volume of Distribution (Vd) of FMC-376","Vd",{"measure":74,"description":75,"timeFrame":53},"Clearance (CL) of FMC-376 from Blood Plasma","CL",{"measure":77,"description":78,"timeFrame":53},"Overall Response Rate (ORR)","Assess per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1",{"measure":80,"description":81,"timeFrame":53},"Duration of Response (DOR)","Assess per RECIST v1.1",{"measure":83,"description":81,"timeFrame":53},"Disease Control Rate (DCR)",{"measure":85,"description":81,"timeFrame":53},"Progression-Free Survival (PFS)",{"measure":87,"timeFrame":53},"Overall Survival (OS)","ALL","18 Years",false,{"inclusion":92,"exclusion":98,"raw_text":104},[93,94,95,96,97],"Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation","Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care","Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1","Adequate hematological, renal, and hepatic function","Agrees not to participate in another interventional study while receiving study drug",[99,100,101,102,103],"Leptomeningeal disease or carcinomatous meningitis","Clinically significant toxicity resulting from prior cancer therapies","Known or suspected hypersensitivity to FMC-376 or any components of the study drug","Condition that would interfere with study drug absorption","Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation\n* Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate hematological, renal, and hepatic function\n* Agrees not to participate in another interventional study while receiving study drug\n\nExclusion Criteria:\n\n* Leptomeningeal disease or carcinomatous meningitis\n* Clinically significant toxicity resulting from prior cancer therapies\n* Known or suspected hypersensitivity to FMC-376 or any components of the study drug\n* Condition that would interfere with study drug absorption\n* Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data",[106,107],"ADULT","OLDER_ADULT",[109,124,132,144,152,164,176,188,200,213,225,232,244,252,265,278,292,304,317,328,341,354,368,378,388,400],{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":114,"contacts":115,"geoPoint":121},"University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center","La Jolla","California","92037","United States",[116],{"name":117,"role":118,"phone":119,"email":120},"Study Coordinator","CONTACT","858-822-5354","rrpatel@health.ucsd.edu",{"lat":122,"lon":123},32.84727,-117.2742,{"facility":125,"status":126,"city":127,"state":112,"zip":128,"country":114,"geoPoint":129},"University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center","COMPLETED","Orange","92868",{"lat":130,"lon":131},33.78779,-117.85311,{"facility":133,"status":8,"city":134,"state":112,"zip":135,"country":114,"contacts":136,"geoPoint":141},"University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center","San Francisco","94158",[137],{"name":138,"role":118,"phone":139,"email":140},"Project Manager","418-969-0533","phu.lam@ucsf.edu",{"lat":142,"lon":143},37.77493,-122.41942,{"facility":145,"status":126,"city":146,"state":147,"zip":148,"country":114,"geoPoint":149},"Florida Cancer Specialists and Research Institute","Lake Mary","Florida","32746",{"lat":150,"lon":151},28.75888,-81.31784,{"facility":153,"status":8,"city":154,"state":155,"zip":156,"country":114,"contacts":157,"geoPoint":161},"Northwest Cancer Centers","Dyer","Indiana","46311",[158],{"name":117,"role":118,"phone":159,"email":160},"219-924-8178","karyn.burnworth@usoncology.com",{"lat":162,"lon":163},41.4942,-87.52171,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":114,"contacts":169,"geoPoint":173},"The University of Kansas Cancer Center","Fairway","Kansas","66205",[170],{"name":117,"role":118,"phone":171,"email":172},"913-945-7552","CTNurseNav@kumc.edu",{"lat":174,"lon":175},39.02223,-94.6319,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":114,"contacts":181,"geoPoint":185},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",[182],{"name":117,"role":118,"phone":183,"email":184},"877-338-7425","matthew_olszewski@dfci.harvard.edu",{"lat":186,"lon":187},42.35843,-71.05977,{"facility":189,"status":8,"city":190,"state":191,"zip":192,"country":114,"contacts":193,"geoPoint":197},"Karmanos Cancer Institute","Detroit","Michigan","48201",[194],{"name":117,"role":118,"phone":195,"email":196},"313-576-9816","galiciv@karmanos.org",{"lat":198,"lon":199},42.33143,-83.04575,{"facility":201,"status":8,"city":202,"state":203,"zip":204,"country":114,"contacts":205,"geoPoint":210},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[206],{"name":207,"role":118,"phone":208,"email":209},"Program Manager","267-414-6179","jennifer.louie2@pennmedicine.upenn.edu",{"lat":211,"lon":212},39.95238,-75.16362,{"facility":214,"status":8,"city":215,"state":216,"zip":217,"country":114,"contacts":218,"geoPoint":222},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",[219],{"name":117,"role":118,"phone":220,"email":221},"888-513-6613","adeshmukh1@mdanderson.org",{"lat":223,"lon":224},29.76328,-95.36327,{"facility":226,"status":126,"city":227,"state":216,"zip":228,"country":114,"geoPoint":229},"Community Clinical Trials","Kingwood","77339",{"lat":230,"lon":231},30.05691,-95.18349,{"facility":233,"status":8,"city":234,"state":216,"zip":235,"country":114,"contacts":236,"geoPoint":241},"South Texas Accelerated Research Therapeutics, LLC","San Antonio","78229",[237],{"name":238,"role":118,"phone":239,"email":240},"Physician Referral Coordinator","210-593-5265","isabel.jimenez@startsa.com",{"lat":242,"lon":243},29.42412,-98.49363,{"facility":245,"status":8,"city":234,"state":216,"zip":235,"country":114,"contacts":246,"geoPoint":251},"UT Health San Antonio",[247],{"name":248,"role":118,"phone":249,"email":250},"Clinical Trials Specialist","210-450-5798","goodwine@uthscsa.edu",{"lat":242,"lon":243},{"facility":253,"status":8,"city":254,"state":255,"zip":256,"country":114,"contacts":257,"geoPoint":262},"START Mountain Region","West Valley City","Utah","84119",[258],{"name":259,"role":118,"phone":260,"email":261},"Director, Clinical Operation","801-907-4770","marie.asay@startthecure.com",{"lat":263,"lon":264},40.69161,-112.00105,{"facility":266,"status":8,"city":267,"state":268,"zip":269,"country":114,"contacts":270,"geoPoint":275},"Virginia Cancer Specialists","Fairfax","Virginia","22031",[271],{"name":272,"role":118,"phone":273,"email":274},"Clinical Trials Nurse Navigator","703-636-1473","carrie.friedman@usoncology.com",{"lat":276,"lon":277},38.84622,-77.30637,{"facility":279,"status":8,"city":280,"state":281,"zip":282,"country":283,"contacts":284,"geoPoint":289},"Macquarie University","Macquarie Park","New South Wales","2109","Australia",[285],{"name":286,"role":118,"phone":287,"email":288},"Study Contact","+61 2 9812 2956","clinicaltrials@mq.edu.au",{"lat":290,"lon":291},-33.78105,151.12757,{"facility":293,"status":8,"city":294,"state":295,"zip":296,"country":283,"contacts":297,"geoPoint":301},"Tasman Health Care","Southport","Queensland","4215",[298],{"name":286,"role":118,"phone":299,"email":300},"(07) 5613 2480","research@tasmanhealthcare.com.au",{"lat":302,"lon":303},-27.96724,153.39796,{"facility":305,"status":8,"city":306,"state":307,"zip":308,"country":283,"contacts":309,"geoPoint":314},"Icon Cancer Centre Kurralta Park","Kurralta Park","South Australia","5037",[310],{"name":311,"role":118,"phone":312,"email":313},"Sue Yeend","+61 8 84740240","adelaideresearch@icon.team",{"lat":315,"lon":316},-34.95142,138.56702,{"facility":318,"status":8,"city":319,"state":307,"zip":320,"country":283,"contacts":321,"geoPoint":325},"GenesisCare North Adelaide","North Adelaide","5006",[322],{"name":117,"role":118,"phone":323,"email":324},"08 8463 2500","oncologyresearchSA@genesiscare.com",{"lat":326,"lon":327},-34.90733,138.59141,{"facility":329,"status":8,"city":330,"state":331,"zip":332,"country":283,"contacts":333,"geoPoint":338},"Eastern Health - Box Hill Hospital","Box Hill","Victoria","3128",[334],{"name":335,"role":118,"phone":336,"email":337},"Oncology Trials Manager","+61 3 9094 9564","karen.lim@monash.edu",{"lat":339,"lon":340},-37.81887,145.12545,{"facility":342,"status":8,"city":343,"state":344,"zip":345,"country":283,"contacts":346,"geoPoint":351},"Linear Clinical Research Ltd","Nedlands","Western Australia","6009",[347],{"name":348,"role":118,"phone":349,"email":350},"Head of Project Operations","61 (08) 6382 5100","actcmanagement@linear.org.au",{"lat":352,"lon":353},-31.98184,115.8073,{"facility":355,"status":8,"city":356,"state":357,"zip":358,"country":359,"contacts":360,"geoPoint":365},"Seoul National University Hospital","Seoul","Jongno-gu","03080","South Korea",[361],{"name":362,"role":118,"phone":363,"email":364},"Medical Service","+82-2-2072-2890","international@snuh.org",{"lat":366,"lon":367},37.566,126.9784,{"facility":369,"status":8,"city":356,"state":370,"zip":371,"country":359,"contacts":372,"geoPoint":377},"Severance Hospital","Seodaemun-gu","03722",[373],{"name":374,"role":118,"phone":375,"email":376},"International Health Care Center","+82-2-2228-5800","ihcc@yuhs.ac",{"lat":366,"lon":367},{"facility":379,"status":8,"city":356,"state":380,"zip":381,"country":359,"contacts":382,"geoPoint":387},"Korea University Anam Hospital","Seongbuk-gu","02841",[383],{"name":384,"role":118,"phone":385,"email":386},"International Healthcare Center","+82-2-920-5677","kumcihc@kumc.or.kr",{"lat":366,"lon":367},{"facility":389,"status":8,"city":390,"state":391,"zip":392,"country":359,"contacts":393,"geoPoint":397},"Seoul National University Bundang Hospital","Gyeonggi-do","Seongnam-si","13620",[394],{"name":384,"role":118,"phone":395,"email":396},"+82-31-787-2034","ihsi@snubh.org",{"lat":398,"lon":399},37.58944,126.76917,{"facility":401,"status":8,"city":390,"state":402,"zip":403,"country":359,"contacts":404,"geoPoint":407},"The Catholic University of Korea, St. Vincent's Hospital","Suwon-si","16247",[405],{"name":374,"role":118,"phone":406},"+82-31-249-8016",{"lat":398,"lon":399},[409],{"name":410,"role":118,"phone":411,"email":412},"Medical Lead","+1 (650) 457-1005","clinicaltrials@frontiermeds.com",[414],{"name":410,"affiliation":13,"role":415},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":419,"biomarkers":424},[420,421,422,423],"Colorectal Carcinoma","Lung Non-Small Cell Carcinoma","Pancreatic Carcinoma","Solid Neoplasm",[425],"GTPase KRas",{"nct_id":4,"found":15,"summary":427,"prompt_version":17},{"design":428,"status":429,"heading":430,"summary":431,"follow_up":432,"word_count":433,"commitments":434,"compensation":435,"drugs_mentioned":436},"This study is an interventional trial with an unclear status, planning to enroll 403 participants. It will be conducted in three parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion).","completed","A Study of FMC-376 for Advanced Solid Tumors with KRAS G12C Mutations","This study is testing a drug called FMC-376, given as an oral capsule daily, for people with advanced solid tumors that have a specific genetic change called a KRAS G12C mutation. To join, you must have solid tumors that are advanced (unresectable or metastatic) and have the KRAS G12C mutation. You should also have tried and not responded to standard treatments, or if standard treatment isn't suitable. The study will look at how safe FMC-376 is by tracking side effects and other problems for up to 24 months. The goal is to find the right dose and see how well it works. This study is currently unclear about its recruitment status and plans to enroll about 403 participants.","Adverse Events (AEs) will be measured for approximately 24 months.",118,"Not specified in the trial record.","Not stated in the trial record.",[42]]