[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637602":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":26,"responsibleParty":46,"collaborators":20,"id":48,"slug":20,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":20,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":20,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts","EXPERIMENTAL","Part A: Dose Escalation Participants will receive the designated dose. Enrollment into dose escalation may be from any advanced solid tumors with KRAS G12D mutation.\n\nPart B: Dose Expansion:\n\nUpon completing DLT observation for a dose level, investigators and sponsor may discuss selecting a specific cancer type for expansion at prior dose.",[13],"Drug: LT-010391",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","LT-010391","LT-010391 tablets, oral, once daily",[9],null,[22],{"name":5,"role":23,"phone":24,"phoneExt":20,"email":25},"CONTACT","+86-21-50561622","jxu@leadingtac.com",[27],{"facility":28,"status":20,"city":29,"state":30,"zip":31,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Zhejiang Cancer Hospital","Hangzhou","Zhejiang","310022","China",{"type":34,"coordinates":35},"Point",[36,37],120.16142,30.29365,{"lat":37,"lon":36},[40,44],{"name":41,"role":23,"phone":42,"phoneExt":20,"email":43},"Zhengbo Song, MD","86571-88122146","irb@zjcc.org.cn",{"name":41,"role":45,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100637602",false,"NCT07624214","Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors","A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation;\n* Failed standard therapy, intolerant to standard therapy, or no standard therapy is available;\n* ECOG Performance Status of 0 or 1;\n* Adequate organ function\n\nExclusion Criteria:\n\n* History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured;\n* Primary central nervous system (CNS) tumors\n* leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":57,"type":58},198,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors",[64,65,66,67],"Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Advanced Solid Tumors","NOT_YET_RECRUITING","2026-05-31",{"date":71,"type":72},"2026-06-03","ACTUAL",{"date":74,"type":58},"2026-07",{"date":76,"type":58},"2029-04",{"name":5,"class":6},1]