[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594498":3},{"organization":4,"armGroups":7,"interventions":54,"overallOfficials":60,"centralContacts":79,"locations":85,"responsibleParty":325,"collaborators":60,"id":327,"slug":328,"hasResults":329,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":60,"eligibilityCriteria":333,"healthyVolunteers":329,"sex":334,"minAge":335,"maxAge":60,"enrollmentInfo":336,"targetDuration":60,"studyType":339,"phases":340,"briefSummary":343,"conditions":344,"keywords":350,"overallStatus":88,"whyStopped":60,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":374},{"fullName":5,"class":6},"Verastem, Inc.","INDUSTRY",[8,14,19,23,27,32,36,41,45,50],{"label":9,"type":10,"description":11,"interventionNames":12},"VS-7375 Dose Escalation","EXPERIMENTAL","To determine the recommended phase 2 dose (RP2D) for VS-7375 in patients with 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MD",{"facility":307,"status":88,"city":308,"state":309,"zip":310,"country":311,"countryCode":312,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Peninsula and Southeast Oncology","Frankston","Victoria","3199","Australia","AU",{"type":95,"coordinates":314},[315,316],145.12291,-38.14458,{"lat":316,"lon":315},[319,323],{"name":320,"role":82,"phone":321,"phoneExt":60,"email":322},"Albert Goikhman","61 3 9781 5244","ag@paso.com.au",{"name":324,"role":106,"phone":60,"phoneExt":60,"email":60},"Vinod Ganju, MBBS",{"type":326,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR","100594498","phase-1-a-phase-12-study-of-vs-7375-in-patients-with-kras-g12d-mutated-solid-tumors-100594498",false,"NCT07020221","A Phase 1\u002F2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors","A Phase 1\u002F2, Open-label Study of VS-7375, a KRAS G12D (ON\u002FOFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors","Key Inclusion Criteria:\n\n* Individuals ≥18 years of age.\n* Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC).\n* Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate organ function\n* Adequate cardiac function\n* Recovered from all AEs due to previous therapies to Grade ≤1 or baseline.\n* Agreement to use highly effective contraception\n\nKey Exclusion Criteria:\n\n* Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1,\n* Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1\n* Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.\n* History of treatment with direct and specific KRAS G12D inhibitors.\n* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.\n* Inability to swallow oral medications.\n* Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease\n* Individuals who are pregnant or breastfeeding.","ALL","18 Years",{"count":337,"type":338},295,"ESTIMATED","INTERVENTIONAL",[341,342],"PHASE1","PHASE2","This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.",[345,346,347,348,349],"Pancreatic Ductal Adenocarcinoma","Non Small Cell Lung Cancer","Colorectal Cancer","Solid Tumor, Adult","G12D Mutated KRAS",[351,352,346,353,347,354,355,345,356,357,358,359,360,361,362,363,364],"KRAS G12D mutation","Solid tumors","Lung Cancer","Metastatic Cancer","Pancreatic Cancer","NSCLC","CRC","PDAC","Pancreatic Neoplasms","Colorectal Neoplasms","Lung Neoplasms","Gastrointestinal Neoplasms","KRAS","RAS","2026-04-21",{"date":367,"type":368},"2026-04-22","ACTUAL",{"date":370,"type":368},"2025-06-24",{"date":372,"type":338},"2028-12",{"name":5,"class":6},14]