[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642372":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":47,"studyPopulation":47,"armGroups":53,"interventions":69,"overallOfficials":47,"centralContacts":85,"locations":47,"responsibleParty":94,"collaborators":47,"id":96,"slug":47,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":47,"enrollmentInfo":105,"targetDuration":47,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":47,"overallStatus":114,"whyStopped":47,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":47},{"fullName":5,"class":6},"Verastem, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":40},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 - 2L CRC only","Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)","6 months",{"measure":14,"description":15,"timeFrame":12},"To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab or panitumumab, administered on a daily oral schedule in participants with KRAS G12D-mutated 2L+ CRC","Proportion\u002Fnumber of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions\u002Freductions and discontinuations",{"measure":17,"description":15,"timeFrame":12},"To characterize the safety and tolerability of VS-7375 in combination with cetuximab + mFOLFOX, administered on a daily oral schedule in participants with KRAS G12D-mutated 1L CRC",[19,23,27,30,34,37],{"measure":20,"description":21,"timeFrame":22},"Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments","To evaluate additional efficacy parameters of VS-7375 monotherapy and VS-7375 in combination with cetuximab or panitumumab or cetuximab + mFOLFOX, administered on a daily oral schedule in participants with KRAS G12D-mutated CRC","24 months",{"measure":24,"description":25,"timeFrame":26},"Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax","Maximum concentration (Cmax)","20 weeks",{"measure":28,"description":29,"timeFrame":26},"Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC","Area under plasma Concentration (AUC) 0 to t",{"measure":31,"description":32,"timeFrame":33},"To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type","CA19-9, CEA, CA-125","Up to 2.5 years",{"measure":35,"description":36,"timeFrame":22},"To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30)","The EORTC QLQ-C30 is a validated questionnaire to assess the quality of life of colorectal cancer patients",{"measure":38,"description":39,"timeFrame":22},"Time to next therapy","To assess the interval between initiation of study treatment and initiation of subsequent treatment",[41],{"measure":42,"description":43,"timeFrame":22},"Imaging of tumor metabolism changes in 2L monotherapy patients","To assess tumor metabolism dynamics on FDG-PET\u002FCT",{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":47,"timePerspective":47,"maskingInfo":49},"RANDOMIZED","CROSSOVER",null,"TREATMENT",{"masking":50,"maskingDescription":47,"whoMasked":51},"SINGLE",[52],"OUTCOMES_ASSESSOR",[54,62,65],{"label":55,"type":56,"description":57,"interventionNames":58},"VS-7375 Monotherapy or Preferred Combination in 2L+ CRC","EXPERIMENTAL","Participants randomized to a treatment in 2:1 ratio",[59,60,61],"Drug: VS-7375","Drug: cetuximab","Drug: panitumumab",{"label":63,"type":56,"description":47,"interventionNames":64},"VS-7375 with chosen regimen in 2L+ CRC",[59,60,61],{"label":66,"type":56,"description":47,"interventionNames":67},"VS-7375 + cetuximab and mFOLFOX in 1L CRC",[68],"Drug: Cetuximab + mFOLFOX6",[70,75,79,82],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":47},"DRUG","VS-7375","Taken by mouth",[55,63],{"type":71,"name":76,"description":77,"armGroupLabels":78,"otherNames":47},"cetuximab","Intravenous infusion",[55,63],{"type":71,"name":80,"description":77,"armGroupLabels":81,"otherNames":47},"panitumumab",[55,63],{"type":71,"name":83,"description":77,"armGroupLabels":84,"otherNames":47},"Cetuximab + mFOLFOX6",[66],[86,91],{"name":87,"role":88,"phone":89,"phoneExt":47,"email":90},"Verastem Call Center","CONTACT","7812924204","VS-7375-203TrialSupport@verastem.com",{"name":92,"role":88,"phone":47,"phoneExt":47,"email":93},"Luke Chung, MD","VS-7375-203Medical@verastem.com",{"type":95,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100642372",false,"NCT07659795","A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer","A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON\u002FOFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)","TARGET-D 203","Inclusion Criteria:\n\n* Histopathology confirmed metastatic CRC\n* Measurable disease per RECIST 1.1\n* Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)\n* ECOG PS=0 or 1\n\n  2L+ patients:\n* Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma\n* Have documented disease progression during or following their most recent prior line of therapy\n* Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.\n\n  1L patients:\n* Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.\n\nExclusion Criteria:\n\n* Have any other documented co-existing common RAS mutation(s)\n* Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter\n* Major surgery within 4 weeks of first treatment dose\n* Radiation therapy (RT) within 1 week of first treatment dose\n* Receipt of prior direct RAS inhibitor\n* Receipt of more than 1 investigational therapy\n* Untreated or symptomatic CNS metastasis\n* Receipt of strong CYP3A4 inhibitor\u002Finducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter\n* Receipt of PPI or H2 blocker within 5 days\n* Inability to swallow oral medication\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","18 Years",{"count":106,"type":107},150,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer",[113],"Colorectal Cancer","NOT_YET_RECRUITING","2026-06-15",{"date":117,"type":118},"2026-06-22","ACTUAL",{"date":120,"type":107},"2026-06",{"date":122,"type":107},"2028-12",{"name":5,"class":6}]