[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"g12d-mutated-kras\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:g12d-mutated-kras":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641650","phase-2-a-phase-2-study-of-vs-7375-in-patients-with-kras-g12d-mutated-pancreatic-cancer-100641650",false,"NCT07644559","A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer","A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON\u002FOFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)","Inclusion Criteria:\n\n* Histopathology confirmed PDAC\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\nAdequate organ function\n\nVS-7375 + cetuximab (2L PDAC) :\n\n-Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months\n\nVS-7375 + cetuximab (1L PDAC) :\n\n-Treatment-naïve or received ≤ 1 cycle of SoC 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; RT to brain or lung within 2 weeks of first treatment dose\n* History of drug-induced Interstitial Lung Disease\n* Receipt of prior direct RAS inhibitor\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":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer",[26,27],"Pancreatic Ductal Adenocarcinoma (PDAC)","G12D Mutated KRAS",[29,30,31,32,33,34,35],"KRAS G12D mutation","KRAS","PDAC","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer","Pancreatic Neoplasms","RAS","RECRUITING","2026-08-13",{"date":39,"type":40},"2026-08-17","ACTUAL",{"date":42,"type":40},"2026-06-16",{"date":44,"type":20},"2028-12",{"name":46,"class":47},"Verastem, Inc.","INDUSTRY",24,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":80,"locationsCount":81},"100594498","phase-1-a-phase-12-study-of-vs-7375-in-patients-with-kras-g12d-mutated-solid-tumors-100594498","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.",{"count":57,"type":20},295,[59,23],"PHASE1","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.",[32,62,63,64,27],"Non Small Cell Lung Cancer","Colorectal Cancer","Solid Tumor, Adult",[29,66,62,67,63,68,33,32,69,70,31,34,71,72,73,30,35],"Solid tumors","Lung Cancer","Metastatic Cancer","NSCLC","CRC","Colorectal Neoplasms","Lung Neoplasms","Gastrointestinal Neoplasms","2026-04-21",{"date":76,"type":40},"2026-04-22",{"date":78,"type":40},"2025-06-24",{"date":44,"type":20},{"name":46,"class":47},14]