[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07644559":3,"trial-entities:NCT07644559":421,"trial-summary:NCT07644559":425},{"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":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":49,"secondary_outcomes":57,"sex":79,"minimum_age":80,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":101,"locations":104,"central_contacts":410,"overall_officials":418,"references":419,"see_also_links":420},"NCT07644559","VS-7375-201","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)","RECRUITING","2028-12","2026-07","2026-08-04","2026-06-16","Verastem, Inc.","INDUSTRY",false,"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",null,[19,20],"Pancreatic Ductal Adenocarcinoma (PDAC)","G12D Mutated KRAS",[22,23,24,25,26,27,28],"KRAS G12D mutation","KRAS","PDAC","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer","Pancreatic Neoplasms","RAS","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},180,"ESTIMATED",[37,45],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","VS-7375","Taken by mouth",[42,43,44],"VS-7375 + cetuximab 1L PDAC","VS-7375 + cetuximab 2L PDAC","VS-7375 Monotherapy",{"type":38,"name":46,"description":47,"armGroupLabels":48},"cetuximab","Subcutaneous infusion",[42,43],[50,54],{"measure":51,"description":52,"timeFrame":53},"Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1","Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)","6 months",{"measure":55,"description":56,"timeFrame":53},"To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.","Proportion\u002Fnumber of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions\u002Freductions and discontinuations.",[58,62,66,69,73,76],{"measure":59,"description":60,"timeFrame":61},"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, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.","24 months",{"measure":63,"description":64,"timeFrame":65},"Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax","Maximum concentration (Cmax)","20 weeks",{"measure":67,"description":68,"timeFrame":65},"Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC","Area under plasma Concentration (AUC) 0 to t",{"measure":70,"description":71,"timeFrame":72},"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":74,"description":75,"timeFrame":61},"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 pancreatic ductal adenocarcinoma patients",{"measure":77,"description":78,"timeFrame":61},"Time to next therapy.","To assess the interval between initiation of study treatment and initiation of subsequent","ALL","18 Years",{"inclusion":82,"exclusion":89,"raw_text":100},[83,84,85,86,87,88],"Histopathology confirmed PDAC","Measurable disease per RECIST 1.1","Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)","ECOG PS=0 or 1","Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months","Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease",[90,91,92,93,94,95,96,97,98,99],"Have any other documented co-existing common RAS mutation(s)","Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter","Major surgery within 4 weeks of first treatment dose","Radiation therapy (RT) within 1 week of first treatment dose; RT to brain or lung within 2 weeks of first treatment dose","History of drug-induced Interstitial Lung Disease","Receipt of prior direct RAS inhibitor","Untreated or symptomatic CNS metastasis","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","Receipt of PPI or H2 blocker within 5 days","Inability to swallow oral medication","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",[102,103],"ADULT","OLDER_ADULT",[105,122,133,147,161,176,191,202,216,228,242,256,271,283,297,308,322,337,351,366,381,397],{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":119},"START- Los Angeles","Los Angeles","California","90025","United States",[112,116],{"name":113,"role":114,"email":115},"Hope Team","CONTACT","hopeteam@startresearch.com",{"name":117,"role":118},"Navid Hafez, MD","PRINCIPAL_INVESTIGATOR",{"lat":120,"lon":121},34.05223,-118.24368,{"facility":123,"status":8,"city":107,"state":108,"zip":124,"country":110,"contacts":125,"geoPoint":132},"Valkyrie Clinical Trials","90067",[126,130],{"name":127,"role":114,"phone":128,"email":129},"Trenis Palmer","4245351874","trenis.palmer@vctcare.com",{"name":131,"role":118},"David Berz, MD",{"lat":120,"lon":121},{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":110,"contacts":138,"geoPoint":144},"Moffitt Cancer Center","Tampa","Florida","33612",[139,142],{"name":140,"role":114,"email":141},"Brianna Holder","Brianna.Holder@moffitt.org",{"name":143,"role":118},"Dae-Won Kim, MD",{"lat":145,"lon":146},27.94752,-82.45843,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":110,"contacts":152,"geoPoint":158},"Johns Hopkins University","Baltimore","Maryland","21287",[153,156],{"name":154,"role":114,"email":155},"Colleen Apostol","apostco@jhmi.edu",{"name":157,"role":118},"Mari Nakazawa, MD",{"lat":159,"lon":160},39.29038,-76.61219,{"facility":162,"status":8,"city":163,"state":164,"zip":165,"country":110,"contacts":166,"geoPoint":173},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",[167,171],{"name":168,"role":114,"phone":169,"email":170},"Danielle Lindquist","857-215-2351","DanielleA_Lindquist@DFCI.HARVARD.EDU",{"name":172,"role":118},"Kimberly Perez, MD",{"lat":174,"lon":175},42.35843,-71.05977,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":110,"contacts":181,"geoPoint":188},"University of Michigan","Ann Arbor","Michigan","48109",[182,186],{"name":183,"role":114,"phone":184,"email":185},"Cancer Answer Line","1-800-865-1125","CancerAnswerLine@med.umich.edu",{"name":187,"role":118},"Vaibhav Sahai, MD",{"lat":189,"lon":190},42.27756,-83.74088,{"facility":192,"status":8,"city":193,"state":179,"zip":194,"country":110,"contacts":195,"geoPoint":199},"START Midwest","Grand Rapids","49546",[196,197],{"name":113,"role":114,"email":115},{"name":198,"role":118},"Sreenivasa Chandana, MD",{"lat":200,"lon":201},42.96336,-85.66809,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":110,"contacts":207,"geoPoint":213},"Washington University","St Louis","Missouri","63110",[208,211],{"name":209,"role":114,"email":210},"Olive Pressey","olive@wustl.edu",{"name":212,"role":118},"Kian-Huat Lim, MD",{"lat":214,"lon":215},38.62727,-90.19789,{"facility":217,"status":8,"city":218,"state":219,"zip":220,"country":110,"contacts":221,"geoPoint":225},"START New Jersey","East Brunswick","New Jersey","08816",[222,223],{"name":113,"role":114,"email":115},{"name":224,"role":118},"Bruno Fang, MD",{"lat":226,"lon":227},40.42788,-74.41598,{"facility":229,"status":8,"city":230,"state":230,"zip":231,"country":110,"contacts":232,"geoPoint":239},"NYU-Manhattan","New York","10016",[233,237],{"name":234,"role":114,"phone":235,"email":236},"Monica Dureja","2122634415","Monica.Dureja@nyulangone.org",{"name":238,"role":118},"Kristen Spencer, MD",{"lat":240,"lon":241},40.71427,-74.00597,{"facility":243,"status":8,"city":244,"state":245,"zip":246,"country":110,"contacts":247,"geoPoint":253},"University of North Carolina","Chapel Hill","North Carolina","27599",[248,251],{"name":249,"role":114,"email":250},"Catherine Griffin","catherine_griffin@med.unc.edu",{"name":252,"role":118},"Ashwin Somasundaram, MD",{"lat":254,"lon":255},35.9132,-79.05584,{"facility":257,"status":8,"city":258,"state":259,"zip":260,"country":110,"contacts":261,"geoPoint":268},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",[262,266],{"name":263,"role":114,"phone":264,"email":265},"Karlie Williams","6153297274","Karlie.Williams@scri.com",{"name":267,"role":118},"Meredith Pelster, MD",{"lat":269,"lon":270},36.16589,-86.78444,{"facility":272,"status":8,"city":273,"state":274,"zip":275,"country":110,"contacts":276,"geoPoint":280},"START Dallas","Fort Worth","Texas","76104",[277,278],{"name":113,"role":114,"email":115},{"name":279,"role":118},"Salwan Almutar, MD",{"lat":281,"lon":282},32.72541,-97.32085,{"facility":284,"status":8,"city":285,"state":274,"zip":286,"country":110,"contacts":287,"geoPoint":294},"MD Anderson Cancer Center","Houston","77054",[288,292],{"name":289,"role":114,"phone":290,"email":291},"Michelle Escano-Caballero","7137941776","MEscano@mdanderson.org",{"name":293,"role":118},"Shubham Pant, MD",{"lat":295,"lon":296},29.76328,-95.36327,{"facility":298,"status":8,"city":299,"state":274,"zip":300,"country":110,"contacts":301,"geoPoint":305},"START- San Antonio","San Antonio","78229",[302,303],{"name":113,"role":114,"email":115},{"name":304,"role":118},"Drew Rasco, MD",{"lat":306,"lon":307},29.42412,-98.49363,{"facility":309,"status":8,"city":310,"state":311,"zip":312,"country":110,"contacts":313,"geoPoint":319},"START- Mountain Region","West Valley City","Utah","84119",[314,317],{"name":315,"role":114,"email":316},"Julianna Daley","Julianna.daley@startresearch.com",{"name":318,"role":118},"William McKean, MD",{"lat":320,"lon":321},40.69161,-112.00105,{"facility":323,"status":8,"city":324,"state":325,"zip":326,"country":110,"contacts":327,"geoPoint":334},"UVA Health","Charlottesville","Virginia","22903",[328,332],{"name":329,"role":114,"phone":330,"email":331},"Clinical Trials Navigator","4349820539","UVACANCERTRIALS@uvahealth.org",{"name":333,"role":118},"Matthew Reilley, MD",{"lat":335,"lon":336},38.02931,-78.47668,{"facility":338,"status":8,"city":339,"state":325,"zip":340,"country":110,"contacts":341,"geoPoint":348},"Virginia Cancer Specialists","Fairfax","22031",[342,346],{"name":343,"role":114,"phone":344,"email":345},"Michelle Blair","4342437264","TNS8MW@uvahealth.org",{"name":347,"role":118},"Alexander Spira, MD",{"lat":349,"lon":350},38.84622,-77.30637,{"facility":352,"status":8,"city":353,"state":354,"zip":355,"country":110,"contacts":356,"geoPoint":363},"Virginia Mason","Seattle","Washington","98101",[357,361],{"name":358,"role":114,"phone":359,"email":360},"Kara Turner","206-341-1245","Kara.Turner@commonspirit.org",{"name":362,"role":118},"Vincent Picozzi, MD",{"lat":364,"lon":365},47.60621,-122.33207,{"facility":367,"status":8,"city":368,"state":369,"zip":370,"country":110,"contacts":371,"geoPoint":378},"UW Health","Madison","Wisconsin","53792",[372,376],{"name":373,"role":114,"phone":374,"email":375},"Cancer Connect","8006228922","cancerconnect@uwhealth.org",{"name":377,"role":118},"Noelle LoConte, MD",{"lat":379,"lon":380},43.07305,-89.40123,{"facility":382,"status":8,"city":383,"state":384,"zip":385,"country":386,"contacts":387,"geoPoint":394},"ICON Kurralta Park","Kurralta Park","South Australia","5037","Australia",[388,392],{"name":389,"role":114,"phone":390,"email":391},"Sarah Gartland","08 84740420","Sarah.gartland@icon.team",{"name":393,"role":118},"Carolyn Bampton, MD",{"lat":395,"lon":396},-34.95142,138.56702,{"facility":398,"status":8,"city":399,"zip":400,"country":386,"contacts":401,"geoPoint":407},"ICON Cancer Centre","South Brisbane","QLD 4101",[402,405],{"name":403,"role":114,"email":404},"Apryl Chelin","Apryl.chelin@icon.team",{"name":406,"role":118},"Jermaine Coward, MD",{"lat":408,"lon":409},-27.48034,153.02049,[411,415],{"name":412,"role":114,"phone":413,"email":414},"Verastem Call Center","7812924204","VS-7375-201TrialSupport@verastem.com",{"name":416,"role":114,"email":417},"Luke Chung, MD","VS-7375-201Medical@verastem.com",[],[],[],{"nct_id":4,"conditions":422,"biomarkers":423},[25],[424],"GTPase KRas",{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]