[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07021898":3,"trial-entities:NCT07021898":167,"trial-summary:NCT07021898":172},{"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":20,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":54,"secondary_outcomes":79,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":111,"locations":114,"central_contacts":153,"overall_officials":161,"references":165,"see_also_links":166},"NCT07021898","ERAS-4001-01","A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.","A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors","RECRUITING","2028-12","2025-12","2025-12-03","2025-08-06","Erasca, Inc.","INDUSTRY",true,"The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 will be given alone or in combination with other treatments.","This is a first-in-human, Phase 1\u002F1b, open-label, multicenter clinical study of ERAS-4001 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of ERAS-4001 in combination with other cancer therapies.",[19],"Metastatic Solid Tumors",[21,22,23,24,25,26,27,28,29,30,31],"Solid Tumor","Advanced Solid Tumor","Solid malignancies","Targeted therapy","Molecular alterations","pembrolizumab","Keytruda","panitumumab","Vectibix","Metastatic solid tumor","Neoplasms","INTERVENTIONAL","TREATMENT",[35],"PHASE1",{"count":37,"type":38},200,"ESTIMATED",[40,46],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DRUG","ERAS-4001","ERAS-4001 Administered orally",[45],"ERAS-4001 Monotherapy Dose Optimization.",{"type":41,"name":47,"description":48,"armGroupLabels":49,"otherNames":51},"ERAS-4001 in combination","ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.",[50],"ERAS-4001 Combination Dose Optimization",[52,53],"Keytruda (pembrolizumab)","Vectibix (panitumumab)",[55,59,61,63,66,70,73,76],{"measure":56,"description":57,"timeFrame":58},"Dose Limiting Toxicities (DLT)","Based on toxicities observed","Study Day 1 up to Day 21",{"measure":60,"description":57,"timeFrame":58},"Maximum tolerated dose (MTD)",{"measure":62,"description":57,"timeFrame":58},"Recommended dose for expansion (RDE)",{"measure":64,"description":65,"timeFrame":58},"Adverse Events","Incidence and severity of treatment-emergent AEs and serious AEs",{"measure":67,"description":68,"timeFrame":69},"Plasma concentration (Cmax)","Maximum plasma concentration of ERAS-4001","Study Day 1 up to Day 65",{"measure":71,"description":72,"timeFrame":69},"Time to achieve Cmax (Tmax)","Time of achieve maximum plasma concentration of ERAS-4001",{"measure":74,"description":75,"timeFrame":69},"Area under the curve","Area under the plasma concentration-time curve of ERAS-4001",{"measure":77,"description":78,"timeFrame":69},"Half-life","Half-life of ERAS-4001",[80,84,86],{"measure":81,"description":82,"timeFrame":83},"Objective Response Rate (ORR)","Based on assessment of radiographic imaging per RECIST version 1.1","Assessed up to 24 months from time of first dose",{"measure":85,"description":82,"timeFrame":83},"Duration of Response (DOR)",{"measure":87,"description":82,"timeFrame":83},"Time to Response (TTR)","ALL","18 Years","99 Years",false,{"inclusion":93,"exclusion":102,"raw_text":110},[94,95,96,97,98,99,100,101],"Age ≥ 18 years","Willing and able to give written informed consent","Pathological documentation of tumor type and mutation prior to the first dose of study drug(s)","There is no available standard systemic therapy available for the patient's tumor histology and\u002For molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy","Able to swallow oral medication","Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1","Adequate cardiovascular, hematological, liver, and renal function","Willing to comply with all protocol-required visits, assessments, and procedures",[103,104,105,106,107,108,109],"Previous treatment with a RAS inhibitor","Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-4001","Received prior palliative radiation within 14 days of Cycle 1, Day 1","Have primary central nervous system (CNS) tumors","Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption","Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs","Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willing and able to give written informed consent\n* Pathological documentation of tumor type and mutation prior to the first dose of study drug(s)\n* There is no available standard systemic therapy available for the patient's tumor histology and\u002For molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy\n* Able to swallow oral medication\n* Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Adequate cardiovascular, hematological, liver, and renal function\n* Willing to comply with all protocol-required visits, assessments, and procedures\n\nExclusion Criteria:\n\n* Previous treatment with a RAS inhibitor\n* Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-4001\n* Received prior palliative radiation within 14 days of Cycle 1, Day 1\n* Have primary central nervous system (CNS) tumors\n* Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption\n* Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs\n* Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial",[112,113],"ADULT","OLDER_ADULT",[115,124,132,139,145],{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":120,"geoPoint":121},"Sarah Cannon Research Institute (SCRI) Oncology Partners","Nashville","Tennessee","32703","United States",{"lat":122,"lon":123},36.16589,-86.78444,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":120,"geoPoint":129},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"lat":130,"lon":131},29.76328,-95.36327,{"facility":133,"status":8,"city":134,"state":127,"zip":135,"country":120,"geoPoint":136},"NEXT Oncology","Irving","75039",{"lat":137,"lon":138},32.81402,-96.94889,{"facility":133,"status":8,"city":140,"state":127,"zip":141,"country":120,"geoPoint":142},"San Antonio","78229",{"lat":143,"lon":144},29.42412,-98.49363,{"facility":146,"status":8,"city":147,"state":148,"zip":149,"country":120,"geoPoint":150},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"lat":151,"lon":152},47.60621,-122.33207,[154,159],{"name":155,"role":156,"phone":157,"email":158},"Erasca Clinical Team","CONTACT","+1-858-465-6511","clinicaltrials@erasca.com",{"name":160,"role":156},"Les Brail, Study Director, PhD",[162],{"name":163,"affiliation":13,"role":164},"Gerri Lee","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":168,"biomarkers":170},[169],"Solid Neoplasm",[171],"GTPase KRas",{"nct_id":4,"found":15,"summary":173,"prompt_version":183},{"design":174,"status":175,"heading":176,"summary":177,"follow_up":178,"word_count":179,"commitments":180,"compensation":181,"drugs_mentioned":182},"This is a Phase 1\u002F1b, open-label study, meaning you and your doctors will know which treatment you are receiving. It will enroll about 200 participants.","completed","A Study of ERAS-4001 for Advanced or Metastatic Solid Tumors with KRAS Mutations","This study is testing a new drug called ERAS-4001 in people with advanced or metastatic (spread to other parts of the body) solid tumors that have certain KRAS mutations. The main goal is to see if ERAS-4001 is safe and how much can be given without causing too many side effects. ERAS-4001 will be given by itself or in combination with other approved cancer treatments like Keytruda (pembrolizumab) or Vectibix (panitumumab). You may be able to join if you are at least 18 years old, have a solid tumor with a KRAS mutation, and have limited or no other standard treatment options. The study is looking to enroll about 200 participants, but its current status is unclear.","The primary safety endpoints are measured from Study Day 1 up to Day 21.",117,"Not specified in the trial record.","Not stated in the trial record.",[42],"v2"]