[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07397338":3,"trial-entities:NCT07397338":252,"trial-summary:NCT07397338":259},{"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":25,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":38,"interventions":41,"primary_outcomes":72,"secondary_outcomes":87,"sex":110,"minimum_age":111,"maximum_age":112,"healthy_volunteers":15,"eligibility_criteria":113,"std_ages":130,"locations":133,"central_contacts":244,"overall_officials":249,"references":250,"see_also_links":251},"NCT07397338","RMC-APEX-103","Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors","A Phase 1\u002F2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors","RECRUITING","2029-05","2026-07","2026-08-03","2026-01-30","Revolution Medicines, Inc.","INDUSTRY",false,"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.","This is an open-label, multicenter, Phase 1\u002F2 study of RAS(ON) inhibitors in combination with ivonescimab with or without other anti-cancer agents in adults with advanced or metastatic solid tumors with a RAS mutation to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of three arms: Arm A:daraxonrasib in combination with ivonescimab; Arm B: elironrasib in combination with ivonescimab; and Arm C: zoldonrasib in combination with ivonescimab. All arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion. Part 1 dose exploration will explore the safety and tolerability of individual RAS(ON) inhibitors in combination with ivonescimab. Part 2 dose expansion will explore the safety, tolerability, and antitumor activity of the individual RAS(ON) inhibitors with ivonescimab +\u002F- anti-cancer therapies.",[19,20,21,22,23,24],"Advanced Solid Tumors","Metastatic Solid Tumors","Non-small Cell Lung Cancer (NSCLC)","NSCLC","Colorectal Cancer (CRC)","CRC",[19,20,26,22,27,24,28,29,30,31,32],"Non-small Cell Lung Cancer","Colorectal Cancer","RAS","NRAS","KRAS","HRAS","RAS Mutation","INTERVENTIONAL","TREATMENT",[36,37],"PHASE1","PHASE2",{"count":39,"type":40},370,"ESTIMATED",[42,48,52,56,60,63,66,69],{"type":43,"name":44,"description":45,"armGroupLabels":46},"DRUG","Daraxonrasib","oral tablets",[47],"Arm A: Daraxonrasib + Ivonescimab Combination",{"type":43,"name":49,"description":45,"armGroupLabels":50},"Elironrasib",[51],"Arm B: Elironrasib + Ivonescimab Combination",{"type":43,"name":53,"description":45,"armGroupLabels":54},"Zoldonrasib",[55],"Arm C: Zoldonrasib + Ivonescimab Combination",{"type":43,"name":57,"description":58,"armGroupLabels":59},"Ivonescimab","IV infusion",[47,51,55],{"type":43,"name":61,"description":58,"armGroupLabels":62},"Carboplatin\u002FCisplatin + Pemetrexed (Dose Expansion Only)",[47],{"type":43,"name":64,"description":58,"armGroupLabels":65},"cetuximab (Cohort C2 Only)",[55],{"type":43,"name":67,"description":58,"armGroupLabels":68},"Carboplatin\u002FCisplatin + Pemetrexed (Cohort B2 Only)",[51],{"type":43,"name":70,"description":45,"armGroupLabels":71},"Daraxonrasib (Cohort B1 only)",[51],[73,77,80,83],{"measure":74,"description":75,"timeFrame":76},"Number of patients with adverse events (AEs)","Number of patients with AEs as assessed by CTCAE v5.","Up to approximately 4 years",{"measure":78,"description":79,"timeFrame":76},"Changes in vital signs","Number of patients with changes in vital signs.",{"measure":81,"description":82,"timeFrame":76},"Changes in clinical laboratory test values","Number of patients with changes in clinical laboratory test values.",{"measure":84,"description":85,"timeFrame":86},"Dose Limiting Toxicities","Number of patients with dose limiting toxicities","28 days",[88,92,95,98,101,104,107],{"measure":89,"description":90,"timeFrame":91},"Concentration of RAS(ON) inhibitors and ivonescimab","Trough and peak blood concentrations of RAS(ON) inhibitors and ivonescimab over time as applicable.","Up to Cycle 6 Day 1 (each cycle is 21 days)",{"measure":93,"description":94,"timeFrame":76},"Objective Response Rate (ORR)","ORR per response evaluation criteria in solid tumors (RECIST) v1.1",{"measure":96,"description":97,"timeFrame":76},"Duration of Response (DOR)","DOR per RECIST v1.1",{"measure":99,"description":100,"timeFrame":76},"Disease Control Rate (DCR)","DCR per RECIST v1.1",{"measure":102,"description":103,"timeFrame":76},"Time to response (TTR)","TTR per RECIST v1.1",{"measure":105,"description":106,"timeFrame":76},"Progression free survival (PFS)","PFS per RECIST v1.1",{"measure":108,"description":109,"timeFrame":76},"Anti-drug Antibody (ADA) of ivonescimab","Number and percentage of patients with anti-ivonescimab antibody","ALL","18 Years",null,{"inclusion":114,"exclusion":124,"raw_text":129},[115,116,117,118,119,120,121,122,123],"At least 18 years old and has provided informed consent.","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.","Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.","Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration).","Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \\& B for Part 2 Dose Expansion).","Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).","Measurable disease per RECIST v1.1","Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).","Able to take oral medications.",[125,126,127,128],"Head and neck squamous cell carcinoma.","Any conditions that may affect the ability to take or absorb study drug.","Major surgery within 4 weeks prior to receiving study drug(s).","Patient is unable or unwilling to comply with protocol-required study visits or procedures.","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.\n* Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration).\n* Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \\& B for Part 2 Dose Expansion).\n* Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).\n* Measurable disease per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Head and neck squamous cell carcinoma.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 4 weeks prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Other inclusion\u002Fexclusion criteria may apply.",[131,132],"ADULT","OLDER_ADULT",[134,149,163,176,189,202,207,219,231],{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":139,"contacts":140,"geoPoint":146},"USC Norris Comprehensive Cancer Center","Los Angeles","California","90033","United States",[141],{"name":142,"role":143,"phone":144,"email":145},"Lorraine Martinez Seng, RN","CONTACT","323-865-0967","Lorraine.Martinez@med.usc.edu",{"lat":147,"lon":148},34.05223,-118.24368,{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":139,"contacts":154,"geoPoint":160},"Eastern Connecticut Hematology and Oncology Associates","Norwich","Connecticut","06360",[155],{"name":156,"role":143,"phone":157,"phoneExt":158,"email":159},"Spiro Curis","860-886-8362","ext 251","Scuris@echoct.com",{"lat":161,"lon":162},41.52426,-72.07591,{"facility":164,"status":8,"city":165,"state":166,"zip":167,"country":139,"contacts":168,"geoPoint":173},"Health Partners Cancer Center at Regions Hospital","Saint Paul","Minnesota","55101",[169],{"name":170,"role":143,"phone":171,"email":172},"Lisa Wahowske","651-254-1517","Lisa.A.Wahowske@HealthPartners.com",{"lat":174,"lon":175},44.94441,-93.09327,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":139,"contacts":181,"geoPoint":186},"Tennessee Oncology","Nashville","Tennessee","37023",[182],{"name":183,"role":143,"phone":184,"email":185},"Henry Black","615-879-6410","hblack@tnonc.com",{"lat":187,"lon":188},36.16589,-86.78444,{"facility":190,"status":8,"city":191,"state":192,"zip":193,"country":139,"contacts":194,"geoPoint":199},"MD Anderson Cancer Center","Houston","Texas","77030",[195],{"name":196,"role":143,"phone":197,"email":198},"Ly Nguyen","832-794-3672","LMNguyen1@mdanderson.org",{"lat":200,"lon":201},29.76328,-95.36327,{"facility":190,"status":8,"city":191,"state":192,"zip":193,"country":139,"contacts":203,"geoPoint":206},[204],{"name":205,"role":143,"phone":197,"email":198},"Ly M. Nguyen",{"lat":200,"lon":201},{"facility":208,"status":8,"city":209,"state":192,"zip":210,"country":139,"contacts":211,"geoPoint":216},"NEXT Dallas","Irving","75039",[212],{"name":213,"role":143,"phone":214,"email":215},"Mofopefoluwa \"Fope\" Akinwale","972-893-8800","fakinwale@nextoncology.com",{"lat":217,"lon":218},32.81402,-96.94889,{"facility":220,"status":8,"city":221,"state":192,"zip":222,"country":139,"contacts":223,"geoPoint":228},"NEXT Oncology","San Antonio","78229",[224],{"name":225,"role":143,"phone":226,"email":227},"Jordan Georg","210-580-9521","jgeorg@nextoncology.com",{"lat":229,"lon":230},29.42412,-98.49363,{"facility":232,"status":8,"city":233,"state":234,"zip":235,"country":139,"contacts":236,"geoPoint":241},"NEXT Virginia","Fairfax","Virginia","22031",[237],{"name":238,"role":143,"phone":239,"email":240},"Maybelle De La Rosa","703-783-4518","mdelarosa@nextoncology.com",{"lat":242,"lon":243},38.84622,-77.30637,[245],{"name":246,"role":143,"phone":247,"email":248},"Revolution Medicines Study Director","1-844-2-REVMED","medinfo@revmed.com",[],[],[],{"nct_id":4,"conditions":253,"biomarkers":257},[254,255,256],"Colorectal Carcinoma","Lung Non-Small Cell Carcinoma","Solid Neoplasm",[258],"RAS Family Oncogene",{"nct_id":4,"found":260,"summary":261,"prompt_version":271},true,{"design":262,"status":263,"heading":264,"summary":265,"follow_up":266,"word_count":267,"commitments":268,"compensation":269,"drugs_mentioned":270},"This is an open-label, multicenter study, meaning both you and your doctors will know which treatment you are receiving. It is a Phase 1\u002F2 study, which typically means it's an early-stage trial looking at safety and initial effectiveness. Approximately 370 participants are planned.","completed","Study of RAS(ON) Inhibitors with Ivonescimab for Advanced Solid Tumors","This study is testing new combinations of medicines for people with advanced or metastatic (spread to other parts of the body) solid tumors that have a specific genetic change called a RAS mutation (in KRAS, HRAS, or NRAS). You would receive one of three RAS(ON) inhibitor drugs (daraxonrasib, elironrasib, or zoldonrasib) as oral tablets, combined with ivonescimab given through an IV. Some participants may also receive additional anti-cancer therapies like Carboplatin\u002FCisplatin + Pemetrexed. The main goals are to see how safe these combinations are and how well your body tolerates them. Researchers will also look for early signs that the treatments are shrinking tumors. You must be at least 18 years old, have a good performance status (ECOG 0 or 1), and have tried and progressed on previous standard treatments. The study is currently unclear on its recruitment status and plans to enroll 370 participants.","Researchers will monitor for side effects, changes in vital signs, and lab test values for up to approximately 4 years.",145,"Not specified in the trial record.","Not stated in the trial record.",[44,49,53,57],"v2"]