[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07094113":3,"trial-entities:NCT07094113":418,"trial-summary:NCT07094113":426},{"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":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":54,"secondary_outcomes":65,"sex":95,"minimum_age":96,"maximum_age":97,"healthy_volunteers":15,"eligibility_criteria":98,"std_ages":102,"locations":105,"central_contacts":403,"overall_officials":409,"references":413,"see_also_links":414},"NCT07094113","20240031","AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors","A Phase 1\u002F1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors","RECRUITING","2031-04-20","2026-07","2026-07-30","2025-07-31","Amgen","INDUSTRY",false,"The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when administered alone or in combination with other agents in participants with advanced or metastatic solid tumors harboring KRAS alterations.\n\nThis is a dose-escalation study in which participants will be assigned to multiple dose levels (DLs) of AMG 410, either as monotherapy or in combination with other agents, followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose (MTD)-the highest dose with acceptable safety and manageable side effects-or the Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered advanced or metastatic solid tumors.","This is a multicenter, multinational, open-label Phase 1\u002F1b study designed to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of AMG 410 in adult participants with advanced or metastatic solid tumors characterized by KRAS alterations.\n\nThe study will begin with a dose-escalation phase, during which AMG 410 will be administered orally, either as monotherapy or in combination with other agents. Dose escalation will follow a model-based approach to identify the MTD or RP2D.\n\nFollowing dose escalation, additional expansion cohorts may be enrolled at selected dose levels to further characterize the safety profile, PK\u002FPD relationships, and preliminary efficacy in specific tumor types or molecular subgroups.\n\nParticipants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria. The maximum duration of AMG 410 administration in this study is 3 years.",[19],"KRAS Altered Advanced or Metastatic Solid Tumors",[21,22,23,24,25,26,27],"Non-small cell lung cancer","NSCLC","Colorectal cancer","CRC","Pancreatic ductal adenocarcinoma","PDAC","AMG 410","INTERVENTIONAL","TREATMENT",[31],"PHASE1",{"count":33,"type":34},434,"ESTIMATED",[36,46,50],{"type":37,"name":27,"description":38,"armGroupLabels":39},"DRUG","Administered as an oral tablet.",[40,41,42,43,44,45],"Part 1: China-specific Cohort","Part 1: Food Effect Substudy Cohort","Part 1: Monotherapy Dose Exploration","Part 2: Monotherapy Dose Expansion","Part 3a: Combination Therapy Dose Exploration and Dose Expansion","Part 3b: Combination Therapy Dose Exploration and Dose Expansion",{"type":37,"name":47,"description":48,"armGroupLabels":49},"Pembrolizumab","Administered as an intravenous (IV) infusion.",[44],{"type":37,"name":51,"description":52,"armGroupLabels":53},"Panitumumab","Administered as an IV infusion.",[45],[55,58,62],{"measure":56,"timeFrame":57},"Number of Participants with Dose Limiting Toxicities (DLTs)","Up to 28 days",{"measure":59,"description":60,"timeFrame":61},"Number of Participants with Treatment Emergent Adverse Events (TEAEs)","Clinically significant changes in safety assessments (vital signs, electrocardiograms \\[ECGs\\], and clinical laboratory tests) are to be reported as adverse events.","Up to approximately 3 years",{"measure":63,"description":64,"timeFrame":61},"Number of Participants with Serious Adverse Events (SAEs)","Clinically significant changes in safety assessments (vital signs, ECGs, and clinical laboratory tests) are to be reported as adverse events.",[66,69,71,73,75,77,79,81,83,85,88,90,92],{"measure":67,"timeFrame":68},"Maximum Concentration (Cmax) of AMG 410","Up to 85 days",{"measure":70,"timeFrame":68},"Time to Reach Cmax (Tmax) of AMG 410",{"measure":72,"timeFrame":68},"Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 410",{"measure":74,"timeFrame":61},"Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1",{"measure":76,"timeFrame":61},"Clinical Benefit per RECIST v1.1",{"measure":78,"timeFrame":61},"Duration of Response (DoR) per RECIST v1.1",{"measure":80,"timeFrame":61},"Time to Response (TTR) per RECIST v1.1",{"measure":82,"timeFrame":61},"Progression-free Survival (PFS) per RECIST v1.1",{"measure":84,"timeFrame":61},"Overall Survival (OS)",{"measure":86,"timeFrame":87},"Food Effect Substudy Cohort: Cmax of AMG 410 in the Fed and\u002For Fasted State","Up to 24 days",{"measure":89,"timeFrame":87},"Food Effect Substudy Cohort: Tmax of AMG 410 in the Fed and\u002For Fasted State",{"measure":91,"timeFrame":87},"Food Effect Substudy Cohort: AUC Over the Dosing Interval of AMG 410 in the Fed and\u002For Fasted State",{"measure":93,"timeFrame":94},"Change From Baseline in Tumor Phosphorylated Extracellular Signal Regulated Kinase (pERK)","Baseline up to approximately 3 years","ALL","18 Years",null,{"inclusion":99,"exclusion":100,"raw_text":101},[],[],"Inclusion Criteria:\n\n1. Age ≥ 18 years (or \\> legal age within the country if it is older than 18 years).\n2. Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT amplification assay.\n3. Participants must have no standard of care treatment options or have actively refused such therapy.\n4. Able to swallow and retain per oral administered study treatment.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n6. Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator.\n7. Adequate organ function.\n8. Archival (formalin-fixed, paraffin-embedded \\[FFPE\\]) tumor tissue or block collected within 5 years before screening must be available. Participants without archived tumor tissue may undergo tumor biopsy before AMG 410 dosing (Day1).\n\nExclusion Criteria:\n\n1. Untreated symptomatic central nervous system or leptomeningeal metastases.\n2. Uncontrolled pleural effusion and\u002For ascites.\n3. History of other malignancy within the past 5 years.\n4. Active systemic infection or symptoms that indicate an acute and\u002For uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment.\n5. History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).\n6. Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.\n7. History of solid organ transplant.\n8. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.\n9. Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n10. Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1.\n11. Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment.\n12. Major surgery within 28 days of first dose of study treatment.\n13. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.",[103,104],"ADULT","OLDER_ADULT",[106,115,122,130,138,146,154,162,170,178,186,195,203,211,219,226,235,243,251,260,268,276,284,292,299,307,315,322,329,338,343,348,356,364,368,377,384,388,396],{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":111,"geoPoint":112},"City of Hope National Medical Center","Duarte","California","91010","United States",{"lat":113,"lon":114},34.13945,-117.97729,{"facility":116,"status":8,"city":117,"state":109,"zip":118,"country":111,"geoPoint":119},"University of California Los Angeles","Los Angeles","90095",{"lat":120,"lon":121},34.05223,-118.24368,{"facility":123,"status":8,"city":124,"state":125,"zip":126,"country":111,"geoPoint":127},"Emory University","Atlanta","Georgia","30322",{"lat":128,"lon":129},33.749,-84.38798,{"facility":131,"status":8,"city":132,"state":133,"zip":134,"country":111,"geoPoint":135},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":136,"lon":137},42.35843,-71.05977,{"facility":139,"status":8,"city":140,"state":141,"zip":142,"country":111,"geoPoint":143},"Siteman Cancer Center - Washington University","St Louis","Missouri","63110",{"lat":144,"lon":145},38.62727,-90.19789,{"facility":147,"status":8,"city":148,"state":149,"zip":150,"country":111,"geoPoint":151},"Duke Cancer Center","Durham","North Carolina","27710",{"lat":152,"lon":153},35.99403,-78.89862,{"facility":155,"status":8,"city":156,"state":157,"zip":158,"country":111,"geoPoint":159},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"lat":160,"lon":161},39.95238,-75.16362,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":111,"geoPoint":167},"Sarah Cannon Research Institute Oncology Partners","Nashville","Tennessee","37203",{"lat":168,"lon":169},36.16589,-86.78444,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":111,"geoPoint":175},"Next Oncology","San Antonio","Texas","78229",{"lat":176,"lon":177},29.42412,-98.49363,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":111,"geoPoint":183},"Next Virginia","Fairfax","Virginia","22031",{"lat":184,"lon":185},38.84622,-77.30637,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":191,"geoPoint":192},"Chris OBrien Lifehouse","Camperdown","New South Wales","2050","Australia",{"lat":193,"lon":194},-33.88965,151.17642,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":191,"geoPoint":200},"The Queen Elizabeth Hospital","Woodville South","South Australia","5011",{"lat":201,"lon":202},-34.88186,138.53477,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":191,"geoPoint":208},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000",{"lat":209,"lon":210},-37.814,144.96332,{"facility":212,"status":8,"city":213,"zip":214,"country":215,"geoPoint":216},"Universitair Ziekenhuis Antwerpen","Edegem","2650","Belgium",{"lat":217,"lon":218},51.15662,4.44504,{"facility":220,"status":8,"city":221,"zip":222,"country":215,"geoPoint":223},"Universitair Ziekenhuis Gent","Ghent","9000",{"lat":224,"lon":225},51.05,3.71667,{"facility":227,"status":8,"city":228,"state":229,"zip":230,"country":231,"geoPoint":232},"Cross Cancer Institute","Edmonton","Alberta","T6G 1Z2","Canada",{"lat":233,"lon":234},53.55014,-113.46871,{"facility":236,"status":8,"city":237,"state":238,"zip":239,"country":231,"geoPoint":240},"Princess Margaret Cancer Centre","Toronto","Ontario","M5G 1Z5",{"lat":241,"lon":242},43.70643,-79.39864,{"facility":244,"status":8,"city":245,"state":246,"zip":247,"country":231,"geoPoint":248},"Sir Mortimer B Davis - Jewish General Hospital","Montreal","Quebec","H3T 1E2",{"lat":249,"lon":250},45.50884,-73.58781,{"facility":252,"status":8,"city":253,"state":254,"zip":255,"country":256,"geoPoint":257},"Beijing Cancer Hospital","Beijing","Beijing Municipality","100142","China",{"lat":258,"lon":259},39.9075,116.39723,{"facility":261,"status":8,"city":262,"state":263,"zip":264,"country":256,"geoPoint":265},"Chongqing University Cancer Hospital","Chongqing","Chongqing Municipality","400044",{"lat":266,"lon":267},29.56026,106.55771,{"facility":269,"status":8,"city":270,"state":271,"zip":272,"country":256,"geoPoint":273},"Jinan Central Hospital","Jinan","Shandong","250013",{"lat":274,"lon":275},36.66833,116.99722,{"facility":277,"status":8,"city":278,"zip":279,"country":280,"geoPoint":281},"Rigshospitalet","Copenhagen","2100","Denmark",{"lat":282,"lon":283},55.67594,12.56553,{"facility":285,"status":8,"city":286,"zip":287,"country":288,"geoPoint":289},"Centre Leon Berard","Lyon","69008","France",{"lat":290,"lon":291},45.74906,4.84789,{"facility":293,"status":8,"city":294,"zip":295,"country":288,"geoPoint":296},"Gustave Roussy","Villejuif","94805",{"lat":297,"lon":298},48.7939,2.35992,{"facility":300,"status":8,"city":301,"zip":302,"country":303,"geoPoint":304},"Universitaetsklinikum Essen","Essen","45147","Germany",{"lat":305,"lon":306},51.45657,7.01228,{"facility":308,"status":8,"city":309,"zip":310,"country":311,"geoPoint":312},"Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda","Milan","20162","Italy",{"lat":313,"lon":314},42.78235,12.59836,{"facility":316,"status":8,"city":317,"zip":318,"country":311,"geoPoint":319},"Azienda Ospedaliero Universitaria Pisana","Pisa","56126",{"lat":320,"lon":321},43.70853,10.4036,{"facility":323,"status":8,"city":324,"zip":325,"country":311,"geoPoint":326},"Centro Ricerche Cliniche Di Verona Societa responsabilita limitata","Verona","37134",{"lat":327,"lon":328},45.43854,10.9938,{"facility":330,"status":8,"city":331,"state":332,"zip":333,"country":334,"geoPoint":335},"Aichi Cancer Center","Nagoya","Aichi-ken","464-8681","Japan",{"lat":336,"lon":337},35.18147,136.90641,{"facility":339,"status":8,"city":340,"state":341,"zip":342,"country":334},"National Cancer Center Hospital East","Kashiwa-shi","Chiba","277-8577",{"facility":344,"status":8,"city":345,"state":346,"zip":347,"country":334},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045",{"facility":349,"status":8,"city":350,"zip":351,"country":352,"geoPoint":353},"Universitair Medisch Centrum Utrecht","Utrecht","3584 CX","Netherlands",{"lat":354,"lon":355},52.09083,5.12222,{"facility":357,"status":8,"city":358,"zip":359,"country":360,"geoPoint":361},"Seoul National University Hospital","Seoul","03080","South Korea",{"lat":362,"lon":363},37.566,126.9784,{"facility":365,"status":8,"city":358,"zip":366,"country":360,"geoPoint":367},"Asan Medical Center","05505",{"lat":362,"lon":363},{"facility":369,"status":8,"city":370,"state":371,"zip":372,"country":373,"geoPoint":374},"Hospital Universitari Vall d Hebron","Barcelona","Catalonia","08023","Spain",{"lat":375,"lon":376},41.38879,2.15899,{"facility":378,"status":8,"city":379,"zip":380,"country":373,"geoPoint":381},"Fundacion Jimenez Diaz","Madrid","28040",{"lat":382,"lon":383},40.4165,-3.70256,{"facility":385,"status":8,"city":379,"zip":386,"country":373,"geoPoint":387},"Hospital Universitario 12 de Octubre","28041",{"lat":382,"lon":383},{"facility":389,"status":8,"city":390,"zip":391,"country":392,"geoPoint":393},"Sarah Cannon Research Institute UK","London","W1G 6AD","United Kingdom",{"lat":394,"lon":395},51.50853,-0.12574,{"facility":397,"status":8,"city":398,"zip":399,"country":392,"geoPoint":400},"Royal Marsden Hospital","Sutton","SM2 5PT",{"lat":401,"lon":402},51.35,-0.2,[404],{"name":405,"role":406,"phone":407,"email":408},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[410],{"name":411,"affiliation":13,"role":412},"MD","STUDY_DIRECTOR",[],[415],{"label":416,"url":417},"AmgenTrials clinical trials website","http:\u002F\u002Fwww.amgentrials.com",{"nct_id":4,"conditions":419,"biomarkers":424},[420,421,422,423],"Colorectal Carcinoma","Lung Non-Small Cell Carcinoma","Pancreatic Ductal Adenocarcinoma","Solid Neoplasm",[425],"GTPase KRas",{"nct_id":4,"found":427,"summary":428,"prompt_version":438},true,{"design":429,"status":430,"heading":431,"summary":432,"follow_up":433,"word_count":434,"commitments":435,"compensation":436,"drugs_mentioned":437},"This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll up to 434 participants.","completed","AMG 410 for KRAS-Altered Advanced or Metastatic Solid Tumors","This study is testing a new medicine called AMG 410, by itself or with other approved medicines like Pembrolizumab and Panitumumab. It's for people with advanced or metastatic (spread) solid tumors that have a specific change in the KRAS gene. Researchers want to see how safe AMG 410 is, what side effects it might cause, and if it can help shrink tumors. They are looking for the highest dose that is safe and manageable. You would need to have a KRAS gene alteration to join this study. The study will track side effects for up to three years. The current status of this study is unclear.","Researchers will track side effects for up to approximately three years after you start treatment.",106,"You would take AMG 410 as an oral tablet, and potentially receive Pembrolizumab or Panitumumab through an IV (intravenous) infusion. Treatment could continue for up to three years.","Not stated in the trial record.",[27,47,51],"v2"]