[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07090499":3,"trial-entities:NCT07090499":351,"trial-summary:NCT07090499":360},{"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":32,"study_type":56,"primary_purpose":57,"phases":58,"enrollment_info":60,"interventions":63,"primary_outcomes":72,"secondary_outcomes":88,"sex":122,"minimum_age":123,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":124,"std_ages":140,"locations":143,"central_contacts":337,"overall_officials":343,"references":346,"see_also_links":347},"NCT07090499","C5951001","A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","RECRUITING","2029-07-08","2026-07","2026-07-22","2025-08-20","Pfizer","INDUSTRY",false,"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.",null,[19,20,21,22,23,24,25,26,27,28,29,30,31],"Advanced\u002FMetastatic Solid Tumors","Bladder Cancer","Urothelial Carcinoma","Advanced Non-Small Cell Lung Cancer","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Head and Neck Cancer","Esophageal Cancer","Gastroesophageal Junction Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Esophageal Adenocarcinoma","Pancreatic Adenocarcinoma","Pancreatic Cancer",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55],"B6C","integrin beta 6","ADC","antibody drug conjugate","bladder cancer","urothelial carcinoma","non-small cell lung cancer","NSCLC","head and neck cancer","HNSCC","SCCHN","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","PDAC","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6","INTERVENTIONAL","TREATMENT",[59],"PHASE1",{"count":61,"type":62},310,"ESTIMATED",[64],{"type":65,"name":66,"description":67,"armGroupLabels":68},"DRUG","PF-08046876","Intravenous administration",[69,70,71],"Part 1 Dose Escalation","Part 2 Dose Expansion","Part 2 Dose Optimization",[73,77,81,85],{"measure":74,"description":75,"timeFrame":76},"Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation","AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.","Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)",{"measure":78,"description":79,"timeFrame":80},"Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy","Occurrence of DLTs as defined by the protocol","Baseline to end of DLT evaluation period",{"measure":82,"description":83,"timeFrame":84},"Part 1: Recommended Monotherapy Dose for Expansion","RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings","Baseline to 30 days post last study drug administration",{"measure":86,"description":87,"timeFrame":84},"Part 2: Recommended Phase 2 Dose","RP2D will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.",[89,93,97,101,105,109,111,113,116,118],{"measure":90,"description":91,"timeFrame":92},"Objective Response Rate (ORR)","ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).","Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)",{"measure":94,"description":95,"timeFrame":96},"Duration of Response (DOR)","DOR as defined per RECIST 1.1.","From the date of the first objective response to the date of disease progression or death (approximately 2 years)",{"measure":98,"description":99,"timeFrame":100},"Progression Free Survival (PFS)","PFS as defined per RECIST 1.1.","From Baseline to date of first disease progression or death (approximately 2 Years)",{"measure":102,"description":103,"timeFrame":104},"Overall Survival (OS)","OS defined as the time until death due to any cause.","From baseline to up to 3 years",{"measure":106,"description":107,"timeFrame":108},"Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax)","Evaluate the single and multiple dose PK of PF-08048676.","Baseline to approximately 30 days after last dose of study drug",{"measure":110,"description":107,"timeFrame":108},"PK: Time to Reach Maximum Observed Plasma Concentration (Tmax)",{"measure":112,"description":107,"timeFrame":108},"PK: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)",{"measure":114,"description":115,"timeFrame":108},"Incidence of Anti-Drug Antibody (ADA)","To evaluate the immunogenicity of PF-08046876.",{"measure":117,"description":115,"timeFrame":108},"Incidence of Neutralizing Antibodies (NAb)",{"measure":119,"description":120,"timeFrame":121},"Percent change of immune cells within tumors based on multiplex immunofluorescence","This measure will assess changes in the presence or activation of immune cells in the tumor microenvironment using RNA and\u002For Immunohistochemistry (IHC) assays.","Baseline through 4-7 weeks after first dose of study drug","ALL","18 Years",{"inclusion":125,"exclusion":134,"raw_text":139},[126,127,128,129,130,131,132,133],"18 years of age or older","Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas","Measurable disease","ECOG Performance status 0-1","Part 1: progression or relapse following standard treatments","Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting","Resolution of acute effects of prior anticancer therapy to baseline or Grade 1","Consent to submit required pre-treatment tumor tissue as medically feasible",[135,136,137,138],"Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )","Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion","Pulmonary disease meeting protocol exclusion","Other unacceptable abnormalities as defined by protocol","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol",[141,142],"ADULT","OLDER_ADULT",[144,153,160,168,171,178,181,189,192,196,203,211,215,222,230,233,241,248,252,259,266,273,282,285,293,301,310,318,322,330],{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":149,"geoPoint":150},"City of Hope National Medical Center","Duarte","California","91010","United States",{"lat":151,"lon":152},34.13945,-117.97729,{"facility":154,"status":8,"city":155,"state":147,"zip":156,"country":149,"geoPoint":157},"City of Hope at Irvine Lennar","Irvine","92618",{"lat":158,"lon":159},33.66946,-117.82311,{"facility":161,"status":162,"city":163,"state":147,"zip":164,"country":149,"geoPoint":165},"Ronald Reagan UCLA Medical Center","NOT_YET_RECRUITING","Los Angeles","90095",{"lat":166,"lon":167},34.05223,-118.24368,{"facility":169,"status":162,"city":163,"state":147,"zip":164,"country":149,"geoPoint":170},"UCLA Department of Medicine-Hematology\u002FOncology",{"lat":166,"lon":167},{"facility":172,"status":162,"city":173,"state":147,"zip":174,"country":149,"geoPoint":175},"Santa Monica UCLA Medical Center & Orthopaedic Hospital","Santa Monica","90404",{"lat":176,"lon":177},34.01949,-118.49138,{"facility":179,"status":162,"city":173,"state":147,"zip":174,"country":149,"geoPoint":180},"UCLA Hematology\u002FOncology - Santa Monica",{"lat":176,"lon":177},{"facility":182,"status":8,"city":183,"state":184,"zip":185,"country":149,"geoPoint":186},"Smilow Cancer Hospital - Yale New Haven Health","New Haven","Connecticut","06510",{"lat":187,"lon":188},41.30815,-72.92816,{"facility":190,"status":8,"city":183,"state":184,"zip":185,"country":149,"geoPoint":191},"Yale - New Haven Hospital - Yale Cancer Center",{"lat":187,"lon":188},{"facility":193,"status":8,"city":183,"state":184,"zip":194,"country":149,"geoPoint":195},"Smilow Cancer Hospital Phase 1 Unit","06511",{"lat":187,"lon":188},{"facility":197,"status":8,"city":198,"state":184,"zip":199,"country":149,"geoPoint":200},"Smilow Cancer Hospital - Trumbull","Trumbull","06611",{"lat":201,"lon":202},41.24287,-73.20067,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":149,"geoPoint":208},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"lat":209,"lon":210},42.35843,-71.05977,{"facility":212,"status":8,"city":205,"state":206,"zip":213,"country":149,"geoPoint":214},"Dana-Farber Cancer Institute","02215",{"lat":209,"lon":210},{"facility":216,"status":8,"city":217,"state":206,"zip":218,"country":149,"geoPoint":219},"Dana-Farber Cancer Institute - Chestnut Hill","Newton","02467",{"lat":220,"lon":221},42.33704,-71.20922,{"facility":223,"status":8,"city":224,"state":225,"zip":226,"country":149,"geoPoint":227},"Sarah Cannon Research Institute - Pharmacy","Nashville","Tennessee","37203",{"lat":228,"lon":229},36.16589,-86.78444,{"facility":231,"status":8,"city":224,"state":225,"zip":226,"country":149,"geoPoint":232},"SCRI Oncology Partners",{"lat":228,"lon":229},{"facility":234,"status":8,"city":235,"state":236,"zip":237,"country":149,"geoPoint":238},"The University of Texas MD Anderson Cancer Center - Conroe","Conroe","Texas","77384",{"lat":239,"lon":240},30.31188,-95.45605,{"facility":242,"status":8,"city":243,"state":236,"zip":244,"country":149,"geoPoint":245},"University of Texas MD Anderson Cancer Center","Houston","77030",{"lat":246,"lon":247},29.76328,-95.36327,{"facility":249,"status":8,"city":243,"state":236,"zip":250,"country":149,"geoPoint":251},"The University of Texas, MD Anderson Cancer Center - West Houston","77079",{"lat":246,"lon":247},{"facility":253,"status":8,"city":254,"state":236,"zip":255,"country":149,"geoPoint":256},"The University of Texas, MD Anderson Cancer Center - League City","League City","77573",{"lat":257,"lon":258},29.50745,-95.09493,{"facility":260,"status":8,"city":261,"state":236,"zip":262,"country":149,"geoPoint":263},"NEXT Oncology","San Antonio","78229",{"lat":264,"lon":265},29.42412,-98.49363,{"facility":267,"status":8,"city":268,"state":236,"zip":269,"country":149,"geoPoint":270},"The University of Texas, MD Anderson Cancer Center - Sugar Land","Sugar Land","77478",{"lat":271,"lon":272},29.61968,-95.63495,{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":278,"geoPoint":279},"Princess Margaret Cancer Centre","Toronto","Ontario","M5G 1Z5","Canada",{"lat":280,"lon":281},43.70643,-79.39864,{"facility":274,"status":8,"city":275,"state":276,"zip":283,"country":278,"geoPoint":284},"M5G 2M9",{"lat":280,"lon":281},{"facility":286,"status":8,"city":287,"state":288,"zip":289,"country":278,"geoPoint":290},"McGill University Health Centre","Montreal","Quebec","H4A 3J1",{"lat":291,"lon":292},45.50884,-73.58781,{"facility":294,"status":8,"city":295,"zip":296,"country":297,"geoPoint":298},"Pan American Center for Oncology Trials, LLC","Rio Piedras","00935","Puerto Rico",{"lat":299,"lon":300},18.39745,-66.04989,{"facility":302,"status":8,"city":303,"state":304,"zip":305,"country":306,"geoPoint":307},"Hospital Universitari Vall d'Hebron","Barcelona","Barcelona [barcelona]","08035","Spain",{"lat":308,"lon":309},41.38879,2.15899,{"facility":311,"status":8,"city":312,"state":313,"zip":314,"country":306,"geoPoint":315},"Hospital Universitario 12 de Octubre","Madrid","Madrid, Comunidad de","28041",{"lat":316,"lon":317},40.4165,-3.70256,{"facility":319,"status":8,"city":312,"zip":320,"country":306,"geoPoint":321},"Hospital Universitario Fundación Jiménez Díaz","28040",{"lat":316,"lon":317},{"facility":323,"status":162,"city":324,"zip":325,"country":326,"geoPoint":327},"Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London","London","EC1A 7BE","United Kingdom",{"lat":328,"lon":329},51.50853,-0.12574,{"facility":331,"status":8,"city":332,"zip":333,"country":326,"geoPoint":334},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"lat":335,"lon":336},53.48095,-2.23743,[338],{"name":339,"role":340,"phone":341,"email":342},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[344],{"name":339,"affiliation":13,"role":345},"STUDY_DIRECTOR",[],[348],{"label":349,"url":350},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C5951001",{"nct_id":4,"conditions":352,"biomarkers":359},[353,354,355,356,357,358],"Bladder Carcinoma","Esophageal Carcinoma","Lung Non-Small Cell Carcinoma","Malignant Head and Neck Neoplasm","Pancreatic Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":361,"summary":362,"prompt_version":372},true,{"design":363,"status":364,"heading":365,"summary":366,"follow_up":367,"word_count":368,"commitments":369,"compensation":370,"drugs_mentioned":371},"This is an interventional study, meaning participants will receive the study drug. It involves different groups receiving varying doses of PF-08046876.","completed","A Study of PF-08046876 for Advanced Solid Tumors","This study is testing a new treatment called PF-08046876 for people with advanced bladder, lung, head and neck, esophagus, or pancreas cancer. PF-08046876 is an \"antibody drug conjugate\" (ADC), which is a type of medicine designed to find and kill cancer cells. You would receive PF-08046876 through an IV (a needle in your vein). The main goal is to see how safe PF-08046876 is and what side effects it might cause. Researchers will also look at the highest dose that can be given safely. This study is currently recruiting up to 310 participants.","Participants will be monitored for side effects for up to 30 days after their last dose of PF-08046876 or until they start a new anticancer therapy.",93,"Participants will receive PF-08046876 intravenously. The study will monitor for side effects from the start of treatment up to 30 days after the last dose or starting new cancer therapy.","Not stated in the trial record.",[66],"v2"]