[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07227168":3,"trial-entities:NCT07227168":299,"trial-summary:NCT07227168":313},{"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":28,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":51,"secondary_outcomes":79,"sex":99,"minimum_age":100,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":101,"std_ages":118,"locations":121,"central_contacts":291,"overall_officials":296,"references":297,"see_also_links":298},"NCT07227168","STRO-004-ST1","A Study of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Cancer","A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Solid Tumors","RECRUITING","2028-04","2026-08","2026-08-27","2025-11-07","Sutro Biopharma, Inc.","INDUSTRY",false,"This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts:\n\n* Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF).\n* Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity.\n* Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.",null,[19,20,21,22,23,24,25,26,27],"Head and Neck Squamous Cell Carcinoma HNSCC","Non-Small Cell Lung Cancer NSCLC","Esophageal Cancer","Gastric Cancer","Colorectal Cancer","Pancreatic Ductal Adenocarcinoma (PDAC)","Cervical Cancer","Endometrial Cancer","Urothelial Cancer",[29,30,31,32],"Tissue Factor (TF)","STRO-004","Antibody Drug Conjugate","ADC","INTERVENTIONAL","TREATMENT",[36],"PHASE1",{"count":38,"type":39},200,"ESTIMATED",[41,48],{"type":42,"name":30,"description":43,"armGroupLabels":44},"DRUG","IV Infusion",[45,46,47],"Part 1A STRO-004 Monotherapy","Part 1B STRO-004 Monotherapy","Part 1C STRO-004 in Combination with Pembrolizumab",{"type":42,"name":49,"description":43,"armGroupLabels":50},"Pembrolizumab",[47],[52,55,58,61,64,67,70,73,77],{"measure":53,"timeFrame":54},"Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)","Up to Day 21",{"measure":56,"timeFrame":57},"Part 1A, 1B: Percentage of participants with Treatment-Emergent Adverse Events (TEAEs), with severity determined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale","Up to 12 Months",{"measure":59,"timeFrame":60},"Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scale","Up to 12 months",{"measure":62,"description":63,"timeFrame":60},"Part 1B: Objective Response Rate (ORR)","Best response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)",{"measure":65,"description":66,"timeFrame":60},"Part 1B: Disease control rate (DCR)","The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1",{"measure":68,"description":69,"timeFrame":60},"Part 1B: Duration of Response (DOR)","Time from first occurrence of objective response to the time of Progressive Disease (PD) according to RECIST v1.1 or death from any cause, whichever comes first",{"measure":71,"description":72,"timeFrame":60},"Part 1B: Progression-Free Survival (PFS)","Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first",{"measure":74,"description":75,"timeFrame":76},"Part 1B: 12-month survival rate","Percentage of participants alive 12 months after first dose of study treatment","12 months",{"measure":78,"timeFrame":60},"Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale",[80,82,85,88,91,94,96],{"measure":81,"timeFrame":60},"Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints",{"measure":83,"description":84,"timeFrame":60},"Part 1A, 1B, 1C: Immunogenicity","As measured by circulating antidrug antibody (ADA) over time",{"measure":86,"description":60,"timeFrame":87},"Part 1A: Objective Response Rate (ORR)","Best response of CR or PR per RECIST V1.1",{"measure":89,"description":90,"timeFrame":60},"Part 1A, 1C: Disease Control Rate (DCR)","Proportion of participants with best response of CR, PR or SD per RECIST V1.1",{"measure":92,"description":93,"timeFrame":60},"Part 1A, 1C: Duration of Response (DOR)","Time from first occurrence of objective response to the time of PD according to RECIST v1.1 or death from any cause, whichever comes first",{"measure":95,"description":72,"timeFrame":60},"Part 1A,1C: Progression-Free Survival (PFS)",{"measure":97,"description":98,"timeFrame":76},"Part 1A,1C: 12-month survival rate","Proportion of participants alive 12 months after the date of first dose of study treatment","ALL","18 Years",{"inclusion":102,"exclusion":111,"raw_text":117},[103,104,105,106,107,108,109,110],"Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal\u002FGastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma","Age 18 years or older","Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1","Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies","Availability of tumor tissue","Measurable disease per RECIST 1.1","Adequate organ function","Participants receiving anticoagulants must be on a stable dose",[112,113,114,115,116],"Eye disorders","Untreated brain metastases","Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition","Previous solid organ or bone marrow transplantation","Concurrent participation in another therapeutic treatment trial","Inclusion Criteria:\n\n* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal\u002FGastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma\n* Age 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies\n* Availability of tumor tissue\n* Measurable disease per RECIST 1.1\n* Adequate organ function\n* Participants receiving anticoagulants must be on a stable dose\n\nExclusion Criteria:\n\n* Eye disorders\n* Untreated brain metastases\n* Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition\n* Previous solid organ or bone marrow transplantation\n* Concurrent participation in another therapeutic treatment trial",[119,120],"ADULT","OLDER_ADULT",[122,143,164,183,204,221,238,258,273],{"facility":123,"status":8,"city":124,"state":125,"zip":126,"country":127,"contacts":128,"geoPoint":140},"UC San Diego Moores Cancer Center","San Diego","California","92037","United States",[129,134,137],{"name":130,"role":131,"phone":132,"email":133},"Gloria Neilson","CONTACT","858-822-5677","gneilson@health.ucsd.edu",{"name":135,"role":131,"phone":132,"email":136},"Kathy Velasco, M.D.","kcvelasco@health.ucsd.edu",{"name":138,"role":139},"Lyudmila Bazhenova, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":141,"lon":142},32.71571,-117.16472,{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":127,"contacts":148,"geoPoint":161},"SCRI Denver","Denver","Colorado","80218",[149,153,156,158],{"name":150,"role":131,"phone":151,"email":152},"Jessica Ellis","720-754-2610","Jessica.Ellis@SarahCannon.com",{"name":154,"role":131,"phone":151,"email":155},"Julia Etchart","Julia.Etchart@SarahCannon.com",{"name":157,"role":139},"Gerald Falchook, MD",{"name":159,"role":160},"Kim Freitas, MSN","SUB_INVESTIGATOR",{"lat":162,"lon":163},39.73915,-104.9847,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":127,"contacts":169,"geoPoint":180},"Georgetown University Medical Center","Washington D.C.","District of Columbia","20007",[170,174,178],{"name":171,"role":131,"phone":172,"email":173},"Matthew Caffet","202-687-8632","mc2731@georgetown.edu",{"name":175,"role":131,"phone":176,"email":177},"Chul Kim, M.D.","(202) 444-2223","chul.kim@gunet.georgetown.edu",{"name":179,"role":139},"Joshua E. Reuss, M.D.",{"lat":181,"lon":182},38.89511,-77.03637,{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":127,"contacts":188,"geoPoint":201},"SCRI FCS Sarasota","Sarasota","Florida","34232",[189,194,197,199],{"name":190,"role":131,"phone":191,"phoneExt":192,"email":193},"Sarah Gwirtz","941-377-9993","option 1","Sarah.Gwirtz@flcancer.com",{"name":195,"role":131,"phone":191,"phoneExt":192,"email":196},"Heather Schmitz","heather.schmitz@flcancer.com",{"name":198,"role":139},"Manish Patel, MD",{"name":200,"role":160},"Kimberly Ott, MD",{"lat":202,"lon":203},27.33643,-82.53065,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":127,"contacts":209,"geoPoint":218},"Mass General Cancer Center","Boston","Massachusetts","02114",[210,214,217],{"name":211,"role":131,"phone":212,"email":213},"Leon Pappas, MD","617-643-5470","lpappas3@mgb.org",{"name":215,"role":131,"phone":212,"email":216},"Julia Rapisadra","jrapisarda@mgh.harvard.edu",{"name":211,"role":139},{"lat":219,"lon":220},42.35843,-71.05977,{"facility":222,"status":8,"city":223,"state":223,"zip":224,"country":127,"contacts":225,"geoPoint":235},"Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai","New York","10029",[226,230,233],{"name":227,"role":131,"phone":228,"email":229},"Jordan Cuevas","212-824-7945","Jordan.Cuevas@mssm.edu",{"name":231,"role":131,"phone":228,"email":232},"Gabriela Fazilov","gabriela.fazilov@mssm.edu",{"name":234,"role":139},"Deborah Doroshow, M.D.",{"lat":236,"lon":237},40.71427,-74.00597,{"facility":239,"status":8,"city":240,"state":241,"zip":242,"country":127,"contacts":243,"geoPoint":255},"NEXT Austin","Austin","Texas","78758",[244,248,251,253],{"name":245,"role":131,"phone":246,"email":247},"Kayla Grossi","737-610-5200","kgrossi@nextoncology.com",{"name":249,"role":131,"phone":246,"email":250},"China Whitwer","cwhitwer@nextoncology.com",{"name":252,"role":139},"Sheena Sahota, MD",{"name":254,"role":160},"Ildefonso I. Rodriguez-Rivera, MD",{"lat":256,"lon":257},30.26715,-97.74306,{"facility":259,"status":8,"city":260,"state":241,"zip":261,"country":127,"contacts":262,"geoPoint":270},"NEXT San Antonio","San Antonio","78229",[263,265,266,268],{"name":245,"role":131,"phone":264,"email":247},"210-580-9511",{"name":249,"role":131,"phone":264,"email":250},{"name":267,"role":139},"David Sommerhalder, MD",{"name":269,"role":160},"Ismael Rodriguez, MD",{"lat":271,"lon":272},29.42412,-98.49363,{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":127,"contacts":278,"geoPoint":288},"NEXT Virginia","Fairfax","Virginia","22031",[279,281,284,286],{"name":245,"role":131,"phone":280,"email":247},"703-783-4510",{"name":282,"role":131,"phone":280,"email":283},"Allison Delgado","adelgado@nextoncology.com",{"name":285,"role":139},"Mohamad A. Salkeni, MD",{"name":287,"role":160},"Neel Belani, MD",{"lat":289,"lon":290},38.84622,-77.30637,[292],{"name":293,"role":131,"phone":294,"email":295},"Sutro Clinical Development","650-801-6416","ClinicalTrials@sutrobio.com",[],[],[],{"nct_id":4,"conditions":300,"biomarkers":311},[301,302,303,304,305,306,307,308,309,310],"Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Head and Neck Squamous Cell Carcinoma","Lung Non-Small Cell Carcinoma","Pancreatic Ductal Adenocarcinoma","Solid Neoplasm","Urothelial Carcinoma",[312],"Tissue Factor",{"nct_id":4,"found":314,"summary":315,"prompt_version":325},true,{"design":316,"status":317,"heading":318,"summary":319,"follow_up":320,"word_count":321,"commitments":322,"compensation":323,"drugs_mentioned":324},"This is an interventional study with an unclear phase, aiming to enroll 200 participants. It involves different parts to test STRO-004 alone and in combination with pembrolizumab.","completed","A Study of STRO-004 for Metastatic Cancer","This study is testing a new drug called STRO-004, sometimes combined with pembrolizumab, for adults with metastatic (cancer that has spread) or locally advanced solid tumors. This includes cancers like head and neck, lung, esophageal, gastric, and colorectal cancer. The main goals are to see how safe STRO-004 is, what side effects it might cause, and if it shows any signs of shrinking tumors. The study has three parts: one to find the right dose of STRO-004 alone, another to further evaluate that dose, and a third to test STRO-004 with pembrolizumab. You could be eligible if you are 18 or older and have one of the listed cancers.","Participants will be monitored for side effects and laboratory changes for up to 12 months.",109,"Not specified in the trial record.","Not stated in the trial record.",[30,49],"v2"]