[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549895":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":138,"collaborators":35,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":35,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":35,"enrollmentInfo":149,"targetDuration":35,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":168,"overallStatus":40,"whyStopped":35,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Angiex, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Phase","EXPERIMENTAL","AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses, with an expansion cohort in advanced angiosarcoma.",[13],"Drug: AGX101",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion Phase","AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","AGX101","Antibody Drug Conjugate",[9,15],[25],"ADC",[27],{"name":28,"affiliation":29,"role":30},"Glen Weiss, MD","Medical Lead","STUDY_DIRECTOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","857-203-7808",null,"trials@angiex.com",[38,56,74,91,107,123],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"USC\u002FNorris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90033","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.24368,34.05223,{"lat":50,"lon":49},[53],{"name":54,"role":55,"phone":35,"phoneExt":35,"email":35},"Diana Hanna, MD","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":40,"city":58,"state":59,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Florida Cancer Specialist","Sarasota","Florida","34232",{"type":47,"coordinates":62},[63,64],-82.53065,27.33643,{"lat":64,"lon":63},[67,72],{"name":68,"role":33,"phone":69,"phoneExt":70,"email":71},"Nancy Olsen","941-377-9993","1 21655","nolsen@flcancer.com",{"name":73,"role":55,"phone":35,"phoneExt":35,"email":35},"Judy Wang, MD",{"facility":75,"status":40,"city":76,"state":77,"zip":78,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":47,"coordinates":80},[81,82],-90.19789,38.62727,{"lat":82,"lon":81},[85,89],{"name":86,"role":33,"phone":87,"phoneExt":35,"email":88},"Sara Mitchum","314-273-8602","saram@wustl.edu",{"name":90,"role":55,"phone":35,"phoneExt":35,"email":35},"Saiama Waqar, MD",{"facility":92,"status":40,"city":93,"state":94,"zip":95,"country":44,"countryCode":45,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Sarah Cannon Research Center","Nashville","Tennessee","37203",{"type":47,"coordinates":97},[98,99],-86.78444,36.16589,{"lat":99,"lon":98},[102,105],{"name":103,"role":33,"phone":35,"phoneExt":35,"email":104},"Rebecca Beaman","becky.beaman@scri.com",{"name":106,"role":55,"phone":35,"phoneExt":35,"email":35},"Meredith P Pelster, MD",{"facility":108,"status":40,"city":109,"state":110,"zip":111,"country":44,"countryCode":45,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"NEXT Oncology","San Antonio","Texas","78229",{"type":47,"coordinates":113},[114,115],-98.49363,29.42412,{"lat":115,"lon":114},[118,121],{"name":119,"role":33,"phone":35,"phoneExt":35,"email":120},"Amanda Betancourt","abetancourt@nextoncology.com",{"name":122,"role":55,"phone":35,"phoneExt":35,"email":35},"Ismael Rodriguez Rivera, MD",{"facility":108,"status":40,"city":124,"state":125,"zip":126,"country":44,"countryCode":45,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Fairfax","Virginia","22031",{"type":47,"coordinates":128},[129,130],-77.30637,38.84622,{"lat":130,"lon":129},[133,136],{"name":134,"role":33,"phone":135,"phoneExt":35,"email":35},"Blake Patterson","703-783-4505",{"name":137,"role":55,"phone":35,"phoneExt":35,"email":35},"Alexander Spira, MD",{"type":139,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100549895","phase-1-a-study-to-evaluate-safety-tolerability-and-preliminary-activity-of-agx101-in-participants-with-advanced-solid-tumors-100549895",false,"NCT06440005","A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors","A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed unresectable, locally advanced, or metastatic solid tumors.\n* Refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor\n* Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C); Biologic therapy (eg, antibodies): ≥ 3 weeks; Small molecule therapies: ≥ 5 × half-life\n* Have an ECOG performance status of 0 to 1\n* Have adequate organ function\n* LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition (MUGA) scan\n* Highly effective contraception for both male and female patients throughout the study\n\nExclusion Criteria:\n\n* Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed and approved by Sponsor\n* Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and\u002For asymptomatic CNS metastases allowed)\n* Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies (patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be eligible after discussion with the Sponsor)\n* Has an active vasculitis that has required systemic treatment in the past 2 years prior to starting study treatment\n* Significant (ie, ≥ Grade 2) ocular disturbances\n* Variceal bleeding within 6 months prior to treatment, currently untreated or incompletely treated varices with bleeding, or who otherwise are at a high risk of bleeding\n* Any other concurrent antineoplastic treatment except for allowed local radiation of lesions for palliation (to be considered non-target lesions after treatment) and hormone ablation\n* Uncontrolled or life-threatening symptomatic concomitant disease, including known symptomatic HIV positive with an AIDS defining opportunistic infection within the last year, known symptomatic active hepatitis B or C, or known active tuberculosis\n* Has undergone a major surgery within 3 weeks prior to starting study treatment or has inadequate healing or recovery from complications of surgery prior to starting study treatment\n* Has received prior radiotherapy within 2 weeks prior to starting study treatment\n* Has or had a potentially life-threatening second malignancy requiring systemic treatment within the last 3 years, or which would impede evaluation of treatment response\n* Clinically significant cardiovascular disease\n* Patients on a potent CYP3A inhibitor or CPY3A inducer who cannot be changed to another medication\n* Has an active infection requiring concurrent systemic antibiotic therapy\n* A woman of child-bearing potential (WOCBP) who has a positive pregnancy test prior to treatment\n* Is breastfeeding or expecting to conceive or father children within the projected duration of the study","ALL","18 Years",{"count":150,"type":151},80,"ESTIMATED","INTERVENTIONAL",[154],"PHASE1","AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously.\n\nDosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.",[157,158,159,160,161,162,163,164,165,166,167],"Cancer","Advanced Cancer","Locally Advanced Carcinoma","Metastatic Solid Tumor","Breast Cancer","Prostate Cancer","Colorectal Cancer","Pancreatic Cancer","Liver Cancer","Angiosarcoma","Solid Tumor",[25,22,21],"2026-02-08",{"date":171,"type":172},"2026-02-11","ACTUAL",{"date":174,"type":172},"2024-07-22",{"date":176,"type":151},"2027-09-06",{"name":5,"class":6},6]