[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Angiex, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33,34,35,36],"Cancer","Advanced Cancer","Locally Advanced Carcinoma","Metastatic Solid Tumor","Breast Cancer","Prostate Cancer","Colorectal Cancer","Pancreatic Cancer","Liver Cancer","Angiosarcoma","Solid Tumor",[38,39,40],"ADC","Antibody Drug Conjugate","AGX101","RECRUITING","2026-02-08",{"date":44,"type":45},"2026-02-11","ACTUAL",{"date":47,"type":45},"2024-07-22",{"date":49,"type":20},"2027-09-06",{"name":51,"class":52},"Angiex, Inc.","INDUSTRY",6,""]