[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06265688":3,"trial-entities:NCT06265688":171,"trial-summary:NCT06265688":175},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":48,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":91,"locations":94,"central_contacts":159,"overall_officials":165,"references":169,"see_also_links":170},"NCT06265688","CTMX-2051-101","First In Human Study of CX-2051 in Advanced Solid Tumors","An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors","RECRUITING","2029-03-31","2026-07","2026-07-15","2024-04-02","CytomX Therapeutics","INDUSTRY",true,"The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors.","The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051 as monotherapy and as combination therapy (CX-2051 combined with bevacizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 as monotherapy and\u002For combination therapy in indication-specific expansion cohorts.",[19],"Solid Tumor, Adult",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},160,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","CX-2051","Investigational drug",[31,34],"CX-2051 + bevacizumab",{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Bevacizumab","IV infusion",[34],[40],"Avastin",[42,46],{"measure":43,"description":44,"timeFrame":45},"Safety and tolerability of CX-2051","The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level","44 months",{"measure":47,"description":44,"timeFrame":45},"Determine the recommended Phase 2 dose (RP2D)",[49,53,56,59,62,65,68],{"measure":50,"description":51,"timeFrame":52},"Objective response rate (ORR)","ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment","60 months",{"measure":54,"description":55,"timeFrame":52},"Duration of response (DOR)","DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.",{"measure":57,"description":58,"timeFrame":52},"Progression-free survival (PFS)","PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.",{"measure":60,"description":61,"timeFrame":52},"Time to Treatment Failure (TTF)","TTF defined as the time from first dose of study intervention to the date of premature discontinuation for any reason, including tumor progression, severe toxicity, participant withdrawal, or death.",{"measure":63,"description":64,"timeFrame":52},"Disease control rate (DCR)","DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.",{"measure":66,"description":67,"timeFrame":52},"Duration of disease control (DODC)","DODC defined as the time from the first documentation of confirmed CR, PR, or SD (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.",{"measure":69,"description":70,"timeFrame":52},"Overall survival (OS)","OS defined as the time from the first dose of study intervention to death due to any cause","ALL","18 Years",null,false,{"inclusion":76,"exclusion":81,"raw_text":90},[77,78,79,80],"Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy","Eastern Cooperative Oncology Group (ECOG) performance status of 0-1","Measurable disease per RECIST v1.1","Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue",[82,83,84,85,86,87,88,89],"Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated","Known active central nervous system (CNS) involvement by malignancy","Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1","Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload","Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1","Elevated baseline laboratory values","Serious concurrent illness","Pregnant or breast feeding","Inclusion Criteria:\n\n* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Measurable disease per RECIST v1.1\n* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue\n* Additional inclusion criteria may apply\n\nExclusion Criteria:\n\n* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated\n* Known active central nervous system (CNS) involvement by malignancy\n* Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1\n* Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload\n* Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1\n* Elevated baseline laboratory values\n* Serious concurrent illness\n* Pregnant or breast feeding\n* Additional exclusion criteria may apply",[92,93],"ADULT","OLDER_ADULT",[95,104,112,120,128,136,144,151],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"geoPoint":101},"Sarah Cannon Research Institute at HealthONE","Denver","Colorado","80218","United States",{"lat":102,"lon":103},39.73915,-104.9847,{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":100,"geoPoint":109},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"lat":110,"lon":111},42.35843,-71.05977,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":100,"geoPoint":117},"Montefiore Medical Center","The Bronx","New York","10461",{"lat":118,"lon":119},40.84985,-73.86641,{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":100,"geoPoint":125},"Carolina BioOncology Institute, PLLC","Huntersville","North Carolina","28078",{"lat":126,"lon":127},35.41069,-80.84285,{"facility":129,"status":8,"city":130,"state":131,"zip":132,"country":100,"geoPoint":133},"Sarah Cannon Research Institute, LLC","Nashville","Tennessee","37203",{"lat":134,"lon":135},36.16589,-86.78444,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":100,"geoPoint":141},"START - Dallas\u002FFort Worth","Fort Worth","Texas","76104",{"lat":142,"lon":143},32.72541,-97.32085,{"facility":145,"status":8,"city":146,"state":139,"zip":147,"country":100,"geoPoint":148},"START San Antonio LLC","San Antonio","78229",{"lat":149,"lon":150},29.42412,-98.49363,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":100,"geoPoint":156},"NEXT Virginia","Fairfax","Virginia","22031",{"lat":157,"lon":158},38.84622,-77.30637,[160],{"name":161,"role":162,"phone":163,"email":164},"Karen Deane","CONTACT","650-515-3185","clinicaltrials@cytomx.com",[166],{"name":167,"affiliation":13,"role":168},"Monika Vainorius, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":172,"biomarkers":174},[173],"Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":176,"prompt_version":73},{"design":177,"status":178,"heading":179,"summary":180,"follow_up":181,"word_count":182,"commitments":183,"compensation":184,"drugs_mentioned":185},"This is a first-in-human interventional study with an unspecified phase, enrolling about 160 participants. It has two parts: dose escalation to find the maximum tolerated dose, and dose expansion to further assess safety and preliminary anti-tumor activity.","completed","CX-2051 for Advanced Solid Tumors","This study is testing a new investigational drug called CX-2051, both alone and in combination with bevacizumab, for adults with advanced solid tumors. CX-2051 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells. The main goals are to understand the safety and side effects of CX-2051 and to find the best dose for future studies. You might be able to join if your cancer has progressed after standard treatments and you have a good performance status. The study aims to enroll 160 participants.","The safety and tolerability of CX-2051 will be measured for 44 months, and the recommended Phase 2 dose will be determined at 44 months.",91,"You would need to consent to a fresh biopsy or provide recent archival tumor tissue. Additional inclusion criteria may apply, and the study will assess safety and tolerability.","Not stated in the trial record.",[31,36]]