[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06307795":3,"trial-entities:NCT06307795":276,"trial-summary:NCT06307795":283},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":58,"sex":96,"minimum_age":97,"maximum_age":17,"healthy_volunteers":98,"eligibility_criteria":99,"std_ages":113,"locations":116,"central_contacts":264,"overall_officials":269,"references":274,"see_also_links":275},"NCT06307795","ANS014004-I-US-01","A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors","RECRUITING","2027-10","2026-04","2026-04-17","2024-06-24","Avistone Biotechnology Co., Ltd.","INDUSTRY",true,"This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.",null,[19],"Locally Advanced or Metastatic Solid Tumors",[21,22,23],"ROS1","NTRK","ROS1\u002FNTRK","INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},63,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","ANS014004","Varying doses of ANS014004",[37],"ANS014004 Monotherapy",[39,43,47,51,54],{"measure":40,"description":41,"timeFrame":42},"Incidence of Adverse Events (AEs)","Number of patients with adverse events by system organ class and preferred term","From the time of first dose to 28 days post last dose of ANS014004",{"measure":44,"description":45,"timeFrame":46},"Incidence of Serious Adverse Events (SAEs)","Number of patients with serious adverse events by system organ class and preferred term","From time of first dose to 28 days post last dose of ANS014004",{"measure":48,"description":49,"timeFrame":50},"Incidence of dose-limiting toxicities (DLT) as defined in the protocol","Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol","From time of first dose of ANS014004 to end of DLT period (approximately 30 days)",{"measure":52,"description":53,"timeFrame":46},"Incidence of baseline laboratory finding, ECG and vital signs changes","measured by laboratory and vital sign variables over time including change from",{"measure":55,"description":56,"timeFrame":57},"Proportion of patients with radiological response (ORR)","Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1","From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）",[59,63,66,69,73,77,81,84,87,90,93],{"measure":60,"description":61,"timeFrame":62},"Objective Response Rate (ORR)","The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)","From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)",{"measure":64,"description":65,"timeFrame":62},"Duration of Response (DoR)","The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)",{"measure":67,"description":68,"timeFrame":62},"Disease Control Rate (DCR)","From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression",{"measure":70,"description":71,"timeFrame":72},"Progression free Survival (PFS)","The time from first dose until RECIST 1.1 defined disease progression or death due to any cause","rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)",{"measure":74,"description":75,"timeFrame":76},"Overall Survival (OS)","The time from the date of the first dose of study treatment until death due to any cause","From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years)",{"measure":78,"description":79,"timeFrame":80},"Pharmacokinetics of ANS014004: Plasma PK concentrations","Measurement of plasma concentrations of ANS014004, total antibody and total unconjugated warhead","From date of first dose up until 28 days post last dose",{"measure":82,"description":83,"timeFrame":80},"Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC)","Measurement of PK parameters: Area under the concentration time curve (AUC)",{"measure":85,"description":86,"timeFrame":80},"Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max)","Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)",{"measure":88,"description":89,"timeFrame":80},"Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max)","Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)",{"measure":91,"description":92,"timeFrame":80},"Pharmacokinetics of ANS014004: Clearance","Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)",{"measure":94,"description":95,"timeFrame":80},"Pharmacokinetics of ANS014004: Half-life","Measurement of PK parameters: Terminal elimination half-life (t 1\u002F2)","ALL","18 Years",false,{"inclusion":100,"exclusion":107,"raw_text":112},[101,102,103,104,105,106],"Age ≥ 18 years","Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1","Life expectancy ≥ 12 weeks","Measurable disease per RECIST v1.1","Adequate organ and marrow function as defined in the protocol","With a pathogenetic MET alteration or ROS1 alteration or NTRK alternation",[108,109,110,111],"Active infection including tuberculosis and HBV, HCV or HIV","Known active or untreated CNS metastases","Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression","Participants with serious cardiovascular or cerebrovascular diseases","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Life expectancy ≥ 12 weeks\n* Measurable disease per RECIST v1.1\n* Adequate organ and marrow function as defined in the protocol\n* With a pathogenetic MET alteration or ROS1 alteration or NTRK alternation\n\nExclusion Criteria:\n\n* Active infection including tuberculosis and HBV, HCV or HIV\n* Known active or untreated CNS metastases\n* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression\n* Participants with serious cardiovascular or cerebrovascular diseases",[114,115],"ADULT","OLDER_ADULT",[117,126,134,142,150,157,165,173,181,189,196,212,225,238,251],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"geoPoint":123},"University of California, San Diego","San Diego","California","92093","United States",{"lat":124,"lon":125},32.71571,-117.16472,{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":122,"geoPoint":131},"Sarah Cannon Research Institute","Denver","Colorado","80218",{"lat":132,"lon":133},39.73915,-104.9847,{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":122,"geoPoint":139},"Advent Health","Orlando","Florida","32804",{"lat":140,"lon":141},28.53834,-81.37924,{"facility":143,"status":8,"city":144,"state":145,"zip":146,"country":122,"geoPoint":147},"Henry Ford Health Cancer","Detroit","Michigan","48202",{"lat":148,"lon":149},42.33143,-83.04575,{"facility":151,"status":8,"city":152,"state":152,"zip":153,"country":122,"geoPoint":154},"NYU Langone Health","New York","10003",{"lat":155,"lon":156},40.71427,-74.00597,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":122,"geoPoint":162},"The University of Texas - MD Anderson Cancer Center","Houston","Texas","77030",{"lat":163,"lon":164},29.76328,-95.36327,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":122,"geoPoint":170},"NEXT Oncology, Virginia","Fairfax","Virginia","22031",{"lat":171,"lon":172},38.84622,-77.30637,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":122,"geoPoint":178},"Swedish Cancer Institute","Seattle","Washington","98195",{"lat":179,"lon":180},47.60621,-122.33207,{"facility":182,"status":8,"city":183,"state":184,"country":185,"geoPoint":186},"BC Cancer Vancouver Centre","Vancouver","British Columbia","Canada",{"lat":187,"lon":188},49.24966,-123.11934,{"facility":190,"status":8,"city":191,"state":192,"country":185,"geoPoint":193},"Princess Margaret Cancer Centre","Toronto","Ontario",{"lat":194,"lon":195},43.70643,-79.39864,{"facility":197,"status":198,"city":199,"state":200,"zip":201,"country":202,"contacts":203,"geoPoint":209},"Beijing Chest Hospital","NOT_YET_RECRUITING","Beijing","Beijing Municipality","101149","China",[204],{"name":205,"role":206,"phone":207,"email":208},"Gen Lin","CONTACT","86-89509000","lingen@bjxkyy.cn",{"lat":210,"lon":211},39.9075,116.39723,{"facility":213,"status":198,"city":214,"state":215,"zip":216,"country":202,"contacts":217,"geoPoint":222},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang","150010",[218],{"name":219,"role":206,"phone":220,"email":221},"Yan Yu","8645186298000","gpyuyan@163.com",{"lat":223,"lon":224},45.75,126.65,{"facility":226,"status":198,"city":227,"state":228,"zip":229,"country":202,"contacts":230,"geoPoint":235},"Henan Cancer Hospital","Zhengzhou","Henan","450008",[231],{"name":232,"role":206,"phone":233,"email":234},"Yanqiu ZHAO","400-0371-818","13938252350@163.com",{"lat":236,"lon":237},34.75778,113.64861,{"facility":239,"status":198,"city":240,"state":241,"zip":242,"country":202,"contacts":243,"geoPoint":248},"Shandong Cancer Hospital","Jinan","Shandong","250117",[244],{"name":245,"role":206,"phone":246,"email":247},"Yan Zhang","8653187984777","zhangyan0681@163.com",{"lat":249,"lon":250},36.66833,116.99722,{"facility":252,"status":198,"city":253,"state":254,"zip":255,"country":202,"contacts":256,"geoPoint":261},"Shanghai Chest Hospital","Shanghai","Shanghai Municipality","200030",[257],{"name":258,"role":206,"phone":259,"email":260},"Shun LU","86 21-222-00000","shun_lu@hotmail.com",{"lat":262,"lon":263},31.22222,121.45806,[265],{"name":266,"role":206,"phone":267,"email":268},"Avistone Clinical Study Information Center","8610 84148921","information.center@avistonebio.com",[270],{"name":271,"affiliation":272,"role":273},"Medical Director Clinical Science","Beijing Avistone Biotechnology Co., Ltd.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":277,"biomarkers":279},[278],"Solid Neoplasm",[280,281,282],"MET Gene","NTRK Family Gene","ROS1 Gene",{"nct_id":4,"found":15,"summary":284,"prompt_version":294},{"design":285,"status":286,"heading":287,"summary":288,"follow_up":289,"word_count":290,"commitments":291,"compensation":292,"drugs_mentioned":293},"This is a Phase 1, first-in-human study, meaning it's one of the first times this drug is being tested in people. It is an open-label study, so both you and your doctors will know you are receiving ANS014004. The study plans to enroll about 63 participants.","completed","A Study of ANS014004 for Advanced Solid Tumors","This study is testing a drug called ANS014004 in people with locally advanced or metastatic (spread to other parts of the body) solid tumors. The main goal is to see how safe ANS014004 is and what side effects it might cause. Researchers will also look at how the drug moves through the body and if it shows any early signs of helping to treat the cancer. You might be able to join if you are at least 18 years old, have a good general health status, and your tumor has specific changes in the MET, NTRK, or ROS1 genes. The study is open to both men and women.","Your safety will be monitored from the time of your first dose to 28 days after your last dose of ANS014004.",108,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]