[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06656390":3,"trial-entities:NCT06656390":475,"trial-summary:NCT06656390":479},{"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":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":101,"locations":104,"central_contacts":467,"overall_officials":472,"references":473,"see_also_links":474},"NCT06656390","ALK201-01","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors","A First-in-Human, Open-Label, Multi-Center Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors","RECRUITING","2028-04-22","2026-03","2026-05-22","2024-10-24","Shanghai Allink Biotherapeutics Co., Ltd.","INDUSTRY",true,"This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.",null,[19,20],"Advanced Cancer","Advanced Solid Tumors",[22],"First-in-human","INTERVENTIONAL","TREATMENT",[26,27],"PHASE1","PHASE2",{"count":29,"type":30},202,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","ALK201","Administered intravenously, once every 3 weeks",[37],"Part A: Dose-escalation Phase, Part B: Dose-expansion Phase",[39],{"measure":40,"description":41,"timeFrame":42},"To evaluate the safety and tolerability of ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.","Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.","Approximately 36 months",[44,47,50,52,54,56,58,60,62,64,67,70,72,74,76,78],{"measure":45,"description":46,"timeFrame":42},"To evaluate the pharmacokinetics (PK) of ALK201.","PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)",{"measure":48,"description":49,"timeFrame":42},"To evaluate the pharmacokinetics (PK) of ALK201","PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)",{"measure":48,"description":51,"timeFrame":42},"PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)",{"measure":48,"description":53,"timeFrame":42},"PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)",{"measure":48,"description":55,"timeFrame":42},"PK parameters after single and multiple doses: trough Concentration(Ctrough)",{"measure":48,"description":57,"timeFrame":42},"PK parameters after single and multiple doses: Clearance(CL)",{"measure":48,"description":59,"timeFrame":42},"PK parameters after single and multiple doses: apparent Distribution Volume(Vd)",{"measure":48,"description":61,"timeFrame":42},"PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)",{"measure":48,"description":63,"timeFrame":42},"PK parameters after single and multiple doses: terminal half-life (t1\u002F2)",{"measure":65,"description":66,"timeFrame":42},"To evaluate the immunogenicity of ALK201.","The generation of anti-drug antibodies (ADAs).",{"measure":68,"description":69,"timeFrame":42},"To evaluate the preliminary antitumor activity of ALK201","Objective Response Rate (ORR)",{"measure":68,"description":71,"timeFrame":42},"Duration of Response (DOR)",{"measure":68,"description":73,"timeFrame":42},"Disease Control Rate (DCR)",{"measure":68,"description":75,"timeFrame":42},"Progression-Free Survival (PFS)",{"measure":68,"description":77,"timeFrame":42},"Overall Survival (OS)",{"measure":79,"description":80,"timeFrame":42},"To evaluate the biomarkers.","Descriptive analysis will be made to describe the correlation between clinical outcomes and FGFR2 genetic alterations.","ALL","18 Years","75 Years",false,{"inclusion":86,"exclusion":93,"raw_text":100},[87,88,89,90,91,92],"Men and women ≥18 and ≤75 years old on the day of signing the ICF","At least 1 measurable lesion per RECIST v1.1","Expected survival ≥3 months","Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1","Adequate organ function","Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms",[94,95,96,97,98,99],"Active or pre-existing autoimmune diseases that may relapse","Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage","Allergies to any component of ALK201 or other monoclonal antibodies","Primary central nervous system malignancies, or active metastases to central nervous system and\u002For metastases to meninges","Combined with ≥ Grade 2 stomatitis and\u002For nose bleeding at screening","Vaccinated with live vaccines within 4 weeks prior to the first dose","Inclusion Criteria:\n\n* Men and women ≥18 and ≤75 years old on the day of signing the ICF\n* At least 1 measurable lesion per RECIST v1.1\n* Expected survival ≥3 months\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1\n* Adequate organ function\n* Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms\n\nExclusion Criteria:\n\n* Active or pre-existing autoimmune diseases that may relapse\n* Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage\n* Allergies to any component of ALK201 or other monoclonal antibodies\n* Primary central nervous system malignancies, or active metastases to central nervous system and\u002For metastases to meninges\n* Combined with ≥ Grade 2 stomatitis and\u002For nose bleeding at screening\n* Vaccinated with live vaccines within 4 weeks prior to the first dose\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",[102,103],"ADULT","OLDER_ADULT",[105,118,129,140,151,163,173,182,191,202,212,218,227,237,243,252,262,272,282,292,301,311,317,323,333,342,352,361,370,379,389,399,409,422,432,442,452,458],{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":115},"Denver Drug Development Unit","Denver","Colorado","80218","United States",[112],{"name":113,"role":114},"Dr.Jason Henry","CONTACT",{"lat":116,"lon":117},39.73915,-104.9847,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":110,"contacts":123,"geoPoint":126},"UCF Lake Nona Cancer Center","Orlando","Florida","32827",[124],{"name":125,"role":114},"Dr.Cesar Perez",{"lat":127,"lon":128},28.53834,-81.37924,{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":110,"contacts":134,"geoPoint":137},"University Medical Center New Orleans","New Orleans","Louisiana","70112",[135],{"name":136,"role":114},"Dr. Shou-Ching Tang",{"lat":138,"lon":139},29.95465,-90.07507,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":110,"contacts":145,"geoPoint":148},"Sarah Cannon Research Institute Oncology Partners","Nashville","Tennessee","37203",[146],{"name":147,"role":114},"Dr. Meredith Pelster",{"lat":149,"lon":150},36.16589,-86.78444,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":156,"contacts":157,"geoPoint":160},"Cancer Care Wollongong","Wollongong","New South Wales","2500","Australia",[158],{"name":159,"role":114},"Dr. Udit Nindra",{"lat":161,"lon":162},-34.424,150.89345,{"facility":164,"status":8,"city":165,"state":166,"country":156,"contacts":167,"geoPoint":170},"Sunshine Coast University Private Hospital","Birtinya","Queensland",[168],{"name":169,"role":114},"Dr Michelle Morris",{"lat":171,"lon":172},-26.74322,153.11913,{"facility":174,"status":8,"city":175,"state":166,"country":156,"contacts":176,"geoPoint":179},"Mater Cancer Care Center","South Brisbane",[177],{"name":178,"role":114},"Dr Catherine Shannon",{"lat":180,"lon":181},-27.48034,153.02049,{"facility":183,"status":8,"city":184,"country":156,"contacts":185,"geoPoint":188},"Macquarie University Hospital","Macquarie",[186],{"name":187,"role":114},"Dr Andrew Parsonson",{"lat":189,"lon":190},-35.25126,149.06363,{"facility":192,"status":8,"city":193,"state":194,"country":195,"contacts":196,"geoPoint":199},"Anhui Provincial Cancer Hospital","Hefei","Anhui","China",[197],{"name":198,"role":114},"Yifu He",{"lat":200,"lon":201},31.86389,117.28083,{"facility":203,"status":8,"city":204,"state":205,"country":195,"contacts":206,"geoPoint":209},"Fujian Cancer Hospital","Fuzhou","Fujian",[207],{"name":208,"role":114},"Jianwei Yang",{"lat":210,"lon":211},26.06139,119.30611,{"facility":213,"status":8,"city":204,"state":205,"country":195,"contacts":214,"geoPoint":217},"Fujian Medical University Union Hospital",[215],{"name":216,"role":114},"Xiaoyan Lin",{"lat":210,"lon":211},{"facility":219,"status":8,"city":220,"state":205,"country":195,"contacts":221,"geoPoint":224},"The First Affiliated Hospital Of Xiamen University","Xiamen",[222],{"name":223,"role":114},"Linli Chen",{"lat":225,"lon":226},24.47979,118.08187,{"facility":228,"status":8,"city":229,"state":230,"country":195,"contacts":231,"geoPoint":234},"Guangdong Province People's Hospital","Guangzhou","Guangdong",[232],{"name":233,"role":114},"Jian Xiao",{"lat":235,"lon":236},23.11667,113.25,{"facility":238,"status":8,"city":229,"state":230,"country":195,"contacts":239,"geoPoint":242},"Sun Yat-sen University Cancer Center",[240],{"name":241,"role":114},"Ruihua Xu",{"lat":235,"lon":236},{"facility":244,"status":8,"city":245,"state":230,"country":195,"contacts":246,"geoPoint":249},"Cancer Hospital Of Shantou University Medical College","Shantou",[247],{"name":248,"role":114},"Yi Jiang",{"lat":250,"lon":251},23.35489,116.67876,{"facility":253,"status":8,"city":254,"state":255,"country":195,"contacts":256,"geoPoint":259},"Guangxi Medical University Cancer Hospital","Nanning","Guangxi",[257],{"name":258,"role":114},"Yongqiang Li",{"lat":260,"lon":261},22.81667,108.31667,{"facility":263,"status":8,"city":264,"state":265,"country":195,"contacts":266,"geoPoint":269},"Affiliated Hospital of Chengde Medical University","Chengde","Hebei",[267],{"name":268,"role":114},"Qingshan Li",{"lat":270,"lon":271},40.9519,117.95883,{"facility":273,"status":8,"city":274,"state":275,"country":195,"contacts":276,"geoPoint":279},"Harbin Medical University Canser Hospital","Harbin","Heilongjiang",[277],{"name":278,"role":114},"Yanqiao Zhang",{"lat":280,"lon":281},45.75,126.65,{"facility":283,"status":8,"city":284,"state":285,"country":195,"contacts":286,"geoPoint":289},"The First Affiliated Hospital of Henan University of Science & Technology","Luoyang","Henan",[287],{"name":288,"role":114},"Shegan Gao, Ruinuo Jia",{"lat":290,"lon":291},34.67345,112.43684,{"facility":293,"status":8,"city":294,"state":285,"country":195,"contacts":295,"geoPoint":298},"Henan Cancer Hospital","Zhengzhou",[296],{"name":297,"role":114},"Suxia Luo, Yanqiu Zhao",{"lat":299,"lon":300},34.75778,113.64861,{"facility":302,"status":8,"city":303,"state":304,"country":195,"contacts":305,"geoPoint":308},"Hubei Cancer Hospital","Wuhan","Hubei",[306],{"name":307,"role":114},"Xinjun Liang",{"lat":309,"lon":310},30.58333,114.26667,{"facility":312,"status":8,"city":303,"state":304,"country":195,"contacts":313,"geoPoint":316},"Tongji Hospital, Tongji Medical College of Hust",[314],{"name":315,"role":114},"Xianglin Yuan",{"lat":309,"lon":310},{"facility":318,"status":8,"city":303,"state":304,"country":195,"contacts":319,"geoPoint":322},"Union Hospital, Tongji Medical College,Huazhong University of Science and Technology",[320],{"name":321,"role":114},"Rui Meng",{"lat":309,"lon":310},{"facility":324,"status":8,"city":325,"state":326,"country":195,"contacts":327,"geoPoint":330},"Hunan Cancer Hospital","Changsha","Hunan",[328],{"name":329,"role":114},"Zhenyang Liu",{"lat":331,"lon":332},28.19874,112.97087,{"facility":334,"status":8,"city":335,"state":326,"country":195,"contacts":336,"geoPoint":339},"The Central Hospital of Yongzhou","Yongzhou",[337],{"name":338,"role":114},"Sijuan Ding",{"lat":340,"lon":341},26.42389,111.61306,{"facility":343,"status":8,"city":344,"state":345,"country":195,"contacts":346,"geoPoint":349},"The First People's Hospital of Changzhou","Changzhou","Jiangsu",[347],{"name":348,"role":114},"Jun Wu",{"lat":350,"lon":351},31.77359,119.95401,{"facility":353,"status":8,"city":354,"state":345,"country":195,"contacts":355,"geoPoint":358},"Jiangsu Province Hospital","Nanjing",[356],{"name":357,"role":114},"Yongmei Yin",{"lat":359,"lon":360},32.06167,118.77778,{"facility":362,"status":8,"city":363,"state":345,"country":195,"contacts":364,"geoPoint":367},"The Second Affiliated Hospital of Soochow University","Suzhou",[365],{"name":366,"role":114},"Zhixiang Zhuang",{"lat":368,"lon":369},31.30408,120.59538,{"facility":371,"status":8,"city":372,"state":345,"country":195,"contacts":373,"geoPoint":376},"Xuzhou Central Hospital ( Southeast University Affiliated Hopstal )","Xuzhou",[374],{"name":375,"role":114},"Liang Han",{"lat":377,"lon":378},34.20442,117.28386,{"facility":380,"status":8,"city":381,"state":382,"country":195,"contacts":383,"geoPoint":386},"First Affiliated Hospital of Gannan Medical University","Ganzhou","Jiangxi",[384],{"name":385,"role":114},"Huaqiu Shi",{"lat":387,"lon":388},25.84664,114.9326,{"facility":390,"status":8,"city":391,"state":392,"country":195,"contacts":393,"geoPoint":396},"Liaoning Cancer Hospital","Shenyang","Liaoning",[394],{"name":395,"role":114},"Jingdong Zhang",{"lat":397,"lon":398},41.79222,123.43278,{"facility":400,"status":8,"city":401,"state":402,"country":195,"contacts":403,"geoPoint":406},"Shandong Cancer Hospital","Jinan","Shandong",[404],{"name":405,"role":114},"Qi Dang, Xiaoyong Tang",{"lat":407,"lon":408},36.66833,116.99722,{"facility":410,"status":8,"city":411,"state":412,"zip":413,"country":195,"contacts":414,"geoPoint":419},"Shanghai East Hospital","Shanghai","Shanghai Municipality","200000",[415],{"name":416,"role":114,"phone":417,"email":418},"Zhou fei","86-021-38804818","story185@126.com",{"lat":420,"lon":421},31.22222,121.45806,{"facility":423,"status":8,"city":424,"state":425,"country":195,"contacts":426,"geoPoint":429},"West China Hospital of Sichuan University","Chengdu","Sichuan",[427],{"name":428,"role":114},"Yan Zhang",{"lat":430,"lon":431},30.66667,104.06667,{"facility":433,"status":8,"city":434,"state":435,"country":195,"contacts":436,"geoPoint":439},"Yunnan Cancer Hospital","Kunming","Yunnan",[437],{"name":438,"role":114},"Lin Xie",{"lat":440,"lon":441},25.03889,102.71833,{"facility":443,"status":8,"city":444,"state":445,"country":195,"contacts":446,"geoPoint":449},"Sir Run Run Shaw Hospital Zhejiang University School of Medical","Hangzhou","Zhejiang",[447],{"name":448,"role":114},"Yong Fang",{"lat":450,"lon":451},30.29365,120.16142,{"facility":453,"status":8,"city":444,"state":445,"country":195,"contacts":454,"geoPoint":457},"The First Affiliated Hospital Zhejiang University School Of Medicine",[455],{"name":456,"role":114},"Haiping Jiang, Jian Liu",{"lat":450,"lon":451},{"facility":459,"status":8,"city":460,"country":195,"contacts":461,"geoPoint":464},"ChongQing University Cancer Hospital","Chongqing",[462],{"name":463,"role":114},"Yongsheng Li",{"lat":465,"lon":466},29.56026,106.55771,[468],{"name":469,"role":114,"phone":470,"email":471},"ALK Tang","+8618502921630","xftang@allinkbio.com",[],[],[],{"nct_id":4,"conditions":476,"biomarkers":478},[477],"Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":480,"prompt_version":490},{"design":481,"status":482,"heading":483,"summary":484,"follow_up":485,"word_count":486,"commitments":487,"compensation":488,"drugs_mentioned":489},"This is an open-label study, meaning you and your doctors will know you are receiving ALK201. It will involve about 202 participants across multiple locations.","completed","A Study of ALK201 for Advanced Solid Tumors","This study is testing a new drug called ALK201 in people with advanced solid tumors. It's the first time this drug is being given to humans. Researchers want to see how safe ALK201 is, how well your body handles it (tolerability), and how it moves through your body (pharmacokinetics). They also want to see if it can shrink tumors. The study aims to find the highest safe dose and the best dose to use in future studies. You might be able to join if you are between 18 and 75 years old, have advanced solid tumors that can be measured, and are expected to live at least 3 months. The study plans to enroll 202 participants.","The primary goals of the study will be measured over approximately 36 months.",116,"ALK201 will be given through a vein (intravenously) once every three weeks. The study will last approximately 36 months to evaluate safety and tolerability.","Not stated in the trial record.",[34],"v2"]