[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04192344":3,"trial-entities:NCT04192344":248,"trial-summary:NCT04192344":252},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":46,"sex":71,"minimum_age":72,"maximum_age":15,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":96,"locations":99,"central_contacts":234,"overall_officials":243,"references":246,"see_also_links":247},"NCT04192344","ABSK021-101","A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor","A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor","RECRUITING","2026-12-31","2026-03","2026-03-19","2020-01-20","Abbisko Therapeutics Co, Ltd","INDUSTRY",null,"This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.","The study will start with a dose escalation part of single-agent ABSK021 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK021 at recommended dose of expansion (RDE) will be followed for further evaluating safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.",[19,20],"Neoplasms","Tenosynovial Giant Cell Tumor",[20,22,23],"TGCT","Solid tumors","INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},276,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","ABSK021","ABSK021 oral capsule",[34],[38,42],{"measure":39,"description":40,"timeFrame":41},"Incidence of DLTs","DLT(dose-limiting toxicity)","At the end of Cycle 1 (each cycle is 28 days)",{"measure":43,"description":44,"timeFrame":45},"Incidence and Severity of AEs","Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)","Through study completion, an average of 6 months",[47,51,54,58,62,65,68],{"measure":48,"description":49,"timeFrame":50},"PFS","Progression-Free Survival (PFS)","From date of enrollment until the date of first documented progression or death, assessed up to 12 months",{"measure":52,"description":53,"timeFrame":50},"DoR","Duration of Response (DoR)",{"measure":55,"description":56,"timeFrame":57},"DCR","Disease Control Rate (DCR)","24 weeks post-dose",{"measure":59,"description":60,"timeFrame":61},"Cmax","The peak plasma concentration of a drug after administration","Pre-dose and multiple timepoints (up to 72 hours) post-dose",{"measure":63,"description":64,"timeFrame":61},"tmax","Time to reach Cmax",{"measure":66,"description":67,"timeFrame":61},"Bioavailability","The systemically available fraction of a drug",{"measure":69,"description":70,"timeFrame":61},"Elimination half-life","The time required for the concentration of the drug to reach half of its original value","ALL","18 Years",false,{"inclusion":75,"exclusion":80,"raw_text":95},[76,77,78,79],"Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists","ECOG (electrocorticogram) performance status 0\\~1","Life expectancy ≥ 3 months","Adequate organ function and bone marrow function",[81,82,83,84,85,86,87,88,89,90,91,92,93,94],"Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)\u002FCSF-1R (colony stimulating factor 1 receptor) pathway inhibitors","Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment","Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication","Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)","Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence","Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo","Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug","Concomitant use of strong inhibitors or inducers of CYP3A4","Active central nervous system (CNS) metastases","Impaired cardiac function or clinically significant cardiac disease","Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study","Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection","Refractory\u002Funcontrolled ascites or pleural effusion","Pregnant or nursing","Inclusion Criteria:\n\n* Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists\n* ECOG (electrocorticogram) performance status 0\\~1\n* Life expectancy ≥ 3 months\n* Adequate organ function and bone marrow function\n\nFor patients with tenosynovial giant cell tumor (TGCT) :\n\n1. A diagnosis of TGCT \\[i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);\n2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;\n3. Others\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)\u002FCSF-1R (colony stimulating factor 1 receptor) pathway inhibitors\n* Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment\n* Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication\n* Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)\n* Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence\n* Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo\n* Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug\n* Concomitant use of strong inhibitors or inducers of CYP3A4\n* Active central nervous system (CNS) metastases\n* Impaired cardiac function or clinically significant cardiac disease\n* Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study\n* Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection\n* Refractory\u002Funcontrolled ascites or pleural effusion\n* Pregnant or nursing\n\nFor patients with tenosynovial giant cell tumor (TGCT) :\n\n1. Known allergy or hypersensitivity to any component of the investigational drug product\n2. For expansion part, previous treatment with CSF 1\u002FCSF 1R pathway inhibitors (not applicable for TGCT patients in US）\n3. Others",[97,98],"ADULT","OLDER_ADULT",[100,110,119,127,135,149,160,167,174,177,184,187,194,201,204,212,223],{"facility":101,"status":102,"city":103,"state":104,"zip":105,"country":106,"geoPoint":107},"Precision NextGen Oncology","ACTIVE_NOT_RECRUITING","Beverly Hills","California","90212","United States",{"lat":108,"lon":109},34.07362,-118.40036,{"facility":111,"status":112,"city":113,"state":114,"zip":115,"country":106,"geoPoint":116},"SCRI at HealthOne","COMPLETED","Denver","Colorado","80218-1238",{"lat":117,"lon":118},39.73915,-104.9847,{"facility":120,"status":112,"city":121,"state":122,"zip":123,"country":106,"geoPoint":124},"The Winship Cancer Institute of Emory University","Atlanta","Georgia","30322",{"lat":125,"lon":126},33.749,-84.38798,{"facility":128,"status":112,"city":129,"state":130,"zip":131,"country":106,"geoPoint":132},"MD Anderson Cancer Center","Houston","Texas","77030",{"lat":133,"lon":134},29.76328,-95.36327,{"facility":136,"status":8,"city":137,"state":138,"country":139,"contacts":140,"geoPoint":146},"Beijing Jishuitan Hospital","Beijing","Beijing Municipality","China",[141,144],{"name":142,"role":143},"Xiaohui Niu, MD","CONTACT",{"name":142,"role":145},"PRINCIPAL_INVESTIGATOR",{"lat":147,"lon":148},39.9075,116.39723,{"facility":150,"status":8,"city":151,"state":152,"country":139,"contacts":153,"geoPoint":157},"The First Affiliated Hospital of Sun Yat-sen University","Guangdong","Guangzhou",[154,156],{"name":155,"role":143},"Jingnan Shen, MD",{"name":155,"role":145},{"lat":158,"lon":159},42.76832,129.33635,{"facility":161,"status":112,"city":162,"state":163,"country":139,"geoPoint":164},"Hebei Medical University Third Hospital","Shijiazhuang","Hebei",{"lat":165,"lon":166},38.04139,114.47861,{"facility":168,"status":102,"city":169,"state":170,"country":139,"geoPoint":171},"Henan Cancer Hospital","Zhengzhou","Henan",{"lat":172,"lon":173},34.75778,113.64861,{"facility":175,"status":112,"city":169,"state":170,"country":139,"geoPoint":176},"The First Affiliated Hospital of Zhengzhou Universtity",{"lat":172,"lon":173},{"facility":178,"status":102,"city":179,"state":180,"country":139,"geoPoint":181},"Jiangsu Province Hospital","Nanjing","Jiangsu",{"lat":182,"lon":183},32.06167,118.77778,{"facility":185,"status":102,"city":179,"state":180,"country":139,"geoPoint":186},"Nanjing Drum Tower Hospital",{"lat":182,"lon":183},{"facility":188,"status":112,"city":189,"state":190,"country":139,"geoPoint":191},"Liaoning Cancer Hospital","Shenyang","Liaoning",{"lat":192,"lon":193},41.79222,123.43278,{"facility":195,"status":112,"city":196,"state":197,"country":139,"geoPoint":198},"Huashan Hospital of Fudan University","Shanghai","Shanghai Municipality",{"lat":199,"lon":200},31.22222,121.45806,{"facility":202,"status":112,"city":196,"state":197,"country":139,"geoPoint":203},"Shanghai Sixth People's Hospital",{"lat":199,"lon":200},{"facility":205,"status":8,"city":206,"state":207,"country":139,"contacts":208},"Xi'an Hong Hui Hospital","Xian","Shanxi",[209,211],{"name":210,"role":143},"Zhichao Tong, MD",{"name":210,"role":145},{"facility":213,"status":8,"city":214,"state":215,"country":139,"contacts":216,"geoPoint":220},"West China Hospital of Sichuan University","Chengdu","Sichuan",[217,219],{"name":218,"role":143},"Yong Zhou, MD",{"name":218,"role":145},{"lat":221,"lon":222},30.66667,104.06667,{"facility":224,"status":8,"city":225,"state":226,"country":139,"contacts":227,"geoPoint":231},"The Second Affiliated Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang",[228,230],{"name":229,"role":143},"Zhaoming Ye, MD",{"name":229,"role":145},{"lat":232,"lon":233},30.29365,120.16142,[235,239],{"name":236,"role":143,"phone":237,"email":238},"YUAN LU","+86-21-68910052","clinical@abbisko.cn",{"name":240,"role":143,"phone":241,"email":242},"Siqing Fu, MD","(713)792-4318","siqingfu@mdanderson.org",[244],{"name":240,"affiliation":245,"role":145},"M.D. Anderson Cancer Center",[],[],{"nct_id":4,"conditions":249,"biomarkers":251},[250,20],"Solid Neoplasm",[],{"nct_id":4,"found":253,"summary":254,"prompt_version":264},true,{"design":255,"status":256,"heading":257,"summary":258,"follow_up":259,"word_count":260,"commitments":261,"compensation":262,"drugs_mentioned":263},"This is an open-label study, meaning you and your doctors will know you are receiving ABSK-021. It will start with a dose escalation phase to find the safest dose, followed by an expansion phase to further evaluate safety and early anti-tumor activity.","completed","A Study of ABSK-021 for Advanced Solid Tumors and Tenosynovial Giant Cell Tumor","This study is testing a new targeted therapy called ABSK-021, given as an oral capsule, for people with advanced solid tumors or tenosynovial giant cell tumor (TGCT). It aims to find out how safe ABSK-021 is, how well your body tolerates it, and how it moves through your body. The study will also look for early signs that the treatment might shrink tumors. You may be able to join if you are 18 or older, have a solid tumor that has progressed or for which standard treatments aren't working, and meet other health requirements. The study plans to enroll up to 276 participants. The current status of the study is unclear.","Your safety will be monitored throughout the study, which is expected to last an average of 6 months.",111,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]