[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605565":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":248,"collaborators":20,"id":250,"slug":251,"hasResults":252,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":20,"eligibilityCriteria":256,"healthyVolunteers":252,"sex":257,"minAge":258,"maxAge":20,"enrollmentInfo":259,"targetDuration":20,"studyType":262,"phases":263,"briefSummary":265,"conditions":266,"keywords":20,"overallStatus":48,"whyStopped":20,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},{"fullName":5,"class":6},"Abbisko Therapeutics Co, Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: ABSK043 in combination with Glecirasib","EXPERIMENTAL","This is an open-label phase 2 study with an escalation part and an expansion part.\n\n• Escalation Part: up to 50 previously treated patients with KRASG12C mutation. Does Escalation Cohort(Part A): up to 30previously treated patients with KRASG12C mutation.\n\nDose Confirmation Cohort(Part B): up to 20previously treated patients with KRASG12C mutation.\n\n• Expansion Part: up to 36 treatment-naïve patients with KRASG12C mutation.",[13],"Drug: ABSK043 in combination with Glecirasib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ABSK043 in combination with Glecirasib","Dose escalation cohort( Part A) ABSK043 150 mg BID in combination with Glecirasib 200 mg QD will be selected as the starting dose.\n\nBased on the accumulated safety data and PK profile, the Safety Review Committee (SRC), composed of the investigator and the sponsor, may discuss and agree to allow exploration of other possible doses.\n\nDose confirmation cohort (Part B) and Expansion cohort Patients in dose confirmation cohort and expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity.\n\nAll patients will continue to receive combination therapy every 21 days until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator decision to discontinue treatment, or end of the study.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yinan Lin","CONTACT","+86-21-68910052","clinical@abbisko.cn",[28,46,60,69,82,96,109,122,135,148,161,174,187,200,213,222,235],{"facility":29,"status":30,"city":31,"state":32,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The First Affiliated Hospital of Anhui Medical University","NOT_YET_RECRUITING","Hefei","Anhui","China","CN",{"type":36,"coordinates":37},"Point",[38,39],117.28083,31.86389,{"lat":39,"lon":38},[42,44],{"name":43,"role":24,"phone":20,"phoneExt":20,"email":20},"Yiruo Zhang",{"name":43,"role":45,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":47,"status":48,"city":49,"state":50,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality",{"type":36,"coordinates":52},[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57,59],{"name":58,"role":24,"phone":20,"phoneExt":20,"email":20},"Jian Fang",{"name":58,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":61,"status":30,"city":49,"state":50,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Cancer Hospital Chinese Academy of Medical Sciences",{"type":36,"coordinates":63},[53,54],{"lat":54,"lon":53},[66,68],{"name":67,"role":24,"phone":20,"phoneExt":20,"email":20},"Jianchun 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Shang",{"name":120,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":123,"status":30,"city":124,"state":125,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":36,"coordinates":127},[128,129],113.64861,34.75778,{"lat":129,"lon":128},[132,134],{"name":133,"role":24,"phone":20,"phoneExt":20,"email":20},"Qiming Wang",{"name":133,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":136,"status":30,"city":137,"state":138,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Tongji Hospital Tongji Medical College of Hust","Wuhan","Hubei",{"type":36,"coordinates":140},[141,142],114.26667,30.58333,{"lat":142,"lon":141},[145,147],{"name":146,"role":24,"phone":20,"phoneExt":20,"email":20},"Qian Chu",{"name":146,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":149,"status":48,"city":150,"state":151,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Hunan Cancer Hospitial","Changsha","Hunan",{"type":36,"coordinates":153},[154,155],112.97087,28.19874,{"lat":155,"lon":154},[158,160],{"name":159,"role":24,"phone":20,"phoneExt":20,"email":20},"Yongchang Zhang",{"name":159,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":162,"status":48,"city":163,"state":164,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Zhongda Hospital Southeast University","Nanjing","Jiangsu",{"type":36,"coordinates":166},[167,168],118.77778,32.06167,{"lat":168,"lon":167},[171,173],{"name":172,"role":24,"phone":20,"phoneExt":20,"email":20},"Shuhua 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Sun",{"name":198,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":201,"status":48,"city":202,"state":203,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Shanghai Chest Hospital","Shanghai","Shanghai Municipality",{"type":36,"coordinates":205},[206,207],121.45806,31.22222,{"lat":207,"lon":206},[210,212],{"name":211,"role":24,"phone":20,"phoneExt":20,"email":20},"Shun Lu",{"name":211,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":214,"status":48,"city":202,"state":203,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":215,"geoPoint":217,"contacts":218},"Shanghai Pulmonary Hospital",{"type":36,"coordinates":216},[206,207],{"lat":207,"lon":206},[219,221],{"name":220,"role":24,"phone":20,"phoneExt":20,"email":20},"Chunxia Su",{"name":220,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":223,"status":30,"city":224,"state":225,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi’an","Shanxi",{"type":36,"coordinates":227},[228,229],113.52486,35.99785,{"lat":229,"lon":228},[232,234],{"name":233,"role":24,"phone":20,"phoneExt":20,"email":20},"Yu Yao",{"name":233,"role":45,"phone":20,"phoneExt":20,"email":20},{"facility":236,"status":48,"city":237,"state":238,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"West China Hospital Sichuan University","Chengdu","Sichuan",{"type":36,"coordinates":240},[241,242],104.06667,30.66667,{"lat":242,"lon":241},[245,247],{"name":246,"role":24,"phone":20,"phoneExt":20,"email":20},"Guowei Che",{"name":246,"role":45,"phone":20,"phoneExt":20,"email":20},{"type":249,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100605565","phase-2-a-phase-2-clinical-study-of-combination-therapy-with-absk043-and-glecirasib-100605565",false,"NCT07164170","A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib","An Open-label Phase II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ABSK043 in Combination With Glecirasib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring a KRAS G12C Mutation","Inclusion Criteria:\n\n1. Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form.\n2. Gender was not limited patients aged ≥18 years at the time of signing the informed consent.\n3. Histologically or cytologically confirmed locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC).\n\n   For patients in the dose-escalation cohort (Part A) of the escalation part:\n\n   Patients must have experienced disease progression following at least one line of prior standard systemic therapy, but no more than two lines of systemic therapy.\n\n   For patients in the dose confirmation cohort (Part B) of the escalation part :\n   1. Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A);\n   2. Documented or central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .\n\n   For patients in the expansion cohort of the expansion part :\n   1. Patients who have not received prior systemic therapy for locally advanced or unresectable\u002Fmetastatic disease;\n   2. Central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .\n4. Tumor tissue or blood test report confirmed KRASG12C mutation.\n5. Patients must have at least one measurable lesion as defined by RECIST v1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0\\~1.\n7. Expected survival time of ≥3 months.\n8. Patients must have adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components.\n2. Toxicities from prior antitumor therapy have not returned to baseline or stabilized.\n3. Patients with active brain metastases.\n4. The patient currently has active interstitial lung disease.\n5. Patients currently have active autoimmune disease or a history of autoimmune disease that may be at risk for recurrence.\n6. Any condition requiring systemic treatment with corticosteroids.\n7. Uncontrolled or significant cardiovascular disease.\n8. Has a known human immunodeficiency virus (HIV) infection that is not well controlled.\n9. Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study","ALL","18 Years",{"count":260,"type":261},86,"ESTIMATED","INTERVENTIONAL",[264],"PHASE2","This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.",[267],"Non-Small Cell Lung Cancer","2026-06-16",{"date":270,"type":271},"2026-06-17","ACTUAL",{"date":273,"type":271},"2025-09-22",{"date":275,"type":261},"2029-07-30",{"name":5,"class":6},17]