[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549548":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":21,"responsibleParty":36,"collaborators":38,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":21,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":21,"enrollmentInfo":50,"targetDuration":21,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":21,"overallStatus":60,"whyStopped":21,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":21},{"fullName":5,"class":6},"Suzhou Genhouse Bio Co., Ltd.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"\"GH21 + D-1553\" Group","EXPERIMENTAL","GH21 capsules combined with D-1553 tablets were administrated orally",[13,14],"Drug: GH21","Drug: D-1553",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","GH21","GH21 Capsules, Oral Drug Specification: 3mg\u002Fcapsule; 10mg\u002Fcapsule",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"D-1553","D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg\u002Ftablet",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Jieqi Tang, bachelor","CONTACT","+8613311557758","tangjieqi@genhousebio.com",{"name":33,"role":29,"phone":34,"phoneExt":21,"email":35},"Zhengbo Song, Doctorate","+8613857153345","zjccgcp_phase1@126.com",{"type":37,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[39],{"name":40,"class":6},"Zhejiang Cancer Hospital","100549548","phase-1-gh21-combined-with-d-1553-in-kras-g12c-mutant-advanced-solid-tumors-100549548",false,"NCT06435455","GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors","A Phase Ib\u002FII Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GH21 Capsule Combined With D-1553 Tablets in Patients With Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation","Inclusion Criteria:\n\n* The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);\n* Age ≥18 years old, male or female;\n* KRAS G12C mutant advanced solid tumor;\n* ECOG Performance Status of 0 or 1\n* At least one measurable lesion as defined by RECIST 1.1\n\nExclusion Criteria:\n\n* acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%;\n* Patients who have a history of severe allergy, or have a history of allergy to the experimental drug\u002Fany excipient\u002Fcombination drug, or have a history of allergy to multiple drugs;\n* There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;\n* Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and\u002For other grade ≤2 adverse events that do not pose a safety risk);\n* Pregnant and lactating women;\n* The investigator considers that there are any clinical or laboratory abnormalities or other reasons to be unsuitable for participating in this clinical study.","ALL","18 Years",{"count":51,"type":52},126,"ESTIMATED","INTERVENTIONAL",[55,56],"PHASE1","PHASE2","This s a multi-center, open-label phase Ib\u002FII study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.",[59],"Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation","NOT_YET_RECRUITING","2024-07-03",{"date":63,"type":64},"2024-07-08","ACTUAL",{"date":66,"type":52},"2024-07-01",{"date":68,"type":52},"2027-12-31",{"name":5,"class":6}]