[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-solid-tumors-harboring-kras-g12c-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-solid-tumors-harboring-kras-g12c-mutation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"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":19,"type":20},126,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27],"Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation","NOT_YET_RECRUITING","2024-07-03",{"date":31,"type":32},"2024-07-08","ACTUAL",{"date":34,"type":20},"2024-07-01",{"date":36,"type":20},"2027-12-31",{"name":38,"class":39},"Suzhou Genhouse Bio Co., Ltd.","OTHER"]