[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648331":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HW221043 Tablets Group","EXPERIMENTAL",null,[13],"Drug: HW221043 Tablets",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","HW221043 Tablets","HW221043 Tablets for oral administration at specified doses on scheduled days.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Lifei Liu","CONTACT","+86-27-87173753","liulifei@renfu.com.cn",[27],{"facility":28,"status":11,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},[41,46],{"name":42,"role":23,"phone":43,"phoneExt":44,"email":45},"Xiaohua Wu, Doctorate","+86-21-64175590","81000","wu.xh@fudan.edu.cn",{"name":47,"role":23,"phone":48,"phoneExt":11,"email":49},"Jian Zhang, Doctorate","+8618017312991","syner2000@163.com",{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100648331","phase-1-a-phase-iaib-study-of-hw221043-in-participants-with-advanced-solid-tumors-100648331",false,"NCT07719920","A Phase Ia\u002FIb Study of HW221043 in Participants With Advanced Solid Tumors","A Phase I Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HW221043 Tablets in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Men or women ≥18 years old.\n* Histologically and\u002For cytologically confirmed recurrent or metastatic advanced solid tumors.\n* Absence of available standard therapy, failure of standard therapy, or ineligibility for standard therapy.\n* Survival expectation is ≥12 weeks.\n* Adequate major organ function at screening; no blood transfusion or hematopoietic growth factor administration within 14 days prior to screening; and no significant abnormalities in hematology, coagulation profiles, or blood chemistry.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Presence of at least one measurable target lesion as defined by RECIST 1.1\n* Participants are willing to provide tumor tissue samples.\n* Participants of childbearing potential must be non-pregnant at screening. Male and female of childbearing potential must agree to use effective methods of contraception throughout the study.\n* Participants must have demonstrated a full understanding of the study, voluntarily signed the informed consent form (ICF), and be willing and able to comply with all study procedures and required follow-up visits.\n\nExclusion Criteria:\n\n* Allergic to HW221043 Tablet or its components.\n* Has a treatment history of KIF18A inhibitor.\n* Known presence of a recognizable hypermutated phenotype.\n* Prior receipt of any unapproved investigational drug or therapy within 28 days before first dose.\n* Inadequate washout from prior antitumor therapy.\n* Use of any medication that may interfere with the safety conduct of the study within 14 days prior to the first dose (or within at least 5 half-lives of the agent, whichever is longer), or planned use of such medications during the study period.\n* Continuous use of systemic corticosteroids within 4 weeks prior to the first dose.\n* Live vaccination within 28 days prior to first dose or anticipated during the study.\n* Major surgery within 28 days prior to the first dose of the investigational product.\n* Major surgical procedure within 28 days prior to first dose.\n* History of another active malignancy within 3 years prior to initiation of the investigational product.\n* ≥ Grade 2 prior antitumor therapy-related toxicity per CTCAE v6.0 (except abnormalities deemed clinically insignificant).\n* Tumor invasion into adjacent vital organs, major vessels, or central nervous system (CNS), or evidence of progressive brain metastases.\n* Presence of severe underlying pulmonary disease, severe cardiac\u002Fcerebrovascular disease, or clinically significant QTc prolongation.\n* Presence of an active infectious disease.\n* Diagnosis of an autoimmune disease or presence of an immunodeficient state.\n* Inability to swallow oral medications, or uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal dysfunction likely to affect drug absorption.\n* History of alcohol abuse or substance abuse.\n* Women who are pregnant, breastfeeding, or planning to become pregnant\u002F breastfeeding during the study.\n* Any condition that, in the judgment of the Investigator, would make the participant unsuitable for enrollment.","ALL","18 Years",{"count":62,"type":63},99,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","This is a Phase Ia\u002FIb, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HW221043 tablets in participants with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).",[69],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-07-17",{"date":73,"type":74},"2026-07-22","ACTUAL",{"date":76,"type":63},"2026-07-30",{"date":78,"type":63},"2029-12-31",{"name":5,"class":6},1]