[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648331":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":15,"studyPopulation":15,"armGroups":36,"interventions":42,"overallOfficials":15,"centralContacts":48,"locations":54,"responsibleParty":79,"collaborators":15,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":15,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":15,"enrollmentInfo":90,"targetDuration":15,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":15,"overallStatus":57,"whyStopped":15,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"Adverse Events (AE) or Serious Adverse Events (SAE)","Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE 6.0.","2 years",{"measure":14,"description":15,"timeFrame":12},"Dose Limited Toxicity (DLT)",null,[17,20,22,25,28],{"measure":18,"description":19,"timeFrame":12},"Maximum Plasma Concentration (Cmax)","Highest Plasma Concentration of HW221043",{"measure":21,"description":15,"timeFrame":12},"Area Under the Concentration-Time Curve (AUC)",{"measure":23,"description":24,"timeFrame":12},"Tmax","Time to Achieve Cmax",{"measure":26,"description":15,"timeFrame":27},"Objective Response Rate (ORR)","2 years to 3 years",{"measure":29,"description":15,"timeFrame":27},"Progression-Free Survival (PFS)",{"allocation":31,"interventionModel":32,"interventionModelDescription":15,"primaryPurpose":33,"observationalModel":15,"timePerspective":15,"maskingInfo":34},"NA","SINGLE_GROUP","TREATMENT",{"masking":35,"maskingDescription":15,"whoMasked":15},"NONE",[37],{"label":38,"type":39,"description":15,"interventionNames":40},"HW221043 Tablets Group","EXPERIMENTAL",[41],"Drug: HW221043 Tablets",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":15},"DRUG","HW221043 Tablets","HW221043 Tablets for oral administration at specified doses on scheduled days.",[38],[49],{"name":50,"role":51,"phone":52,"phoneExt":15,"email":53},"Lifei Liu","CONTACT","+86-27-87173753","liulifei@renfu.com.cn",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":64,"coordinates":65},"Point",[66,67],121.45806,31.22222,{"lat":67,"lon":66},[70,75],{"name":71,"role":51,"phone":72,"phoneExt":73,"email":74},"Xiaohua Wu, Doctorate","+86-21-64175590","81000","wu.xh@fudan.edu.cn",{"name":76,"role":51,"phone":77,"phoneExt":15,"email":78},"Jian Zhang, Doctorate","+8618017312991","syner2000@163.com",{"type":80,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"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":91,"type":92},99,"ESTIMATED","INTERVENTIONAL",[95],"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).",[98],"Advanced Solid Tumors","2026-09-10",{"date":101,"type":102},"2026-09-11","ACTUAL",{"date":99,"type":102},{"date":105,"type":92},"2029-12-31",{"name":5,"class":6},1]