[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643466":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":11,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"QLF4113 dose escalation arm","EXPERIMENTAL",null,[13],"Drug: QLF4113 for injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","QLF4113 for injection","A PSMA\u002FCD3\u002FCD2 antibody",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Jun Guo, Doctor","CONTACT","0086-10- 88121122","guoj307@126.com",{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100643466","phase-1-qlf4113-in-participants-with-metastatic-prostate-cancer-100643466",false,"NCT07636707","QLF4113 in Participants With Metastatic Prostate Cancer","An Open-label, Multicenter Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLF4113 for Injection in Participants With Metastatic Prostate Cancer.","Inclusion Criteria:\n\n* Participants voluntarily agree to participate and sign the informed consent form.\n* Male, aged ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Life expectancy ≥ 3 months.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine carcinoma or small cell carcinoma features.\n* Confirmed metastatic Castration-Resistant Prostate Cancer (mCRPC).\n* Failed or are intolerant to standard therapies\n* Adequate function of major organs as defined by the protocol.\n* Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).\n* Prior to the first use of the investigational drug, recovery from all reversible adverse events (AEs) related to prior anticancer treatments\n\nExclusion Criteria:\n\n* Previously treated with drugs targeting CD3 or CD2.\n* Significant Cardiovascular Diseases\n* Active, Uncontrolled Infections\n* Immunosuppressive Treatment before the first dose of the investigational drug\n* Clinically Uncontrolled Third-Space Fluid Accumulation\n* History of Other Malignancies within 5 years prior to the first dose of the investigational drug\n* Moderate to Severe Pulmonary Diseases significantly affecting lung function,\n* Current Hepatic Encephalopathy, Hepatorenal Syndrome, or Cirrhosis classified as Child-Pugh B or worse.\n* Allergy to the Investigational Drug or its Components.\n* Any Condition deemed by the investigator to increase study-related risks, interfere with the interpretation of study results, or otherwise render the participant unsuitable for inclusion.","MALE","18 Years",{"count":38,"type":39},140,"ESTIMATED","INTERVENTIONAL",[42],"PHASE1","This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in participants with metastatic prostate cancer.\n\nThe Phase I trial consists of two parts: Phase Ia and Phase Ib. Phase Ia is a dose-escalation study of QLF4113 monotherapy to determine the recommended phase two dose and assess safety and PK. Then the study will proceed to Phase Ib, a dose-expansion study to further evaluate the preliminary efficacy and safety of QLF4113 monotherapy under the selected doses.",[45],"Prostate Cancer","NOT_YET_RECRUITING","2026-06-04",{"date":49,"type":50},"2026-06-09","ACTUAL",{"date":52,"type":39},"2026-07-20",{"date":54,"type":39},"2028-12-05",{"name":5,"class":6}]