[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643466":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":36,"interventions":42,"overallOfficials":29,"centralContacts":48,"locations":29,"responsibleParty":54,"collaborators":29,"id":56,"slug":29,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":29,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":29,"enrollmentInfo":64,"targetDuration":29,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":29,"overallStatus":73,"whyStopped":29,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":29},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":29},[9,13,16,20,23,27],{"measure":10,"description":11,"timeFrame":12},"Maximum tolerated dose (MTD) (Phase Ia)","Maximum tolerated dose is defined as the previous dose level at which 2 or more out of 2-6 participants experienced a dose-limited toxicity (DLT).","From first dose of study treatment until the end of Cycle 1 (21 days)",{"measure":14,"description":15,"timeFrame":12},"Maximum administered dose (MAD)(Phase Ia)","MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.",{"measure":17,"description":18,"timeFrame":19},"recommended phase II dose (RP2D)","The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ia study.","Through phase Ia completion, approximately 1 year.",{"measure":21,"description":22,"timeFrame":19},"The incidence and severity of adverse events (AE) (Phase Ib)","Incidence and severity of adverse events (AEs) evaluated according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCA) Version 6.0 (v6.0) and American Society for Transplantation and Cellular Therapy (ASTCT)",{"measure":24,"description":25,"timeFrame":26},"PSA50 response (Phase Ib)","Best response until progression, as defined by Response Evaluation Criteria in Solid Tumors （RECIST） version (v1.1) and Prostate Cancer Clinical Trials Working Group 3 (PCGW3).","From Screening to confirmed progressive disease (approximately 1 year)",{"measure":28,"description":29,"timeFrame":26},"Objective response rate (ORR) (phase Ib)",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"NA","SINGLE_GROUP","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE",[37],{"label":38,"type":39,"description":29,"interventionNames":40},"QLF4113 dose escalation arm","EXPERIMENTAL",[41],"Drug: QLF4113 for injection",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":29},"DRUG","QLF4113 for injection","A PSMA\u002FCD3\u002FCD2 antibody",[38],[49],{"name":50,"role":51,"phone":52,"phoneExt":29,"email":53},"Jun Guo, Doctor","CONTACT","0086-10- 88121122","guoj307@126.com",{"type":55,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","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":65,"type":66},140,"ESTIMATED","INTERVENTIONAL",[69],"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.",[72],"Prostate Cancer","NOT_YET_RECRUITING","2026-06-04",{"date":76,"type":77},"2026-06-09","ACTUAL",{"date":79,"type":66},"2026-07-20",{"date":81,"type":66},"2028-12-05",{"name":5,"class":6}]