[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659903":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":38,"interventions":45,"overallOfficials":31,"centralContacts":50,"locations":31,"responsibleParty":56,"collaborators":31,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":31,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":31,"enrollmentInfo":67,"targetDuration":31,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":31,"overallStatus":76,"whyStopped":31,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":31},{"fullName":5,"class":6},"Shanghai Qilu Pharmaceutical Research and Development Center LTD","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":31},[9,13,16,20,24,28],{"measure":10,"description":11,"timeFrame":12},"Maximum tolerated dose (MTD) (Phase Ia)","MTD is determined based on the incidence of protocol-defined DLT during the first treatment cycle. Using the 3+3 dose-escalation design, MTD is defined as the highest dose level at which fewer than a predefined proportion of subjects experience DLT, while the next higher dose level exceeds the DLT threshold","From first dose of study treatment until the end of Cycle 1（each cycle is 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) (Phase Ia)","The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ib study.","Through phase Ia completion, an average of 1 year",{"measure":21,"description":22,"timeFrame":23},"The incidence and severity of adverse events (AE) (Phase Ia)","Incidence and severity of adverse events (AEs) evaluated according to the NCI-CTCAE v5.0","Through phase Ib completion, an average of 1 year",{"measure":25,"description":26,"timeFrame":27},"Prostate-specific antigen (PSA) 50% response (PSA50 response)","Proportion of subjects with ≥ 50% PSA decrease","From Screening to confirmed progressive disease (approximately 1 year)",{"measure":29,"description":30,"timeFrame":27},"Objective response rate (ORR) (phase Ib)","Best response until progression, as defined by RECIST 1.1 and PCGW3",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"QLS2401","EXPERIMENTAL","Once-Weekly administration; each 3-week period constitutes one treatment cycle (this may be adjusted based on preliminary study results)",[44],"Drug: QLS2401",[46],{"type":47,"name":40,"description":48,"armGroupLabels":49,"otherNames":31},"DRUG","Participants will receive QLS2401 via intravenous (IV) or subcutaneous injection",[40],[51],{"name":52,"role":53,"phone":54,"phoneExt":31,"email":55},"Jinming Yu, Doctor","CONTACT","13806406293","sdyujinming@126.com",{"type":57,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100659903","phase-1-a-study-of-qls2401-injection-in-participants-with-advanced-prostate-cancer-100659903",false,"NCT07869888","A Study of QLS2401 Injection in Participants With Advanced Prostate Cancer","An Open-label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLS2401 Injection in Participants With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Study participants enrolled voluntarily and signed an informed consent form. Male participants aged ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Expected survival time of at least 3 months.\n* Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell carcinoma features.\n* Metastatic prostate cancer confirmed by imaging.\n* Belong to mCRPC.\n* Stage Ia participants with mCRPC who have failed or are intolerant to standard treatment.\n* Stage I participants with mCRPC who have failed or are intolerant to standard treatment.\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 administration of the test drug, recover from all reversible adverse events (AEs) experienced during prior anticancer therapy.\n\nExclusion Criteria:\n\n1. Patients who have previously received any of the following treatments are eligible:\n\n   Patients who have previously received targeted therapies targeting PSMA or STEAP1; for Stage Ia and Stage Ib Cohort 1, prior treatment with PSMA-targeted radionuclide ligand therapy (RLT) is permitted.\n\n   Patients who have previously received T-cell conjugate (TCE)-based therapies; Subjects who have received other systemic small-molecule anticancer therapy within 2 weeks prior to the first dose of the investigational product, or macromolecular antitumor therapy within 28 days prior to the first dose of the investigational product, will be excluded, except for medications used to maintain castration status.\n\n   Patients who have received traditional Chinese medicine for antineoplastic indications within 2 weeks prior to the first administration of the investigational drug; e) Patients currently receiving treatment with any drug known to prolong the QT interval or may precipitate torsades de pointes ventricular tachycardia, or who have received such drugs prior to the first administration without having reached the corresponding washout period.\n2. Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or metastatic spinal cord compression requiring hormonal therapy (at doses exceeding the physiological substitution dose) prior to the first administration of the investigational drug;\n3. Receipt of radiotherapy involving irradiation of more than 25% of the bone marrow within 4 weeks prior to the first administration of the investigational drug; or receipt of localized radiotherapy (excluding cranial radiotherapy) within 2 weeks prior to the first administration of the investigational drug;\n4. Receipt of treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational drug (sufficient wound healing following major surgery must be clinically assessed); or planned bilateral orchiectomy during the study treatment period;\n5. History of epilepsy or occurrence of any condition that could trigger epileptic seizures within 12 months prior to the first administration of the investigational drug;\n6. Study participants with a history of psychotropic medication abuse, alcohol use disorder, or substance use disorder; or those with a documented history of neurological or psychiatric disorders that may contribute to poor treatment adherence.\n7. Has clinically significant cardiovascular or cerebrovascular disease.\n8. Administer a live attenuated vaccine within 4 weeks prior to the first dose of the investigational drug; or if administration of a live attenuated vaccine is anticipated during the study period.\n9. Pre-existing clinically uncontrolled third-space effusion prior to initial administration of the test drug.\n10. Previous history of hypertensive crisis or hypertensive encephalopathy.\n11. According to the investigator's judgment, the participant may pose an increased risk related to the study, potentially interfere with the interpretation of study results, or be deemed unsuitable for enrollment by the investigator.","MALE","18 Years",{"count":68,"type":69},252,"ESTIMATED","INTERVENTIONAL",[72],"PHASE1","This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLS2401 as monotherapy in patients with advanced prostate cancer.\n\nThe Phase I trial is divided into Phase Ia and Phase Ib components. The Phase Ia component involves a dose-escalation study of QLS2401 as monotherapy; should the results from the Phase Ia study meet the predefined criteria, a Phase Ib efficacy-expansion study of QLS2401 as monotherapy will be conducted.",[75],"Advanced Prostate Cancer","NOT_YET_RECRUITING","2026-10-07",{"date":79,"type":80},"2026-10-13","ACTUAL",{"date":82,"type":69},"2026-11-06",{"date":84,"type":69},"2029-03-30",{"name":5,"class":6}]