[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601818":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":21,"locations":26,"responsibleParty":43,"collaborators":21,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":21,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":21,"enrollmentInfo":54,"targetDuration":21,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":29,"whyStopped":21,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Hansoh BioMedical R&D Company","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-20093+HRS-5041","EXPERIMENTAL","Participants will receive HS-20093 at RP2D and HRS-5041 at Dose1 or Dose2.",[13,14],"Drug: HS-20093","Drug: HRS-5041",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","HS-20093","Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"HRS-5041","HRS-5041 was given oral administration, QD, at a 21-day cycle.",[9],[27],{"facility":28,"status":29,"city":30,"state":21,"zip":21,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":34,"coordinates":35},"Point",[36,37],121.45806,31.22222,{"lat":37,"lon":36},[40],{"name":28,"role":41,"phone":42,"phoneExt":21,"email":21},"CONTACT","021-34778299",{"type":44,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100601818","phase-1-phase-ib-study-of-hs-20093hrs-5041-in-patients-with-advanced-prostate-cancer-100601818",false,"NCT07115446","Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer","A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Men greater than or equal to 18 years.\n* Voluntarily to participate, Signed and dated Informed Consent Form.\n* Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard treatment).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1.\n* Estimated life expectancy ≥ 12 weeks.\n* Men should use adequate contraceptive measures throughout the study, up to 3 months after the last dose of HRS-5041 or 4.5 months after the last dose of HS-20093 (whichever is later).\n\nExclusion Criteria:\n\n* Treatment with any of the following:\n\n  a. Previous or current treatment with B7-H3 targeted therapy. b. Previous treatment with AR PROTAC. c. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 21 days prior to the first scheduled dose of HS-20093+HRS-5041. d. brain metastases.\n* Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ dysfunction.\n* Severe, uncontrolled or active cardiovascular diseases.\n* Severe or uncontrolled diabetes.\n* The presence of active infectious diseases.\n* Any known or suspected interstitial lung disease.\n* History of serious neuropathy or mental disorders.\n* History of severe hypersensitivity reaction, severe infusion reaction.\n* Hypersensitivity to any ingredient of HS-20093.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.","MALE","18 Years",{"count":55,"type":56},63,"ESTIMATED","INTERVENTIONAL",[59],"PHASE1","HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors.\n\nThis is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.",[62],"Advanced Prostate Cancer",[64,65,18],"Advanced prostate cancer","B7H3","2025-11-28",{"date":68,"type":69},"2025-12-05","ACTUAL",{"date":71,"type":69},"2025-08-19",{"date":73,"type":56},"2028-12",{"name":5,"class":6},1]