[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635862":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":50,"centralContacts":51,"locations":61,"responsibleParty":78,"collaborators":50,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":50,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":50,"enrollmentInfo":89,"targetDuration":50,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":106,"whyStopped":50,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm1：Part Ia Dose Escalation","EXPERIMENTAL","Participants with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determined dose-escalation cohorts or at intermediate dose levels every 2 weeks",[13],"Biological: Intervention1：FXB0871",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm2：Part Ib Dose Expansion (NSCLC, RP2D)","Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks",[18],"Biological: Intervention2：FXB0871",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm3：Part Ib Dose Expansion(NSCLC, \u003CRP2D)","Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at a selected lower dose than RP2D from Phase Ia by intravenous infusion every 2 weeks",[23],"Biological: Intervention3：FXB0871",{"label":25,"type":10,"description":26,"interventionNames":27},"Arm4：Part Ib Dose Expansion(HCC, RP2D)","Participants with locally advanced or metastatic IO-resistant HCC will receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks",[28],"Biological: Intervention4：FXB0871",[30,37,42,46],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BIOLOGICAL","Intervention1：FXB0871","FXB0871 is administered by intravenous infusion at pre-determined dose level in Part Ia every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.",[9],[36],"TEV-56278",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Intervention2：FXB0871","FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.",[15],[36],{"type":31,"name":43,"description":39,"armGroupLabels":44,"otherNames":45},"Intervention3：FXB0871",[20],[36],{"type":31,"name":47,"description":39,"armGroupLabels":48,"otherNames":49},"Intervention4：FXB0871",[25],[36],null,[52,57],{"name":53,"role":54,"phone":55,"phoneExt":50,"email":56},"Caicun Zhou","CONTACT","+86 13301825532","caicunzhoudr@163.com",{"name":58,"role":54,"phone":59,"phoneExt":50,"email":60},"Fei Zhou","+86 13801751704","story185@126.com",[62],{"facility":63,"status":50,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Shanghai East Hospital","Shanghai","Shanghai Municipality","200000","China","CN",{"type":70,"coordinates":71},"Point",[72,73],121.45806,31.22222,{"lat":73,"lon":72},[76,77],{"name":53,"role":54,"phone":55,"phoneExt":50,"email":56},{"name":58,"role":54,"phone":59,"phoneExt":50,"email":60},{"type":79,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100635862","phase-1-phase-iaib-study-of-fxb0871-monotherapy-in-locally-advancedmetastatic-solid-tumors-100635862",false,"NCT07558200","Phase Ia\u002FIb Study of FXB0871 Monotherapy in Locally Advanced\u002FMetastatic Solid Tumors","A Phase 1a\u002F1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety, Anti-tumor Activity, Pharmacokinetic\u002FPharmacodynamic Characteristics of FXB0871 as Monotherapy in Participants With Selected Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Signed informed consent.\n* Age ≥18 years.\n* Histologically confirmed selected locally advanced or metastatic solid tumor with progression on, intolerance to, or no suitable standard therapy.\n* ECOG performance status 0 or 1.\n* At least one measurable lesion per RECIST v1.1.\n* Pretreatment tumor tissue available (archival or fresh biopsy).\n* Life expectancy ≥12 weeks.\n* Oxygen saturation ≥92% on room air.\n* Left ventricular ejection fraction \\>50%.\n* Adequate hematologic, coagulation, renal, hepatic, and cardiac function.\n* Women of childbearing potential and sexually active men must use highly effective contraception.\n* Tumor-specific eligibility applies, including prior anti-PD-(L)1 treatment failure for the selected cohorts.\n\nKey Exclusion Criteria:\n\n* Systemic anti-cancer therapy, major surgery, or radical radiotherapy within 4 weeks before first dose.\n* Prior treatment with IL-2, IL-15, or IL-7.\n* Active autoimmune disease requiring systemic treatment or immunodeficiency.\n* Systemic corticosteroids (≥10 mg\u002Fday prednisone equivalent) or other immunosuppressive therapy within 28 days before first dose, with limited protocol-defined exceptions.\n* Active or untreated central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.\n* Uncontrolled infection or clinically significant unresolved toxicities from prior therapy.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease, uncontrolled effusions\u002Fascites, uncontrolled hypertension, or QTcF \\>470 ms.\n* Active hepatitis B\u002FC, syphilis, or HIV infection.\n* Clinically significant interstitial lung disease or active noninfectious pneumonitis.\n* Pregnancy or breastfeeding.\n* Any other serious medical or psychiatric condition that, in the investigator's judgment, would make participation inappropriate.","ALL","18 Years",{"count":90,"type":91},138,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","This is a phase 1a\u002F1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with selected locally advanced or metastatic solid tumors. In Part Ia, participants with selected solid tumors that have progressed after, are intolerant to, or are not suitable for standard therapy will receive FXB0871 in dose-escalation cohorts to determine the maximum tolerated dose and\u002For recommended phase 2 dose. In Part Ib, participants with PD-(L)1-resistant non-small cell lung cancer or hepatocellular carcinoma will receive FXB0871 in dose-expansion cohorts to further evaluate antitumor activity, safety, and dose optimization.",[97,98,99],"Solid Tumors","Non-Small Cell Lung Cancer","Hepatocellular Carcinoma",[101,36,102,103,104,105],"FXB0871","PD-1","IL-2","Dose Escalation","Dose Expansion","NOT_YET_RECRUITING","2026-04-23",{"date":109,"type":110},"2026-04-30","ACTUAL",{"date":112,"type":91},"2026-05-15",{"date":114,"type":91},"2030-11-18",{"name":5,"class":6},1]