[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620789":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"LaNova Medicines Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LM-108 in combination with Toripalimab","EXPERIMENTAL",null,[13],"Drug: LM-108 in combination with Toripalimab",{"label":15,"type":16,"description":11,"interventionNames":17},"Paclitaxel injection intravenous infusion","ACTIVE_COMPARATOR",[18],"Drug: Paclitaxel injection intravenous infusion",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Paclitaxel injection administered at a dose of 80 mg\u002Fm² on Day 1, 8, and 15 every 4 weeks",[15],[28],{"name":29,"affiliation":30,"role":31},"Lin Shen","Peking University Cancer Hospital & Institute","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Mengmeng Liu","CONTACT","+86 13918118040","mengmengliu@lanovamed.com",{"name":39,"role":35,"phone":40,"phoneExt":11,"email":41},"Paul Kong","+86 13564682439","paulkong@lanovamed.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":29,"role":35,"phone":40,"phoneExt":11,"email":58},"linshenpku@163.com",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100620789","phase-3-lm-108-in-combination-with-toripalimab-versus-paclitaxel-injection-for-the-treatment-of-subjects-with-ccr8-positive-gastric-and-gastroesophageal-junction-adenocarcinoma-100620789",false,"NCT07362186","LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma","A Phase III, Open-Label, Multicenter, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of LM-108 in Combination With Toripalimab Versus Paclitaxel Injection as Second-Line Therapy for CCR8-Positive Locally Advanced or Metastatic Gastric Cancer\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Individuals who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Age 18 years or older, male or female.\n3. Weight ≥ 40 kg or Body Mass Index (BMI)≥ 18.5 kg\u002Fm²\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n5. Life expectancy ≥ 3 months.\n6. Individuals must have histologically or cytologically confirmed locally advanced or metastatic gastric\u002Fgastroesophageal junction adenocarcinoma and be ineligible for curative surgery or radiotherapy.\n7. Confirmed CCR8-positive by the central laboratory.\n8. HER2-negative, low-expressing, or non-expressing.\n9. Individuals must experience radiographic progression during or after prior standard first-line therapy, or who developed intolerance to treatment due to chemotherapy-related toxicity\n10. At least one lesion.\n11. Have appropriate organ and marrow function in laboratory examinations.\n12. Women of childbearing potential have a negative pregnancy test and must not be breastfeeding. All of reproductive potential agree to use effective contraception throughout the study period and for 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Received treatment targeting the same target or other drugs acting on regulatory T cells (Tregs).\n2. Received antitumor treatments such as chemotherapy, radiotherapy, biological therapy, immunotherapy, or Chinese herbal medicine or Chinese herbal preparations within 2-4 weeks (depending on the specific anticancer drug) prior to the first dose.\n3. Received anti-PD-(L)1 antibody immunotherapy and experienced disease progression confirmed by RECIST 1.1 assessment within ≤2 months after treatment initiation.\n4. Use of any live vaccine within 4 weeks prior to the first dosing of study drugs.\n5. Individuals who received major surgery or interventional treatment within 4 weeks prior to the first dosing of study drugs.\n6. Individuals who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of study drugs.\n7. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0, individuals who experienced ≥ Grade 3 immune-related adverse events during prior immunotherapy, or terminated prior immunotherapy due to severe or life-threatening immune-related adverse events.\n8. Any other pathological type.\n9. Uncontrollable clinical third-space fluid accumulation.\n10. Unstable or progressive central nervous system (CNS) metastases or carcinomatous meningitis (meningeal metastases).\n11. Individuals with a known history of autoimmune diseases.\n12. For individuals with drug allergies or contraindications.\n13. The investigator determined that there are other situations that are not suitable for participation in this study.","ALL","18 Years",{"count":71,"type":72},400,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","This is a phase III， Multicenter, Randomized study， evaluating the efficacy and Safety of LM-108(an Anti-CCR8 mAb) in combination With Toripalimab Versus Paclitaxel Injection in subjects with CCR8-Positive locally advanced or metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma.",[78],"Locally Advanced or Metastatic GC and GCJ Adenocarcinoma","2026-05-06",{"date":81,"type":82},"2026-05-11","ACTUAL",{"date":84,"type":82},"2026-04-30",{"date":86,"type":72},"2028-09-28",{"name":5,"class":6},1]