[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-gc-and-gcj-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-gc-and-gcj-adenocarcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"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":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Locally Advanced or Metastatic GC and GCJ Adenocarcinoma","RECRUITING","2026-05-06",{"date":30,"type":31},"2026-05-11","ACTUAL",{"date":33,"type":31},"2026-04-30",{"date":35,"type":20},"2028-09-28",{"name":37,"class":38},"LaNova Medicines Limited","INDUSTRY"]