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.
Individuals who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
Age 18 years or older, male or female.
Weight ≥ 40 kg or Body Mass Index (BMI)≥ 18.5 kg/m²
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Received treatment targeting the same target or other drugs acting on regulatory T cells (Tregs).
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.
Received anti-PD-(L)1 antibody immunotherapy and experienced disease progression confirmed by RECIST 1.1 assessment within ≤2 months after treatment initiation.
Use of any live vaccine within 4 weeks prior to the first dosing of study drugs.
Parallel
LM-108 in combination with Toripalimab
DrugLM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks
Paclitaxel injection intravenous infusion
DrugPaclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks
Overall survival (OS)
OS was defined as the time from date of randomization until death from any cause
Progression Free Survival (PFS)
PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
Objective response rate (ORR)
ORR is defined as the proportion of subjects achieving the best overall response (BOR) of CR or PR. BOR refers to the best response recorded during the period from the date of randomization to the date of objective progression documented according to RECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy (whichever occurs first).
Duration of response (DOR)
defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Disease control rate (DCR)
defined as the proportion of participants who achieved CR, PR, or stable disease (SD) , based on Investigator assessment.
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