LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma

Inclusion criteria

• 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.
• Life expectancy ≥ 3 months.
• Individuals must have histologically or cytologically confirmed locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma and be ineligible for curative surgery or radiotherapy.
• Confirmed CCR8-positive by the central laboratory.
• HER2-negative, low-expressing, or non-expressing.
• Individuals must experience radiographic progression during or after prior standard first-line therapy, or who developed intolerance to treatment due to chemotherapy-related toxicity
• At least one lesion.
• Have appropriate organ and marrow function in laboratory examinations.
• 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.

Exclusion criteria

• 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.
• Individuals who received major surgery or interventional treatment within 4 weeks prior to the first dosing of study drugs.
• 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.
• 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.
• Any other pathological type.
• Uncontrollable clinical third-space fluid accumulation.
• Unstable or progressive central nervous system (CNS) metastases or carcinomatous meningitis (meningeal metastases).
• Individuals with a known history of autoimmune diseases.
• For individuals with drug allergies or contraindications.
• The investigator determined that there are other situations that are not suitable for participation in this study.