LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects … (NCT07362186) | Clinical Trial Compass
Not Yet RecruitingPhase 3
LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
China400 participantsStarted 2026-04-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
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.