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RecruitingPhase 3NCT07362186

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/Gastroesophageal Junction Adenocarcinoma

Sponsor

LaNova Medicines Limited

Enrollment

400 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Locally Advanced or Metastatic GC and GCJ Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • 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 Criteria13

  • 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.

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Interventions

DRUGLM-108 in combination with Toripalimab

LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks

DRUGPaclitaxel injection intravenous infusion

Paclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks

Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT07362186