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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат LM-108 in combination with Toripalimab
  LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks
• Препарат Paclitaxel injection intravenous infusion
  Paclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks

Первичные конечные точки

• Overall survival (OS) [Срок оценки: up to 42 months]

Вторичные конечные точки (5)

• Progression Free Survival (PFS) [Срок оценки: up to 42 months]
• Objective response rate (ORR) [Срок оценки: up to 42 months]
• Duration of response (DOR) [Срок оценки: Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to 42 months]
• Disease control rate (DCR) [Срок оценки: From start of treatment to date of documented disease progression, up to approximately 42 months]
• Incidence of adverse events (AEs) [Срок оценки: up to 42 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07362186 · LM108-03-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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