NCT07362186招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
LM-108 in combination with Toripalimab
Experimental
干预措施: LM-108 in combination with Toripalimab (Drug)
Paclitaxel injection intravenous infusion
Active Comparator
干预措施: Paclitaxel injection intravenous infusion (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: up to 42 months
OS was defined as the time from date of randomization until death from any cause
次要结局
- Progression Free Survival (PFS)(up to 42 months)
- Objective response rate (ORR)(up to 42 months)
- Duration of response (DOR)(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)(From start of treatment to date of documented disease progression, up to approximately 42 months)
- Incidence of adverse events (AEs)(up to 42 months)
研究者
研究点 (1)
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