NCT06351020进行中（未招募）3 期
A Phase III, Open-Label, Multi Center, Randomized Study of LM-302 Versus Treatment of Physician's Choice (TPC) in Patients With CLDN18.2-Positive, Locally Advanced or Metastatic Gastric(GC) and Gastroesophageal Junction(GEJ) Adenocarcinoma.
LaNova Medicines Zhejiang Co., Ltd.3 个研究点 分布在 1 个国家目标入组 387 人开始时间: 2024年6月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 387
- 试验地点
- 3
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old, male and female
- •Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
- •Has received and progressed on at least 2 lines of systemic therapy. A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy.
- •Centrally confirmed CLDN18.2-positive
- •HER2 negative
- •At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1)
- •ECOG: 0-1
- •Expected survival ≥12 weeks;
- •Good blood reserve and liver, kidney and coagulation function
- •Willing to provide informed consent for study participation.
排除标准
- •Within the first 5 years of randomization, there is a history of malignant tumors other than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma that have been cured and cured after treatment
- •Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation
- •Urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and 24-hour urine protein quantification>1g
- •Individuals with a history of severe cardiovascular and cerebrovascular diseases
- •Individuals who are unable to control or have serious illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks prior to initial medication, interstitial pneumonia/lung disease requiring intervention during screening, and tumor related pain requiring local treatment during screening
- •Current peripheral sensory or motor neuropathy ≥ grade 2
- •Uncontrollable third space effusion in clinical practice
- •Received or planned to undergo major surgery or intervention during the study period within the first 28 days of randomization
- •The researcher determined that there are other situations that are not suitable for participation in this study
研究组 & 干预措施
LM-302
Experimental
Patients will accept LM-302 monotherapy
干预措施: LM-302 (Drug)
Physician's choice Apatinib or Irinotecan
Active Comparator
Patients will accept Apatinib or Irinotecan monotherapy
干预措施: Apatinib (Drug)
Physician's choice Apatinib or Irinotecan
Active Comparator
Patients will accept Apatinib or Irinotecan monotherapy
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: up to 42 months
OS was defined defined as the time from date of randomization until death from any cause.
Progression Free Survival (PFS)
时间窗: up to 42 months
PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
次要结局
- Disease control rate (DCR)(From start of treatment to date of documented disease progression, up to approximately 42 months)
- Objective response rate (ORR)(From start of treatment to date of documented disease progression, up to approximately 42 months)
- AE and SAE(From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose)
- Evaluate the immunogenicity of LM-302(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 approximately 42 months)
- Evaluation of pharmacokinetic characteristics of LM-302(up to 42 months)
- Evaluation of pharmacokinetic characteristics of total antibody(up to 42 months)
- Evaluation of pharmacokinetic characteristics of MMAE(up to 42 months)
研究者
研究点 (3)
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