A Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants With Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received>=2 Prior Lines of Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- overall survival(OS)
研究概览
简要总结
This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. The primary objective of this study is to determine Overall Survival (OS) of IBI343 plus best supportive care (BSC) compared with placebo plus BSC.
详细描述
This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. It is planned to enroll 201 participants, and participants will be randomized to receive IBI343 plus BSC or placebo plus BSC in a 2:1 ratio.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan.
- •Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer.
- •Have received and progression after at least two systemic therapies(must including a fluorouracil-based and a gemcitabine-based therapy).
- •ECOG PS score of 0 or
- •Adequate bone marrow and organ function
- •Confirmed as CLDN18.2 positive.
排除标准
- •Participation in another interventional study, except observational or post-intervention follow-up.
- •Prior treatment with topoisomerase inhibitor-based ADC.
- •Has received the last dose of an anti-cancer therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
- •Plans to receive other anti-tumor treatments during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed) .
- •Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria.
- •History of other primary malignancies, except cured or low-risk of recurrence.
研究组 & 干预措施
Experimental Arm
IBI343
干预措施: IBI343 (Drug)
Control Arm
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
overall survival(OS)
时间窗: approximately 24 months
Overall survival (OS) is defined as the time from randomization to death from any cause.
次要结局
- progression free survival(PFS)(approximately 24 months)
- Objective response rate (ORR)(approximately 24 months)
- disease control rate (DCR)(approximately 24 months)
- duration of response (DoR)(approximately 24 months)
- time to response (TTR)(approximately 24 months)
- Adverse Event(approximately 24 months)
- Area under the plasma concentration versus time curve (AUC)(approximately 24 months)
- immunogenicity(approximately 24 months)
- maximum concentration (Cmax)(approximately 24 months)
- time to maximum concentration (Tmax)(approximately 24 months)