A Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 464
- 试验地点
- 117
- 主要终点
- progression free survival(PFS)
研究概览
简要总结
This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)
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
- •Able and willing to sign a written Informed Consent Form(ICF) and to comply with protocol-specified visits and related procedures.
- •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 (anti-PD-(L)1 in combination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. The subject has ≤ 4 prior lines of systemic therapy.
- •Has histopathologically confirmed CLDN18.2-positive disease.
- •Is a man or woman of 18 years of age or older at the time of signing the ICF.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
排除标准
- •Has HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positive by in situ hybridization) disease.
- •Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
- •Has a history of treatment with topoisomerase inhibitorbased antibody-drug conjugate(s).
- •Has received the last dose of an anti-cancer therapy (including traditional Chinese medicine indicated for gastric cancer in the package insert, but excluding herbal prescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
- •Plans to receive other anti-cancer therapy during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed).
研究组 & 干预措施
Active Comparator: control arm
There are three drugs ( irinotecan, paclitaxel,or FTD/TPI (only are applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment)) in active contral arm, the subjects will receive the drug based on investigator's choice
干预措施: Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） (Drug)
IBI343 monotherapy
IBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .
干预措施: IBI343 (Drug)
结局指标
主要结局
progression free survival(PFS)
时间窗: within approximately 20 months
Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause.
overall survival(OS)
时间窗: within approximately 26 months
Overall survival (OS) is defined as the time from randomization to death from any cause.
次要结局
- area under the curve (AUC)(within approximately 20 months)
- trough concentration (Ctrough)(within approximately 20 months)
- clearance (CL)(within approximately 20 months)
- volume of distribution (V)(within approximately 20 months)
- disease control rate (DCR)(within approximately 20 months)
- time to response (TTR)(within approximately 20 months)
- Objective response rate (ORR)(within approximately 20 months)
- disease control rate (DCR)(within approximately 20 months)
- duration of response (DoR)(within approximately 20 months)
- time to response (TTR)(within approximately 20 months)
- area under the curve (AUC)(within approximately 20 months)
- maximum concentration (Cmax)(within approximately 20 months)
- time to maximum concentration(Tmax)(within approximately 20 months)
- trough concentration (Ctrough)(within approximately 20 months)
- clearance (CL)(within approximately 20 months)
- volume of distribution (V)(within approximately 20 months)
- Incidence of anti-drug antibody (ADA)(within approximately 20 months)
- neutralizing antibody (NAb)(within approximately 20 months)