JPRN-jRCT2031220143招募中1 期
A phase 1b/2 dose escalation and expansion study of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy or pembrolizumab-containing combinations for HER2+ gastrointestinal cancers
Mayor JoAl0 个研究点目标入组 40 人开始时间: 2022年6月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:
- •- Cohorts 1A, 1B, 1C, and 1D
- •- Gastric adenocarcinoma
- •- GEJ adenocarcinoma
- •- Esophageal adenocarcinoma
- •- Cholangiocarcinoma
- •- Gallbladder carcinoma
- •- Cohorts 1E, 1F, 1G, and 2A
- •- Gastric adenocarcinoma
- •- GEJ adenocarcinoma
- •- Esophageal adenocarcinoma
- •- Cohort 2B
- •Note: Cohorts 1A and 1B are not recruiting in Japan
- •2. Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G.
- •3. HER2+ disease, as determined by historic or local laboratory testing
- •4. Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator
- •Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator
- •5. Age 18 years or older at time of consent or >= the age of majority per regional requirements
- •6. Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
排除标准
- •1. History of known hypersensitivity to planned study treatment
- •2. Known to be positive for Hepatitis B or C
- •3. For Cohorts 2A and 2B: prior anti-HER2 therapies
- •For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)
研究者
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