A Phase 1b Study of TAS-120 and Pembrolizumab
- Conditions
- Patients with advanced or metastatic esophageal carcinoma or non-small-cell lung cancer
- Registration Number
- jRCT2080224975
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 207
Be willing and able to provide written informed consent for the trial. Able to take medications orally. Have a measurable disease per RECIST 1.1 Have adequate organ function value Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other protocol procedures Feasibility phase Have histologically confirmed advanced or metastatic solid tumors Be positive for FGF/FGFR abnormalities Expansion phase Have histologically confirmed advanced or metastatic esophageal carcinoma or non-small cell lung cancer Have mRNA of FGFR 1, 2, 3, or 4 overexpression in tumor tissue sample (non-small cell lung cancer)
Have a serious illness or medical conditions.
Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to futibatinib and any drug similar to futibatinib in structure or class
Study & Design
- Study Type
- Interventional
- Study Design
- phase 1b, open-label, nonrandomized, multicenter study
- Primary Outcome Measures
Name Time Method - safety
efficacy
Safety, Efficacy
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Japan
Location not specified
Japan