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
- JPRN-jRCT2080224975
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 223
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
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety, Efficacy
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety, Efficacy