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Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
Sponsor: BeyondBio Inc.
Summary
This study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer.
Official title: A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination with Gemcitabine in Patient with Locally Advanced or Metastatic Pancreatic Cancer
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2018-05-14
Completion Date
2026-12-31
Last Updated
2025-03-10
Healthy Volunteers
No
Interventions
BEY1107
Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.
Gemcitabine
Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.
Locations (1)
Yonsei University Health System Severance Hospital
Seoul, South Korea