Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03579836
PHASE1/PHASE2

Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer

Sponsor: BeyondBio Inc.

View on ClinicalTrials.gov

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

DRUG

BEY1107

Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.

COMBINATION_PRODUCT

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