NCT03579836

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: BeyondBio Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The key purpose of the main part of the study is to assess the MTD, safety and efficacy of BEY1107 as monotherapy and combination therapy for locally advanced and/or metastatic pancreatic cancer. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of BEY1107, to determine the MTD. Patient will receive BEY1107 for 4 weeks in monotherapy for each cohort (administered in a 3-weeks-on / 1-week-off) during Phase I-1 trial. At next stage, patient will receive BEY1107 with gemcitabine for 4weeks in phase I-2 trial. Final stage, patient will receive BEY1107 with gemcitabine for 24weeks in phase II trial. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival of fresh biopsy tissue will also be collected for biomarker analysis.

Conditions

• Locally Advanced or Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-14
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2018-07-09
• Last updated: 2025-03-10

Locations

1 site across 1 country: South Korea