RecruitingPhase 1Phase 2NCT03579836

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


Sponsor

BeyondBio Inc.

Enrollment

75 participants

Start Date

May 14, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of a new drug called BEY1107 — either on its own or combined with a standard chemotherapy drug called gemcitabine — in patients with pancreatic cancer. **You may be eligible if...** - You have been diagnosed with pancreatic ductal adenocarcinoma or undifferentiated pancreatic carcinoma, confirmed by biopsy or cytology - You have at least one tumor that can be measured on a scan - Your ability to carry out daily activities is rated 0, 1, or 2 on the standard medical scale - You have a life expectancy of at least 12 weeks - Your bone marrow, kidney, and liver function meet the required levels **You may NOT be eligible if...** - You have previously received treatment for locally advanced or metastatic pancreatic cancer - You recently had major surgery - You have uncontrolled cancer that has spread to the brain - You have an active serious bacterial infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBEY1107

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

COMBINATION_PRODUCTGemcitabine

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

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NCT03579836