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Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT03579836•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.

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.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
•2. At lease one measurable lesion according to RECIST v.1.1
•3. Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
•4. Over 12 weeks of Life expectancy
•5. Adequate Bone marrow, Renal and Liver function at screening

Exclusion Criteria

•1. A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
•2. Major surgery history at screening
•3. Uncontrolled brain metastasis evidence
•4. Active bacterial infection patients
•5. Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
•6. expected Pregnant or breast-feeding patients
•7. HIV, Active hepatitis B or C infection
•8. A patient who has hypersensitivity with BEY1107 or Gemcitabine

Locations (1)

Yonsei University Health System Severance Hospital

Seoul, South Korea

Key Dates

Start Date

May 14, 2018

Primary Completion Date

November 30, 2026

Completion Date

December 31, 2026

Last Updated

March 10, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced or Metastatic Pancreatic Cancer

Interventions

BEY1107

DRUG

Gemcitabine

COMBINATION_PRODUCT

Contacts

BeyondBio Inc.

CONTACT

+82-42-716-0020 clinicaltrials@beyondbio.co.kr

Masitinib Plus Gemcitabine in Pancreatic Cancer

NCT03766295

Locally Advanced or Metastatic Pancreatic Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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