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Clinical Trials in South Korea / NCT03579836
Recruiting Phase 1/2

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

NCT03579836 · tracked via the Priya Life Science South Korea tracker
Sponsor
BeyondBio Inc
Phase
Phase 1/2
Started
2018-05-14
Last updated
2025-03-10

Condition(s) studied

Locally Advanced or Metastatic Pancreatic Cancer

Investigational drug(s) / intervention(s)

BEY1107 →Gemcitabine

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.

Study 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

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • MTD & Safety assessment (Phase I)
  • DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health System Severance Hospital Seoul South Korea Recruiting

More BeyondBio Inc. trials in South Korea

A Phase 2 Study to Evaluate the Safety and Efficacy of BEY2153 in Patients with Early Alzheimer's Disease Starting soon
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer Recruiting
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03579836 on ClinicalTrials.gov ↗ ← All trials in South Korea