Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
Recruiting · NCT03579836 · Interventional (participants receive a specific treatment) · Lead sponsor: BeyondBio Inc.
View the official record on ClinicalTrials.gov →Interventions studied
BEY1107Gemcitabine
What this trial is about
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.
Who can take part
Age range
20 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- At lease one measurable lesion according to RECIST v.1.1
- Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
- Over 12 weeks of Life expectancy
- Adequate Bone marrow, Renal and Liver function at screening
Exclusion criteria
- A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
- Major surgery history at screening
- Uncontrolled brain metastasis evidence
- Active bacterial infection patients
- Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
- expected Pregnant or breast-feeding patients
- HIV, Active hepatitis B or C infection
- A patient who has hypersensitivity with BEY1107 or Gemcitabine
Where it is running
1 location listed.
- Yonsei University Health System Severance Hospital - Seoul, South Korea