Locally Advanced or Metastatic Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer
Brief 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.
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.
Sponsors
BeyondBio Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD & Safety assessment (Phase I) | 0 |
| DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II) | 0 |
Secondary
| Measure | Time frame |
|---|---|
| DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I) | 0 |
| AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I) | 0 |
| Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II) | 0 |
| ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II) | 0 |
| Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I) | 0 |
Countries
South Korea
Contacts
Primary ContactBeyondBio Inc.
Outcome results
None listed