Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
NCT ID: NCT03579836
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2018-05-14
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase I-1 (#4 Cohort)
BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
BEY1107
Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.
Phase I-2 (#3 Cohort)
BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
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.
Phase II (#1 Cohort)
BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
80 Years
ALL
No
Sponsors
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BeyondBio Inc.
INDUSTRY
Responsible Party
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Locations
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Yonsei University Health System Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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BEY-2018-01
Identifier Type: -
Identifier Source: org_study_id
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