Clinical trial · Interventional
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
NCT03579836CI-TRIAL-00086971recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Pancreatic Cancer | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEY1107 | Drug | — | UNRESOLVED |
| Gemcitabine | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I-1 (#4 Cohort)
- description
- BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
- interventionNames
- Drug: BEY1107
- type
- EXPERIMENTAL
- label
- Phase I-2 (#3 Cohort)
- description
- BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
- interventionNames
- Drug: BEY1107
- Combination Product: Gemcitabine
- type
- EXPERIMENTAL
- label
- Phase II (#1 Cohort)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.