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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Locally Advanced or Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: BEY1107
* Combination Product: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase I-1 (#4 Cohort)<br>BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) | Drug: BEY1107<br>* Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.<br>|
| Experimental: Phase I-2 (#3 Cohort)<br>BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) | Drug: BEY1107<br>* Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.<br>Combination Product: Gemcitabine<br>* Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.<br>|
| Experimental: Phase II (#1 Cohort)<br>BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off) | Drug: BEY1107<br>* Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.<br>Combination Product: Gemcitabine<br>* Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD & Safety assessment (Phase I) |  | 0 | 
| DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II) |  | 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I) |  | 0 | 
| Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I) |  | 0 | 
| DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I) |  | 0 | 
| ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II) |  | 0 | 
| Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II) |  | 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer