Back to resultsEvaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient With Pancreatic Cancer
Primary Purpose
Locally Advanced or Metastatic Pancreatic Cancer
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BEY1107
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic Pancreatic Cancer focused on measuring Pancreatic Cancer
Eligibility Criteria
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
Sites / Locations
- Yonsei University Health System Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Phase I-1 (#4 Cohort)
Phase I-2 (#3 Cohort)
Phase II (#1 Cohort)
Arm Description
BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
Outcomes
Primary Outcome Measures
MTD & Safety assessment (Phase I)
DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)
Secondary Outcome Measures
AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)
DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I)
ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II)
Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03579836
Brief Title
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient With Pancreatic Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeyondBio Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Pancreatic Cancer
Keywords
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase I-1 (#4 Cohort)
Arm Type
Experimental
Arm Description
BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
Arm Title
Phase I-2 (#3 Cohort)
Arm Type
Experimental
Arm Description
BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
Arm Title
Phase II (#1 Cohort)
Arm Type
Experimental
Arm Description
BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
Intervention Type
Drug
Intervention Name(s)
BEY1107
Intervention Description
Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.
Intervention Type
Combination Product
Intervention Name(s)
Gemcitabine
Intervention Description
Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.
Primary Outcome Measure Information:
Title
MTD & Safety assessment (Phase I)
Time Frame
0
Title
DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)
Time Frame
0
Secondary Outcome Measure Information:
Title
AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Time Frame
0
Title
Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Time Frame
0
Title
DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Time Frame
0
Title
ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II)
Time Frame
0
Title
Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II)
Time Frame
0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeyondBio Inc.
Phone
+82-42-716-0020
Email
clinicaltrials@beyondbio.co.kr
Facility Information:
Facility Name
Yonsei University Health System Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient With Pancreatic Cancer
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