Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
- Conditions
- Locally Advanced or Metastatic Pancreatic Cancer
- Interventions
- Combination Product: Gemcitabine
- Registration Number
- NCT03579836
- Lead Sponsor
- BeyondBio Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase I-1 (#4 Cohort) BEY1107 BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) Phase I-2 (#3 Cohort) BEY1107 BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) Phase I-2 (#3 Cohort) Gemcitabine BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) Phase II (#1 Cohort) BEY1107 BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off) Phase II (#1 Cohort) Gemcitabine BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
- Primary Outcome Measures
Name Time Method MTD & Safety assessment (Phase I) 0 DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II) 0
- Secondary Outcome Measures
Name Time Method Cmax 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 DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I) 0 AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I) 0
Trial Locations
- Locations (1)
Yonsei University Health System Severance Hospital
🇰🇷Seoul, Korea, Republic of