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
Overview
- Phase
- Phase 1
- Intervention
- BEY1107
- Conditions
- Locally Advanced or Metastatic Pancreatic Cancer
- Sponsor
- BeyondBio Inc.
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- MTD & Safety assessment (Phase I)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Phase I-1 (#4 Cohort)
BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
Intervention: BEY1107
Phase I-2 (#3 Cohort)
BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
Intervention: BEY1107
Phase I-2 (#3 Cohort)
BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
Intervention: Gemcitabine
Phase II (#1 Cohort)
BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
Intervention: BEY1107
Phase II (#1 Cohort)
BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
Intervention: Gemcitabine
Outcomes
Primary Outcomes
MTD & Safety assessment (Phase I)
Time Frame: 0
DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)
Time Frame: 0
Secondary Outcomes
- Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II)(0)
- ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II)(0)
- Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)(0)
- DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I)(0)
- AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)(0)