Clinical trial NCT03579836: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Locally Advanced or Metastatic Pancreatic Cancer
Keywords: Pancreatic Cancer
Lead sponsor: BeyondBio Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MTD & Safety assessment (Phase I)
timeFrame: 0
measure: DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)
timeFrame: 0
Secondary outcomes:
measure: AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)
timeFrame: 0
measure: Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)
timeFrame: 0
measure: DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I)
timeFrame: 0
measure: ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II)
timeFrame: 0
measure: Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II)
timeFrame: 0
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital
Study officials:
References: