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

July 23, 2019 updated by: BeyondBio Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
MTD & Safety assessment (Phase I)
DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeyondBio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

June 8, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 25, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEY-2018-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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