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

Sponsor
BeyondBio Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03579836
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
41
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. MTD & Safety assessment (Phase I) [0]

  2. DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II) [0]

Secondary Outcome Measures

  1. AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I) [0]

  2. Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I) [0]

  3. DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I) [0]

  4. ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II) [0]

  5. Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II) [0]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yonsei University Health System Severance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • BeyondBio Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BeyondBio Inc.
ClinicalTrials.gov Identifier:
NCT03579836
Other Study ID Numbers:
  • BEY-2018-01
First Posted:
Jul 9, 2018
Last Update Posted:
Jul 25, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by BeyondBio Inc.
Pancreatic Cancer
Additional relevant MeSH terms:
Pancreatic Neoplasms
Gemcitabine

Study Results

No Results Posted as of Jul 25, 2019