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

Locally Advanced or Metastatic Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03579836
• Other study ID #: BEY-2018-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2018
• Est. completion date: October 2021

Study information

• Verified date: July 2019
• Source: BeyondBio Inc.
• Contact: BeyondBio Inc.
• Phone: +82-42-716-0020
• Email: clinicaltrials[@]beyondbio.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
BeyondBio Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD & Safety assessment (Phase I)		0
Primary	DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)		0
Secondary	AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)		0
Secondary	Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)		0
Secondary	DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I)		0
Secondary	ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II)		0
Secondary	Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II)		0