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NCT Number: NCT03579836

Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with 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.

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Key information

Conditions

Locally Advanced or Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Yonsei University Health System Severance Hospital

Seoul, South Korea

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
  • At lease one measurable lesion according to RECIST v.1.1
  • Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
  • Over 12 weeks of Life expectancy
  • Adequate Bone marrow, Renal and Liver function at screening

Exclusion criteria

  • A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
  • Major surgery history at screening
  • Uncontrolled brain metastasis evidence
  • Active bacterial infection patients
  • Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
  • expected Pregnant or breast-feeding patients
  • HIV, Active hepatitis B or C infection
  • A patient who has hypersensitivity with BEY1107 or Gemcitabine

Treatment and study plan

BEY1107

Drug

Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.

Gemcitabine

Combination Product

Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.

Primary outcomes

  1. MTD & Safety assessment (Phase I)

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

Secondary outcomes

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

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

BeyondBio Inc.

CONTACT

[email protected]

+82-42-716-0020

Sponsors and collaborators

Lead sponsor

BeyondBio Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2018
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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