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

NCT03579836 | Recruiting Phase 1

• 1 other identifier: BEY-2018-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced or Metastatic Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• MTD & Safety assessment (Phase I)

  0

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

  0

Secondary Outcomes (5)

• AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)

  0

• Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)

  0

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

  0

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

  0

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

  0

Study Arms (3)

Phase I-1 (#4 Cohort)

EXPERIMENTAL

BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)

Drug: BEY1107

Phase I-2 (#3 Cohort)

EXPERIMENTAL

BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)

Drug: BEY1107; Combination Product: Gemcitabine

Phase II (#1 Cohort)

EXPERIMENTAL

BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)

Drug: BEY1107; Combination Product: Gemcitabine

Interventions

BEY1107 DRUG

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

Phase I-1 (#4 Cohort); Phase I-2 (#3 Cohort); Phase II (#1 Cohort)

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.

Phase I-2 (#3 Cohort); Phase II (#1 Cohort)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeyondBio Inc.: lead

Study Sites (1)

Yonsei University Health System Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

BeyondBio Inc.

CONTACT

+82-42-716-0020; clinicaltrials@beyondbio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 9, 2018
• Study Start: May 14, 2018
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)