Actively Recruiting
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
Led by BeyondBio Inc. · Updated on 2025-03-10
75
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- At least one measurable tumor lesion according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy longer than 12 weeks
- Adequate bone marrow, kidney, and liver function at screening
You will not qualify if you...
- Previous treatment for locally advanced or metastatic pancreatic cancer
- History of major surgery at screening
- Evidence of uncontrolled brain metastasis
- Presence of active bacterial infection
- Other malignant tumors except basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid cancer
- Pregnant or breastfeeding women
- Infection with HIV, active hepatitis B or C
- Known allergy to BEY1107 or gemcitabine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yonsei University Health System Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
B
BeyondBio Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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