Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
Recruiting
Phase 1Phase 2Interventional Study
Locally Advanced or Metastatic Pancreatic Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
20 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
BeyondBio Inc. · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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…
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
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