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

Trial ID: NCT03579836

Interventional - Phase 1/2 - Recruiting

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

Interventions

• BEY1107
• Gemcitabine

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

Sponsor

BeyondBio Inc.

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows