Evaluating BEY1107 with Gemcitabine for Pancreatic Cancer
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
This study is testing a new drug called BEY1107, alone and with another medication called gemcitabine, to see if it can help people with advanced pancreatic cancer feel better and improve their treatment options.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | BeyondBio Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03579836 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety and efficacy of BEY1107, both as a standalone treatment and in combination with gemcitabine, for patients with locally advanced or metastatic pancreatic cancer. The study will determine the maximum tolerated dose (MTD) of BEY1107 through a phased approach, starting with monotherapy and progressing to combination therapy. Participants will receive treatment over a series of weeks, with blood samples and biopsy tissues collected for further analysis of safety and biomarkers.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma, who have at least one measurable lesion and meet specific health criteria.
Not a fit: Patients with a history of treatment for pancreatic cancer, uncontrolled brain metastasis, or certain infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with pancreatic cancer, potentially improving their outcomes.
How similar studies have performed: While this approach is novel, other studies have explored similar combinations in pancreatic cancer, but the specific efficacy of BEY1107 remains to be established.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Seoul
- Yonsei University Health System Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: BeyondBio Inc.
- Email: clinicaltrials@beyondbio.co.kr
- Phone: +82-42-716-0020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.