Evaluating BEY1107 with Gemcitabine for Pancreatic Cancer
Official title: 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
Run by BeyondBio Inc. · NCT03579836 · Data updated 2026-11-12
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 |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | BeyondBio Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | May 14, 2018 |
| Main results expected | November 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 10, 2025 |
| Trial ID | NCT03579836 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with a history of treatment for pancreatic cancer, uncontrolled brain metastasis, or certain infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel, other studies have explored similar combinations in pancreatic cancer, but the specific efficacy of BEY1107 remains to be established.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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NALIRIFOX plus adebrelimab and PULSAR as first-line treatment for advanced pancreatic cancer
This study tests a combination of NALIRIFOX chemotherapy with adebrelimab and PULSAR as first-line therapy for locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma to see if it is safe and shows initial signs of effectiveness.
-
HRS-4642 with chemotherapy and immunotherapy for advanced pancreatic cancer
This study tries adding HRS-4642 to standard chemotherapy and/or an immune therapy to see if it helps people with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
-
KN510 and KN713 with mFOLFIRINOX for advanced pancreatic cancer
This trial will try to see if adding oral KN510 and KN713 to mFOLFIRINOX helps adults with unresectable locally advanced or metastatic pancreatic cancer.
-
Chemotherapy followed by ablative SBRT for locally advanced inoperable pancreatic cancer
This trial will try chemotherapy followed by high-dose focused radiation (SBRT) as the first treatment for adults with locally advanced, inoperable pancreatic cancer.
-
Chemotherapy With IMD10 (Focused Ultrasound) for Borderline Resectable or Locally Advanced Pancreatic Cancer
This trial tests whether adding IMD10 focused ultrasound to a standard chemotherapy regimen helps people with borderline resectable or locally advanced pancreatic cancer see better survival.
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Personalized management for borderline resectable and locally advanced pancreatic cancer
This study is testing if giving chemotherapy first can help people with borderline resectable and locally advanced pancreatic cancer have surgery and improve their chances of survival.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.