NCT03579836RecruitingPhase 1/2
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with 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
Source: ClinicalTrials.gov · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 8 Jun 2018
- Start date
- 14 May 2018
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- BeyondBio Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT03579836
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 75
- From 14 May 2018 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery history at screening
Other illness
- A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
- Active bacterial infection patients
- Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
- HIV, Active hepatitis B or C infection
- A patient who has hypersensitivity with BEY1107 or Gemcitabine
Other
- Uncontrolled brain metastasis evidence
- expected Pregnant or breast-feeding patients
Who the study is looking for
- Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- At lease one measurable lesion according to RECIST v.1.1
- Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
- Over 12 weeks of Life expectancy
- Adequate Bone marrow, Renal and Liver function at screening
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University Health System, Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.