drugset / Trial / NCT04935359
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study was to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aimed to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel could reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.
Timeline
- Start
- 2021-09-30
- Primary completion
- 2024-08-13
- Completion
- 2024-08-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NISEVOKITUG | Monoclonal antibody | 2100 mg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | — |