drugset / Trial / NCT05141149
First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
The first in human clinical study is planned as an open-label, dose-escalation, and dose-expansion, multicentre, two-part, Phase 1/2a study of PBP1510 administered to patients with advanced/metastatic pancreatic cancer. The study will be conducted in two parts, Part 1 as a PBP1510 single agent dose-escalation, and PBP1510 dose-escalation in combination with gemcitabine, and Part 2 as PBP1510 dose-expansion at the RP2D in combination with gemcitabine.
Timeline
- Start
- 2023-06-05
- Primary completion
- 2026-02
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | PBP1510 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | PBP1510 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | PBP1510 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | PBP1510 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | PBP1510 | Monoclonal antibody | 15 mg/kg | Intravenous |