drugset / Trial / NCT04338763
RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer
Phase 1
Unknown
48 enrolled
Rise Biopharmaceuticals, Inc.
T-TOP Clinical Research Co., Ltd. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I, multi center study to evaluate the safety and efficacy and determine the maximum tolerated dose (MTD) of RP72 as monotherapy and RP72 in combination with Gemcitabine in patients with pancreatic cancer. The study has two arms: Arm A: RP72 monotherapy Arm B: RP72 in combination with Gemcitabine Both treatment arms will follow a standard 3+3 design. Up to 48 adult patients with pancreatic cancer will be enrolled in this study.
Timeline
- Start
- 2021-04-19
- Primary completion
- 2024-10-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Subject | RP72 | Protein / enzyme biologic | — | Intravenous |