drugset / Trial / NCT06278454
Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.
Timeline
- Start
- 2024-01-09
- Primary completion
- 2027-12
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NRT6008 | Other / unclassified | — | Other |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Background | Irinotecan | Small molecule | 180 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |