drugset / Trial / NCT06229496
Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma
Non-randomizedSequentialOpen-labelTreatment
Summary
A Phase 1b, open-label, multicenter, dose escalation and dose expansion study of S-1 in combination with nab-paclitaxel and gemcitabine (GAS) in subjects with metastatic pancreatic adenocarcinoma. This study is a dose escalation and dose expansion study with the objective to establish the MTD and/or RP2D and/or DLT of nab-paclitaxel and gemcitabine in combination with a body surface area(BSA)-based dose of S-1 in subject with metastatic pancreatic adenocarcinoma.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | — |
| Subject | S-1 | Small molecule | — | — |