drugset / Trial / NCT04643405
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
NaSingle-groupOpen-labelTreatment
Summary
This study is a two stage study consisting of a dose escalation phase Ib and a phase II study which include subjects with previously-treated, advanced pancreatic adenocarcinoma. Dose Limiting Toxicities (DLTs) and maximum tolerated dose (MTD) of APG1387 in combination with nab-paclitaxel and gemcitabine will be evaluated in the dose escalation phase Ib. Safety and efficacy of APG1387 plus gemcitabine and nab-paclitaxel will be evaluated in phase II.
Timeline
- Start
- 2021-03-17
- Primary completion
- 2024-06-25
- Completion
- 2024-12-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APG-1387 | Small molecule | 20 mg | Intravenous |
| Subject | APG-1387 | Small molecule | 30 mg | Intravenous |
| Subject | APG-1387 | Small molecule | 45 mg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |