drugset / Trial / NCT04643405

APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

NCT04643405

Phase 1/2 Terminated 21 enrolled Ascentage Pharma Group Inc.
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

EvaluationDrugModalityDoseRoute
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