AMP946 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer
Status:
Not yet recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
This is a multicentre, open label, two-part study to determine whether AMP945, when given
prior to dosing with gemcitabine and nab-paclitaxel, improves response to therapy in
first-line patients with unresectable or metastatic pancreatic cancer.
Part A is a phase 1b dose-escalation design that will enrol at least 3 participants in each
of 4 dose-level cohorts, to determine the RP2D of AMP945 to be explored in Part B.
Part B will determine the efficacy of the AMP945 regimen at the RP2D, and will be run as a
Simon Two-stage design; Stage 1 will enrol 26 participants. If ≤5 of the 26 participants show
an objective response, then recruitment will be paused and a detailed analysis of futility
will be performed. If the study is deemed futile, recruitment will cease. If the study is
determined to be not futile or >5 of the 26 participants show an objective response,
recruitment will continue, and an additional 24 participants will be enrolled in Stage 2.