The trial will progress to enrol subjects in nearly 25 US institutions.
In the Phase Ib trial, the safety and tolerability of ivaltinostat will be analysed in three varying dose cohorts, enrolling locally advanced or metastatic PDAC patients who have received a minimum of one therapy previously.
The Phase II trial will have metastatic PDAC patients without any evidence of disease progression following Folfirinox treatment.
Following randomisation, these subjects will be given either an ivaltinostat/capecitabine combination treatment or capecitabine as a single agent.
Analysing the impact of ivaltinostat on boosting progression-free survival (PFS) is the primary endpoint of the trial.
Objective response rate (ORR), disease control rate (DCR), and overall survival (OS) are the trial’s key secondary endpoints.
A new anticancer treatment candidate, ivaltinostat hinders histone deacetylase’s enzymatic activity.
It was analysed for anticancer effects to treat metastatic PDAC and myelodysplastic syndrome.
According to findings from a Phase II trial in subjects with unresectable or metastatic PDAC who have not received any treatment previously, ivaltinostat offered DCR, ORR, and a median OS of 93.8%, 25%, and 10.8 months, respectively.
CG Pharmaceuticals CEO Dr Joong Myung Cho said: “Dosing of the first patient is a significant milestone for ivaltinostat as there is a great unmet medical need for the PDAC patients.
“We are very excited about the start of this trial as ivaltinostat has demonstrated promising signs of efficacy from previous preclinical and clinical studies.”