On May 6, 2024 CG Pharmaceuticals, a late-stage clinical biopharmaceutical company specializing in metastatic pancreatic ductal adenocarcinoma (PDAC) maintenance therapy (NCT05249101), reported that it will feature one of its investigators, Dr. Christos Fountzilas from Roswell Park Comprehensive Cancer Center, at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago on June 1st, 1:30 – 4:30 PM CDT, during the Gastrointestinal Cancer session (TPS4206) (Press release, CG Pharmaceuticals, MAY 6, 2024, View Source [SID1234642703]). He will be presenting some of the findings from our completed Phase 1b and study design of the on-going Phase 2 clinical trial. Commencement of treatment for the first patient of Phase 2 began on January 9th, 2024, and the study will continue to recruit patients in approximately 25 institutions throughout the US.
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In the Phase 2 study, metastatic PDAC patients who show no evidence of disease progression after treatment with FOLFIRINOX, mFOLFIRINOX or NALIRIFOX will receive either the ivaltinostat/capecitabine combination therapy or capecitabine monotherapy after randomization. The primary endpoint is to evaluate ivaltinostat’s effect on improving progression free survival (PFS), while key secondary endpoints include objective response rate (ORR), disease control rate (DCR), and overall survival (OS).
About Ivaltinostat:
Ivaltinostat is a potential first-in-class novel therapeutic candidate for pancreatic ductal adenocarcinoma that inhibits enzymatic activity of histone deacetylase and has been evaluated for solid tumors and hematologic malignancies.