On August 18, 2022 CG Pharmaceuticals, Inc. reported the first patient dosed with the ivaltinostat and capecitabine combination therapy for the Phase 1b/2 pancreatic adenocarcinoma (PDAC) maintenance study (Press release, CG Therapeutics, AUG 18, 2022, View Source [SID1234618496]).
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Commencement of treatment for the first patient began on Aug 15, 2022, and the study will continue to recruit patients in approximately 25 institutions throughout the US.
The Phase 1b study will investigate the safety and tolerability of ivaltinostat in 3 different dose cohorts with locally advanced or metastatic PDAC who have completed at least one prior therapy. In the Phase 2 study, metastatic PDAC patients who show no evidence of disease progression after treatment with FOLFIRINOX 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).
Dr. Joong Myung Cho, CEO of CG Pharmaceuticals and CrystalGenomics, stated "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."
About Ivaltinostat
Ivaltinostat is a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase (HDAC). Ivaltinostat has been evaluated for anticancer effect for metastatic PDAC and myelodysplastic syndrome (MDS). The results of the Phase 2 study with unresectable or metastatic PDAC patients who have not had prior treatment were 93.8%, 25%, and 10.8 months, respectively for DCR, ORR and median OS. These results were published in the June 2022 publication of "International Journal of Cancer".