Policy & Regulation
CG Pharmaceuticals begins ivaltinostat phase two study for metastatic pancreatic ductal adenocarcinoma
20 November 2023 -

CG Pharmaceuticals, a wholly owned US subsidiary of South Korea-based Crystal Gernomics, announced on Friday that it has started a phase two study in metastatic pancreatic ductal adenocarcinoma (PDAC) with the recommended Phase two dose (RP2D) of ivaltinostat (ClinicalTrials.gov ID NCT05249101).

The RP2D of ivaltinostat (250 mg/m2) was determined by the Safety Review Committee (SRC) following a thorough safety data review from 3 cohorts of increasing dose levels of ivaltinostat in combination with a fixed dose of capecitabine. The SRC has unanimously recommended proceeding to Phase 2, marking a significant milestone. The study is open for patient enrolment, effective immediately.

During Phase two, metastatic PDAC subjects that show no evidence of disease progression after an initial treatment with FOLFIRINOX are to receive either combination therapy or capecitabine monotherapy. The study's primary endpoint is progression free survival.