CG Pharmaceuticals has started the Phase II trial of ivaltinostat with the recommended Phase II dose (RP2D) for the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC).

The Safety Review Committee (SRC) has determined the RP2D of ivaltinostat (250mg/m²) after reviewing safety data from three cohorts with its increasing dose levels in combination with a fixed capecitabine dose.

The study is open for subject enrolment, following a unanimous recommendation from the SRC.

In the Phase II study, patients with metastatic PDAC who exhibit no evidence of disease progression after treatment with FOLFIRINOX initially will be assigned to receive either capecitabine monotherapy or combination therapy.

Progression-free survival (PFS) is the primary endpoint of the trial.

CG Pharmaceuticals global strategic planning vice-president Dr Gene Cho said: “I am thrilled and honoured to share this important study milestone and witness the commencement of Phase II, with an enrolment target of 52 patients.

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“We extend our heartfelt gratitude to our investigators, partners, and, most importantly, our patients for their invaluable participation in this critical study.”

Ivaltinostat is a new anticancer therapeutic candidate designed for inhibiting the enzymatic activity of histone deacetylase. It has been assessed for haematologic malignancies and solid tumours.

CG Pharmaceuticals, a wholly owned US subsidiary of CG Invites, is focused on the development of advanced therapies to treat patients with cancer.