CrystalGenomics Starts Fourth Patient Dosing of Ivaltinostat in US Pancreatic Cancer Clinical Trial

"Smooth Recruitment of Patients for Clinical Phase 1b/2"

[Asia Economy Reporter Lee Gwan-joo] CrystalGenomics announced on the 20th that it has started dosing the 4th patient in the US for the Ivaltinostat pancreatic cancer Phase 1b/2 trial.

Currently, two additional subjects are being screened at hospitals in the US, and if they meet the clinical trial criteria, patient recruitment for Cohort 1 is expected to be completed by early October.

The 4th patient dosing took place at the Roswell Park Comprehensive Cancer Center in Buffalo, New York. After the first patient successfully completed the clinical trial cycle on the 17th of last month, dosing for three new patients began simultaneously.

In this clinical trial, 18 patients with advanced or metastatic pancreatic cancer who have had at least one prior treatment experience will be administered increasing doses to evaluate pharmacokinetics (PK), pharmacodynamics (PD), adverse reactions, and tolerability, in order to select the optimal Phase 2 clinical dosing.

Subsequently, Phase 2 will recruit a total of 52 patients with advanced or metastatic pancreatic cancer whose disease has not progressed after FOLFIRINOX therapy. The trial will compare the efficacy of combination therapy of Ivaltinostat and Roche's capecitabine with capecitabine monotherapy as a control group, evaluating progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and other endpoints.

A CrystalGenomics representative stated, “As we are conducting clinical collaboration with world-renowned oncology experts such as Roswell Park Comprehensive Cancer Center, Clinical Research Alliance, and Karmanos Cancer Institute in the US, we will strive to produce objective data.”

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