CrystalGenomics Administers First Patient with 'Ivaltinostat' in US Pancreatic Cancer Clinical Trial

[Asia Economy Reporter Lee Gwan-ju] CrystalGenomics announced on the 17th that it has completed the first patient dosing for the Phase 1b/2 clinical trial of 'Ivaltinostat' for pancreatic cancer in the United States.

The first patient dosing took place at the University Medical Center New Orleans in the United States. Going forward, patient recruitment and dosing will be conducted at more than 25 clinical sites.

This clinical trial targets 18 patients with advanced or metastatic pancreatic cancer who have had at least one prior treatment experience, to evaluate dose-dependent pharmacokinetics, pharmacodynamics, adverse reactions, and tolerability. Through analysis of each dose, the optimal dosing for the Phase 2 clinical trial will be selected.

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

Prior to the U.S. trial, a Phase 2 clinical trial of Ivaltinostat was conducted at Sinchon Severance Hospital on 24 patients with unresectable advanced or metastatic pancreatic cancer who had not received prior treatment. The results showed a disease control rate (DCR) of 93.8%, an objective response rate (ORR) of 25%, and a median overall survival (mOS) of 10.8 months. Compared to the results of the standard treatment regimen using only two drugs (gemcitabine and erlotinib), these key indicators improved nearly twofold.

A CrystalGenomics representative stated, “With more than 25 hospitals participating in the U.S. trial alone, we are fully prepared to achieve good results based on our previous clinical trial experience and are doing our best to secure objective data.”

This content was produced with the assistance of AI translation services.