CrystalGenomics Applies for IND Approval for Phase 2/3 Clinical Trial in Pancreatic Cancer

[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 29th that it has submitted an Investigational New Drug application (IND) to the Ministry of Food and Drug Safety for approval of the Phase 2/3 clinical trial of ‘Ivaltinostat,’ which is being developed as a first-line treatment for pancreatic cancer.

The Phase 2/3 clinical trial for pancreatic cancer will be conducted on 170 patients with unresectable locally advanced or metastatic pancreatic cancer. The efficacy will be evaluated by dividing patients into a test group receiving a combination of Ivaltinostat and gemcitabine+erlotinib, and a control group. This will be compared with the currently most prescribed first-line treatment, the FOLFIRINOX regimen.

Approximately 30 patients will be enrolled in comparative trials for both the triple combination of Ivaltinostat and the FOLFIRINOX regimen. Based on interim evaluation results, each treatment arm will be expanded. The Phase 3 trial will be conducted by increasing the number of patients by 55 per arm, resulting in 85 patients per treatment arm (total 170 patients) for the Phase 3 trial.

The primary endpoints include improvements in overall survival (OS), progression-free survival (PFS), and disease control rate (DCR) with Ivaltinostat compared to the FOLFIRINOX regimen group.

Professor Siyoung Song of Yonsei University College of Medicine is the principal investigator of the clinical trial. The trial will recruit pancreatic cancer patients and be conducted using a randomized, open-label design.

Professor Siyoung Song of Yonsei Severance Hospital explained, "Ivaltinostat is an excellent new drug candidate," adding, "There was some regret in the earlier Phase 2 trial due to an insufficient number of patients completing the entire treatment cycle." He further stated, "If the Phase 2/3 trial is successfully conducted, it could mark a significant breakthrough in overcoming pancreatic cancer."

A CrystalGenomics representative explained, "In the earlier Phase 2 trial, we confirmed extended overall survival and safety in patients who completed the entire treatment cycle." They emphasized, "Although we initially planned to apply directly for Phase 3, due to concerns about the necessity of a control group and disagreements regarding the number of subjects, we plan to reapply for conditional approval through the Phase 2/3 trial."

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