CrystalGenomics Completes Dosing of 'Ivaltinostat' in Cohort 1 of US Pancreatic Cancer Phase 1b/2 Clinical Trial

Jo Jung-myung, CEO of Crystal Genomics.

[Asia Economy Reporter Lee Gwan-joo] CrystalGenomics announced on the 6th that it has completed dosing for patients in Cohort 1 (dose 60 mg/㎡) of the US Phase 1b/2 clinical trial of 'Ivaltinostat' for pancreatic cancer.

After starting dosing for the first patient on August 15 and completing dosing and follow-up observation for the sixth patient, recruitment of 6 patients is currently underway for Cohort 2 (dose 125 mg/㎡). In Cohort 1, no dose-limiting toxicities (DLT) or serious adverse drug reactions were observed in any patient.

The Phase 1b trial involves 18 patients with progressive or metastatic pancreatic cancer who have had at least one prior treatment. The dosing is escalated from Cohort 1 to Cohort 2 and Cohort 3 (250 mg/㎡) to evaluate pharmacokinetics (PK), pharmacodynamics (PD), adverse reactions, and to select the optimal dose for the Phase 2 trial.

Subsequently, the Phase 2 trial will recruit a total of 52 patients with progressive or metastatic pancreatic cancer whose disease has not progressed after FOLFIRINOX therapy. Patients will be randomly assigned to a test group receiving a combination of Ivaltinostat and capecitabine or a control group receiving capecitabine monotherapy, to compare and evaluate efficacy endpoints such as progression-free survival (PFS), disease control rate (DCR), and overall survival (OS).

The clinical trial is being conducted at 25 institutions across the United States. A CrystalGenomics official stated, "Currently, multiple clinical trial sites are screening patients for Cohort 2, and if these patients meet the inclusion and exclusion criteria of the trial, recruitment for Cohort 2 patients is expected to proceed rapidly."