Incuron Announces Notice of Allowance from FDA to Commence Clinical Trials of CBL0137.
Incuron announces the receipt of a Notice of Allowance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application (#124239) for CBL0137.
A Phase 1 Dose-Escalation and Cohort-Expansion Study of Intravenous CBL0137 in Subjects with Previously Treated Hematological Cancers is being initiated in 9 US and Russian clinical centers.
This clinical trial is a Phase 1, open-label, sequential-group, dose-escalation (Part 1) and cohort-expansion study (Part 2) evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of CBL0137.
Exploratory objectives for the study include changes relating to FACT (Facilitates Chromatin Transcription) partitioning, p53 expression, NF-κB pathway activation as assessed in peripheral blood mononuclear cells (PBMC) or circulating tumor cells and changes in the plasma concentrations of disease-associated chemokines and cytokines.
The safety, pharmacokinetics and pharmacodynamics of oral and intravenous formulations of CBL0137 are currently being investigated in two ongoing Phase 1 clinical trials in adults with advanced metastatic solid tumors cancers and lymphomas in Russia and USA.