The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law.
Background and Rationale:
• TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, a compound which may affect cancer cell growth and survival. Thus, TAS4464 may help in the treatment of cancer.
Phase 1:
Primary:
* To investigate the safety and tolerability of TAS4464
* To identify a tolerated dose of TAS4464
Secondary:
* To investigate the preliminary efficacy of TAS4464
* To investigate the pharmacokinetics (PK) and the pharmacogenomics (PGx) of TAS4464
* To investigate the pharmacodynamics of TAS4464
