Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications

Exclusion Criteria

• •Prior exposure to a selective RNR inhibitor (Note: Prior exposure to chemotherapies with nonselective RNR inhibitory activity e.g., gemcitabine is permitted),
• •Receipt of any approved or considered standard of care anticancer drug(s) or biological product(s) within 4 weeks or 5 half-lives,
• •Hematologic malignancies,
• •Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol,
• •Prior or concurrent malignancies, with exceptions per study protocol,
• •History of HBV, HCV, or HIV infection,
• •Clinically significant cardiac condition,
• •Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications,
• •QTcF \> 470 msec,
• •Concurrent use of strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9, or CYP2C19,