Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications
BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.
- EligibilityCriteria: Inclusion Criteria:  Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists, Availability of FFPE tumor tissue, archival or newly obtained, Measurable disease as defined by RECIST Version 1.1, Adequate hematologic function, Adequate hepatic and renal function, Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1, Other inclusion criteria per study protocol.  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, Other exclusion criteria per study protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult