Abstract
2505Background: CC-115 is a potent inhibitor of DNA-PK and TOR kinase (DNA-PKi/TORKi) with broad pre-clinical anti-tumor activity. Methods: Subjects with relapsed/refractory advanced solid and hematologic cancers enrolled in a first-in-human Phase 1a/b study of CC-115 given orally once or twice daily until disease progression in dose escalation and expansion cohorts. Results: 44 subjects evaluated across 10 dose escalation cohorts (0.5 – 40 mg) established 10 mg twice-daily (BID) as the recommended dose for cohort expansion in 62 additional subjects with glioblastoma multiforme (GBM: 14), head and neck squamous carcinoma (HNSCC: 18), chronic lymphocytic leukemia (CLL: 8), and ETS-overexpressing tumors (castration-resistant prostate cancer [CRPC: 12] and Ewing’s sarcoma [ES: 10]). The most common (> 20%) expansion phase related adverse events were fatigue (37%), nausea (31%), decreased appetite (29%), and hyperglycemia (24%). Linear, dose proportional exposure was observed with a terminal half life of 4 to...
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