Phase I study of BPM 31510 in advanced solid tumors: Omics-based molecular correlation to outcome for patient stratification.

2550Background: BPM 31510 targets the metabolic machinery of cancer cells to reverse the Warburg effect. The current study evaluates BPM 31510 as a 6-day continuous infusion as a single agent and in combination with 3 standard weekly chemotherapy regimens. The study was designed to determine the Phase II dose and infer multi-omic patient-centric signatures identifying molecular predictive markers of clinical benefit and patient stratification. Methods: Eligible patients (pts) (aged ≥ 18 y) were relapsed/refractory to standard therapy. The monotherapy arm received IV BPM 31510 for 6 d in continuous infusion in 28-d cycles, and combination arms (gemcitabine, 5-FU or docetaxel) were primed for 3 wks followed by weekly dosing in a 6 wk cycle. Doses were escalated in a 3+3 schema. Endpoints were safety, PK and multi-omics analysis. Tumor response is evaluated at wk 2 and then after every 2 cycles. Results: As of 10 Dec 2015, 85 pts have been enrolled. DLTs were reported at 171mg/kg in mono and at 137mg/kg in t...