Phase Ia/b Multicenter Study of BPM31510IV Targeting Mitochondrial Metabolism/Warburg Effect as Monotherapy and Combination Chemotherapy in Solid Tumor Patients

BPM31510IV is a lipid nanodispersion of oxidized CoQ10 that alters the Warburg effect and displays anticancer activity. BPM31510IV seems to synergize with chemotherapy to induce cancer cell apoptosis, likely through mitochondrial priming. An initial phase I monotherapy study demonstrated that BPM31510IV is well tolerated in patients with advanced solid tumors. Based on these observations, the safety and preliminary antitumor activity of BPM31510IV were further explored in a phase Ia/Ib study in combination with chemotherapy. Results indicated that BPM31510IV monotherapy and BPM31510IV combined with chemotherapy are well tolerated, demonstrating preliminary evidence of antitumor activity and inducing physiologic and molecular changes consistent with altered mitochondrial metabolism. The most common adverse events were changes in coagulation parameters. Overall, this study provides valuable MTD and surrogate efficacy data that support the continued clinical development of BPM31510IV.