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

ABSTRACT:

Purpose

BPM31510IV, a highly bioavailable intravenously administered coenzyme Q10 (CoQ10) formulation, was evaluated in a phase Ia/Ib study as monotherapy and in combination with chemotherapy in patients with advanced solid tumors.

Patients and methods

Using a 3 + 3 design, patients received twice-weekly intravenous infusions of BPM31510IV monotherapy (arm 1) or combined with gemcitabine, 5-fluorouracil/leucovorin, or docetaxel (arm 2); crossover between arms was permitted. Tumor response was assessed by RECIST1.1. Pharmacokinetic and multiomics pharmacodynamic (PD) analyses were performed on plasma and core biopsy samples.

Results

A total of 97 patients were enrolled, 33 in arm 1 and 71 in arm 2 (seven patients crossed from arm 1 to arm 2). The MTD was 171 mg/kg for

SUBMITTER: Subbiah V 

PROVIDER: S-EPMC12727275 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature