A Phase 1a/b Non-randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously to Patients with Solid Tumors

• The patient has a histologically confirmed solid tumor that is metastatic or unresectable for which standard measures do not exist or are no longer effective. (Patients with primary brain cancer or lymphoma are permitted. Patients with brain metastases are allowed if whole brain radiation was performed and is documented stable for ≥ 6 weeks)

• The patient is at least 18 years old.

• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• The patient has a life expectancy of \> 3 months.

• Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study

• Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment.

• The patient has adequate organ and marrow function as follows:

• ANC ≥ 1500 mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL,

• serum creatinine ≤1.8 mg/dL or creatinine clearance \> 50 mL/min (Appendix I);

• bilirubin ≤ 1.5 mg/dL; alanine aminotransferase (ALT), aspartate transaminase (AST) ≤ 2.5 times the upper limit of normal if no liver involvement or ≤ 5 times the upper limit of normal with liver involvement.

• The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).

• The patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (PTT), and an International Normalized Ratio within normal limits.

• The patient is capable of understanding and complying with the protocol and has signed the informed consent document.