Phase 1, Dose-Escalation, Open-label, Safety and Pharmacokinetic, First in Human Study of BXQ-350 Administered as a Single Agent by Intravenous Infusion in Adult Patients With Advanced Solid Tumors and Recurrent High-Grade Gliomas

• Each patient must meet the following criteria:

‣ Provide signed, written informed consent prior to the initiation of any study-specific procedures

⁃ Have histologically or cytologically confirmed diagnosis of advanced solid tumor cancer (excluding lymphomas) for which there is no further standard therapy or when standard therapy is contraindicated. Patients with HGG must have shown unequivocal evidence for recurrence or progression by MRI scan or must have histologically proven tumor recurrence.

⁃ Patients with HGG: Have previously received radiotherapy and temozolomide

⁃ For patients with HGG and receiving glucocorticoid therapy, must be on stable or decreasing equivalent daily dose of glucocorticoids for 2 weeks (14 days) prior to dose assignment

⁃ Have measurable or non-measurable disease per RECIST 1.1 criteria for solid tumors and RANO criteria for HGG

⁃ Are males or females aged ≥ 18 years

⁃ Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2

⁃ Have acceptable liver function defined as:

• Total serum bilirubin ≤ 1.5 × upper limit of normal for the study site (ULN) (in patients with known Gilbert Syndrome, total bilirubin ≤ 3 × ULN, with direct bilirubin ≤ 1.5 × ULN)

∙ Aspartate Transaminase (AST), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alanine Transaminase (ALT), Serum Glutamic-Pyruvic Transamine (SGPT) ≤ 3 × ULN (if liver metastases are present, then ≤ 5 × ULN is allowed)

∙ Serum albumin ≥ 3 g/dL

⁃ Have acceptable renal function defined as:

‣ Serum creatinine ≤ 1.5 × ULN, OR calculated creatinine clearance ≥ 45 mL/min for patients with creatinine levels above 1.5 mg/dL

‣ Have acceptable bone marrow function defined as:

⁃ Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

• Platelet count ≥ 100,000 cells/mm3

• Hemoglobin \> 9.0 g/dL

‣ Have acceptable coagulation parameters defined as:

⁃ International normalized ratio (INR) ≤ 2 × ULN

• Activated partial thromboplastin time (aPTT) within normal limits

‣ Have a negative serum pregnancy test result at screening (for females of child bearing potential (FCBP); not applicable to patients who are unable to become pregnant, including those with tubal ligation, bilateral oophorectomy and/or hysterectomy, post-menopausal is defined as \> 12 months since last menstrual cycle)

‣ FCBP and male patients whose sexual partner(s) are FCBP must agree to abstain from heterosexual activity or use a double barrier method of contraception (e.g., condom and occlusive cap with spermicide) or highly effective contraception (intrauterine device or system, established hormonal contraceptive methods on a stable dose from the time of the last menstrual cycle, or vasectomized partner with confirmed azoospermia) from the time of study entry to 1 month after the last day of treatment