Safety, Dose Tolerance, Pharmacokinetics, Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors

Inclusion Criteria

• Patient is male or female aged ≥18 years.
• Patient provided signed and dated informed consent prior to initiation of any study procedures.
• Patient is likely to have a new bladder tumor based on clinical presentation or is at high risk for tumor recurrence based on previous history.
• Patient has a cystoscopically confirmed bladder tumor and will be scheduled to undergo TURBT.
• Patient has not received prior treatment for bladder cancer or completed their last intravesical therapy >6 months before screening.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).
• Patient has a predicted life expectancy of ≥3 months.
• Patient has adequate renal function (creatinine ≤1.5 × the upper limit of the normal range (ULN) or an estimated glomerular filtration rate (eGFR) of >30 mL/min/1.73 m2).
• Patient has adequate hepatic function, as evidenced by a total bilirubin ≤1.5 × ULN, aspartate aminotransferase (AST) ≤3 × ULN and /or alanine aminotransferase (ALT) ≤3 × ULN.
• Patient has adequate bone marrow function, as evidenced by hemoglobin ≥9.0 g/dL in the absence of transfusion within the previous 72 hours, platelet count ≥100×10^9cells/L, and absolute neutrophil count (ANC) ≥1.5×10^9 cells/L.
• Patient has no significant ischemic heart disease or myocardial infarction within 6 months before the first dose of CPX-POM and currently has adequate cardiac function, as evidenced by a left ventricular ejection fraction of >50% as assessed by multi-gated acquisition (MUGA) or ultrasound/echocardiography (ECHO); and corrected QT interval by Fridericia's correction formula (QTcF) 150/100 mmHg despite optimal medical therapy).
• Patient has an uncontrolled or severe intercurrent medical condition. The decision to exclude a patient from the study for an uncontrolled or severe intercurrent medical condition will be made by the Principal Investigator. Examples could include epilepsy, resistant infection, or any other neurological disease that would make clinical assessment difficult.
• Patient underwent major surgery or radiation therapy within 4 weeks before the first dose of CPX-POM or received an investigational drug or device within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the first dose of CPX-POM. A minimum of 10 days between termination of the investigational drug and administration of CPX-POM is required.
• If female, patient is pregnant or breast-feeding.
• Patient has evidence of a serious active infection (e.g., infection requiring treatment with IV antibiotics).
• Patient has a known, active Hepatitis A infection.
• Patient has known human immunodeficiency virus (HIV) or Hepatitis B, or C infection, as such patients may be at increased risk for toxicity due to concomitant treatment and disease-related symptoms may preclude accurate assessment of the safety of CPX POM.
• Patient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study.
• Patient is taking warfarin.
• Patients may not have another malignancy that could interfere with the evaluation of safety or efficacy of the study drug. Patients with a prior malignancy will be allowed without approval in the following circumstances:
• Not currently active and diagnosed at least 3 years prior to the date of registration.
• Non-invasive diseases such as low risk cervical cancer or any cancer in situ.
• Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy), and in which no chemotherapy was indicated.(e.g., low/intermediate risk prostate cancer, etc.).
• Non-muscle invasive bladder cancer (NMIBC) for which