A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

Exclusion criteria

• . Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.
• . Has received a prior total cumulative anthracycline dose of ≥ 350 mg/m2 doxorubicin (or equivalent anthracycline dose).
• . Has clinically significant or untreated central nervous system (CNS) metastases or leptomeningeal disease requiring treatment, as determined by the Investigator.
• . Patients who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal PSA) within 2 years of study entry.
• . Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.
• . In the opinion of the investigator, has uncontrolled hypertension (systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \>100 mm Hg), unstable angina, CHF (New York Heart Association (NYHA) Class \>II), left ventricular ejection fraction (LVEF) \<55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment (exceptions include atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline (T or I).
• . Has a screening baseline mean corrected QTcF interval by Fridericia (QTcF) of \>480 msec. Electrocardiograms (ECGs) will be evaluated locally at the investigator site. Has any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 msec). Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, known family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval, a baseline resting bradycardia \<45 beats/min or a baseline resting tachycardia of \>100 beats/min.
• . HIV infection: