Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer

Exclusion criteria

• . Known central nervous system metastasis that is unstable within the last 2 months
• . Prior malignancy within the past 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin, ductal carcinoma in situ of breast, in situ cervical carcinoma, and superficial bladder cancer
• . Residual AEs \>Grade 2 from previous treatment
• . Myocardial infarction within 6 months prior to C1D1 treatment, and/or prior diagnoses of congestive heart failure (New York Heart Association Class III or IV), unstable angina, unstable cardiac arrhythmia requiring medication; and/or the participant is at risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or long QT syndrome)
• . Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg confirmed upon repeated measures
• . Left ventricular ejection fraction \<50% as determined by echocardiogram (ECHO) performed at screening or within 30 days prior to C1D1
• . QT/QTc interval \>480 msec, before C1D1 treatment administration, as determined by screening electrocardiogram (ECG)
• . Received anti-tumor therapy (chemotherapy, investigational product, radiotherapy, retinoid therapy, or hormonal therapy) within 2 weeks (less than 14 days) prior to C1D1 with no residual toxicity \>Grade 1; antibody therapy, molecular targeted therapy within 5 half-lives prior to C1D1