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

Inclusion Criteria:

Provision of a signed informed consent
Female participants of non-childbearing potential, ≥18 years of age
Anticipated life expectancy >3 months at the time of screening
Metastatic ovarian epithelial cancer that are platinum-resistant, and has no better option available in the investigator's opinion
Recurrent symptomatic malignant ascites having required at least 2 paracenteses within a 45-day interval prior to baseline paracentesis
Participants who have an indwelling draining IP catheter (to be drained only under medical supervision)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2

Adequate hematological function, defined as:

Platelet count ≥100,000/μL
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) <1.5 times the upper limit of normal (ULN)
Absolute neutrophil count ≥1,000/μL
Hemoglobin ≥9 g/dL, without the need for transfusion in the 2 weeks prior to screening
Adequate renal function, defined as serum creatinine ≤2.0 times ULN and creatinine clearance >50 mL/min or estimated glomerular filtration rate (eGFR) >50 mL/min/1.73 m^2

Adequate liver function, defined as:

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN for participants without liver metastases, or ≤5 times ULN in the presence of liver metastases
Bilirubin ≤2.0 times ULN, unless participant has known Gilbert's syndrome
Adequate venous access
Participant is willing and able to comply with the requirements of the protocol

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
Major surgery within 4 weeks (less than 28 days) prior to C1D1
Active joint inflammation or other immune disorder involving joints (osteoarthritis is not exclusionary)
Active infection involving IV antibiotics within 2 weeks prior to C1D1
Positive serology test for hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis
Positive serology test for human immunodeficiency virus (HIV) type 1 and 2, or known history of other immunodeficiency disease
Participant has received a live vaccine within 2 weeks (less than 14 days) prior to C1D1
Known hypersensitivity to any component of recombinant protein production by Chinese Hamster Ovary (CHO) cells
Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests and ECG), that in medical judgment of the investigator may impede the participant's participation in the study, pose increased risk to the participant, and/or confound the results of the study
Participant is a family member or employee of the investigator