Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

Inclusion Criteria:

Age 18 years or older
Histologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer.
Platinum resistant disease, defined as progression within ≤ 6 months from completion of most recent regimen and calculated from the date of the last administered dose of platinum therapy
Must have available archived tumor tissue OR if archived tissue is not available, willing to provide a fresh tumor biopsy
Must have radiologic imaging with a computerized tomography (CT) scan or magnetic resonance imaging (MRI) within 4 weeks of first dose of study drug
Received at least 1 but not more than 3 therapy regimens, not including maintenance or adjuvant therapy
Must have ovarian cancer that is measurable according to RECIST 1.1
ECOG performance status of 0-1
Normal gastrointestinal (GI), bone marrow, liver and kidney function
At least 28 days between termination of prior anti-cancer or hormonal therapy and administration of AVB-S6-500

Exclusion Criteria:

Primary platinum-refractory disease (defined as progression during the first platinum regimen or within 4 weeks of completion of the first platinum regimen)
Currently being treated with concurrent anti-cancer therapy or any other interventional treatment or trial
Received prior therapy with Pac or PLD in the recurrent setting, depending on physician-chosen chemotherapy for this study
Significant cardiac disease history
Has other prior or concurrent malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
Symptomatic CNS metastasis or metastases
Serious active infection requiring IV antibiotics and/or hospitalization at study entry
Has known previous or current human immune deficiency (HIV) syndrome, hepatitis B, or hepatitis C
Has had paracentesis for ascites within 3 months