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 enrollment

- 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)

- 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 human immune deficiency (HIV) syndrome, hepatitis B, or hepatitis C