A PHASE 1B/2 RANDOMIZED, CONTROLLED STUDY OF AVB-S6-500 IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN OR PACLITAXEL IN PATIENTS WITH PLATINUM-RESISTANT RECURRENT OVARIAN CANCER

NOT ENROLLING
Protocol # :
18-554
Conditions
Ovarian Cancer
Phase
I/II
Disease Sites
Ovary
Principal Investigator
Liu, Joyce, F
Site Investigator
Yeku, Oladapo, O.
Site Research Nurses
Bowes, Brittany, N.
Colella, Tina
Hindenach, Sarah
Hurley-Whalen, Christin
Keis, Rylee
Morrissey, Stephanie, C.

Trial Description

This is a Phase 1b/2 study of AVB-S6-500 in combination with pegylated liposomal doxorubicin
(PLD) or paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer. The
phase 1b portion of the study is open label and patients will receive either AVB-S6-500+PLD
or AVB-S6-500+ Pac. The Phase 2 portion of the study is randomized, double-blind,
placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination
with PLD or Pac versus placebo plus PLD or Pac.

Eligibility Requirements

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

18-554