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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03639246.
While this study was planned as two-part study consisting of a Phase 1b and a Phase 2
portion, the sponsor decided not to proceed with the Phase 2 portion.
The Phase 1b portion of the study was a multicenter, 2-group, open-label design to
evaluate the safety and tolerability of AVB-S6-500 combined with PLD or Pac in subjects
with platinum-resistant recurrent ovarian cancer. The decision to enroll in the Phase 2
portion of the study was to be driven by the recommendation of a safe and tolerable dose
of AVB-S6-500 in combination with each chemotherapy backbone; however, enrollment into
the Phase 2 portion was not initiated per Sponsor decision. Given that sufficient data
were obtained in the Phase 1b portion AVB-S6-500 + Pac group, the decision was made to
pursue a randomized Phase 3 to further study the benefit of this combination versus
paclitaxel alone in patients with platinum resistant ovarian cancer.
Lead OrganizationAravive, Inc.
