Clinical TrialMay 5, 2026, 08:08 AM
Zentalis Doses First Patient in Phase 3 ASPENOVA Trial for Ovarian Cancer
AI Summary
Zentalis Pharmaceuticals announced the dosing of the first patient in its global Phase 3 ASPENOVA clinical trial for azenosertib, targeting Cyclin E1-positive platinum-resistant ovarian cancer (PROC). This randomized, confirmatory trial aims to enroll approximately 420 patients, comparing azenosertib monotherapy to standard-of-care chemotherapy. The trial is part of a dual-track regulatory strategy, with the ongoing DENALI Phase 2 trial pursuing accelerated approval and ASPENOVA designed to support full approval, with its design aligned with FDA requirements. Azenosertib, a WEE1 inhibitor, has Fast Track Designation and targets a biomarker-selected population representing about 50% of PROC patients.
Key Highlights
- First patient dosed in the Phase 3 ASPENOVA clinical trial for azenosertib.
- The trial evaluates azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
- ASPENOVA is a randomized, confirmatory trial expected to enroll approximately 420 patients.
- It compares azenosertib monotherapy (400mg QD 5:2) to standard-of-care chemotherapy.
- The trial supports full approval, complementing the DENALI Phase 2 for accelerated approval.
- Topline readout for the DENALI Part 2 trial is expected by year-end 2026.
- Azenosertib has received Fast Track Designation from the U.S. FDA.
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