FDA Lifts Partial Clinical Hold on Trials Evaluating Azenosertib in Advanced Solid Tumors

The FDA has lifted the partial clinical hold on studies evaluating the WEE1 inhibitor azenosertib in advanced solid tumors. The hold was initially placed on the phase 1 ZN-c3-001 trial, phase 2 DENALI trial for platinum-resistant ovarian cancer, and phase 2 TETON trial for uterine serous carcinoma due to 2 deaths from presumed sepsis in the DENALI trial. After reviewing Zentalis Pharmaceuticals' complete response package, the FDA allowed the studies to resume without changes to the clinical development plan.