The FDA has placed clinical holds on three trials run by Zentalis Pharmaceuticals after two study participants died, the biopharmaceutical company said June 18.
The San Diego-based company has been conducting a phase 1 and two phase 2 studies on azenosertib, a drug candidate for advanced solid tumors and hematologic malignancies. Two recent deaths in one of the phase 2 studies, which was targeting ovarian cancer, have led to a partial clinical hold.
The deaths are suspected to be related to sepsis, the drugmaker said in a news release.
The other phase 2 study is investigating how azenosertib affects uterine serous carcinoma, and the phase 1 trial is testing the therapy in solid tumors. More than 500 patients have received the experimental medicine.
"Patient safety is our top priority and any deaths that occur in the setting of clinical trials are unfortunate," Kimberly Blackwell, MD, CEO of Zentalis, said in the release. "We are working closely with the FDA to resolve this partial clinical hold as quickly as possible."