Nuvation Bio (NUVB) said Monday that it has finalized a protocol amendment to upgrade an ongoing study of its cancer drug, safusidenib, from a mid-stage to a late-stage trial.
The expanded registrational study now includes patients with high-risk or high-grade IDH1-mutant astrocytoma who have completed standard care, the company said.
Participant enrollment for the trial will increase from 100 to 300 patients across the US, China, and Australia, Nuvation Bio said.
The updated protocol also introduces a new group to evaluate the treatment in patients with grade 3 IDH1-mutant oligodendroglioma who have not received chemotherapy or radiation, the company said.
Shares of the company were up less than 1% in recent Monday premarket activity.