NEW YORK – AnHeart Therapeutics said on Thursday that the first patient has been treated in a Phase II trial of safusidenib in patients with grades 2 or 3 recurrent or progressive IDH1-mutant glioma.
Researchers will evaluate five doses of safusidenib monotherapy in the Phase II trial to confirm the optimal dose. Part two of the trial will then evaluate efficacy and safety of safusidenib in IDH1-mutant glioma. Researchers will enroll 95 patients across both parts of the trial.
In results from the Phase I trial of safusidenib, published in June 2022, the drug demonstrated a response rate of 17.1 percent for enhancing gliomas, or those that have contrast enhancement in imaging, and 33.3 percent for non-enhancing gliomas.
AnHeart, based in New York, is also studying safusidenib in IDH1-mutant cholangiocarinoma and other solid tumors. The firm is also developing a ROS1 inhibitor, taletrectinib, that it is studying in ROS1-fusion positive non-small cell lung cancer and NTRK fusion-positive solid tumors.