Sellas Life Sciences doses first patient in Phase 2a trial of GFH009

SELLAS Life Sciences announced that the first patient has been dosed in a Phase 2a study of its novel and highly selective CDK9 inhibitor, GFH009, in combination with venetoclax and azacitidine in patients with relapsed/refractory acute myeloid leukemia who did not respond or stopped responding to venetoclax-based therapies. Topline data is expected during the fourth quarter of this year. The Phase 2a clinical trial is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of GFH009 in combination with aza/ven. The study will enroll up to 20 r/r AML patients, 10 patients per dose level, all of whom will receive standard doses of aza/ven after they became unresponsive to venetoclax combinations including aza/ven, with the addition of GFH009. Treatment will continue for as long as there are no dose limiting toxicities and no progression of disease. Bone marrow will be assessed after the first two infusions of GFH009: at day 14 and day 28. Thereafter, bone marrow assessments will be made every 28 days. In addition to safety and tolerability of GFH009 in combination with aza/ven, the primary endpoints are composite complete response rate and duration of response. Additional endpoints include event free survival, overall survival, and pharmacokinetic and pharmacodynamic assessments.