Cero doses third patient in starting dose cohort of Phase 1 CER-1236 trial

CERo Therapeutics (CERO) dosed the third patient in the starting dose cohort of its Phase 1 clinical trial evaluating CER-1236 in acute myeloid leukemia. Per protocol, three patients are planned at this lowest dose level, and enrollment of the third subject may complete the initial cohort pending the outcome of protocol-defined safety assessments, including the dose-limiting toxicity evaluation period. The ongoing first-in-human, multi-center, open-label, Phase 1/1b study is designed to evaluate the safety, tolerability, and preliminary activity of CER-1236 in patients with AML that is relapsed/refractory, in remission with measurable residual disease, or newly diagnosed with TP53-mutated MDS/AML or AML. The two-part trial begins with dose escalation to establish a recommended Phase 2 dose, followed by an expansion phase to further characterize safety and exploratory efficacy. Primary outcome measures include incidence of adverse events, serious adverse events, dose-limiting toxicities, and preliminary anti-leukemic activity as measured by overall response rate, complete response, composite complete response, and measurable residual disease. Secondary outcome measures include pharmacokinetics.