The phase I trial is being conducted in the US and will include up to 50 patients with advanced solid tumors and lymphoma who have either failed standard therapy or for whom no standard therapy exists. Patients will receive a once-a-week, oral administration of ZEN-012 for three consecutive weeks, followed by a one-week period without treatment.
The cycles are to be repeated every four weeks based on toxicity and response, for up to four cycles. Primary endpoints of the phase I trial will focus on determining the safety and tolerability of ZEN-012 as well as establishing the recommended phase II dose and regimen. Secondary endpoints are aimed at establishing the pharmacokinetics and determining the efficacy based on standard response criteria.
Dr Jurgen Engel, executive vice president for global R&D and COO at Aeterna Zentaris, said: “With this phase I trial, we hope to show that simultaneous inhibition of multiple targets may lead to tumor stabilization and regression. Taking into account the multiple mechanisms of action witnessed in our preclinical programs, we believe this compound has the potential to be a novel, promising multi-targeted oral intermittent cancer therapy.”