The Phase 1, dose-escalation study of MDX-1338 as a monotherapy with chemotherapy is expected to enroll up to 34 patients with relapsed/ refractory AML.
Moreover, this trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary pharmacodynamics and efficacy of MDX-1338.
Howard H. Pien, Chairman and CEO of Medarex, said: we are pleased that MDX-1338 has progressed into the clinic, representing our eighth development candidate in oncology and further enhancing our focus on oncology/immunology therapeutic indications,
We believe that MDX-1338 could have potential activity in multiple cancers. Our first Phase 1 study will be conducted in AML and future studies are expected to target a variety of other leukemias and solid tumors and may involve monotherapy and combination therapy, he added.