Patients will be enrolled in Phase 1a, which consists of two stages: a dose-escalation stage and an expansion stage. IGM-8444 will be used as a single agent and in combination with numerous other agents where standard therapeutic regimens do not exist, have proven to be ineffective or intolerable, or are considered inappropriate.~Colorectal patients may be enrolled in Phase 1b, an open-label, randomized study of IGM-8444+FOLFIRI (± bevacizumab)~IGM-8444 will be investigated in numerous tumor types including all-comers solid tumors, colorectal carcinoma (CRC), sarcoma, non-Hodgkin's lymphoma (NHL), acute myeloid leukemia (AML), and chronic lymphocytic leukemia (CLL).~IGM-8444 will be administered intravenously (IV).~An alternative dosing schedule may be evaluated.
This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of IGM-8444+FOLFIRI (± bevacizumab).