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Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04553692
Study type Interventional
Source IGM Biosciences, Inc.
Contact Clinical Trials
Phone (877) 544-6728
Email clinicaltrials@igmbio.com
Status Recruiting
Phase Phase 1
Start date September 23, 2020
Completion date January 2027

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