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Clinical Trial Summary

This study is a first-in-human, Phase 1, 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 cancers


Clinical Trial Description

Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-8444 in patients with solid tumors, IGM-8444 in combination with FOLFIRI for colorectal carcinoma patients, IGM-8444 in combination with birinapant in patients with solid tumors, and IGM-8444 in combination with venetoclax in patients with CLL/SLL. The IGM-8444 single agent expansion cohort will enroll solid tumor patients and may include relapsed/refractory non-Hodgkin lymphoma patients. The IGM-8444 + FOLFIRI with or without bevacizumab combination expansion cohorts will enroll colorectal carcinoma patients. The IGM-8444 + birinapant combination expansion cohort will enroll solid tumor patients, IGM-8444 in combination with venetoclax will enroll patients with CLL/SLL. 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 650 265 6428
Email [email protected]
Status Recruiting
Phase Phase 1
Start date September 23, 2020
Completion date October 2023

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