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Clinical Trial Summary

This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors. The study design consists of a dose-escalation stage and dose-expansion stage. Study participation will consist of a 28-day screening period, a treatment period, and a safety follow-up period 90-days after the last dose.


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-7354 safety and tolerability in patients with relapsed and/or refractory solid tumors. The dose expansion serial biopsy cohort will assess the intra-tumoral PD changes related to the activity of IGM-7354. IGM-7354 will be administered intravenously (IV). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05702424
Study type Interventional
Source IGM Biosciences, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date January 10, 2023
Completion date March 2026

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