NCT05702424

Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer

An Open-Label, Multicenter, Phase 1 Study of IGM-7354 in Adult Participants With Relapsed and/or Refractory Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: IGM Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	IGM-7354	IGM-7354 is a PD-L1-targeted cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2023-01-27
• Last updated: 2024-07-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study