drugset / Trial / NCT04553692

Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

NCT04553692

Phase 1 Terminated 272 enrolled IGM Biosciences, Inc.
RandomizedSequentialOpen-labelTreatment

Summary

This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitabart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of aplitabart+FOLFIRI+bevacizumab.

Timeline

Start
2020-09-23
Primary completion
2025-01-20
Completion
2025-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Aplitabart Monoclonal antibody Intravenous
Subject Azacitidine Other / unclassified
Subject Birinapant Small molecule Intravenous
Subject Docetaxel Small molecule
Subject Gemcitabine Small molecule
Subject Venetoclax Small molecule
Background Bevacizumab Monoclonal antibody Intravenous
Background Irinotecan Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Background fluorouracil Small molecule Intravenous