NCT04553692

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

An Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) As a Single Agent and in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: IGM Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be enrolled in Phase 1a, which consists of two stages: a dose-escalation stage and an expansion stage. Aplitabart 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 participants may be enrolled in Phase 1b, an open-label, randomized study of aplitabart+FOLFIRI+ bevacizumab. Aplitabart 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). Aplitabart will be administered intravenously (IV). An alternative dosing schedule may be evaluated.

Conditions

• Solid Tumor
• Colorectal Cancer
• Non Hodgkin Lymphoma
• Sarcoma
• Chondrosarcoma
• Small Lymphocytic Lymphoma
• Chronic Lymphocytic Leukemia
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Aplitabart (IGM-8444)	DR5 Agonist Investigational Drug
DRUG	FOLFIRI	Chemotherapy Regimen
DRUG	Bevacizumab (and approved biosimilars)	Targeted Therapy
DRUG	Birinapant	SMAC-mimetic Investigational Drug
DRUG	Venetoclax	Targeted Therapy
DRUG	Gemcitabine	Chemotherapy
DRUG	Docetaxel	Chemotherapy
DRUG	Azacitidine	Chemotherapy

Timeline

• Start date: 2020-09-23
• Primary completion: 2025-01-20
• Completion: 2025-01-20
• First posted: 2020-09-17
• Last updated: 2025-03-28

Locations

58 sites across 5 countries: United States, Australia, France, South Korea, Spain

Regulatory

• FDA-regulated drug study