Venetoclax and Lintuzumab-Ac225 in AML Patients

Phase 1/2 Unknown 38 enrolled Actinium Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

The study is a multicenter, open label Phase I/II trial. 1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapsed/refractory AML. (Phase 1 portion) 2. To assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to 6 months after the start of treatment without receiving other AML therapies. (Phase 2 portion)

Timeline

Start: 2020-01-15
Primary completion: 2023-11
Completion: 2024-06

Publications

Garg R, Allen KJH, Dawicki W, Geoghegan EM, Ludwig DL, Dadachova E. 225Ac-labeled CD33-targeting antibody reverses resistance to Bcl-2 inhibitor venetoclax in acute myeloid leukemia models. Cancer Med. 2021 Feb;10(3):1128-1140. doi: 10.1002/cam4.3665. Epub 2020 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LINTUZUMAB ACTINIUM AC-225	Other / unclassified	0.25 unknown	—
Subject	LINTUZUMAB ACTINIUM AC-225	Other / unclassified	0.5 unknown	—
Subject	LINTUZUMAB ACTINIUM AC-225	Other / unclassified	1 unknown	—
Subject	LINTUZUMAB ACTINIUM AC-225	Other / unclassified	1.5 unknown	—
Background	Spironolactone	Small molecule	25 mg	Oral
Background	Venetoclax	Small molecule	400 mg	Oral

Venetoclax and Lintuzumab-Ac225 in AML Patients

Summary

Timeline

Publications

Drugs

Indications