A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

Phase 1 Completed 61 enrolled AbbVie

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

Timeline

Start: 2016-11-18
Primary completion: 2019-10-29
Completion: 2019-10-29

Publications

Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2):e002015. doi: 10.1136/jitc-2020-002015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABBV-428	Unknown	0.01 mg/kg	Intravenous
Subject	ABBV-428	Unknown	3.6 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	—	Intravenous

Indications

No indication recorded.