A Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)

Phase 1 Terminated 19 enrolled AbbVie

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-176 for participants with advanced solid tumors likely to express Prolactin Receptor (PRLR). The study will consist of 2 cohorts: Dose Escalation and Expanded Recommended Phase 2 Dose.

Timeline

Start: 2017-07-03
Primary completion: 2018-11-27
Completion: 2018-11-27

Outcome

Outcome not reported

Stopped: “Safety”

Publications

Lemech C, Woodward N, Chan N, Mortimer J, Naumovski L, Nuthalapati S, Tong B, Jiang F, Ansell P, Ratajczak CK, Sachdev J. A first-in-human, phase 1, dose-escalation study of ABBV-176, an antibody-drug conjugate targeting the prolactin receptor, in patients with advanced solid tumors. Invest New Drugs. 2020 Dec;38(6):1815-1825. doi: 10.1007/s10637-020-00960-z. Epub 2020 Jun 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABBV-176	Other / unclassified	2.7 ug/kg	Intravenous
Subject	ABBV-176	Other / unclassified	78.3 ug/kg	Intravenous
Subject	ABBV-176	Other / unclassified	99.9 ug/kg	Intravenous
Subject	ABBV-176	Other / unclassified	109.35 ug/kg	Intravenous

Indications

No indication recorded.