A Phase 1 Dose Escalation Study of AMG 780 in Adult Subjects With Advanced Solid Tumors

Phase 1 Terminated 44 enrolled Amgen

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a first in human, open-label, sequential dose escalation and expansion study of AMG 780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will be dependent upon emerging safety and PK data from the dose escalation part of the study.

Timeline

Start: 2010-06
Primary completion: 2013-12
Completion: 2014-04

Outcome

Outcome not reported

Stopped (Business): “Part A, the dose escalation and primary objective of the study, was completed. Part B, the dose expansion, was not conducted due to a business decision.”

Publications

Crockett SD, Barry EL, Mott LA, Snover DC, Wallace K, Baron JA. Predictors of Incident Serrated Polyps: Results from a Large Multicenter Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2022 May 4;31(5):1058-1067. doi: 10.1158/1055-9965.EPI-21-1226.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AMG 780	Unknown	—	Intravenous