Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2
Status:
Completed
Trial end date:
2019-01-28
Target enrollment:
Participant gender:
Summary
This Phase 1b trial is an open label, multi-center study of XMT-1522 administered as an
intravenous infusion once every three weeks. The dose escalation part of the study will
establish the maximum tolerated dose or recommended Phase 2 dose for in patients with
advanced breast cancer and either a HER2 immunohistochemistry (IHC) score of at least 1+
using a validated IHC assay or with evidence of HER2 amplification. Patients with HER2
positive (by IHC or amplification) gastric cancer or nonsmall cell lung cancer may also be
eligible for participation in dose escalation. Upon completion of dose escalation, the cohort
expansion segment of the study will consist of four parallel cohorts of different patients
groups to confirm the maximum tolerated dose or the recommended Phase 2 dose and estimate the
objective response in each of the patient populations.