DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer

Summary

DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy and in combination with trastuzumab and/or capecitabine, or in combination with T-DM1

Timeline

Start

2020-09-21

Primary completion

2022-07-07

Completion

2022-07-07

Publications

• Zhang J, McAndrew NP, Wang X, Du Y, DiCarlo B, Wang M, Chen K, Yu W, Hu X. Preclinical and clinical activity of DZD1516, a full blood-brain barrier-penetrant, highly selective HER2 inhibitor. Breast Cancer Res. 2023 Jul 6;25(1):81. doi: 10.1186/s13058-023-01679-4.

Drugs

Indications