Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer

Summary

HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell growth. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10352 at single dose and multiple doses.

Timeline

Start

2020-09-08

Primary completion

2023-04-30

Completion

2023-08-31

Publications

• Ouyang Q, Wang Y, Zhang J, Wu Q, Wei H, Li C, Qian X, Hu X. HS-10352 in hormone receptor-positive, HER2-negative advanced breast cancer: A phase 1 dose-escalation trial. Cancer Med. 2023 Dec;12(24):21849-21860. doi: 10.1002/cam4.6755. Epub 2023 Dec 1.

Drugs

Indications