A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer

Summary

This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy, safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract cancer (BTC). A total of approximately 30 subjects with advanced BTC will be enrolled. The subjects will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 600 mg orally once daily in the 28-day cycle until disease progression or intolerable toxic reaction, whichever occurs first.

Timeline

Start

2021-06-22

Primary completion

2022-12-28

Completion

2022-12-28

Outcome

Outcome not reported

Stopped: “The primary endpoint did not meet expectation.”

Drugs

Indications