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Phase Study of the HS-10241 in Patients With Advanced Solid Tumors

Phase Study of the HS-10241 in Patients With Advanced Solid Tumors

Recruiting
18-75 years
All
Phase 1

This is a phase 1, open-label, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of single and multiple doses of oral administration of HS-10241 in patients with locally advanced or metastatic solid tumors who have progressed following prior therapy. There is a dose-escalation study, which is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and repeat doses of HS-10241 given once every day (QD). An alternative dosing schedule of twice every day (BID) may be investigated if the drug clearance of HS-10241 is faster than anticipated.

All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Subjects of this study will be permitted to continue therapy with assessments for progression once every 6 weeks, if the product is well tolerated and the subject has stable disease or better. As the disease progresses, survival follow-up is recommended bimonthly.

Study details
    Solid Tumor

NCT04477057

Jiangsu Hansoh Pharmaceutical Co., Ltd.

19 February 2024

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