NCT04477057

PhaseⅠStudy of the HS-10241 in Patients With Advanced Solid Tumors

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

HS-10241 is a highly potent and selective small molecule inhibitor of c-Met kinase. In preclinical studies, it demonstrated strong activity against c-Met kinase in vitro and in vivo, and inhibited tumor cell growth. This study 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-10241 at single dose and multiple doses.

Detailed description

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	HS-10241	HS-10241 is a tablet in the form of 100 mg, oral, once daily.

Timeline

• Start date: 2019-06-21
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2020-07-20
• Last updated: 2020-07-20

Locations

1 site across 1 country: China