NCT05911464

A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10386 in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments.

Detailed description

This is a phase I open label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HS-10386 in subjects with advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HS-10386	Starting dose 10 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of HS-10386, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined

Timeline

• Start date: 2023-03-02
• Primary completion: 2025-10-31
• Completion: 2027-10-31
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: China