Phase 1 Study of the HS-10365 in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title: A Phase 1, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Single and Multiple Doses of Oral Administration of HS-10365 in Patients With Locally Advanced or Metastatic Solid Tumors Who Have Progressed Following Prior Therapy

Status Recruiting

Clinical Trial Summary

HS-10365 is a small molecular, oral potent, selective RET inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of HS-10365 in Chinese advanced solid tumor patients. Anti-tumor activity will be also investigated in this study.

Clinical Trial Description

This is an open-label, multi-center, dose-escalation, first-in-human study in participants with advanced solid tumors, including RET fusion-positive non-small cell lung cancer and other tumors with RET activation. Participants with advanced cancer are eligible if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. There is a dose-escalation study, which is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of single dose and multiple doses of HS-10365 given once every day (QD) or twice every day (BID). An alternative dosing schedule may be investigated if the drug clearance of HS-10365 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 if the product is well tolerated and the subject has stable disease or better. ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

• NCT number: NCT05207787
• Study type: Interventional
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Shun Lu, MD
• Phone: 13601813062
• Email: [email protected]
• Status: Recruiting
• Phase: Phase 1
• Start date: November 9, 2021
• Completion date: December 31, 2023