drugset / Trial / NCT05058352

A Study of HS269 in Patients With Advanced Solid Tumors

NCT05058352 ↗

Phase 1 Unknown 36 enrolled Zhejiang Hisun Pharmaceutical Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I, open-label, first in human study of HS269 tablet, a small molecule highly-selective RET Inhibitor. The dose-escalation study will assess the safety, tolerability, and pharmacokinetics of HS269 and determine the dose and schedule to be used in Phase II. Seventeen to thirty-six patients with advanced solid tumor may be enrolled in this study.

Timeline

Start
2021-10
Primary completion
2022-10
Completion
2023-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HS269 Small molecule 50 mg Oral
Subject HS269 Small molecule 100 mg Oral
Subject HS269 Small molecule 200 mg Oral
Subject HS269 Small molecule 300 mg Oral
Subject HS269 Small molecule 400 mg Oral
Subject HS269 Small molecule 500 mg Oral

Indications