NCT04324372

Clinical Study of HEC68498 in Patients With Advanced Refractory Solid Tumors

An Open Label Multicentric Phase 1 Study of HEC68498 in Patients With Advanced Refractory Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Clinical study of HEC68498 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of HEC68498 in patients with advanced refractory solid tumors

Detailed description

An open label multicentric Phase 1 study of HEC68498 in patients with advanced refractory solid tumors.The study will follow a 3+3 design until significant toxicity as described in the protocol and considering pharmacokinetics of the study drug determined from cohorts.

Conditions

• Advanced Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	HEC68498	HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.

Timeline

• Start date: 2019-02-27
• Primary completion: 2021-02-26
• Completion: 2021-03-26
• First posted: 2020-03-27
• Last updated: 2022-08-12

Locations

1 site across 1 country: China