NCT04843033

A Study to Investigate Safety and Tolerability of SH3809 Tablet in Patients With Advanced Solid Tumors

A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3809 Tablet in Patients With Advanced Solid Tumors in China

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine the safety and tolerability of SH3809 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3809 in solid tumors.

Detailed description

This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3809 tablet, a small molecule inhibitor of SHP2 receptor , in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SH3809 tablet	Starting dose 2mg,oral administered once daily. If tolerated subsequent cohorts will test increasing doses (4mg,6mg,8mg,10mg,12mg) of SH3809.

Timeline

• Start date: 2021-04-02
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2021-04-13
• Last updated: 2021-04-13

Locations

1 site across 1 country: China