NCT03603262

Safety, Tolerability and Pharmacokinetics of SH-1028 in Patients With Advanced NSCLC

A Phase I, Open-label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of SH-1028 Tablets in Patients With Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label study of SH-1028 with dose escalation and dose expansion cohorts in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent.

Detailed description

The study is designed to evaluate safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and orally (PO) administered SH-1028 tablets. The overall study design is shown in the flow chart below, which consists of 2 phases: dose escalation and dose expansion cohort.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SH-1028	Starting dose 60mg,oral administered once daily.If tolerated subsequent cohorts will test increasing doses (100mg,200mg,300mg,400mg) of SH-1028.

Timeline

• Start date: 2018-04-25
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-07-27
• Last updated: 2019-01-28

Locations

1 site across 1 country: China