Spots Global Cancer Trial Database for Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer
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Trial Identification
Brief Title: Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer
Official Title: A Phase I, Open-label Study to Assess the Safety and Tolerability of Ascending Doses of SH-1028 Tablets in Patients With Advanced Solid Cancer
Study ID: NCT03618043
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 1, open-label study of SH-1028 with dose escalation cohorts in locally advanced solid cancer patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent or standard treatment.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Shanghai east hospital, Shanghai, , China
Contact Details
Name: JIN LI, MD
Affiliation: Shanghai East Hospital
Role: PRINCIPAL_INVESTIGATOR
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