drugset
drugset / Trial / NCT03603262

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

NCT03603262 ↗

Phase 1 Unknown 85 enrolled Nanjing Sanhome Pharmaceutical, Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-04-25
Primary completion
2019-12
Completion
2019-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject ORITINIB Small molecule 60 mg Oral
Subject ORITINIB Small molecule 100 mg Oral
Subject ORITINIB Small molecule 200 mg Oral
Subject ORITINIB Small molecule 240 mg Oral
Subject ORITINIB Small molecule 300 mg Oral
Subject ORITINIB Small molecule 400 mg Oral

Indications

non-small cell lung carcinoma