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A Study of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer

Head and Neck Cancer Clinical Trial

Official title:
Phase I, Open-Label, Multiple Dose, Dose-Finding and Expansion Clinical Study to Assess the Safety, Pharmacokinetics, and Efficacy of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer

Clinical Trial Summary

The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR mutated lung cancer.

Clinical Trial Description

This is a Phase I, multi-center, open-label, first-in-human study to determine the MTD and RP2D of DBPR112 and to assess the safety, tolerability and PK of DBPR112 in Asian patients. Patients with non-small cell cancer (NSCLC) who have progressed following prior therapy with an epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor or in patients with squamous cell cancer of head and neck (SCCHN) who have progressed following prior standard therapy will be selected. Approximately 24 to 30 patients will be enrolled in this study as out patients/inpatients, in 2 study centers in Taiwan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03246854
Study type Interventional
Source National Health Research Institutes, Taiwan
Contact
Status Terminated
Phase Phase 1
Start date July 18, 2017
Completion date August 4, 2018
View Details
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