NCT03246854

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Head and Neck Cancer
• NSCLC

Interventions

Type	Name	Description
DRUG	DBPR112	DBPR112 hard gelatin capsule solid dosage formulation; strength: 25 mg, 100 mg.

Timeline

• Start date: 2017-07-18
• Primary completion: 2018-08-04
• Completion: 2018-08-04
• First posted: 2017-08-11
• Last updated: 2020-12-17

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study