NCT01409343

TrasGEX™: Phase 1 Study in Cancer Patients

A Phase I Dose-Escalation and Pharmacokinetic Study of TrasGEX™ in Patients With Locally Advanced or Metastatic HER-2-positive Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Glycotope GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated.

Detailed description

Adult patients with advanced and/or metastatic HER2-positive cancer who were resistant to or for whom there was no standard anti-tumor therapy available at the time of enrollment and who had an estimated life expectancy of at least 3 months were eligible for participation in this study. Patients were to receive the study drug until disease progression (clinical or radiologic), unacceptable toxicity, or any other reason leading to termination of study treatment. Dose-escalation was performed in 3 to 6-patient cohorts.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	TrasGEX™	Patients received TrasGEX intravenously every 3 weeks until disease progression in doses of 12-720 mg in a three-plus-three dose escalation design, including an expansion cohort at the highest dose.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2011-08-04
• Last updated: 2021-05-07

Locations

5 sites across 4 countries: Austria, Germany, Italy, Switzerland