Spots Global Cancer Trial Database for TrasGEX™: Phase 1 Study in Cancer Patients

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Trial Identification

Brief Title: TrasGEX™: Phase 1 Study in Cancer Patients

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

Study ID: NCT01409343

Conditions

Solid Tumors

Interventions

TrasGEX™

Study Description

Brief 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.