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TrasGEX™: Phase 1 Study in Cancer Patients

NCT01409343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-05-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Glycotope Biotechnology GmbH

    collaborator INDUSTRY

  • Glycotope GmbH

    lead INDUSTRY

Principal Investigators

  • Glycotope GmbH · Glycotope GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • Austria
  • Germany
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409343 on ClinicalTrials.gov