TrasGEX™: Dose Escalation Study

This study has been completed.
Sponsor:
Collaborator:
Glycotope Biotechnology GmbH
Information provided by:
Glycotope GmbH
ClinicalTrials.gov Identifier:
NCT01409343
First received: July 18, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

This is 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 will also be evaluated.


Condition Intervention Phase
Solid Tumors
Drug: TrasGEX™
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation and Pharmacokinetic Study of TrasGEX™ in Patients With Locally Advanced or Metastatic HER-2-positive Cancer

Resource links provided by NLM:


Further study details as provided by Glycotope GmbH:

Primary Outcome Measures:
  • optimal dose and regimen of TrasGEX™ [ Time Frame: up to at least 8 weeks after the first TrasGEX™ administration ] [ Designated as safety issue: Yes ]
    The primary objective of this first-in-man study is to determine the optimal dose and regimen of TrasGEX™ in patients with locally advanced or metastatic human epidermal growth factor receptor-2 (HER-2)-positive cancer. The recommended phase II dose needs to have an acceptable safety profile and provides evidence for efficacy based on clinical observations or the pharmacokinetic profile.


Secondary Outcome Measures:
  • To determine preliminary evidence of activity [ Time Frame: approx. every 8 weeks ] [ Designated as safety issue: No ]
    CT or MRI imaging will be performed. Assessment of tumor response (SD, PR, CR. PD) will be performed following a modified version of the revised RECIST guidelines, version 1.1. Basically, patients will receive treatment with TrasGEX™ until progression of disease and/or unacceptable toxicities are observed.

  • safety and tolerability of TrasGEX™ [ Time Frame: until 4 weeks after the last treatment with TrasGEX™ ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of TrasGEX™ in patients with advanced and/or metastatic HER-2-positive cancer at various dose levels considering observed adverse events, laboratory values, vital signs, ECOG performance status and physical examination.

  • To assess the pharmacokinetic (PK) profile of TrasGEX™ (part I) [ Time Frame: prior to 1st infusion until the end of 5th infusion ] [ Designated as safety issue: No ]
    c(max): to determine the PK profile samples will be taken before the first infusion and up to 24 h after after infusion, followed by weekly samples for the first infusion and samples immediately before and after infusion for the following infusions

  • To assess the pharmacokinetic (PK) profile of TrasGEX™ (part II) [ Time Frame: prior to 1st infusion until the end of 5th infusion ] [ Designated as safety issue: No ]
    t(1/2): to determine the PK profile samples will be taken before the first infusion and up to 24 h after after infusion, followed by weekly samples for the first infusion and samples immediately before and after infusion for the following infusions


Estimated Enrollment: 45
Study Start Date: July 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Signed written informed consent granted prior to initiation of any study-specific procedures;
  2. Male or female patients of ≥18 years of age;
  3. ERBB2 (HER-2) gene amplification or ERBB2 overexpression
  4. Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
  5. No anti-tumor therapy of proven benefit available at study enrollment;
  6. Life expectancy of >=3 months;
  7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;
  8. Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™;
  9. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™;

and

Main Exclusion Criteria:

  1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
  2. Major surgery within four weeks of the first dose of TrasGEX™;
  3. Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required;
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
  5. History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
  6. History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™;
  7. Left ventricular ejection fraction <50%;
  8. Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
  9. Pregnancy or lactation; and
  10. Concurrent uncontrolled significant illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409343

Locations
Austria
Glycotope Investigational Site
Graz, Austria, 8036
Glycotope Investigational Site
Innsbruck, Austria, 6020
Sponsors and Collaborators
Glycotope GmbH
Glycotope Biotechnology GmbH
Investigators
Study Director: Glycotope GmbH Glycotope GmbH
  More Information

No publications provided

Responsible Party: Glycotope GmbH, Study Director, Glycotope GmbH
ClinicalTrials.gov Identifier: NCT01409343     History of Changes
Other Study ID Numbers: GEXMab73101
Study First Received: July 18, 2011
Last Updated: December 19, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Glycotope GmbH:
advanced solid cancers
metastatic solid cancers

ClinicalTrials.gov processed this record on April 17, 2014