Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TrasGEX™: Phase 1 Study in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01409343
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
Glycotope Biotechnology GmbH
Information provided by (Responsible Party):
Glycotope GmbH

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: TrasGEX™ Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: TrasGEX
A total of 37 patients with advanced HER2-positive carcinomas and progressive disease.
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.




Primary Outcome Measures :
  1. optimal dose and regimen of TrasGEX™ [ Time Frame: up to at least 8 weeks after the first TrasGEX™ administration ]
    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 :
  1. To determine preliminary evidence of activity [ Time Frame: approx. every 8 weeks ]
    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.

  2. safety and tolerability of TrasGEX™ [ Time Frame: until 4 weeks after the last treatment with TrasGEX™ ]
    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.

  3. To assess the pharmacokinetic (PK) profile of TrasGEX™ (part I) [ Time Frame: prior to 1st infusion until the end of 5th infusion ]
    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

  4. To assess the pharmacokinetic (PK) profile of TrasGEX™ (part II) [ Time Frame: prior to 1st infusion until the end of 5th infusion ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409343


Locations
Layout table for location information
Austria
Glycotope Investigational Site
Graz, Austria, 8036
Glycotope Investigational Site
Innsbruck, Austria, 6020
Germany
Glycotope Investigational Site
Hamburg, Germany, 20246
Italy
Glycotope Investigational Site
Milan, Italy
Switzerland
Glycotope Investigational Site
Bellinzona, Switzerland
Sponsors and Collaborators
Glycotope GmbH
Glycotope Biotechnology GmbH
Investigators
Layout table for investigator information
Study Director: Glycotope GmbH Glycotope GmbH
Publications of Results:
Layout table for additonal information
Responsible Party: Glycotope GmbH
ClinicalTrials.gov Identifier: NCT01409343    
Other Study ID Numbers: GEXMab73101
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Keywords provided by Glycotope GmbH:
advanced solid cancers
metastatic solid cancers