TrasGEX™: Phase 1 Study in Cancer Patients
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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
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumors | Drug: TrasGEX™ | Phase 1 |
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.
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.
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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. |
- 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.
- 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.
- 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.
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
- Signed written informed consent granted prior to initiation of any study-specific procedures;
- Male or female patients of ≥18 years of age;
- ERBB2 (HER-2) gene amplification or ERBB2 overexpression
- Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
- No anti-tumor therapy of proven benefit available at study enrollment;
- Life expectancy of >=3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;
- 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™;
- 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:
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
- Major surgery within four weeks of the first dose of TrasGEX™;
- Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
- History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
- 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™;
- Left ventricular ejection fraction <50%;
- Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
- Pregnancy or lactation; and
- Concurrent uncontrolled significant illness

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
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 |
Study Director: | Glycotope GmbH | Glycotope GmbH |
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 |
advanced solid cancers metastatic solid cancers |