Solid Tumors Clinical Trial
Official title:
A Phase I Dose-Escalation and Pharmacokinetic Study of TrasGEX™ in Patients With Locally Advanced or Metastatic HER-2-positive Cancer
NCT number | NCT01409343 |
Other study ID # | GEXMab73101 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | December 2013 |
Verified date | May 2021 |
Source | Glycotope GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | December 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Glycotope Investigational Site | Graz | |
Austria | Glycotope Investigational Site | Innsbruck | |
Germany | Glycotope Investigational Site | Hamburg | |
Italy | Glycotope Investigational Site | Milan | |
Switzerland | Glycotope Investigational Site | Bellinzona |
Lead Sponsor | Collaborator |
---|---|
Glycotope GmbH | Glycotope Biotechnology GmbH |
Austria, Germany, Italy, Switzerland,
Fiedler W, Stoeger H, Perotti A, Gastl G, Weidmann J, Dietrich B, Baumeister H, Danielczyk A, Goletz S, Salzberg M, De Dosso S. Phase I study of TrasGEX, a glyco-optimised anti-HER2 monoclonal antibody, in patients with HER2-positive solid tumours. ESMO O — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | optimal dose and regimen of TrasGEX™ | 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. | up to at least 8 weeks after the first TrasGEX™ administration | |
Secondary | To determine preliminary evidence of activity | 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. | approx. every 8 weeks | |
Secondary | safety and tolerability of 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. | until 4 weeks after the last treatment with TrasGEX™ | |
Secondary | To assess the pharmacokinetic (PK) profile of TrasGEX™ (part I) | 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 | prior to 1st infusion until the end of 5th infusion | |
Secondary | To assess the pharmacokinetic (PK) profile of TrasGEX™ (part II) | 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 | prior to 1st infusion until the end of 5th infusion |
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