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Solid TumorsPhase 1NCT01409343

TrasGEX™: Phase 1 Study in Cancer Patients

A Phase 1 study testing TrasGEX™ in people with Solid Tumors, run by Glycotope GmbH at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
TrasGEX™
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
5 sitesin 4 countries
Study dates
Jul 2011to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Austria2 sites

  • Glycotope Investigational Site

    Graz, 8036

  • Glycotope Investigational Site

    Innsbruck, 6020

Other trials in Austria

Germany1 site

  • Glycotope Investigational Site

    Hamburg, 20246

Other trials in Germany

Italy1 site

  • Glycotope Investigational Site

    Milan

Other trials in Italy

Switzerland1 site

  • Glycotope Investigational Site

    Bellinzona

Other trials in Switzerland

About this study

Official title: A Phase I Dose-Escalation and Pharmacokinetic Study of TrasGEX™ in Patients With Locally Advanced or Metastatic HER-2-positive Cancer

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.

Read the 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.

Conditions
Solid Tumors
Being tested
TrasGEX™
Keywords
advanced solid cancers, metastatic solid cancers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrasGEX™Drug

    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.

Study groups in NCT01409343
Study groupRoleWhat they receive
TrasGEXExperimentalA total of 37 patients with advanced HER2-positive carcinomas and progressive disease.
Receives: Drug: TrasGEX™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to at least 8 weeks after the first TrasGEX™ administration

Secondary outcomes (4)

  1. 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.

    Measured: approx. every 8 weeks

  2. 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.

    Measured: until 4 weeks after the last treatment with TrasGEX™

  3. 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

    Measured: prior to 1st infusion until the end of 5th infusion

  4. 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

    Measured: prior to 1st infusion until the end of 5th infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01409343
Sponsor's protocol ID
GEXMab73101
Status last verified
May 2021
First submitted
18 Jul 2011
Last updated
7 May 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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 Open. 2018 Jun 23;3(4):e000381. doi: 10.1136/esmoopen-2018-000381. eCollection 2018.

    PubMed 30018811

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TrasGEX™ in people with Solid Tumors, run by Glycotope GmbH at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Austria, Germany, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

optimal dose and regimen of TrasGEX™ (time frame: up to at least 8 weeks after the first TrasGEX™ administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01409343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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