Clinical trial NCT01409343: TrasGEX™: Phase 1 Study in Cancer Patients
Official title: A Phase I Dose-Escalation and Pharmacokinetic Study of TrasGEX™ in Patients With Locally Advanced or Metastatic HER-2-positive Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: advanced solid cancers
metastatic solid cancers
Lead sponsor: Glycotope GmbH
Sponsor class: INDUSTRY
Collaborators: name: Glycotope Biotechnology GmbH
First posted: 2011-08-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: optimal dose and regimen of TrasGEX™
timeFrame: up to at least 8 weeks after the first TrasGEX™ administration
Secondary outcomes:
measure: To determine preliminary evidence of activity
timeFrame: approx. every 8 weeks
measure: safety and tolerability of TrasGEX™
timeFrame: until 4 weeks after the last treatment with TrasGEX™
measure: To assess the pharmacokinetic (PK) profile of TrasGEX™ (part I)
timeFrame: prior to 1st infusion until the end of 5th infusion
measure: To assess the pharmacokinetic (PK) profile of TrasGEX™ (part II)
timeFrame: prior to 1st infusion until the end of 5th infusion
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Glycotope Investigational Site
city: Innsbruck
country: Austria
facility: Glycotope Investigational Site
city: Hamburg
country: Germany
facility: Glycotope Investigational Site
city: Milan
country: Italy
facility: Glycotope Investigational Site
city: Bellinzona
country: Switzerland
facility: Glycotope Investigational Site
Study officials:
affiliation: Glycotope GmbH
name: Glycotope GmbH
role: STUDY_DIRECTOR
References:
citation: 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.