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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Jul 2011

Typical duration for phase_1

Geographic Reach

4 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

July 1, 2011

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed

17 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed

Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

2.3 years

First QC Date

July 18, 2011

Last Update Submit

May 4, 2021

Conditions

Solid Tumors

Keywords

advanced solid cancersmetastatic solid cancers

Outcome Measures

Primary Outcomes (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.
up to at least 8 weeks after the first TrasGEX™ administration

Secondary Outcomes (4)

To determine preliminary evidence of activity
approx. every 8 weeks
safety and tolerability of TrasGEX™
until 4 weeks after the last treatment with TrasGEX™
To assess the pharmacokinetic (PK) profile of TrasGEX™ (part I)
prior to 1st infusion until the end of 5th infusion
To assess the pharmacokinetic (PK) profile of TrasGEX™ (part II)
prior to 1st infusion until the end of 5th infusion

Study Arms (1)

TrasGEX

EXPERIMENTAL

A total of 37 patients with advanced HER2-positive carcinomas and progressive disease.

Drug: TrasGEX™

Interventions

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.

TrasGEX

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.