Brief Summary

This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive, locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ 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 Aug 2010

Typical duration for phase_1

Geographic Reach

3 countries

5 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

August 1, 2010

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed

Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

October 15, 2010

Last Update Submit

May 20, 2021

Conditions

Solid Tumors

Keywords

advanced solid cancersmetastatic solid cancers

Outcome Measures

Primary Outcomes (5)

Incidence of Treatment-Emergent Adverse Events (TEAE) assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
TEAE were coded by use of Medical Dictionary for Regulatory Activities (MedDRA) version 13.1
throughout the study until 28±2 days after last infusion
Incidence of clinically relevant abnormal clinical laboratory parameters
graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
from first infusion until 28±2 days following the last infusion
Dose-limiting toxicities (DLT)
DLTs were defined as drug-related: * Hematological or non-hematological toxicity grade 3 (excl. rash) or 4 excluding inadequately treated nausea and vomiting; * In case of skin reaction (rash) grade 4
from first infusion until 28±2 days following the last infusion
Changes of corrected QT interval (QTc) duration
by use of 12-lead electrocardiograms (ECG)
from first infusion until 28±2 days following the last infusion
To define the recommended phase II dose and regimen
Defining a recommended dose for a Phase II study was possible based on the available PK data in combination with the safety and activity data for CetuGEX™
from first infusion until 28±2 days following the last infusion

Secondary Outcomes (10)

Anti-Tumor Activity: Confirmed Best Overall Response Rates
From date of randomization until the date of first documented progression, assessed up to 60 months
Anti-Tumor Activity: Clinical Benefit Rates
From date of randomization until the date of first documented progression, assessed up to 60 months
Eastern Cooperative Oncology Group (ECOG) Performance Status
From date of randomization until 28 days ± 2 days after the end of treatment
Pharmacokinetics (PK): Area under the serum concentration-time curve (AUC)
Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Maximum serum concentration (Cmax)
Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
+5 more secondary outcomes

Study Arms (2)

CetuGEX™, weekly

EXPERIMENTAL

application weekly

Drug: CetuGEX™

CetuGEX™ 2-weekly

EXPERIMENTAL

application biweekly

Drug: CetuGEX™

Interventions

CetuGEX™DRUG

Also known as: tomuzotuximab

CetuGEX™ 2-weeklyCetuGEX™, weekly

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female and age ≥ 18 yrs
Histologically confirmed EGFR positive locally advanced and/or metastatic solid organ tumour
Measurable or non-measurable tumour
Failure of standard therapy or non-availability of standard therapy (Patients must have received at least 1 line of chemotherapy and further standard therapy is not an option at study entry)
All anti-tumour therapies must be completed 4 weeks before start of study treatment; treatment with Cetuximab must be completed at least 6 weeks prior to study start
ECOG Performance Status ≤1 and estimated life expectancy of ≥ 3 months
Adequate organ function:
Bone marrow function: hemoglobin ≥ 100 g/L; white blood cell count (WBC) ≥ 3.0 x 10\^9/L; absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; platelet count ≥ 100 x 10\^9/L
Hepatic: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 x ULN if hepatic metastases present); bilirubin ≤ 1.5 x ULN; alkaline phosphatase ≤ 5.0 x upper limit of normal (ULN)
Renal: creatinine \< 1.5 x ULN
Patients of both genders with procreative potential must use effective contraception while enrolled in the study and for at least 4 weeks after the last study drug infusion
Written informed consent must be obtained prior to conducting any study-specific procedures
For Expansion Phase only:
No prior treatment with Cetuximab allowed

You may not qualify if:

Chemotherapy, radiation, other anti-cancer therapies including any investigational agents at the study enrolment within 4 weeks prior to study enrolment
Concurrent anti-tumour therapy or concurrent immunotherapy
Concurrent systemic steroids except topical (inhaled, topical, nasal) or replacement therapy for the last 28 days.
Major surgery within 4 weeks prior entering the study and/or incomplete recovery from surgery or planned major surgery
Primary or secondary immune deficiency
Clinically active infections \> CTCAE grade 2
Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or Bevacizumab).
Active hepatitis B assessed by serology, hepatitis C by histology; human immunodeficiency virus (HIV) seropositivity
Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥ 3 years will be allowed to enter the study.
Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, chronic symptomatic respiratory disease.
Clinical signs of brain metastasis or leptomeningeal involvement
Symptomatic congestive heart failure (New York Heart Association \[NYHA\] 3 or 4); unstable angina pectoris within 6 months prior to enrollment; significant cardiac arrhythmia, or history of stroke or transient ischemic attack within 1 year.
Active drug abuse or chronic alcoholism
Pregnancy or Breastfeeding

Contact the study team to confirm eligibility.