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Dose-escalation, PK- and Safety Study With Single Agent CetuGEX™ in Patients With EGFR Positive Locally Advanced and/or Metastatic Cancer

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

Dose-escalation, PK- and Safety Study With Single Agent CetuGEX™ in Patients With EGFR Positive Locally Advanced and/or Metastatic Cancer

Inclusion Criteria:

1. Male or female and age ≥ 18 yrs

2. Histologically confirmed EGFR positive locally advanced and/or metastatic solid organ

3. Measurable or non-measurable tumour

4. 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)

5. 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

6. ECOG Performance Status ≤1 and estimated life expectancy of ≥ 3 months

7. 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

- 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

8. 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

9. Written informed consent must be obtained prior to conducting any study-specific

For Expansion Phase only:

10. No prior treatment with Cetuximab allowed

Exclusion Criteria:

1. Chemotherapy, radiation, other anti-cancer therapies including any investigational
agents at the study enrolment within 4 weeks prior to study enrolment

2. Concurrent anti-tumour therapy or concurrent immunotherapy

3. Concurrent systemic steroids except topical (inhaled, topical, nasal) or replacement
therapy for the last 28 days.

4. Major surgery within 4 weeks prior entering the study and/or incomplete recovery from
surgery or planned major surgery

5. Primary or secondary immune deficiency

6. Clinically active infections > CTCAE grade 2

7. Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or

8. Active hepatitis B assessed by serology, hepatitis C by histology; human
immunodeficiency virus (HIV) seropositivity

9. 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.

10. 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.

11. Clinical signs of brain metastasis or leptomeningeal involvement

12. 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.

13. Active drug abuse or chronic alcoholism

14. Pregnancy or Breastfeeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability profile of CetuGEX™ at various dose levels

Outcome Time Frame:

throughout the study

Safety Issue:


Principal Investigator

Glycotope GmbH

Investigator Role:

Study Director

Investigator Affiliation:

Glycotope GmbH


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

August 2010

Completion Date:

June 2013

Related Keywords:

  • Solid Tumors
  • advanced solid cancers
  • metastatic solid cancers