CetuGEX™: Phase 1 Study in Cancer Patients

Glycotope

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: CetuGEX™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01222637

GEXMab52101

Details and patient eligibility

About

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.

Full description

Male or female patients ≥18 years of age with a histologically confirmed locally advanced and/or metastatic solid organ tumor. Patients enrolled in Germany were required to have a positive EGFR overexpression status. Patients must have experienced a failure or non-availability of standard therapy (had received at least one line of chemotherapy and further standard therapy was not an option at study entry). Open-label, non-randomized, inter-patient dose-escalation, multi-center study. Patients were to receive CetuGEX until disease progression or until intolerable toxicities occurred.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female and age ≥ 18 yrs

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

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 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

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 infusion

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

   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 Bevacizumab).
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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

CetuGEX™, weekly

Experimental group

Description:

application weekly

Treatment:

Drug: CetuGEX™

CetuGEX™ 2-weekly

Experimental group

Description:

application biweekly

Treatment:

Drug: CetuGEX™