CetuGEX™: Phase 1 Study in Cancer Patients

NCT ID: NCT01222637

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-10-31

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.

Detailed 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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CetuGEX™, weekly

application weekly

Group Type: EXPERIMENTAL

CetuGEX™

Intervention Type: DRUG

CetuGEX™ 2-weekly

application biweekly

Group Type: EXPERIMENTAL

CetuGEX™

Intervention Type: DRUG

Interventions

CetuGEX™

Intervention Type: DRUG

Other Intervention Names

tomuzotuximab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glycotope GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glycotope GmbH

Role: STUDY_DIRECTOR

Glycotope GmbH

Locations

Glycotope Investigational Site

Hamburg, , Germany

Glycotope Investigational Site

Heidelberg, , Germany

Glycotope Investigational Site

Milan, , Italy

Glycotope Investigational Site

Milan, , Italy

Glycotope Investigational Site

Bellinzona, , Switzerland

Countries

Germany; Italy; Switzerland

References

Fiedler W, Cresta S, Schulze-Bergkamen H, De Dosso S, Weidmann J, Tessari A, Baumeister H, Danielczyk A, Dietrich B, Goletz S, Zurlo A, Salzberg M, Sessa C, Gianni L. Phase I study of tomuzotuximab, a glycoengineered therapeutic antibody against the epidermal growth factor receptor, in patients with advanced carcinomas. ESMO Open. 2018 Feb 1;3(2):e000303. doi: 10.1136/esmoopen-2017-000303. eCollection 2018.

Reference Type: RESULT

PMID: 29464112 (View on PubMed)

Other Identifiers

GEXMab52101

Identifier Type: -

Identifier Source: org_study_id