CetuGEX™: Phase 1 Study in Cancer Patients

G

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

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

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™

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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