Histologically confirmed locally advanced and/or metastatic solid organ tumour MedDRA version: 14.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: CetuGEX
Product Code: CetuGEX
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CetuGex
Current Sponsor code: CetuGex
Concentration unit: mg/ml milligram(s)
Sponsors
Glycotope GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 1. Male or female and age =18 yrs 2. Histologically confirmed locally advanced and/or metastatic solid organ tumour 3. Measurable or non-measurable tumour 4. Not eligible for standard therapy 5. All anti-tumor 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 109/L; absolute neutrophil count (ANC) = 1.5 x 109/L; platelet count = 100 x 109/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 =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
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. Steroids at low and stable dose (up to 20 mg prednisone) given for chronic disease are also permitted 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 Bevazicumab) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: • To evaluate the safety and tolerability profile of CetuGEXTM at various dose levels • To define the recommended phase II dose and regimen ;Secondary Objective: Secondary: • To determine the pharmacokinetics of CetuGEXTM in patients after single and multiple dose applications • To make a preliminary evaluation of anti-tumour activity of CetuGEXTM in the selected patient population (s) ;Primary end point(s): • To evaluate the safety and tolerability profile of CetuGEXTM at various dose levels • To define the recommended phase II dose and regimen ;Timepoint(s) of evaluation of this end point: Response will be evaluated every 8 weeks. Non-measurable disease allowed for inclusion. The events will be followed until resolved, or until the study end, whichever comes later. • Laboratory abnormalities will be recorded throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To determine the pharmacokinetics of CetuGEXTM in patients after single and multiple dose applications • To make a preliminary evaluation of anti-tumour activity of CetuGEXTM in the selected patient population (s) ;Timepoint(s) of evaluation of this end point: Response will be evaluated every 8 weeks. Non-measurable disease allowed for inclusion. Serum PK of CetuGEXTM will be measured at the following time points: • Before the 1st infusion of study med, • End of 1st infusion (D1) • Prior to infusion (D2) • End of infusion (D2) • 4h after end of infusion (D2) • 72 h after start of 1st infusion (D4) • 168h after start of the 1st infusion (D8) only for the 1st pt of each dose level in the wkly dosing scheme & for all pts in the 2- & 3-wkly dosing scheme day 15 after start of the 1st infusion for pts in the 3-wkly dosing scheme • All further infusions: immediately before and immed after each study drug admin until completion of the 6th infusion. • 4 wks after last study drug admin (STV) | — |
Countries
Germany, Italy, Switzerland
Contacts
Public ContactNicola Richter
Granzer Regulatory Consulting & Services
Outcome results
None listed