Recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) MedDRA version: 14.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Symphogen A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx 2. Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation 3. Previous treatment with a marketed anti-EGFR mAb in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing: a. Documented clinical benefit or response for at least 8 weeks (PR, CR or SD verified by CT scan or MRI according to RECIST) on the anti-EGFR mAb-based therapy and b. Documented disease progression (PD verified by CT scan or MRI according to RECIST) during or within 12 weeks following the last administration of anti-EGFR mAb 4. Accessible tumor for biopsy and patient acceptance of repeat tumor biopsies 5. At least one measurable lesion according to RECIST (1.1) at screening* 6. ECOG performance status 0-1 7. Normal organ or bone marrow function as defined below: a. ANC > 1.5 x109/L (1,500/mm3) b. Hemoglobin = 9 g/dl c. Platelet count = 75 x109/L (75,000/mm3) d. Bilirubin 50 ml/min calculated according to Cockroft-Gault h. S-Na, S-K, S-Mg and S-Ca CTCAE =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. More than 2 lines of prior chemotherapy in the palliative setting 2. Expected survival 3 infusion related reactions with chimeric monoclonal antibodies 7. History of other malignancy within 5 years prior to Visit 2, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix or urinary bladder 8. Severe infection requiring iv treatment 9. Any other concurrent uncontrolled disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the investigator 10. Major surgery within 4 weeks prior to Visit 2 and patients must have recovered from effects of major surgery 11. Known HIV positive 12. Known active hepatitis B or C 13. Patients with known allergy to the components in the study drug 14. Clinically significant and uncontrolled cardiac disease including unstable angina, acute myocardial infarction within six months prior to Visit 2, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities and controlled and well treated chronic atrial fibrillation 15. Current participation in any other interventional clinical trial 16. Patients known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder) 17. Male patients not willing to use adequate contraception or female of childbearing potential not willing to use an effective form of contraception such as hormonal birth control, intrauterine device or double barrier method during treatment with Sym004 and at least 3 months thereafter 18. Breast feeding women or women with a positive pregnancy test at Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Rate of Progression Free Survival (PFS) at 24 weeks;Timepoint(s) of evaluation of this end point: At 24 weeks;Main Objective: To assess the efficacy of Sym004 in patients with recurrent and/or metastatic SCCHN who have disease progression during or within 12 weeks after treatment with an anti-EGFR mAb-containing regimen;Secondary Objective: • To assess the safety profile of Sym004 • To assess the biological activity in tumor and skin biopsies • To determine overall survival (OS) • To evaluate potential biomarkers • To determine the pharmacokinetic profile of Sym004 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Clinical assessment takes place on an ongoing basis during the study;Secondary end point(s): • Adverse events • Objective tumor response (according to RECIST (1.1)) • Time to progression (TTP) • Overall survival (OS) • Skin rash (CTCAE grading (v. 4.02), duration) • Biomarkers (e.g. Circulating Tumor Cells, HPV, mutation of EGFR-vIII, KRAS, HRAS, NRAS, BRAF, PIK3CA, PTEN, Her2, Her3, c-Met) • Pharmacokinetic profile (AUC, CL, Cmax, Cmin, T1/2) • Host immune response: Antidrug antibody (ADA) | — |
Countries
Germany, United States
Contacts
Public ContactMarie Moores
Theradex
Outcome results
None listed