The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative patients with operable Squamous Cell Carcinoma of the Oral Cavity . 43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4. Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated after the last administration of IPH2201.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
The first 6 patients will receive IPH2201, IV, at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4.
After the end of treatment with IPH2201, according to standard recommendations in the relevant country .
After the standard surgery, according to standard recommendations in the relevant country
Charité University Medicine Berlin
Berlin, Germany
Instituto Catalan de Oncologia - L'Hospitalet
L'Hospitalet de Llobregat Barcelona, Spain, Spain
Hospital Universitario La Paz
Madrid, Spain
best objective response rate
Time frame: 8 weeks
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