NCT02331875

Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity

Open Label Single Arm Phase Ib-II Study of Pre-operative IPH2201 in Patients With Locally Advanced Resectable Squamous Cell Carcinoma of the Oral Cavity

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Innate Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Squamous Cell Carcinoma of the Oral Cavity

Interventions

Type	Name	Description
DRUG	IPH2201	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.
PROCEDURE	Standard Surgery	After the end of treatment with IPH2201, according to standard recommendations in the relevant country .
RADIATION	Postsurgical Adjuvant Therapy	After the standard surgery, according to standard recommendations in the relevant country

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-01-06
• Last updated: 2017-01-04

Locations

3 sites across 2 countries: Germany, Spain