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

Innate Pharma

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Squamous Cell Carcinoma of the Oral Cavity

Treatments: Drug: IPH2201; Radiation: Postsurgical Adjuvant Therapy; Procedure: Standard Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT02331875

2014-002135-34 (EudraCT Number)

IPH2201-201

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed, primary, previously untreated, resectable squamous cell carcinoma of the oral cavity considered clinically and radiologically as intermediate or high risk, classified II ( with large (≥ 3 cm and ≤ 4cm) cT2cN0cM0 tumors or any cT2cN0cM0 tumor invading neighboring structures) III or IVa according to the American Joint Committee on Cancer
• Adequate liver and renal function

Exclusion criteria

• Other malignancy
• Abnormal cardiac status
• Autoimmune disease
• Serious concurrent uncontrolled medical disorder
• Systemic treatment with corticosteroids or other immunosuppressive agents within 30 days prior to IPH2201 first administration.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

single arm

Experimental group

Description:

IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy

Treatment:

Procedure: Standard Surgery

Drug: IPH2201

Radiation: Postsurgical Adjuvant Therapy