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
Overview
- Phase
- Phase 1
- Intervention
- IPH2201
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity
- Sponsor
- Innate Pharma
- Enrollment
- 3
- Locations
- 3
- Primary Endpoint
- best objective response rate
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
single arm
IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
Intervention: IPH2201
single arm
IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
Intervention: Standard Surgery
single arm
IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
Intervention: Postsurgical Adjuvant Therapy
Outcomes
Primary Outcomes
best objective response rate
Time Frame: 8 weeks