Overview

Copanlisib in Association With Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss

Status:
Terminated

Trial end date:
2019-10-09

Target enrollment:

Participant gender:

Summary

The study consists of two distinct and sequential parts: - A Phase Ib aimed at determining the MTD (Maximum Tolerated Dose) of the combination (copanlisib/cetuximab) and the RP2D - A Phase II aimed at evaluating the efficacy of the combination at the RP2D (Recommended Phase 2 Dose) All patients will be treated with the Copanlisib, a selective PI3KCA inhibitor, in association with Cetuximab.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

UNICANCER

Treatments:

Cetuximab