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Phase Ib/II trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring a ...

Update Il y a 4 ans
Reference: EUCTR2015-004340-19

Phase Ib/II trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring a PI3KCA mutation/amplification and/or a PTEN loss

Woman and Man

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Extract

The primary objective of this study is to determine the MTD of copanlisib used in combination with cetuximab and the RP2D in the phase Ib part and to evaluate the efficacy of the combination at the RP2D in the phase II. Determination of the MTD will be based on the occurrence of DLT during cycle 1.

Inclusion criteria

  • Recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring a PI3KCA mutation/amplification and/or a PTEN loss

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