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First received: September 07, 2023

Clinical Trial: Study of ALE.C04 in Patients With Head and Neck Cancer

Study Status: Completed

Recruit Status: RECRUITING

Condition: Head and Neck Cancer

Study Type: INTERVENTIONAL


Official Title: A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinom

Brief Summary: The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and as monotherapy and to assess anti-tumor activity of ALE.C04 monotherapy and in combination with pembrolizumab in patients with Head and Neck Cancer.

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