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Phase Ib Study of BI 770371 with pembrolizumab in HNSCC (NCT06806852)

 

A Phase Ib, open-label, randomized study of BI 770371 (SIRPα antagonist) in combination with pembrolizumab with or without cetuximab compared with pembrolizumab monotherapy for the first-line treatment of patients with metastatic or recurrent HNSCC1,2

NCT06806852 (1501-0002)
NCT06806852 (1501-0002)


*Treatment discontinuation can be due to progressive disease, unacceptable toxicity, or patient withdrawal. †Recommended dose. ‡Standard dose.
CD47, cluster of differentiation 47; CNS, central nervous system; CPS, combined positive score; DoR, duration of response; HNSCC, head and neck squamous cell carcinoma; OR, objective response; OS, overall survival; PD-1, programmed death protein 1; PD-L1, programmed death-ligand 1; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumours; SIRPα, signal regulatory protein alpha; TRAE, treatment-related adverse event.

References

  1. Laban S, et al. ESMO 2025. Poster 1441TiP

  2. ClinicalTrials.gov. NCT06806852. https://clinicaltrials.gov/study/NCT06806852 (Accessed: February 2026).