An open label, phase I dose-finding and expansion study of BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers, and BI 765179 in combination with pembrolizumab in first-line PD-L1-positive metastatic or incurable, recurrent HNSCC (NCT04958239)1,2
AE, adverse event; AUC, area under the curve; CD137, cluster of differentiation 137; Cmax, peak serum concentration; DLT, dose-limiting toxicity; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; FAP, fibroblast activation protein; HNSCC, head and neck squamous cell carcinoma; MTD, maximum tolerated dose; OR, objective response; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetic; RECIST, Response Evaluation Criteria in Solid Tumours; RDE, recommend dose for expansion.
References
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ClinicalTrials.gov. NCT04958239. https://clinicaltrials.gov/ct2/show/NCT04958239 (Accessed: August 2025).
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Shroff RT, et al. AACR 2025. Poster CT110.