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Phase I dose‑finding and expansion study of BI 765179 in advanced solid tumors and HNSCC (NCT04958239)

 

An open label, Phase I dose-finding study of BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers, and expansion of BI 765179 in combination with pembrolizumab in first-line PD-L1-positive metastatic or incurable, recurrent HNSCC (NCT04958239)1-3

CD137 FAP: NCT04958239 (1463-0001)
CD137 FAP: NCT04958239 (1463-0001)

AE, adverse event; AUC, area under the curve; bsAb, bispecific antibody; CD137, cluster of differentiation 137; Cmax(ss), peak serum concentration (steady state); 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; PD-L1; programmed death ligand-1; PFS, progression-free survival; PK, pharmacokinetic; RDE, recommend dose for expansion; RECIST, Response Evaluation Criteria in Solid Tumours.

References

  1. ClinicalTrials.gov. NCT04958239. https://clinicaltrials.gov/ct2/show/NCT04958239 (Accessed: February 2026).

  2. Shroff RT, et al. AACR 2025. Poster CT110.

  3. Shroff RT, et al. J Clin Oncol 2025;43(16_suppl). Abstract TPS2684.