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Phase I study of BI 765049 ± ezabenlimab in B7‑H6–expressing solid tumors (NCT06091930)

 

Phase I, non-randomized, open-label, multi-center dose escalation and expansion trial of BI 765049 and BI 765049 + ezabenlimab administered by repeated intravenous infusion in Asian patients with malignant solid tumors expressing B7-H6 (NCT06091930)1,2

B7-H6/CD3 antibody: NCT06091930 (1454-0004)
B7-H6/CD3 antibody: NCT06091930 (1454-0004)

*Guided by Bayesian logistic regression model with overdose control.
CNS, central nervous system; CRC, colorectal cancer; DLT, dose-limiting toxicity; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GC, gastric cancer; HCC, hepatocellular carcinoma; HNSCC, head and neck squamous cell carcinoma; iRECIST, Immunotherapy Response Evaluation Criteria in Solid Tumours; NSCLC, non-small cell lung cancer; ORR, objective response rate; PDAC, pancreatic ductal adenocarcinoma; PFS, progression-free survival; PK, pharmacokinetic; RECIST, Response Evaluation Criteria in Solid Tumours.

References

  1. ClinicalTrials.gov. NCT06091930. https://clinicaltrials.gov/study/NCT06091930 (Accessed: February 2026).

  2. Falchook GS, et al. ASCO 2022. Poster TPS3175.