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Phase I study of BI 765063 and BI 770371 with ezabenlimab in advanced solid tumors (NCT05068102)

 

An open-label Phase I PET imaging study to investigate the bio-distribution and tumor uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in patients with head and neck squamous cell carcinoma, non-small cell lung cancer, or melanoma who are treated with ezabenlimab1,2

NCT05068102 (1443-0003)
NCT05068102 (1443-0003)

*In Part 1 of each arm, patients will be entered sequentially. After review of Part 1 data, the Data Review Committee will make the decision whether or not to initiate Part 2 for each arm. †Patients entered into Part 2 will be treated in various dose cohorts of BI 765063 (Arm A) or BI 770371 (Arm B) at Cycle 2. These dose cohorts will be managed sequentially based on the Data Review Committee’s decision.
ECOG PS, Eastern Cooperative Oncology Group performance status; HNSCC, head and neck squamous cell carcinoma; NSCLC, non-small cell lung cancer; PET, positron emission tomography; RECIST, Response Evaluation Criteria in Solid Tumours; SIRPα, signal regulatory protein alpha; SUV, standardized uptake values.

References

  1. ClinicalTrials.gov. NCT05068102. https://clinicaltrials.gov/study/NCT05068102 (Accessed: October 2026).

  2. Pouw JEE, et al. J Nucl Med 2024;65(2_suppl). Abstract 242019.