Phase 1 BI 3819026 anti-LAYN antibody + ezabenlimab PD-1 inhibitor in solid tumors.

This first-in-human, open-label, multicenter Phase 1 dose-escalation study tests BI 3819026 (a Boehringer Ingelheim anti-LAYN/layilin antibody; LAYN is a hyaluronan-binding cell-surface protein implicated in tumor invasion/immune biology) alone for an initial lead-in dose, then in combination with ezabenlimab (BI 754091), Boehringer Ingelheim’s PD-1 (CD279)–blocking monoclonal antibody designed to restore anti-tumor T-cell activity. The primary goal is to define safety/tolerability and determine the maximum tolerated dose and recommended dose for expansion, with repeated visits for adverse event monitoring, labs, imaging, and PK sampling. Eligible patients have unresectable advanced/metastatic solid cancers that are relapsed/refractory and/or lack a remaining standard treatment option; public registry listings also indicate planned/allowed tumor cohorts including colorectal cancer, non-small cell lung cancer, breast cancer, melanoma, hepatocellular carcinoma, and head and neck squamous cell carcinoma. The scientific angle is pairing a novel target (LAYN) with checkpoint blockade to potentially re-shape the tumor microenvironment rather than adding another cytotoxic. In this population today, care is mainly sequential standard regimens by tumor type (targeted therapy or immunotherapy when biomarker-eligible, otherwise chemotherapy and later-line clinical trials), and this study is exploring whether LAYN targeting can broaden or deepen PD-1 responses.