DLL3/CD3 T-cell Engager
A bridge between DLL3-expressing tumor cells and cytolytic T cells
BI 764532: DLL3/CD3 T-cell engager
Our delta-like canonical Notch ligand 3/cluster of differentiation 3 (DLL3/CD3) T-cell engager (BI 764532) * acts as a bridge that directs the activity of cytolytic T cells selectively to DLL3-expressing tumors.1-3
Clinical trials: Our DLL3/CD3 T-cell engager is being investigated in patients with small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs).4-10
*This is an investigational compound and has not been approved. Its safety and efficacy have not been established.
Clinical development
Preclinical results have shown that DLL3/CD3 monotherapy potently inhibited tumor growth in DLL3-positive SCLC xenograft models in a dose-dependent and time-dependent manner. It also modulated the inflammatory environment in the tumor tissue by redirecting CD4-positive and CD8-positive T-cell cytotoxicity toward DLL3-postitive SCLC cells, without affecting DLL3-negative target cells.2
Our DLL3/CD3 T-cell engager is being evaluated in Phase I and II clinical trials in patients with SCLC and NECs.4-10
DLL3/CD3 T-cell engager clinical trials
| Trial number | Phase | Treatment | Patient population | Status |
|---|---|---|---|---|
II | BI 764532 monotherapy | Relapsed/refractory extensive-stage SCLC and other relapsed/refractory NECs | Recruiting | |
| I | BI 764532 + chemotherapy in first-line | Advanced NECs | Recruiting | |
NCT06077500 (DAREON™-8, 1438-0008)6 | I | BI 764532 + standard of care | Advanced SCLC | Recruiting |
NCT05990738 (DAREON™-9, 1438-0009)7 | I | BI 764532 + topotecan | SCLC | Recruiting |
I | BI 764532 monotherapy | Advanced SCLC and other NECs that are positive for DLL3 | Recruiting | |
| I | BI 764532 + ezabenlimab | SCLC and other neuroendocrine tumors that are positive for DLL3 | Recruiting | |
| I | BI 764532 monotherapy | Brain tumor that is positive for DLL3 | Recruiting |
CD3, cluster of differentiation 3; DLL3, delta-like canonical Notch ligand 3; NEC, neuroendocrine carcinoma; SCLC, small-cell lung cancer.
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Boehringer Ingelheim. Data on file.
Hipp S, et al. Clin Cancer Res. 2020;26:5258–5268.
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ClinicalTrials.gov. NCT05990738. http://clinicaltrials.gov/study/NCT05990738 (Accessed: February 2024).
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