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Phase I study of DLL3/CD3 T‑cell engager obrixtamig in SCLC and neuroendocrine neoplasms (NCT04429087)

 

A first-in-human, Phase I, open-label, dose-escalation study of DLL3/CD3 T-cell engager (obrixtamig) in patients with heavily pre-treated advanced DLL3-positive ES-SCLC, epNEC or LCNEC-L (NCT04429087)1,2

DLL3/CD3 T-cell engager: NCT04429087 (1438-0001)
DLL3/CD3 T-cell engager: NCT04429087 (1438-0001)

*Regimen B1 doses were based on PK and transitions from B1 to B2 and B2 to B3 were based on CRS grade >1; †DLL3 testing was performed using an investigational antibody for DLL3 (SP347; Roche Diagnostics); ‡This approach permitted inclusion of patients with poor prognosis and high risk of early progression, whilst more closely resembling the current clinical standard of care in the real-world SCLC setting.
CD3, cluster of differentiation 3; CRS, cytokine release syndrome; DLL3, delta-like ligand 3; DLT, dose-limiting toxicity; epNEC, extrapulmonary neuroendocrine carcinoma; ES-SCLC, extensive-stage small cell lung cancer; LCNEC-L, large cell neuroendocrine carcinoma of the lung; MTD, maximum tolerated dose; OR, objective response; RECIST, Response Evaluation Criteria in Solid Tumours; PK, pharmacokinetics; SCLC, small cell lung cancer; QW: once weekly; Q3W, once every 3 weeks.

References

  1. ClinicalTrials.gov. NCT04429087. https://clinicaltrials.gov/ct2/show/NCT04429087 (Accessed: April 2026).

  2. Wermke M, et al. J Clin Oncol 2025;43(27):3021–3031.