A Phase I, open-label, dose escalation and expansion trial to investigate safety and tolerability of BI 764532 intravenous infusions in combination with standard of care (platinum and etoposide) in first-line treatment of patients with neuroendocrine carcinomas (NEC) (NCT06132113)

DAREON 7 1438-0007 study design

CR, complete response; DLL3, delta-like canonical Notch ligand 3; DLT, dose-limiting toxicity; DoR, duration of response; epNEC, extra-pulmonary neuroendocrine carcinoma; IHC, immunohistochemistry; LCNEC, large-cell neuroendocrine carcinoma; MTD, maximum tolerated dose; NEC, neuroendocrine carcinoma; OR, objective response; PR, partial response; RDE, recommend dose for expansion; RECIST, Response Evaluation Criteria In Solid Tumors; RP2D, recommended Phase II dose; SoC, standard of care.