DAREON®-8: A Phase I, open-label, dose escalation and expansion trial of repeated intravenous infusions of DLL3/CD3 T-cell engager (obrixtamig) combined with standard of care (platinum, etoposide, and anti-PD-L1) in patients with extensive-stage small cell lung carcinoma (NCT06077500)1,2
*Guided by Bayesian logistic regression model with overdose control.
AE, adverse event; CD3, cluster of differentiation 3; DLL3, delta-like canonical Notch ligand 3; DLT, dose-limiting toxicity; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ES-SCLC, extensive-stage small cell lung cancer; MTD, maximum tolerated dose; OR, objective response; PD-L1, programmed death ligand-1; RDE, recommend dose for expansion; RP2D, recommended Phase II dose; SCLC, small cell lung cancer.
References
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ClinicalTrials.gov. NCT06077500. https://clinicaltrials.gov/ct2/show/NCT06077500 (Accessed: August 2025).
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Peters S, et al. ASCO 2024. Poster TPS8127.