Phase Ia first-in-human trial of an immunological fusion protein (BI 3810944) in patients with solid tumors (NCT07224425)

First-in-human, Phase I, open-label, non-randomized, multicenter dose escalation and expansion trial of BI 3810944 in patients with solid tumors¹

*Participant must have exhausted available treatment options known to prolong survival for their disease; ^†Participant should not have received >3 previous lines of treatment (excluding prior systemic regimens received at adjuvant or neoadjuvant setting and excluding treatment with tumour-infiltrating lymphocytes at any timepoint).
AE, adverse event; CNS, central nervous system; CRS, cytokine release syndrome; DC, disease control; DLT, dose-limiting toxicity; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; MTD, maximum tolerated dose; OR, objective response; PFS, progression-free survival; PK, pharmacokinetic; RDE, recommended dose for expansion; RECIST, Response Evaluation Criteria in Solid Tumours; RP2D, recommended Phase II dose.