%0 Journal Article
%A Lauer, U. M.
%A Awada, A.
%A Postel-Vinay, S.
%A Shapiro, G. I.
%A Thieblemont, C.
%A Piha-Paul, S. A.
%A Paik, P. K.
%A Shepard, D. R.
%A Docampo, L. I.
%A Galot, R.
%A Rottey, S.
%A Sadrolhefazi, B.
%A Marzin, K.
%A Musa, H.
%A Schöffski, P.
%T Final results from the phase Ia/Ib study of the novel bromodomain and extra-terminal domain inhibitor, BI 894999, in patients with advanced solid tumors or diffuse large B-cell lymphoma.
%J ESMO open
%V 10
%N 5
%@ 2059-7029
%C [London]
%I Elsevier
%M DKFZ-2025-00755
%P 104499
%D 2025
%X Bromodomain and extraterminal domain (BET) inhibitors have demonstrated efficacy in solid and hematological malignancies. BI 894999, a novel, orally administered BET inhibitor, has demonstrated preclinical efficacy.This was an open-label, dose-finding study evaluating BI 894999 for diffuse large B-cell lymphoma (DLBCL; phase Ia extension) and solid tumors [colorectal cancer (CRC), nuclear protein in testis (NUT) carcinoma, metastatic castration-resistant prostate cancer (mCRPC) and small-cell lung cancer (SCLC); phase Ib cohort]. The primary endpoint was dose-limiting toxicities (DLTs) during the maximum tolerated dose (MTD) period (phase Ia) and treatment period (phase Ib).Eighteen patients with DLBCL were enrolled in the phase Ia extension and 79 with solid tumors in phase Ib cohorts (SCLC, n = 12; CRC, n = 14; mCRPC, n = 11; NUT carcinoma, n = 42). Four patients had DLTs in phase Ia and 17 in phase Ib; the most frequent was grade 4 thrombocytopenia. The MTD for DLBCL was 1.5 mg (days 1-14/21). One patient (5.6
%K bromodomain and extraterminal domain inhibitor (Other)
%K diffuse large B-cell lymphoma (Other)
%K dose escalation (Other)
%K dose-limiting toxicities (Other)
%K solid tumor (Other)
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:40203516
%R 10.1016/j.esmoop.2025.104499
%U https://inrepo02.dkfz.de/record/300305