Bicycle therapeutics announces first patient dosed in phase i/ii trial of bicycle® toxin conjugate bt5528 in patients with advanced solid tumors

Bicycle therapeutics plc announced that the first patient has been dosed in the phase i dose escalation of its phase i/ii study of bt5528, a bicycle toxin conjugate (btc) targeting tumor antigen epha2, in patients with advanced solid tumors associated with epha2 expression. bt5528 is a second-generation btc, which uses a valine-citrulline cleavable linker and a cytotoxin mmae payload. the phase i/ii multi-center, open-label trial will evaluate bt5528 administered once-weekly as a single agent and in combination with nivolumab. the phase i portion is a dose escalation primarily designed to assess the safety and tolerability of bt5528 and to determine a recommended phase ii dose (rp2d). following selection of an rp2d, a phase ii dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of bt5528. the study will be conducted across sites in the u.s. and the uk.
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