RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsNovember 01, 2023 - The FDA has lifted its full clinical hold on Mersana Therapeutics Phase I study of XMT-2056, its investigational STING-directed antibody-drug conjugate, following a patient death.
The clinical hold came in March 2023, following a patient death that was deemed related to XMT-2056. At the time, Mersana was assessing the candidate in a Phase I trial, enrolling previously treated patients with HER2-positive recurrent or metastatic solid tumors.
The fatality occurred in the second patient enrolled in the dose-escalation phase of the early-stage study, pushing the biotech to voluntarily suspend the trial and report the incident to the regulator.
https://www.biospace.com/article/fda-lifts-hold-on-mersana-s-antibody-drug-conjugate-following-patient-death/