On February 9, 2016 ADC Therapeutics SA (ADCT), the oncology drug development company, reported that the first patient has been dosed in a Phase I trial to evaluate its lead antibody drug conjugate (ADC) ADCT-301 in Acute Myeloid Leukemia (AML) (Press release, ADC Therapeutics, FEB 9, 2016, View Source [SID:1234513294]).

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The two stage, Phase l open-label trial will evaluate the tolerability, safety, pharmacokinetics and activity of ADCT-301 in patients with relapsed or refractory CD-25 positive AML. The initial dose escalation phase will recruit up to 30 patients at ten clinical sites across the US and will seek to determine the recommended dose of ADCT-301 for the second stage. The second stage, which will begin once an appropriate dose is identified, will be expanded into the UK and Europe with the recruitment of up to 30 additional patients.

ADCT-301 is composed of HuMax-TAC, a monoclonal antibody directed against CD25 (the alpha chain of the IL-2 receptor) conjugated to ADCT’s highly potent proprietary pyrrolobenzodiazepine (PBD) dimer. In preclinical in vivo models, ADCT-301 exhibited strong dose-dependent anti-tumor activity against CD25-positive cell lines at single low doses.