Alligator Bioscience AB (Alligator)(STO:ATORX), a clinical-stage biotechnology company developing tumour-directed immuno-oncology antibody drugs, announced on Thursday that the outline of the ongoing phase I study with the bispecific drug candidate ATOR-1015 will be showcased at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from 31 May 2019 to 4 June 2019.
Reportedly, the ATOR-1015 phase I study is a first-in-human dose-escalation study in patients with advanced solid malignancies (NCT03782467). The primary aim of the study is to investigate the safety and tolerability of ATOR-1015 and to identify the maximum tolerated dose/recommended dose for subsequent phase II studies.
According to Alligator, the first patient was dosed in March 2019 and the study results are expected to read out in the second half of 2020.
Also, this study design includes accelerated dose titration with one patient cohorts, followed by a modified 3+3 design with at least three patients per dose level. At the maximum tolerated dose, or at a lower dose level, an expansion cohort is planned with up to 14 patients, for additional safety and efficacy evaluation.
Charlotte Russell, chief medical officer at Alligator Bioscience will present the poster (#292b) entitled 'A first-in-human, multicenter, open-label, phase I study in patients with advanced and/or refractory solid malignancies to evaluate the safety of intravenously administered ATOR-1015' by Jeffrey Yachnin et al on 1 June 2019 from 08:00 hours to 11:00 hours, CDT in the session Developmental Immunotherapy and Tumour Immunobiology.
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