AFM11-101
toxicity, haematological toxicity, PD, non-haematological toxicity, NHL
ADVERSE EVENTS, POLAND, NHL
AFM11-101 was a phase 1 open-label, first-in-human, dose-escalation study conducted at 10 sites in Germany, Czech Republic, Poland and the USA between October 2014 and September 2018. The primary objective of the study was to determine the safety and tolerability of AFM11 administered intravenously at weekly intervals over a period of 4 weeks (1 cycle) in patients with NHL, investigating escalating doses and different infusion durations. Secondary objectives included determination of the maximum tolerated dose (MTD; highest dose at which < 33% of patients experienced a dose-limiting toxicity [DLT; any grade 3 or higher non-haematological toxicity or grade 4 or higher haematological toxicity or any treatment delay ≥ 21 days because of drug-related adverse events (AEs)]), with the overall aim of identifying the dose and infusion time for a phase 2 study. In addition, the PK and the biological activity of AFM11 as well as pharmacodynamic (PD) markers in blood were assessed.