Of the 20 SAEs reported, five events, all IRRs, were considered related to ARGX-110. The most common TEAE were fatigue and drug related infusion-related reactions (IRR). ![]() ARGX-110 was generally well tolerated, with no dose-related increase in treatment-emergent adverse events (TEAE). Results: Dose-limiting toxicity was not observed and the maximum tolerated dose was not reached. Samples for pharmacokinetics and pharmacodynamics were collected. Dose-limiting toxicity was evaluated in the 21 days following the first ARGX-110 administration (Cycle 1). ![]() ARGX-110 was administered intravenously every 3 weeks until progression or intolerable toxicity. Experimental Design: Dose escalation with a sequential 3+3 design was performed in five steps at the 0.1, 1, 2, 5, and 10 mg/kg dose levels ( N = 26). Purpose: The purpose of this study was to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor efficacy of ARGX-110, a glyco-engineered monoclonal antibody, targeting CD70, in patients with CD70 expressing advanced malignancies.
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