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A Phase 1, first-in-human, open-label, non-randomized, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AXA-042 as monotherapy in subjects with advanced solid tumors
Axelia Oncology Pty Ltd
This is a dose-escalation and dose-expansion study. AXA-042 will be administered as an intravenous infusion over 30 minutes on Day 1 of each 21-Day Treatment Cycle under supervised administration. The starting dose is proposed to be 0.0001 mg/kg (7 µg for a 70 kg human) of AXA-042. Subsequent dose levels are planned to be calculated as up to a 3-fold increase over the previous dose levels. Approximately 12-18 people are planned to be enrolled in 5-6 sequential dose levels in the study. Additional participations may be enrolled in further dose levels based on emerging data from this study.