AXA-042-FIH-01

The study will be conducted in two parts, with part A registered in this form and part B provided in a separate registration:

Part A will evaluate ascending doses of AXA-042 to investigate its safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy in patients with advanced solid tumors. AXA-042 will be administered as an intravenous infusion over 30 minutes on Day 1 of each 21-Day Treatment Cycle under supervised administration. Based on a comprehensive analysis of the safety, PD, and PK data from nonclinical studies, the starting FIH 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 level. Approximately 20 to 23 patients are planned to be enrolled in 4 to 5 dose levels in the study. Additional patients may be enrolled in further dose levels based on emerging safety, laboratory tests and PK data from this study. Intrasubject dose escalation is permitted for patients enrolled at all dose levels if the subject is tolerating their initial dose, the patients in the next higher dose level have completed the dose-limiting toxicity (DLT) period without evidence of a DLT, and the dose has been declared safe by the Safety Monitoring Committee. It is permitted to escalate the dose twice for each subject as per the discretion of the Principal Investigator and Medical Monitor. If the safety and tolerability profile of AXA-042 is acceptable, study treatment will continue until disease progression, withdrawal of consent, discontinuation from the study, or toxicity that in the opinion of the Investigator or Sponsor requires study treatment discontinuation or the end of the study, whichever occurs first. This part of the study is still ongoing.