First-in-Human, Phase 1 Study of AMT-116, an Anti-CD44v9 Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors

AMT-116 is a ADC targeting CD44v9 with topoisomerase 1 payload.

• In this study, the sponsor and investigators want to learn:
  • How much of the study drug / agent can be given with an acceptable level of side effects
  • The effects of the study drug / agent (good and bad)
  • How much of the study drug / agent is absorbed into the blood and how fast it is removed
  • How the study drug / agent is acting on your body

This study is open label, which means you, the study doctor, and any other people involved in this study will know the study drug and the dose you actually receive.

This study is divided into three periods:

• a screening period (maximum of 28 days),
• a treatment period (you may continue in the treatment period until you choose to stop or the study is stopped),
• and a follow-up period including visits at about 30 days after the last dose of study drug, and every 12 weeks thereafter until you withdraw consent or your study doctor decides that no further follow-up is needed.

During each study period, you will have 1 or more visits with your study doctor at the research site. Some follow-up visits may be completed by a phone call or email.

The number of visits at the research site will depend on how you tolerate the study drug and how your cancer responds to the study drug.

You may be asked to attend the research site for extra visits any time during the study if the study doctor decides that extra assessments are needed for your safety.