A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Trial of Oral ATRN-119 in Patients with Advanced Solid Tumors

ATRN-119 selectively targets and binds to ATR, and inhibits its activity and ATR-mediated signaling. This blocks the downstream phosphorylation of the serine/threonine protein kinase checkpoint kinase 1 (CHK1). This results in the inhibition of DNA damage checkpoint activation, the disruption of DNA damage repair, and the induction of tumor cell apoptosis.

• How much of the study agent can be given with an acceptable level of side effects
• The effects of the study agent (good and bad)
• How much of the study agent is absorbed into the blood and how fast it is removed
• How the study agent is acting on your body

This study has 2 parts, dose escalation and dose expansion.

Dose Escalation means that the amount of the study agent given will be increased in each group of research participants, to find the most appropriate dose for further study.

In the Dose Expansion part of the study, a larger number of people receive the study agent dose determined to be appropriate in the dose escalation part of the study.

The dose of the study agent you receive will be determined based on when you enter into the study.

The study regimen will be given in 56 day cycles. You will receive the study agent daily, by mouth on an empty stomach (at least 2 hours after and at least 1 hour prior to a meal) for 56 days. If the study agent is well tolerated, you will receive the study agent to take for another 56 day cycle. After a higher dose is confirmed safe and if you are tolerating a lower dose, then you may be able to receive a higher dose, if approved by the study doctor.