A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients with Advanced, Refractory or Recurrent Solid Tumors

MC #23-28

NCT #
Condition(s)
Solid Tumor
Molecular Target(s)
CMTR2
Drug Classification(s)
Molecular Targeted Therapy
Agents(s)
AT-1965
Phase(s)
I/II

Mechanism of Action

  • AT-1965 is a CMTR2 inhibitor

Purpose

In this study, the sponsor and investigators want to learn:

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

Study Design

This is a dose escalation/expansion study. Dose Escalation means that the amount of the study drug 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 with a specific tumor type will receive the study drug dose determined to be appropriate in the dose escalation part of the study.

The study regimen will be given in cycles.  Each cycle is 4 weeks (28 days).  You will receive the study drug once every week for the first 3 weeks (on Days 1, 8 and 15) as an IV (intravenous, meaning into a vein) infusion over 3 hours.

Location

Mary Crowley Cancer Research - Medical City Dallas

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