A Phase I/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX-MC138 in Subjects with Advanced Solid Tumors

MC #24-22

NCT #
Condition(s)
Solid Tumor
Molecular Target(s)
miRNA 10b
Drug Classification(s)
Agents(s)
Phase(s)
I/II

Mechanism of Action

TTX-MC138 is a modular, iron oxide nanoparticle-based nanocarrier platform (TTX) coupled to an antagomir against miR-10b

Purpose

  • In this study, the sponsor and investigators want to learn:
    • How much of the study drug can be given with an acceptable level of side effects
    • The effects of the study drug (good and bad)
    • How much of the study drug is absorbed into the blood and how fast it is removed
    • How the study drug is acting on your body
    • If research tests can be used in the future to predict who will benefit from TTX-MC138

Study Design

The study will consist of 3 study periods: Screening (up to 28 days), Treatment (28-day treatment cycles, with dosing on Day 1), and Survival Follow-Up (every 3 months). Each 28-day cycle consists of 1 dose of study drug administered as an IV infusion on Day 1 of each cycle.

Your participation in the study will last approximately 4-5 months while receiving IV infusions of TTX-MC138 once a month followed by survival follow-up every 12 weeks.

Location

Mary Crowley Cancer Research - Medical City Dallas

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