A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants with Advanced Cancer

MC #23-21

NCT #
Condition(s)
Colorectal Cancer
Molecular Target(s)
CDH17
Drug Classification(s)
Antibody Drug Conjugate
Agents(s)
TORL-3-600
Phase(s)
I

Mechanism of Action

  • TORL-3-600 is a CDH(/cadherin)17 targeting ADC

Purpose

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

  • 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

 

Study Design

This is a dose escalation/expansion study that will consist of two parts, Part 1 and Part 2.

Part 1 of the study is called dose escalation. Dose Escalation means that the amount of the study   given will be increased in each group of research participants, to find the most appropriate dose for further study. Participants will be placed in either Group A or Group B

Part 2 of the study is called dose expansion. 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. Part 2 of the study will be conducted in two groups to assess the two dose levels selected in Part 1.

The dose of the study you receive and the part of the study you will be assigned will be determined by when you enter the study.

The study regimen will be given in cycles.  Each cycle is 21 days. You will receive the study through an IV into your veins, given over 30-40 minutes. If you are in Group A you will receive the IV once every 21 days. If you are in Group B you will be given a divided portion of the study agent once every week over a 3-week (21 day) cycle.

Location

Mary Crowley Cancer Research - Medical City Dallas

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