A Phase I/II, First-in-Human, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-24C5 in Patients with Advanced Solid Tumors

MC #23-26

NCT #
Condition(s)
Colorectal Cancer, Gastric/GEJ Cancer, Lung Cancer (NSCLC)
Molecular Target(s)
4-1BB, CEACAM5
Drug Classification(s)
Immunotherapy, Molecular Targeted Therapy
Agents(s)
LM-24C5
Phase(s)
I/II

Mechanism of Action

  • LM-24C5 is a CEACAM5 x 4-1BB bispecific antibody

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

Study Design

This is a dose escalation/expansion study that consists of two phases, Phase 1 and Phase 2.

Phase 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.

Phase 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.

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 14 days.  You will receive the study once every two weeks through intravenous (IV) infusion, given over approximately 60-120 minutes.

Location

Mary Crowley Cancer Research - Medical City Dallas

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