A Phase I/II Study of LYT-200 in People with Solid Tumors

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Full Title

A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Anti-PD-1 in Patients with Metastatic Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug LYT-200 that can be given safely in people with inoperable and metastatic solid tumors that continue growing despite prior treatment. LYT-200 is an immunotherapy that binds to a protein that is often found in higher than usual amounts on tumor cells and in the blood of people with solid tumors. This protein can limit the immune system’s ability to fight cancer cells. LYT-200 “turns off” the protein, allowing the immune system to become active and attack cancer cells. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have an inoperable metastatic solid tumor cancer that continues to grow despite standard therapy or for which no standard therapy exists.
  • At least 4 weeks must pass between the completion of previous treatments and receipt of LYT-200.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Neil Segal at 646-888-4187.

Protocol

21-445

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases