A Phase I Study of TST001 in People with Locally Advanced or Metastatic Digestive Cancers

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Full Title

A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 in Patients with Locally Advanced or Metastatic Solid Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug TST001 alone and with nivolumab immunotherapy in people with locally advanced or metastatic digestive cancers that make a protein called CLDN18.2. TST001 is designed to bind to CLDN18.2 on cancer cells and stimulate the immune system to kill them. Nivolumab further boosts the ability of the immune system to find and destroy cancer cells.

This study will include people with cancers of the stomach (gastric cancer), gastroesophageal junction, pancreas, and bile duct as well as cholangiocarcinoma. Participants will receive TST001 alone or with nivolumab. Both medications are given intravenously (by vein).

Eligibility

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

  • Participants must have locally advanced or metastatic gastric, gastroesophageal, pancreatic, or bile duct cancer or cholangiocarcinoma that cannot be successfully treated with standard therapies.
  • Patients’ tumors must make the CLDN18.2 protein.
  • At least 4 weeks must pass between the completion of prior treatment and receipt of the study therapy.
  • 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.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Yelena Janjigian at 646-888-4186.

Protocol

22-221

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators