A Phase I/II Study of MRG004A in People with Advanced Solid Tumors

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Full Title

An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in Patients with Tissue Factor Positive Advanced or Metastatic Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug MRG004A that can be used safely in people with advanced solid tumors that cannot be successfully treated with standard therapies or for which no standard therapies exist. MRG004A is type of medication called an antibody-drug conjugate. The antibody binds to a protein on cancer cells called tissue factor (TF), and then a chemotherapy drug is released which kills the cancer cells. Participants will have their tumors tested for TF. MRG004A is given intravenously (by vein).

Eligibility

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

  • Participants must have an inoperable or metastatic solid tumor that has come back or continued growing despite standard therapy or for which no standard therapy exists.
  • The serious side effects of previous treatments must go away before MRG004A is given.
  • 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 and to ask about eligibility for this study, please contact the office of Dr. Wungki Park at 646-888-4543.

Protocol

22-066

Phase

I/II

Investigator

Co-Investigators

Diseases