A Phase I Study of HTI-1066 to Treat Metastatic Solid Tumors

Full Title

A Two-Part, Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety and Tolerability of HTI-1066 in Subjects with Advanced Solid Tumors (Including c-Met Positive)

Purpose

The purpose of this study is to find the highest dose of the investigational drug HTI-1066 that can be given safely in patients with metastatic solid tumors that have come back or continued to grow despite prior treatment. HTI-1066 is called an antibody-drug conjugate; it has two different molecules attached to it. One is an antibody, a part of the of the immune system that can target specific features of cancer cells. The second part is a potent anticancer drug. The antibody recognizes and binds to a part of the cancer cell and then releases the anticancer drug into the tumor.

HTI-1066 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a recurrent or persistent metastatic solid tumor.
  • Patients should recover from the side effects of prior treatment before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alexander Drilon at 646-888-4206.

Protocol

19-052

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators