A Phase I/II Study of BA3021 in Patients with Advanced Solid Tumors

Full Title

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients with Advanced Solid Tumors

Purpose

The purpose of this study is to determine the highest dose of the investigational drug BA3021 that can be given safely in patients with advanced solid tumors that cannot be cured with standard therapies. BA3021 is an antibody drug conjugate (ADC). ADCs have two parts: the antibody targets cancer cells and the other part (a chemotherapy drug attached to the antibody) kills cancer cells.

The antibody part of BA3021 was designed to stick to a protein called ROR2, which is found on certain types of cancer cells. The cell-killing part of BA3021 is the chemotherapy drug monomethyl auristatin E (MMAE). When the antibody part of BA3021 sticks to ROR2, the ADC goes inside the cell, MMAE is released, and the chemotherapy drug kills the cancer cell. BA3021 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 metastatic or inoperable solid tumor, such as soft-tissue sarcoma, that cannot be cured with standard therapies or for which no standard therapy exists.
  • Patients’ tumors must contain the ROR2 protein.
  • Patients should recover from the serious side effects of previous treatments 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. William Tap at 646-888-4163.

Protocol

19-064

Phase

I/II

Investigator

Co-Investigators