A Phase I/II Study of BA3011 in Patients with Advanced Cancer

Full Title

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 in Patients with Advanced Solid Tumors

Purpose

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called BA3011 in patients with advanced solid tumors, including non-small cell lung cancer, prostate cancer, and pancreatic cancer. BA3011 is a type of drug called an antibody-drug conjugate (ADC). ADCs have two parts: an antibody that targets cancer cells and a chemotherapy drug that kills cancer cells.

The antibody part of BA3011 sticks to a target on some cancer cells called AXL. The chemotherapy drug is called monomethyl auristatin E (MMAE). When the antibody part of BA3011 attaches to AXL, the ADC goes inside the cell, MMAE is released, and the cell is destroyed.

BA3011 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 an inoperable or metastatic advanced solid tumor, such as non-small cell lung cancer, castration-resistant prostate cancer, or pancreatic cancer, that contains the AXL protein.
  • Patients’ tumors must have come back or continued to grow despite standard therapy.
  • At least 4 weeks must pass between the completion of previous treatment and entry into 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 and to inquire about eligibility for this study, please contact Dr. Eileen O’Reilly at 646-888-4182.

Protocol

18-261

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators