A Phase I Study of BCA101, Alone and Combined with Pembrolizumab Immunotherapy, in People with Advanced Lung Cancer

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Full Title

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFß Fusion Protein BCA101 Alone and in Combination with Pembrolizumab in Patients with EGFR-Driven Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug BCA101 that can be given safely alone and in combination with the immunotherapy drug pembrolizumab in patients with advanced lung cancer that cannot be cured with standard treatments. BCA101 is an antibody that targets two proteins involved in cancer growth called EGFR and TGF-beta. By blocking these proteins, BCA101 may interfere with the signals that spur cancer growth. 

Pembrolizumab works by boosting the ability of the immune system to detect and kill cancer cells. Both BCA101 and pembrolizumab are 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 lung cancer that is driven by EGFR and cannot be successfully treated with standard therapies.
  • Patients must recover from the serious side effects of prior therapies before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Paul Paik at 646-608-3759.

Protocol

20-476

Phase

I

Investigator

Co-Investigators