A Phase I Study of BDC-1001 Alone or in Combination with Pembrolizumab Immunotherapy in People with Advanced Solid Tumors that Make Too Much HER2


Full Title

Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination with Nivolumab in Patients with Advanced HER2-Expressing Solid Tumors


The purpose of this study is to find the highest dose of the investigational drug BDC-1001 that can be given alone or in combination with the immunotherapy drug pembrolizumab in patients with advanced solid tumors that make too much of a protein called HER2. Making too much HER2 causes cancer cells to divide and grow uncontrollably.

BDC-1001 helps the immune system recognize and attack tumor cells that make HER2. Researchers think that combining BDC-1001 with pembrolizumab (which also stimulates the immune system to attack cancer cells) may be an effective treatment for these types of tumors. Patients in this study will receive BDC-1001 alone or with pembrolizumab. Both medications are given intravenously (by vein).

Who Can Join

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

  • Patients must have an advanced solid tumor that cannot be successfully treated with standard therapies and makes too much HER2.
  • 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. Bob Li at 646-888-4226.




Phase I (phase 1)



ClinicalTrials.gov ID