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 Pembrolizumab 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).


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)



Jhaveri, Komal, MD
Ku, Geoffrey, MD