A Phase I/II Study of BDTX-189 in People with Advanced Solid Tumors

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Full Title

A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutations, in Patients with Advanced Solid Malignancies

Purpose

In this study, researchers want to find the highest dose of the investigational drug BDTX-189 that can be given safely in patients with advanced solid tumors that have continued to grow or came back after prior treatment. BDTX-189 targets a family of proteins found on many types of cancer cells called ErbB. If BDTX-189 is able to stop ErbB activity in cancer cells, the cancer cells will die. BDTX-189 is also designed to lessen some of the side effects, such as rashes and diarrhea, that can happen during treatment with similar drugs. It is taken orally (by mouth).

Eligibility

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

  • Patients must have a solid tumor that continues to grow or came back despite prior treatment and cannot be successfully treated with standard therapies.
  • Patients’ tumors must contain a mutation in one of these genes: EGFR, HER2, or HER3.
  • Patients must 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 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. Alison Schram at 646-888-5388.

Protocol

20-189

Phase

I/II

Investigator

Co-Investigators