A Phase I/IIA Study to Evaluate CT7001 in People with Advanced Triple-Negative Breast Cancer

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Full Title

A Modular, Multipart, Multiarm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination with Anti-cancer Treatments in Patients with Advanced Malignancies

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug CT7001 in people with triple-negative breast cancer (TNBC) that has come back, continued to grow, or metastasized despite receiving standard chemotherapy. TNBC is a form of the disease in which the tumor lacks receptors for estrogen, progesterone, and HER2.

CT7001 blocks an enzyme called CDK7, which is thought to have an important role in the growth of cancers like TNBC. Blocking CDK7 may help stop the growth of this cancer. CT7001 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 TNBC that has come back, continued to grow, or metastasized after standard chemotherapy.
  • Patients should recover from the serious side effects of prior treatment 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. Tiffany A. Traina at 646-888-4558.

Protocol

19-296

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases