A Phase IB Study of BAY 1895344 plus Niraparib to Treat Advanced Ovarian Cancer and Other Solid Tumors

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An Open-Label Phase 1b Study To Determine The Maximum Tolerated And/Or Recommended Phase 2 Dose Of The ATR Inhibitor BAY 1895344 In Combination With PARP Inhibitor Niraparib, In Patients With Recurrent Advanced Solid Tumors And Ovarian Cancer

Purpose

The purpose of this study is to find the highest dose of the investigational drug BAY 1895344 that can be given in combination with niraparib in patients with advanced ovarian cancer and other solid tumors. BAY 1895344 works by blocking an enzyme called ATR kinase, which plays an important role in the growth of tumor cells.

Niraparib works by inhibiting PARP, a protein that helps cancer cells repair DNA that has been damaged by cancer treatments. When cancer cells repair damaged DNA, they can continue growing and multiplying, so depriving them of this power with a PARP inhibitor may be an effective approach to treatment.

Combining niraparib with BAY 1895344 may slow or stop the growth of tumor cells by interrupting the processes that happen inside the cells to help them survive and grow. Both drugs are 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 recurrent ovarian cancer, primary peritoneal cancer, fallopian tube cancer, or another recurrent solid tumor.
  • Patients should recover from the 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. Rachel Grisham at 646-497-9055.

Protocol

20-222

Phase

I

Investigator

Co-Investigators