BAY 1895344 for Recurrent Head and Neck Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find the highest dose of radiation and an experimental drug called BAY 1895344 that can be given safely in combination with pembrolizumab to patients with head and neck cancer that has come back.

What is the Condition Being Studied?

Recurrent Head and Neck Cancer

Who Can Participate in the Study?

Adults who:
- Have head and neck cancer that has come back (recurrent) but not spread to other parts of the body
- Finished a course of radiation therapy at least 6 months ago and have not received more than one radiation course
- Have finished taking chemotherapy at least 4 weeks ago
- Are not currently pregnant or planning to become pregnant

Age Group

What is Involved?

There are two parts in this study: a dose escalation part and a dose expansion part.

If you choose to join the study, your doctor will tell you which part you are in.
- Dose escalation: You will take different doses of the study drug (BAY 1895344) with a short course of radiation in addition to the usual doses of pembrolizumab.
- Dose expansion: You will take the highest dose of the study drug in addition to radiation and pembrolizumab.

In either part of the study, you will take the study drug for a total of 2 cycles (21 days in each cycle).

You will get pembrolizumab through an IV in your arm for 30 minutes on the first day of each cycle.

During Cycle 1, you will:
- Start taking the study drug after the first dose of pembrolizumab
- Take the study drug as a pill(s) with a glass of water every 12 hours
- Continue taking the study drug for the first three days of each week for two weeks

During Cycle 2, you will:
- Get three doses of radiation after your pembrolizumab dose (radiation doses are given 2-3 days apart)
- Take the study drug three times before and after each radiation dose

After you have finished both cycles and if you are doing well, you may continue to get pembrolizumab once every 21 days (3 weeks).

Study Details

Full Title
Phase I Trial of BAY 1895344 ATR Inhibitor Combined with Stereotactic Body Radiation Therapy and Pembrolizumab for Recurrent Head and Neck Squamous Cell Carcinoma
Principal Investigator
Radiation Oncologist
Protocol Number
IRB: PRO00107885
NCT: NCT04576091
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center