New Clinical Trial Explores Addition of Anti-Cancer Drug BAY 1895344 to Standard Chemotherapy

A new clinical trial is studying the safety and tolerability of an investigational medication called elimusertib (BAY 1895344) at different doses in combination with the standard-of-care chemotherapy drugs topotecan or irinotecan. The study also aims to estimate the maximum tolerated dose of BAY 1895344.

The phase 1a/1b clinical trial of is being conducted in patients who have advanced small cell lung cancer, poorly differentiated neuroendocrine cancer, or pancreatic cancer. Satya Das, MD, MSCI, at Vanderbilt University Medical Center serves as principal investigator of the study, which is sponsored by the National Cancer Institute.

The clinical trial aims to enroll approximately 87 patients.  

Study Design

The first part of the study focuses on dose escalation (or dose-finding), while the second part focuses on dose expansion, further testing the safety and tolerability of the established dose found in the first part of the trial. While patients eligible for the dose escalation portion of the study can have any cancers for which irinotecan or topotecan is considered standard of care (such as any poorly differentiated neuroendocrine carcinoma), the dose expansion portion is largely focused on patients with extrapulmonary neuroendocrine carcinoma (large cell or small cell type) and small cell lung cancer. 

Participants in the study will receive BAY 1895344 in combination with either topotecan or irinotecan on specific days of their recommended treatment cycle. Treatment will continue unless a patient’s disease gets worse, side effects become too severe, or the patient or their doctor end their participation in the trial. The study team will then follow participants every two months for up to six months after their treatment period ends.

Approximately 54 patients will take part in the dose escalation part of the study and an additional 33 people in the dose expansion part of the trial. Patients participating in the BAY 1895344 trial will know whether they are taking part in the dose escalation or dose expansion part of the study.

About the Drug

BAY 1895344 is a novel DNA damage repair inhibitor that may block some of the enzymes needed for tumor cells to grow. It is possible that the investigational medication, when used in combination with standard chemotherapy drugs, may further slow tumor growth than with chemotherapy alone. 

Next Steps 

Additional information on the BAY 1895344 study can be found at Interested participants should talk to their treatment team about their eligibility and determine if the study is aligned with their treatment goals.