With this trial we would like to further evaluate the safety, tolerability and efficacy of the trial medication BAY-1895344 in combination with Pembrolizumab (tradename ‘Keytruda®’) in patients with advanced cancer (certain types of solid malignant tumors). This combination therapy with Pembrolizumab is being tested in humans for the first time. In doing so, we want to understand the mode of action of this combination therapy and to find out the optimal cancer types for further development of the combination therapy. In addition, we want to observe how the trial medication changes and distributes in the body and how the treated cancer disease responds to this combination therapy.
The trial medication blocks an enzyme called ATR kinase, which is part of the ATR metabolic pathway. The tumor cells are often dependent on the ATR pathway so that they can survive and grow.
Pembrolizmab activates the body’s immune system to fight cancer cells. There is therefore reason to believe that the combination therapy (inhibiting the ATR pathway and activating the immune system) can together better reduce cancer cells growth.
Patients, who are suffering from a malignant solid tumor and where standard treatments are no longer working, can participate. In addition, a certain type of gene deficiency/mutation must be present in these patient populations. Up to 160 patients worldwide will take part. The trial, resp. the combination therapy will continue until it no longer brings benefit or the patient's health worsens.
More information can be found at ‚ClinicalTrials.gov‘.