ATR Inhibitor BAY 1895344 plus pembrolizumab in advanced solid tumors (GI, Pancreatic, mCRPC, NSCLC)

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Updated on 13 October 2021
measurable disease


This clinical study aims to investigate if impairment of the deoxyribonucleic acid damage repair (DDR) pathway by the Elimusertib in combination with blockade of the PD-1/PD-L1 pathway by pembrolizumab, may improve antitumor responses in advanced cancer patients with DDR aberrations, at an acceptable safety profile and an expected positive benefit/risk ratio.


Condition Gastric Cancer, solid tumors, Pancreatic cancer, CRPC, nsclc, solid tumor, mCRPC, Pancreatic Cancer, Prostate Cancer, Lung cancer, Islet Ce417ll Cancer, oncology, NSCLC, Prostate cancer, ATR, Stomach Cancer, GI cancer
Clinical Study IdentifierTX279019
Last Modified on13 October 2021


Yes No Not Sure

Inclusion Criteria

Participant must be ≥18 years of age inclusive, at the time of signing the informed consent
Presence of the putative biomarkers of DDR deficiency in tumor and/or other tissues
Participants must have histologically confirmed solid tumors
Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
Adequate bone marrow function as assessed by laboratory tests to be conducted within 7 days before the first dose of study intervention
Participants must have adequate kidney function, as assessed by the estimated glomerular filtration rate (eGFR) > 40 mL/min per 1.73 m2 within 7 days before the first dose of study intervention
Participants must have adequate liver function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study intervention
Participants must have adequate coagulation, as assessed by laboratory tests as applicable, (to be conducted within 7 days before the first dose of study intervention) or on stable anti-coagulation treatment
Adequate cardiac function per institutional normal measured by echocardiography (recommended) or multigated acquisition (MUGA) scan/cardiac MRI per institutional guidelines
Participants must have measurable disease (at least one measurable lesion) as per RECIST 1.1, or evaluable disease according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) classification as applicable. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions

Exclusion Criteria

Ongoing infections of Common terminology criteria for adverse events (CTCAE) grade ≥2 not responding to therapy or active clinically serious infections
Participants with
a.) Known human immunodeficiency virus (HIV)
b.) Active Hepatitis B infection (positive for Hepatitis B surface antigen (HBsAg)/ Hepatitis B virus (HBV) DNA)
c.) Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay)
Active autoimmune disease (active defined as having autoimmune disease related symptoms and detectable autoantibodies) that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Diagnosis of immunodeficiency or participant is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor
Pleural effusion or ascites that causes respiratory compromise (CTCAE Grade ≥ 2 dyspnea)
History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class >II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial infarction within the past 6 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted)
Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)
Moderate or severe hepatic impairment, i.e., Child-Pugh class B or C. 9. History of organ allograft transplantation 10. Evidence or history of bleeding disorder, i.e., any hemorrhage / bleeding event of CTCAE Grade > 2 within 4 weeks before the first dose of study intervention
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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