Breast Cancer Clinical Trial

Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug

Summary

The purpose of the study is to test how well patients with advanced solid tumors respond to treatment with elimusertib (BAY1895344) in combination with pembrolizumab. In addition researchers want to find for patients the optimal dose of elimusertib in combination with pembrolizumab, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication, elimusertib, works by blocking a substance (ATR Kinase) which is produced by the body and is important for the growth of tumor cells. Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against the tumor.

View Eligibility Criteria

Eligibility Criteria

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 (dose escalation only).
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 m*2 within 7 days before the first dose of study intervention.
Participants must have adequate liver function as assessed by 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 be 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

Known human immunodeficiency virus (HIV)
Active Hepatitis B infection (positive for Hepatitis B surface antigen (HBsAg)/ Hepatitis B virus (HBV) DNA).
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.
History of organ allograft transplantation
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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

56

Study ID:

NCT04095273

Recruitment Status:

Active, not recruiting

Sponsor:

Bayer

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 16 Locations for this study

See Locations Near You

Stanford University - DCT Dept.
Palo Alto California, 94304, United States
Yale Cancer Center
New Haven Connecticut, 06519, United States
Johns Hopkins Hospital/Health System
Baltimore Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Weill Cornell Medical College
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Ohio State University
Columbus Ohio, 43210, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Universitätsklinikum Heidelberg
Heidelberg Baden-Württemberg, 69120, Germany
Eberhard-Karls-Universität Tübingen
Tübingen Baden-Württemberg, 72076, Germany
Fundacion Jimenez Diaz (Clinica de la Concepcion)
Madrid , 28040, Spain
Hospital Madrid Norte Sanchinarro
Madrid , 28050, Spain
Kantonsspital St. Gallen
St. Gallen Sankt Gallen, 9007, Switzerland
Ospedale Regionale di Bellinzona e Valli
Bellinzona Ticino, 6500, Switzerland
Royal Marsden NHS Trust (Surrey)
Sutton Surrey, SM2 5, United Kingdom
Freeman Hospital
Newcastle Upon Tyne Tyne And Wear, NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

56

Study ID:

NCT04095273

Recruitment Status:

Active, not recruiting

Sponsor:


Bayer

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider