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

  • STATUS
    Recruiting
  • End date
    Aug 29, 2024
  • participants needed
    125
  • sponsor
    Bayer
Updated on 12 May 2022

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.

Details
Condition Advanced Solid Tumors
Treatment Pembrolizumab, BAY1895344, Elimusertib (BAY1895344)
Clinical Study IdentifierNCT04095273
SponsorBayer
Last Modified on12 May 2022

Eligibility

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 (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 m2 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)
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
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
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)
symptoms and detectable autoantibodies) that has required systemic treatment
Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)
in the past 2 years (i.e., with use of disease-modifying agents
Moderate or severe hepatic impairment, i.e., Child-Pugh class B or C
History of organ allograft transplantation
corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g
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
thyroxine, insulin, or physiologic corticosteroid replacement therapy for
adrenal or pituitary insufficiency, etc.) is not considered a form of systemic
treatment
Pleural effusion or ascites that causes respiratory compromise (CTCAE Grade ≥ 2 dyspnea)
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