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Participant must be ≥18 years of age inclusive, at the time of signing the informed consent |
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Presence of the putative biomarkers of DDR deficiency in tumor and/or other tissues |
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Participants must have histologically confirmed solid tumors |
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Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1 |
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Adequate bone marrow function as assessed by laboratory tests to be conducted within 7 days before the first dose of study intervention |
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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 |
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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 |
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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 |
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Adequate cardiac function per institutional normal measured by echocardiography (recommended) or multigated acquisition (MUGA) scan/cardiac MRI per institutional guidelines |
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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 |
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Ongoing infections of Common terminology criteria for adverse events (CTCAE) grade ≥2 not responding to therapy or active clinically serious infections
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Participants with
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a.) Known human immunodeficiency virus (HIV)
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b.) Active Hepatitis B infection (positive for Hepatitis B surface antigen (HBsAg)/ Hepatitis B virus (HBV) DNA)
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c.) Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay)
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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)
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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
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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
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Pleural effusion or ascites that causes respiratory compromise (CTCAE Grade ≥ 2 dyspnea)
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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)
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Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)
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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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