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Clinical Trial 19462

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT03188965

Phase: Phase I
Prinicipal Investigator: Jingsong Zhang

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Study Title

An Open-Label, First-in-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose and / or Recommended Phase II Dose of the ATR Inhibitor BAY 1895344 in Patients with Advanced Solid Tumors and Lymphomas



The primary objective of this study is to: - Determine the maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D), safety, tolerability, and pharmacokinetics (PK) of BAY 1895344 as single agent, in patients with advanced solid tumors and lymphomas3 - Determine the maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D) and investigate safety, tolerability and pharmacokinetics (PK) of BAY 1895344 administered in combination with radium-223 dichloride in patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastatic disease4 The secondary objective of the study is to: - Evaluate the response rate of BAY 1895344 in the patient population studied as single agent3 The exploratory objectives of this study are to: - Assess the pharmacodynamic (PD) effects of BAY 1895344 on biomarkers when BAY 1895344 is given as monotherapy - Assess the PK / PD relationships between the exposure to BAY 1895344 in plasma and the effects on safety, tumor response rate, and changes from baseline in PD biomarkers - Assess the relative bioavailability of tablet and liquid service formulation (LSF) of BAY 1895344 - Explore the predictiveness of putative deoxyribonucleic acid damage repair (DDR) deficiency biomarkers and identify molecular signatures in response to BAY1895344 single-agent treatment3, 5




Bay 1895344 ()

Inclusion Criteria

Part A - single-agent dose-escalation part:

  • Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma (NHL). Part B - single-agent expansion part:
  • Patients with DDR deficiency biomarker-positive advanced solid tumors of the following histologies: i) CRPC (castration-resistant prostate cancer); ii) HER2-negative BC that is hormone-receptor positive (estrogen-receptor positive, progesterone-receptor positive, or both) or TNBC (triple negative BC); iii) CRC (colorectal cancer), and iv) gynecological tumors (ovarian, primary peritoneal, and fallopian tube cancers, endometrial cancer, or cervical cancer). The biomarker status of patients in Part B will be evaluated before general screening and only patients with the presence of the putative biomarkers of DDR deficiency will be recruited into general screening.
  • Patients with histologically confirmed advanced cancer and loss of ATM protein by IHC, regardless of the cancer type. The following inclusion criteria apply to ALL (dose-escalation and expansion) patients:
  • Patients with tumors resistant or refractory to standard treatment and in which, in the opinion of the investigator, experimental treatment with BAY1895344 may be of benefit, and no standard therapy would confer clinical benefit to the patient.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Patients must have adequate bone marrow function.

  • Exclusion Criteria

  • Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study
  • 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)
  • Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
  • Patients with known human immunodeficiency virus (HIV) infection
  • Patients who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. Patients with chronic HBV or HCV infection are eligible at the investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.
  • Infections of CTCAE(Common Terminology Criteria for Adverse Events Version) Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade >2

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