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Clinical Trial 19462
Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT03188965
Phase: Phase I
Prinicipal Investigator: Jingsong Zhang
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
Summary
Objective
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
Therapies
Medications
Bay 1895344 ()
Part A - single-agent dose-escalation part:
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