First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumours and Lymphomas

Official 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 BAY1895344 in Patients With Advanced Solid Tumours and Lymphomas

Summary:

The ATR (ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for the treatment of patients with advanced solid tumours and lymphomas. The purpose of the proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further, the response of the cancer to the treatment will be determined.

Trial Description

Primary Outcome:

• The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D) of BAY1895344
• Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A of the study
• Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A.1 of the study
• Incidence of DLTs during Cycle 1 in dose-escalation cohorts during J-arm of the study
• The incidence of serious and nonserious treatment-emergent adverse events (TEAEs)
• Area under the plasma concentration of BAY1895344 vs. time curve from zero to 12 hours after single-dose (AUC[0-12]) and multiple-dose administrations (AUC[0-12]md) in Cycle 1
• Maximum observed drug concentration in plasma of BAY1895344 after single-dose (Cmax) and multiple-dose administrations (Cmax,md) in Cycle 1

• Incidence of solid tumour responses (except CRPC) consistent with the RECIST 1.1 criteria
• Incidence of lymphoma responses consistent with the Lugano Classification
• Incidence of CRPC tumour responses consistent with the recommendations of the PCWG3

View this trial on ClinicalTrials.gov