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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Study drugs will be administered as scheduled
Study drugs will be administered as scheduled
Stanford University
Palo Alto, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Johns Hopkins Hospital/Health System
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Eberhard-Karls-Universität Tübingen
Tübingen, Baden-Wurttemberg, Germany
...and 6 more locations
Incidence of Treatment Emergent Adverse Events (TEAEs) including Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Up to 30 days after last study intervention administration
Severity of Treatment Emergent Adverse Events (TEAEs) including Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Up to 30 days after last study intervention administration
Frequency of Dose limiting toxicities (DLTs) at each dose level during dose escalation of BAY1895344
Time frame: Cycle 1 (21 days)
Recommended phase II dose (RP2D) of BAY1895344
The RP2D will be determined in dose expansion part based on multiple parameters (i.e., safety, tolerability, PK, pharmacodynamics, efficacy) and will be a dose equal to or lower than the MTD (Maximum Tolerated Dose).
Time frame: Up to 24 months
Cmax of Elimusertib
Time frame: Cycle 1 (21 days), Day 8 (dosing schedule 1) or Cycle 1 (21 days), Day 1 (dosing schedule 2)
AUC(0-12) of Elimusertib
If the main parameters AUC(0-12) cannot be calculated reliably, it might become necessary to appoint the additional parameters AUC(0-tlast) as secondary variables.
Time frame: Cycle 1 (21 days), Day 8 (dosing schedule 1) or Cycle 1 (21 days), Day 1 (dosing schedule 2)
Cmax,md of Elimusertib
Time frame: Cycle 1 (21 days), Day 17 (dosing schedule 1) or Cycle 1 (21 days), Day 10 (dosing schedule 2)
AUC(0-12)md of Elimusertib
If the main parameters AUC(0-12)md cannot be calculated reliably, it might become necessary to appoint the additional parameters AUC(0-tlast)md as secondary variables.
Time frame: Cycle 1 (21 days), Day 17 (dosing schedule 1) or Cycle 1 (21 days), Day 10 (dosing schedule 2)
Incidence of Complete response (CR)
Per RECIST 1.1 and for participants with mCRPC consistent with recommendations of the Prostate Cancer Working Group (PCWG3)
Time frame: Up to 24 months
Incidence of partial response (PR)
Per RECIST 1.1 and for participants with mCRPC consistent with recommendations of the Prostate Cancer Working Group (PCWG3)
Time frame: Up to 24 months
Incidence of stable disease (SD)
Per RECIST 1.1 and for participants with mCRPC consistent with recommendations of the Prostate Cancer Working Group (PCWG3)
Time frame: Up to 24 months
Incidence of progressive disease (PD)
Per RECIST 1.1 and for participants with mCRPC consistent with recommendations of the Prostate Cancer Working Group (PCWG3)
Time frame: Up to 24 months
Objective Response Rate (ORR)
Time frame: Up to 24 months
Disease control rate (DCR)
Time frame: Up to 24 months
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