check_circleStudy Completed
Advanced solid tumors
Bayer Identifier:
19741
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to test how well patients with advanced solid tumors respond to treatment with the Elimusertib in combination with pembrolizumab, to find the optimal dose for patients, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
56Trial Dates
September 2019 - April 2023Phase
Phase 1Could I Receive a placebo
NoProducts
Elimusertib (BAY1895344)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Johns Hopkins Hospital/Health System | Baltimore, 21287, United States |
Completed | University of Texas MD Anderson Cancer Center | Houston, 77030-4000, United States |
Completed | Stanford University | Palo Alto, 94304, United States |
Completed | Ohio State University | Columbus, 43210, United States |
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | Yale Cancer Center | New Haven, 06519, United States |
Withdrawn | Universitätsklinikum Carl Gustav Carus Dresden | Dresden, 01307, Germany |
Completed | Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69120, Germany |
Completed | Levine Cancer Institute | Charlotte, 28204-2990, United States |
Completed | Weill Cornell Medical College | New York, 10021, United States |
Completed | Dana-Farber Cancer Institute | Boston, 02115-6084, United States |
Completed | Hospital Madrid Norte Sanchinarro | Madrid, 28050, Spain |
Completed | Fundacion Jimenez Diaz (Clinica de la Concepcion) | Madrid, 28040, Spain |
Completed | Freeman Hospital | Newcastle, NE7 7DN, United Kingdom |
Completed | Kantonsspital St. Gallen | St. Gallen, 9007, Switzerland |
Completed | Ospedale Regionale di Bellinzona e Valli | Bellinzona, 6500, Switzerland |
Primary Outcome
- Incidence of Treatment Emergent Adverse Events (TEAEs) including Treatment Emergent Serious Adverse Events (TESAEs)date_rangeTime Frame:Up to 30 days after last study intervention administration
- Severity of Treatment Emergent Adverse Events (TEAEs) including Treatment Emergent Serious Adverse Events (TESAEs)date_rangeTime Frame:Up to 30 days after last study intervention administration
- Frequency of Dose limiting toxicities (DLTs) at each dose level during dose escalation of BAY1895344date_rangeTime Frame:Cycle 1 (21 days)
- Recommended phase II dose (RP2D) of BAY1895344The 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).date_rangeTime Frame:Up to 24 months
Secondary Outcome
- Cmax of Elimusertibdate_rangeTime Frame:Cycle 1 (21 days), Day 8 (dosing schedule 1) or Cycle 1 (21 days), Day 1 (dosing schedule 2)
- AUC(0-12) of ElimusertibIf 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.date_rangeTime Frame:Cycle 1 (21 days), Day 8 (dosing schedule 1) or Cycle 1 (21 days), Day 1 (dosing schedule 2)
- Cmax,md of Elimusertibdate_rangeTime 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 ElimusertibIf 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.date_rangeTime 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)date_rangeTime 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)date_rangeTime 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)date_rangeTime 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)date_rangeTime Frame:Up to 24 months
- Objective Response Rate (ORR)date_rangeTime Frame:Up to 24 months
- Disease control rate (DCR)date_rangeTime Frame:Up to 24 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
13