check_circleStudy Completed

Advanced solid tumor, Non-Hodgkin’s lymphoma, Mantle cell lymphoma

First-in-human study of ATR inhibitor BAY1895344 in patients with advanced solid tumors and lymphomas

Trial purpose

The ATR (ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for the treatment of patients with advanced solid tumors 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.

Key Participants Requirements

Sex

All

Age

18 Years

Trial summary

Enrollment Goal
229
Trial Dates
July 2017 - September 2023
Phase
Phase 1
Could I Receive a placebo
No
Products
Elimusertib (BAY1895344)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
National University HospitalSingapore, 119228, Singapore
Active, not recruiting
University of Texas MD Anderson Cancer CenterHouston, 77030-4009, United States
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
Freeman HospitalNewcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Kantonsspital St. GallenSt. Gallen, 1009, Switzerland
Withdrawn
UniversitätsSpital ZürichZürich, 8091, Switzerland
Completed
Oncology Institute of Southern SwitzerlandBellinzona, 6500, Switzerland
Withdrawn
Universitätsspital BaselBasel, 4056, Switzerland
Completed
Hôpital Cantonal Universitaire de GenèveGeneva, 1205, Switzerland
Withdrawn
Universitätsmedizin der Johannes Gutenberg Universität MainzMainz, 55131, Germany
Withdrawn
Klinikum der Universität München GrosshadernMünchen, 81377, Germany
Withdrawn
Universitätsklinikum Carl Gustav Carus DresdenDresden, 01307, Germany
Recruiting
National Cancer Center SingaporeSingapore, 168583, Singapore
Withdrawn
Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Withdrawn
Institut Bergonié - Unicancer Nouvelle AquitaineBORDEAUX CEDEX, 33076, France
Withdrawn
Centre Antoine LacassagneNICE CEDEX 2, 06102, France
Completed
Fairfax-Northern Virginia Hematology/Oncology, PCFairfax, 22031, United States
Completed
Emory UniversityAtlanta, 30322, United States
Completed
Weill Cornell Medical CollegeNew York, 10021, United States
Completed
University of Utah - OncologySalt Lake City, 84112, United States
Completed
University Hospitals Cleveland Medical CenterCleveland, 44106, United States
Active, not recruiting
H. Lee Moffitt Cancer Center & Research InstituteTampa, 33612, United States
Withdrawn
Hôpital Henri MondorCRETEIL CEDEX, 94000, France
Withdrawn
Institut de Cancérologie de l'Ouest - Saint HerblainSaint-Herblain, 44800, France
Withdrawn
Centre Hospitalier Lyon SudPIERRE BENITE, 69495, France
Withdrawn
Hopital Hotel Dieu - NantesNANTES CEDEX, 44035, France
Withdrawn
Institut Gustave RoussyVillejuif, 94805, France
Completed
Gabrail Cancer CenterCanton, 44718, United States
Completed
Jefferson Medical CollegePhiladelphia, 19107, United States
Completed
National Cancer Center HospitalChuo-ku, 104-0045, Japan
Completed
Shizuoka Cancer CenterSunto, 411-8777, Japan
Completed
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Withdrawn
Belfast City HospitalBelfast, BT12 7AB, United Kingdom
Completed
Velindre HospitalCardiff, CF14 2TL, United Kingdom
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Integrated Cancer Center of the CHU de QuébecQUEBEC, G1J 1Z4, Canada
Completed
OHRI - The Ottawa HospitalOttawa, K1H 8L6, Canada
Withdrawn
Institut Claudius Regaud - iUCT OncopoleTOULOUSE CEDEX 9, 31059, France
Withdrawn
Hôpital Claude Huriez - LilleLILLE CEDEX, 59037, France
Completed
Dana-Farber Cancer InstituteBoston, 02215, United States
Completed
Beijing Cancer HospitalBeijing, 100142, China
Completed
Texas Oncology- San Antonio NortheastSan Antonio, 78217, United States
Completed
Massachusetts General HospitalBoston, 02114-2696, United States
Withdrawn
University Hospitals Cleveland Medical CenterCleveland, 44106, United States
Completed
US Oncology / EugeneEugene, 97401, United States
Withdrawn
US Oncology / Fort WorthFort Worth, 76014, United States
Completed
City of Hope National Medical CenterDuarte, 91010, United States

Primary Outcome

  • The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D) of BAY1895344
    MTD and/or R2PD will be determined in Cycle 1 of Part A, Part A.1 and J-arm of Part A. The MTD is defined as the maximum dose at which the incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 30%, or the maximum dose tested, whichever is achieved first during dose-escalation.
    date_rangeTime Frame:
    Up to 6 months, minimum: 1 cycle (= 21days)
  • Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A of the study
    date_rangeTime Frame:
    During Cycle 1, 1 cycle=21 days
  • Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A.1 of the study
    date_rangeTime Frame:
    During Cycle 1, 1 cycle=28 days
  • Incidence of DLTs during Cycle 1 in dose-escalation cohorts during J-arm of the study
    date_rangeTime Frame:
    During Cycle 1, 1 cycle=21 days
  • The incidence of serious and nonserious treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    After first administration of study drug up to 30 days after the last dose of study drug
  • 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
    AUC(0-12) and AUC(0-12)md will be evaluated in Part A, A.1 and J-arm of Part A.
    date_rangeTime Frame:
    Pre-dose and up to 12 hours post-dose at Day 1 of Cycle 1 and Day 10 (Part A and J-arm) or Day 17 (Part A.1) of Cycle 1
  • Maximum observed drug concentration in plasma of BAY1895344 after single-dose (Cmax) and multiple-dose administrations (Cmax,md) in Cycle 1
    Cmax and Cmax,md will be evaluated in Part A, A.1 and J-arm of Part A.
    date_rangeTime Frame:
    Pre-dose and up to 12 hours post-dose at Day 1 of Cycle 1 and Day 10 (Part A and J-arm) or Day 17 (Part A.1) of Cycle 1

Secondary Outcome

  • Incidence of solid tumor responses (except CRPC) consistent with the RECIST 1.1 criteria
    Responses include: CR (complete response), PR (partial response), SD (stable disease), PD (progressive disease). CRPC: castration resistant prostate cancer; RECIST: Response Evaluation Criteria in Solid Tumors
    date_rangeTime Frame:
    Through study completion, an average of 4 months
  • Incidence of lymphoma responses consistent with the Lugano Classification
    Responses include: CR (complete response), PR (partial response), SD (stable disease), PD (progressive disease).
    date_rangeTime Frame:
    Through study completion, an average of 4 months
  • Incidence of CRPC tumor responses consistent with the recommendations of the PCWG3
    Responses include: CR (complete response), PR (partial response), SD (stable disease), PD (progressive disease). PCWG3: Prostate Cancer Working Group 3
    date_rangeTime Frame:
    Through study completion, an average of 4 months

Trial design

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 tumors and lymphomas
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
5