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ATR Inhibitor

Part A: single-agent dose-escalation for Mantle Cell Lymphoma

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 months
Awards & highlights

Summary

This trial will test a new drug, BAY1895344, to see if it is safe and tolerable for cancer patients, and to find the maximum dose that can be given safely. The trial will also determine how well the cancer responds to the treatment.

Eligible Conditions
  • Solid Tumors
  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Incidence of DLTs during Cycle 1 in dose-escalation cohorts during J-arm of the study
Incidence of DLTs during Cycle 1 in dose-escalation cohorts during Part A of the study
+4 more
Secondary outcome measures
Incidence of CRPC tumor responses consistent with the recommendations of the PCWG3
Incidence of lymphoma responses consistent with the Lugano Classification
Incidence of solid tumor responses (except CRPC) consistent with the RECIST 1.1 criteria

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part B: single-agent expansionExperimental Treatment1 Intervention
Patients with a) DDR deficiency biomarker-positive advanced solid tumors: castration-resistant prostate cancer (CRPC), HER2-negative breast cancer (BC), colorectal cancer (CRC), and gynecological tumors; OR b) histologically confirmed advanced cancer and loss of ATM regardless of the cancer type receive BAY1895344 at MTD determined at the end of dose escalation.
Group II: Part B.1: single-agent expansion with alternative dosing scheduleExperimental Treatment1 Intervention
Patients with histologically confirmed relapsed or refractory MCL receive BAY1895344 at a dose determined after evaluation of multiple BAY1895344 doses in Part A.1
Group III: Part A: single-agent dose-escalationExperimental Treatment1 Intervention
Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma (NHL) receive BAY1895344 in a 21-day cycle.
Group IV: Part A.1: Single-agent dose escalation with alternative dosing scheduleExperimental Treatment1 Intervention
Patients with histologically confirmed solid tumors or NHL known to be positive for ATM loss and/or ATM deleterious mutations receive BAY1895344 in a 28-day cycle.
Group V: J-arm of Part A: dose escalation cohort in Japanese patientsExperimental Treatment1 Intervention
Japanese patients with histologically confirmed solid tumors receive BAY1895344 at two dose levels: MTD-1 and MTD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elimusertib (BAY1895344)
2019
Completed Phase 1
~290

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,251 Previous Clinical Trials
25,336,687 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,650 Total Patients Enrolled

Media Library

BAY1895344 (ATR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03188965 — Phase 1
Mantle Cell Lymphoma Research Study Groups: Part A: single-agent dose-escalation, Part A.1: Single-agent dose escalation with alternative dosing schedule, J-arm of Part A: dose escalation cohort in Japanese patients, Part B: single-agent expansion, Part B.1: single-agent expansion with alternative dosing schedule
~29 spots leftby Jul 2025
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