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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 4 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,749 Total Patients Enrolled

Bayer Study DirectorStudy DirectorBayer

1,180 Previous Clinical Trials

4,261,710 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still enrollments for this experiment being accepted?

"Per the records on clinicaltrials.gov, this medical trial is recruiting patients. It was initiated on July 6th 2017 and has had its details updated most recently on November 7th 2022."

Answered by AI

To what extent is participation sought for this trial?

"Affirmative. According to information on clinicaltrials.gov, this trial is currently enrolling patients with the initial post dated July 6th 2017 and last update November 7th 2022. 239 participants will be recruited from a single site for this medical experiment."

Answered by AI

Is BAY1895344 a risk-free drug for human consumption?

"Our team at Power judged that BAY1895344 has limited clinical data for safety and efficacy, thus granting it a rating of 1."

Answered by AI

What outcomes is this experiment striving to accomplish?

"According to the trial's sponsor, Bayer, a primary outcome measured over 21 days is determining BAY1895344's Maximum Tolerated Dosage and Recommended Phase II dosage. Additionally, secondary objectives include gauging the Lugano Classification-defined responses (CR, PR SD or PD) of lymphoma patients; RECIST 1.1 criteria-based reactions in solid tumors apart from CRPC; and finally measuring lymphoma patient responses according to the Lugano Classification again."

Answered by AI

Recent research and studies

Journal of Medicinal ChemistryJournal

Damage Incorporated: Discovery of the Potent, Highly Selective, Orally Available ATR Inhibitor BAY 1895344 with Favorable Pharmacokinetic Properties and Promising Efficacy in Monotherapy and in Combination Treatments in Preclinical Tumor Models

Lücking, Ulrich, Lars Wortmann, Antje M. Wengner, Julien Lefranc, Philip Lienau, Hans Briem, Gerhard Siemeister, et al.. 2020. “Damage Incorporated: Discovery of the Potent, Highly Selective, Orally Available ATR Inhibitor BAY 1895344 with Favorable Pharmacokinetic Properties and Promising Efficacy in Monotherapy and in Combination Treatments in Preclinical Tumor Models”. Journal of Medicinal Chemistry. American Chemical Society (ACS). doi:10.1021/acs.jmedchem.0c00369.

clinicaltrials.govStudy

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

2017. "First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03188965.