NCT03188965 is a Phase 1 clinical trial of Elimusertib (BAY1895344) in Advanced Solid Tumor, sponsored by Bayer.

Who is sponsoring NCT03188965?

NCT03188965 is sponsored by Bayer.

What drugs are being tested in NCT03188965?

Interventions in NCT03188965: Elimusertib (BAY1895344).

What condition does NCT03188965 study?

NCT03188965 studies Advanced Solid Tumor, Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma.

Is NCT03188965 still recruiting?

NCT03188965 is currently completed. Last updated 11 October 2023.

Last reviewed 2023-10-11 · How we verify

NCT03188965

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 11 October 2023

What this trial tests

Phase 1 trial testing Elimusertib (BAY1895344) in Advanced Solid Tumor in 229 participants. Completed in 13 September 2023.

Timeline

6 July 2017

Primary endpoint
2 December 2022

13 September 2023

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	229
Start date	6 July 2017
Primary completion	2 December 2022
Estimated completion	13 September 2023
Sites	29 locations across Japan, United Kingdom, Canada, Switzerland, China, Singapore, United States

Drugs / interventions tested

Elimusertib (BAY1895344) — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Non-Hodgkin's Lymphoma — all drugs for Non-Hodgkin's Lymphoma →
Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor or Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

State-of-the-art strategies for targeting the DNA damage response in cancer.
Pilié PG, Tang C, Mills GB, Yap TA. · · 2019 · cited 876× · PMID 30356138 · DOI 10.1038/s41571-018-0114-z
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
First-in-Human Trial of the Oral Ataxia Telangiectasia and RAD3-Related (ATR) Inhibitor BAY 1895344 in Patients with Advanced Solid Tumors.
Yap TA, Tan DSP, Terbuch A, Caldwell R, et al · · 2021 · cited 213× · PMID 32988960 · DOI 10.1158/2159-8290.cd-20-0868
Advances in synthetic lethality for cancer therapy: cellular mechanism and clinical translation.
Topatana W, Juengpanich S, Li S, Cao J, et al · · 2020 · cited 128× · PMID 32883316 · DOI 10.1186/s13045-020-00956-5
Targeting the DNA Damage Response in OSCC with TP53 Mutations.
Lindemann A, Takahashi H, Patel AA, Osman AA, et al · · 2018 · cited 117× · PMID 29489434 · DOI 10.1177/0022034518759068
Ataxia telangiectasia and Rad3-related inhibitors and cancer therapy: where we stand.
Mei L, Zhang J, He K, Zhang J. · · 2019 · cited 104× · PMID 31018854 · DOI 10.1186/s13045-019-0733-6
Organelle-targeted therapies: a comprehensive review on system design for enabling precision oncology.
Yang J, Griffin A, Qiang Z, Ren J. · · 2022 · cited 103× · PMID 36402753 · DOI 10.1038/s41392-022-01243-0
Progress towards a clinically-successful ATR inhibitor for cancer therapy.
Barnieh FM, Loadman PM, Falconer RA. · · 2021 · cited 97× · PMID 34909652 · DOI 10.1016/j.crphar.2021.100017

Verify or expand the search:

Other trials of Elimusertib (BAY1895344)

Trials testing the same drug.

NCT04267939 — ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer · Phase 1 · terminated
NCT04095273 — Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With · Phase 1 · completed

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03188965 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 11 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03188965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing