Elimusertib (BAY 1895344) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 387

Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 1/2, and Phase 2 protocols evaluate the safety, tolerability, pharmacokinetics, and therapeutic potential of the selective ATR inhibitor elimusertib (BAY 1895344) as both monotherapy and combination regimens. These studies investigate indications including advanced solid and hematologic malignancies, relapsed or refractory pediatric sarcomas, non-Hodgkin lymphoma, small cell lung cancer, and ovarian carcinoma. Sponsored by institutions such as the National Cancer Institute, Bayer, GlaxoSmithKline, and M.D. Anderson Cancer Center, these trials record recruitment statuses of completed, active not recruiting, terminated, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04491942	ACTIVE_NOT_RECRUITING	Advanced Bile Duct Carcinoma; Advanced Breast Carcinoma; Advanced Cervical Carcinoma; Advanced Endometrial Carcinoma; Advanced Esophageal Carcinoma; Advanced Gastric Carcinoma; Advanced Head and Neck Carcinoma; Advanced Lung Non-Small Cell Carcinoma; Advanced Lung Small Cell Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Penile Carcinoma; Advanced Pleural Malignant Mesothelioma; Advanced Urothelial Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Stage III Cervical Cancer AJCC v8; Stage III Distal Bile Duct Cancer AJCC v8; Stage III Intrahepatic Bile Duct Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Penile Cancer AJCC v8; Stage III Pleural Diffuse Malignant Mesothelioma AJCC v8; Stage IV Cervical Cancer AJCC v8; Stage IV Distal Bile Duct Cancer AJCC v8; Stage IV Intrahepatic Bile Duct Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Penile Cancer AJCC v8; Stage IV Pleural Diffuse Malignant Mesothelioma AJCC v8; Triple-Negative Breast Carcinoma; Unresectable Urothelial Carcinoma	National Cancer Institute (NCI)	2021-08-25	PHASE1
NCT04576091	ACTIVE_NOT_RECRUITING	Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Recurrent Head and Neck Cutaneous Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma; Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Oral Cavity Squamous Cell Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Recurrent Paranasal Sinus Squamous Cell Carcinoma; Recurrent Salivary Gland Carcinoma; Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage III Hypopharyngeal Carcinoma AJCC v8; Stage III Laryngeal Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8; Stage III Major Salivary Gland Cancer AJCC v8; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage III Sinonasal Cancer AJCC v8; Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage IV Hypopharyngeal Carcinoma AJCC v8; Stage IV Laryngeal Cancer AJCC v8; Stage IV Lip and Oral Cavity Cancer AJCC v8; Stage IV Major Salivary Gland Cancer AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IV Sinonasal Cancer AJCC v8; Unresectable Head and Neck Cutaneous Squamous Cell Carcinoma; Unresectable Head and Neck Squamous Cell Carcinoma; Unresectable Hypopharyngeal Squamous Cell Carcinoma; Unresectable Laryngeal Squamous Cell Carcinoma; Unresectable Oral Cavity Squamous Cell Carcinoma; Unresectable Oropharyngeal Squamous Cell Carcinoma; Unresectable Paranasal Sinus Squamous Cell Carcinoma; Unresectable Salivary Gland Squamous Cell Carcinoma	National Cancer Institute (NCI)	2022-07-06	PHASE1
NCT04616534	ACTIVE_NOT_RECRUITING	Advanced Fallopian Tube Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Adenocarcinoma; Advanced Primary Peritoneal Carcinoma; Fallopian Tube High Grade Serous Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Ovarian High Grade Serous Adenocarcinoma; Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Ovarian Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Primary Peritoneal High Grade Serous Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Fallopian Tube Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage III Primary Peritoneal Cancer AJCC v8; Stage IV Fallopian Tube Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Primary Peritoneal Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma	National Cancer Institute (NCI)	2021-06-01	PHASE1
NCT04535401	ACTIVE_NOT_RECRUITING	Advanced Colorectal Carcinoma; Advanced Digestive System Carcinoma; Advanced Gastric Carcinoma; Advanced Gastroesophageal Junction Adenocarcinoma; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Metastatic Colorectal Carcinoma; Metastatic Digestive System Carcinoma; Metastatic Gastric Carcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Stage III Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8	National Cancer Institute (NCI)	2021-08-13	PHASE1
NCT04514497	ACTIVE_NOT_RECRUITING	Metastatic Lung Small Cell Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Neuroendocrine Carcinoma; Metastatic Pancreatic Adenocarcinoma; Stage III Lung Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Lung Small Cell Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Neuroendocrine Carcinoma; Unresectable Pancreatic Adenocarcinoma	National Cancer Institute (NCI)	2021-10-20	PHASE1
NCT05071209	ACTIVE_NOT_RECRUITING	Recurrent Alveolar Rhabdomyosarcoma; Recurrent Ewing Sarcoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Refractory Alveolar Rhabdomyosarcoma; Refractory Ewing Sarcoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm	National Cancer Institute (NCI)	2021-12-22	PHASE1; PHASE2
NCT04267939	TERMINATED	Advanced Solid Tumors (Excluding Prostate Cancer); Ovarian Cancer	Bayer	2020-02-26	PHASE1
NCT03188965	COMPLETED	Advanced Solid Tumor; Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma	Bayer	2017-07-06	PHASE1
NCT04095273	COMPLETED	Advanced Solid Tumors	Bayer	2019-09-30	PHASE1
NCT05010096	WITHDRAWN	Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Neoplasm in the Bone; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm	M.D. Anderson Cancer Center	2022-03-22	PHASE1
NCT05071209	Active not recruiting	Recurrent Alveolar Rhabdomyosarcoma\|Recurrent Ewing Sarcoma\|Recurrent Lymphoma\|Recurrent Malignant Solid Neoplasm\|Refractory Alveolar Rhabdomyosarcoma\|Refractory Ewing Sarcoma\|Refractory Lymphoma\|Refractory Malignant Solid Neoplasm	National Cancer Institute (NCI)	2021-12-22	Phase 1\|Phase 2
NCT04267939	Terminated	Advanced Solid Tumors (Excluding Prostate Cancer)\|Ovarian Cancer	Bayer\|GlaxoSmithKline	2020-02-26	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-31)

Check the Elimusertib (BAY 1895344) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Elimusertib (BAY 1895344) selectively binds to and inhibits ataxia telangiectasia and Rad3-related (ATR) kinase with an IC50 of 7 nM, thereby blocking DNA damage response signaling and impairing double-strand break repair in proliferating cells. This inhibition leads to severe replication stress, cell cycle arrest, and programmed cell death, providing the mechanistic foundation for its ongoing clinical evaluation in advanced solid tumors, ovarian cancer, and relapsed pediatric sarcomas.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).