Elimusertib

Phase 2Small molecule

Elimusertib is one of 39 small molecule programs targeting Advanced Fallopian Tube Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Advanced Fallopian Tube CarcinomaActive, not recruiting

Advanced Colorectal CarcinomaActive, not recruiting

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8Active, not recruiting

Advanced Bile Duct CarcinomaActive, not recruiting

Refractory Solid TumorsActive, not recruiting

Advanced Fallopian Tube CarcinomaPhase 1

Active, not recruiting

Advanced Colorectal CarcinomaPhase 1

Active, not recruiting

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8Phase 1

Active, not recruiting

Advanced Bile Duct CarcinomaPhase 1

Active, not recruiting

Refractory Solid TumorsPhase 2

Active, not recruiting

Competition

Competitive Landscape

37 competitors in Refractory Solid Tumors

#DrugCompanyPhaseTrials

Camptosar

Pfizer

Phase 2

8 2

Votrient

Novartis

Phase 2

5 3

Oncovin

Eli Lilly

Phase 2

4 4

Keytruda

Merck & Co.

Phase 2

3 5

Opdivo

Bristol-Myers Squibb

Phase 2

3 6

Ibrance

Pfizer

Phase 2

2 7

Tecentriq

Roche

Phase 2

1 8

Plaquenil

Jazz Pharmaceuticals

Phase 2

1 9

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 2

8 10

Cytoxan

BBaxter Healthcare Corporation

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8

NCT04576091

Phase 1Active, not recruiting

Metastatic Lung Small Cell Carcinoma

NCT04514497

Q2 2027

Phase 1Active, not recruiting

Advanced Fallopian Tube Carcinoma

NCT04616534

Phase 1Active, not recruiting

Advanced Bile Duct Carcinoma

NCT04491942

Q3 2027

Phase 1Active, not recruiting

Advanced Colorectal Carcinoma

NCT04535401

Clinical

Trials by Indication[1]

Patients With Advanced Solid Tumors2 trials

Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug

Completed· Bayer logo

Bayer·Phase 1·NCT04095273·56 enrolled

BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT05010096

Refractory Solid Tumors1 trial

Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT05071209·31 enrolled

Ovarian Cancer1 trial

ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer

Terminated· Bayer logo

Bayer·Phase 1·NCT04267939·14 enrolled

Lymphoma1 trial

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

Completed· Bayer logo

Bayer·Phase 1·NCT03188965·229 enrolled

Metastatic Lung Small Cell Carcinoma1 trial

BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)

Active, not recruiting· Takeda logo

Takeda·Phase 1·NCT04514497·29 enrolled

4 more indications

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v81 trial

Phase I Trial of BAY 1895344 ATR Inhibitor Combined With Stereotactic Body Radiation Therapy and Pembrolizumab for Recurrent Head and Neck Squamous Cell Carcinoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04576091·7 enrolled

Advanced Colorectal Carcinoma1 trial

Phase I/Ib Trial of ATR Inhibitor BAY 1895344 in Combination With FOLFIRI in GI Malignancies With a Focus on Metastatic Colorectal and Gastric/Gastroesophageal Cancers

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04535401·10 enrolled

Advanced Bile Duct Carcinoma1 trial

A Phase 1 Trial of the ATR Inhibitor BAY 1895344 in Combination With Cisplatin and With Cisplatin Plus Gemcitabine in Advanced Solid Tumors With an Emphasis on Urothelial Carcinoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04491942·74 enrolled

Advanced Fallopian Tube Carcinoma1 trial

Phase 1 Trial of Gemcitabine Combined With the Elimusertib (BAY 1895344) ATR Inhibitor With Expansion Cohorts in Advanced Pancreatic and Ovarian Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04616534·14 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Elimusertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Elimusertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Elimusertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Bayer

Elimusertib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Patients With Advanced Solid Tumors2 trials

Refractory Solid Tumors1 trial

Ovarian Cancer1 trial

Lymphoma1 trial

Metastatic Lung Small Cell Carcinoma1 trial

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v81 trial

Advanced Colorectal Carcinoma1 trial

Advanced Bile Duct Carcinoma1 trial

Advanced Fallopian Tube Carcinoma1 trial

References

Drug Info

Quick Facts

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