Approval Probability
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Adjusted LOA
ML Risk
Also known as Elimusertib (BAY1895344)
Elimusertib · 1 trial · 3 indications
MTD and/or R2PD will be determined in Cycle 1 of Part A, Part A.1 and J-arm of Part A. The MTD is defined as the maximum dose at which the incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 30%, or the maximum dose tested, whichever is achieved first during dose-escalation.
AUC(0-12) and AUC(0-12)md will be evaluated in Part A, A.1 and J-arm of Part A.
Cmax and Cmax,md will be evaluated in Part A, A.1 and J-arm of Part A.
| Arm | Type | Description |
|---|---|---|
| Part A: single-agent dose-escalation | EXPERIMENTAL | Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma (NHL) receive BAY1895344 in a 21-day cycle. |
| Part A.1: Single-agent dose escalation with alternative dosing schedule | EXPERIMENTAL | 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. |
| J-arm of Part A: dose escalation cohort in Japanese patients | EXPERIMENTAL | Japanese patients with histologically confirmed solid tumors receive BAY1895344 at two dose levels: MTD-1 and MTD. |
| Part B: single-agent expansion | EXPERIMENTAL | 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. |
| Part B.1: single-agent expansion with alternative dosing schedule | EXPERIMENTAL | Patients with histologically confirmed relapsed or refractory MCL receive BAY1895344 at a dose determined after evaluation of multiple BAY1895344 doses in Part A.1 |
| Name | Type | Description |
|---|---|---|
| Elimusertib (BAY1895344) | DRUG | Solution or tablet, oral, to be administered until evidence of tumor progression, unacceptable toxicity, consent withdrawal, or withdrawal from the study at the discretion of the investigator. |
Inclusion Criteria: Part A - single-agent dose-escalation: \- Patients with histologically confirmed solid tumors or NHL. Patients with tumors known to be positive for deoxyribonucleic acid damage repair (DDR) defects (such as ataxia-telangiectasia mutated \[ATM\] deleterious mutation or low ATM e...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Elimusertib is an investigational small molecule being studied in adults with advanced solid tumors, including non-Hodgkin's lymphoma and mantle cell lymphoma. It is not approved for any indication and remains in clinical development. The Phase 1 study enrolled patients 18 years and older across the United States, Canada, China, Japan, Singapore, Switzerland, and the United Kingdom.
Elimusertib targets ATR, a kinase involved in the DNA damage response. It is classified as an ATR inhibitor. By inhibiting ATR, the drug is designed to interfere with tumor cell DNA damage repair pathways. The Phase 1 study was biomarker-selected, meaning patients were enrolled based on specific molecular characteristics related to the drug's target.
Elimusertib is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer conducted the first-in-human Phase 1 study of the ATR inhibitor in patients with advanced solid tumors and lymphomas. The drug is also known by its development code BAY1895344.
Elimusertib is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The single Phase 1 trial, NCT03188965, has been completed and enrolled 229 patients with advanced solid tumors and lymphomas.
Elimusertib has been evaluated in one clinical trial, NCT03188965, titled First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas. This Phase 1 trial is completed and enrolled 229 participants. It was a controlled study without randomization or double-blinding, conducted across seven countries.
Yes, Elimusertib and BAY1895344 refer to the same investigational drug. BAY1895344 is the development code used by Bayer AG, while Elimusertib is the international nonproprietary name. Both names appear in the literature and trial records for the ATR inhibitor being studied in advanced solid tumors and lymphomas.