Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Elimusertib is an investigational small molecule being developed for the treatment of advanced solid tumors. It is also being studied in certain lymphomas, including non-Hodgkin's lymphoma and mantle cell lymphoma. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Elimusertib is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded on the over-the-counter market under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical development for advanced solid tumors and certain lymphomas.
Elimusertib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of advanced solid tumors, non-Hodgkin's lymphoma, and mantle cell lymphoma.
Elimusertib has been studied in one clinical trial, identified as NCT03188965. This was a first-in-human study of the ATR inhibitor BAY1895344 in patients with advanced solid tumors and lymphomas. The trial was completed and enrolled 229 participants across multiple countries, including the United States, Canada, China, Japan, Singapore, Switzerland, and the United Kingdom.
Yes, Elimusertib is also known as BAY1895344. The clinical trial NCT03188965, which studied the drug in advanced solid tumors and lymphomas, refers to it as BAY1895344. This was a first-in-human Phase 1 study that has been completed.