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Elimusertib · 1 trial · 1 indication
The RP2D will be determined in dose expansion part based on multiple parameters (i.e., safety, tolerability, PK, pharmacodynamics, efficacy) and will be a dose equal to or lower than the MTD (Maximum Tolerated Dose).
| Arm | Type | Description |
|---|---|---|
| Dose escalation of Elimusertib | EXPERIMENTAL | 2 dose levels of Elimusertib are planned |
| Dose expansion cohort 1a of Elimusertib | EXPERIMENTAL | Participants with advanced hormone-receptor-positive, Human epidermal growth factor receptor 2 negative breast cancer (HER2-negative BC), known to be positive for Ataxia-telangiectasia mutated (ATM) loss and/or ATM deleterious alterations who have not received prior treatment with immunotherapy. Participants with known microsatellite instability-high (MSI-H) cannot be included |
| Dose expansion cohort 1b of Elimusertib | EXPERIMENTAL | Participants with advanced hormone-receptor-positive, HER2-negative BC, known to be DDR deficiency biomarker-positive (except ATM loss/mutation) who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included. |
| Dose expansion cohort 2a of Elimusertib | EXPERIMENTAL | Participants with advanced Colorectal cancer (CRC) known to be positive for ATM loss and/or ATM deleterious alterations who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included. |
| Dose expansion cohort 2b of Elimusertib | EXPERIMENTAL | Participants with advanced CRC, known to be DDR deficiency biomarker -positive (except ATM loss/mutation) who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included. |
| Dose expansion cohort 3 of Elimusertib | EXPERIMENTAL | Participants with advanced Gastric/gastroesophageal junction cancer (GC/GEJ) known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. |
| Dose expansion cohort 3a of Elimusertib | EXPERIMENTAL | Participants with advanced GC/GEJ cancer and without DDR deficiency alterations as described above. Variants of unknown significance (VUS) of the DDR gene alterations are eligible. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. |
| Dose expansion cohort 4 of Elimusertib | EXPERIMENTAL | Participants with advanced Non-small cell lung cancer (NSCLC) known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. |
| Dose expansion cohort 4a of Elimusertib | EXPERIMENTAL | Participants with advanced NSCLC and without DDR deficiency alterations as described above. VUS of the DDR gene alterations are eligible. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. |
| Dose expansion cohort 5 of Elimusertib | EXPERIMENTAL | Participants with advanced pancreatic cancer, known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included. |
| Dose expansion cohort 5a of Elimusertib | EXPERIMENTAL | Participants with advanced pancreatic cancer and without DDR deficiency alterations as described above, who have not received prior treatment with immunotherapy. VUS of the DDR gene alterations are eligible. Participants with known MSI-H cannot be included. |
| Dose expansion cohort 6 of Elimusertib | EXPERIMENTAL | Participants with advanced Metastatic castration-resistant prostate cancer (mCRPC), known to be DDR deficiency biomarker positive (incl. ATM mutation) and/or positive for ATM loss who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included. |
| Dose expansion cohort 6a of Elimusertib | EXPERIMENTAL | Participants with advanced mCRPC and without DDR deficiency alterations as described above, who have not received prior treatment with immunotherapy. VUS of the DDR gene alterations are eligible. Participants with known MSI-H cannot be included. |
| Name | Type | Description |
|---|---|---|
| Elimusertib (BAY1895344) | DRUG | Study drugs will be administered as scheduled |
| Pembrolizumab (Keytruda®) | DRUG | Study drugs will be administered as scheduled |
Inclusion Criteria: * Participant must be ≥18 years of age inclusive, at the time of signing the informed consent. * Presence of the putative biomarkers of DDR deficiency in tumor and/or other tissues (dose escalation only). * Participants must have histologically confirmed solid tumors . * Eastern...
| 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 studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development. The drug is being evaluated in combination with pembrolizumab to determine the optimal dose, tolerability, and how the body absorbs, distributes, and discharges the drug.
Elimusertib is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this investigational oncology drug for advanced solid tumors.
Elimusertib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed, evaluating the drug in combination with pembrolizumab in patients with advanced solid tumors.
Elimusertib has one completed clinical trial, NCT04095273, a Phase 1 study in advanced solid tumors. The trial enrolled 56 patients across the United States, Germany, Spain, Switzerland, and the United Kingdom. It evaluated Elimusertib in combination with pembrolizumab.
No, Elimusertib is not the same as pembrolizumab. Elimusertib is the investigational drug being studied, while pembrolizumab is a separate therapy used in combination with Elimusertib in the clinical trial. The study aims to test how well patients respond to the combination treatment.