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BAY1125976 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| BAY1125976 [once daily, dose-esc.] | EXPERIMENTAL | Oral administration once daily. Starting dose is 10 mg and will be escalated depending on any dose-limiting toxicities |
| BAY1125976 [twice daily, dose-esc.] | EXPERIMENTAL | Oral administration twice daily. Starting dose is 40mg twice daily and will be escalated depending on any dose-limiting toxicities |
| BAY1125976 [MTD] | EXPERIMENTAL | Oral administration of the defined MTD which shows optimal safety, PK profile, PD target inhibition and preliminary efficacy (once daily or twice daily) in different patient groups |
| Name | Type | Description |
|---|---|---|
| BAY1125976 | DRUG | Oral administration once daily. Starting dose is 10 mg and will be escalated depending on any dose-limiting toxicities |
Inclusion Criteria: * For dose escalation cohorts: Subjects with advanced, histologically or cytologically confirmed solid tumors are eligible. Subjects' tumors (all comers) must be refractory to standard treatment with no standard therapy available, or subjects actively refuse any treatment, which...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
BAY1125976 is an investigational oncology drug being studied for the treatment of neoplasms, which are abnormal tissue growths including solid tumors. It was evaluated in a Phase 1 dose escalation study in patients with advanced cancers. It is not approved for any indication and remains in clinical development.
BAY1125976 targets AKT1 and AKT2, two isoforms of the AKT kinase. It is an allosteric inhibitor of AKT 1/2, meaning it binds to a site on the enzyme distinct from the active site to block its activity. The AKT pathway is frequently dysregulated in cancer, and the trial enrolled biomarker-selected patients.
BAY1125976 is being developed by Bayer AG, a multinational pharmaceutical and life sciences company. Bayer's American Depositary Receipts trade on the OTC market under the ticker BAYRY. The compound is an internally discovered small molecule and is part of Bayer's oncology pipeline.
BAY1125976 is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT01915576, a dose escalation study in patients with neoplasms. There are currently no active trials listed for this drug. It is investigational and has not been approved by the FDA or any regulatory agency.
BAY1125976 has been studied in one completed Phase 1 trial, NCT01915576, titled "Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients." The trial enrolled 79 patients across the United States, France, Germany, and Switzerland. It was a controlled, non-randomized, open-label study in adults with neoplasms.