Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY2927088 · 5 trials · 5 indications
ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) per RECIST 1.1 by BICR. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \<10 mm. PR is defined as a ≥30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)
Cmax: Maximum observed drug concentration
AUC: Area under the concentration vs time curve from zero to infinity
Cmax: Maximum observed drug concentration
AUC: Area under the concentration vs time curve
| Arm | Type | Description |
|---|---|---|
| BAY2927088 | EXPERIMENTAL | Adult participants with metastatic or unresectable solid tumors with HER-2 activating mutations including: colorectal, biliary tract, bladder, cervical, endometrial, breast, and other solid tumor types. Participants will receive BAY2927088 20 mg BID until disease progression per RECICST 1.1, unacceptable toxicity, or until any other withdrawal criteria. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BID: twice a day |
| Healthy participants from United States | EXPERIMENTAL | The healthy volunteers will be confined to the clinic throughout the intervention period of the study. The study includes visits during screening, intervention, and follow-up. |
| BAY2927088 + Itraconazole (ITZ) | EXPERIMENTAL | Participant will receive single dose BAY2927088 on Days 1 and 8, will receive itraconazole daily from Day 5 to Day 11. |
| BAY2927088 + Carbamazepine (CBZ) | EXPERIMENTAL | Participant will receive BAY2927088 single dose on Days 1 and 14, will receive carbamazepine daily from Day 3 to Day 15. |
| Intervention A - Intervention B - Intervention C | EXPERIMENTAL | Intervention A: BAY2927088 is administered under fasted status. Intervention B: BAY2927088 is administered under fed status (light low-fat meal). Intervention C: BAY2927088 is administered under fed status (high fat, high calorie meal). Each participant will subsequently undergo a fourth intervention period that includes dosing with BAY2927088 and esomeprazole. |
| Intervention B - Intervention C- Intervention A | EXPERIMENTAL | Intervention A: BAY2927088 is administered under fasted status. Intervention B: BAY2927088 is administered under fed status (light low-fat meal). Intervention C: BAY2927088 is administered under fed status (high fat, high calorie meal). Each participant will subsequently undergo a fourth intervention period that includes dosing with BAY2927088 and esomeprazole. |
| Intervention C - Intervention A - Intervention B | EXPERIMENTAL | Intervention A: BAY2927088 is administered under fasted status. Intervention B: BAY2927088 is administered under fed status (light low-fat meal). Intervention C: BAY2927088 is administered under fed status (high fat, high calorie meal). Each participant will subsequently undergo a fourth intervention period that includes dosing with BAY2927088 and esomeprazole. |
| Healthy volunteers | EXPERIMENTAL | The healthy volunteers will be confined to the clinic throughout the Intervention Period of the study. The study includes visits during Screening, Intervention, and Follow-up. |
| Name | Type | Description |
|---|---|---|
| BAY2927088 | DRUG | tablet, oral |
| Midazolam | DRUG | Oral administration |
| Itraconazole | DRUG | Capsule, 100 mg, oral. |
| Carbamazepine | DRUG | Tablet, 100 mg, 200mg and 300mg, oral. |
| Esomeprazole | DRUG | Oral administration |
| Food | OTHER | light low-fat meal or high fat, high calorie meal |
| Dabigatran etexilate | DRUG | Oral administration. |
| Rosuvastatin | DRUG | Oral administration. |
Inclusion Criteria: * Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, ...
| 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 |
BAY2927088 is an investigational small molecule being developed for advanced solid tumors and advanced non-small cell lung cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BAY2927088 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.
BAY2927088 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. All four of its registered clinical trials are Phase 1 studies.
BAY2927088 has four completed Phase 1 trials: NCT06329895, NCT06348888, NCT06360211, and NCT06378658. These studies evaluated drug interactions and the effects of food and esomeprazole on the drug's blood levels in healthy participants.
No alternative names for BAY2927088 have been reported. The drug is identified solely by its code name BAY2927088 in clinical trial registries and development documentation.