Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY2927088_formulation A · 1 trial · 3 indications
In Dose Escalation (including participants from Backfill)
Cmax: Maximum/peak concentration
AUC: Area under the concentration vs. time curve. AUC(0-24): AUC from time 0 to 24 hours post dose. QD: Quaque die (once daily)
If applicable. AUC(0-12): AUC from time 0 to 12 hours post dose. BID: Bis in die, 2 times daily.
Cmax,md: Cmax after multiple dose administrations
AUC(0-24)md: AUC(0-24) after multiple dose administrations
If applicable AUC(0-12)md: AUC(0-12) after multiple dose administrations
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | Doses of BAY2927088 will be increased in a stepwise fashion up to the MTD or MAD. |
| Backfill | EXPERIMENTAL | Dose Escalation and Backfill run concurrently |
| Dose expansion | EXPERIMENTAL | Eight independent groups (group A, B1, B2, C, D, E, F, G, H) are planned. Dose Expansion may start at a dose level that has been evaluated in Escalation/Backfill in at least 9 participants and considered safe or at any other dose levels that are below the highest dose level that is considered safe. |
| Extension part | EXPERIMENTAL | Initiation of the Extension part will depend on the benefit-risk profile observed during Dose Expansion. Additionally, enrollment may be prematurely terminated based on emerging data at the discretion of the Sponsor. |
| Name | Type | Description |
|---|---|---|
| BAY2927088_formulation A | DRUG | Oral administration |
| BAY2927088_formulation B_1 | DRUG | Oral administration |
| BAY2927088_formulation B_2 | DRUG | Oral administration |
| BAY2927088_formulation B_3 | DRUG | Oral administration |
Inclusion Criteria: * Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded). * Documented disease progression after treatment with at least one pri...
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BAY2927088 formulation A is an investigational small molecule being developed for the treatment of advanced non-small cell lung cancer (NSCLC) in patients whose tumors have mutations in the EGFR and/or HER2 genes. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BAY2927088 formulation A targets cancers driven by mutations in the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) genes. It is being studied specifically in advanced non-small cell lung cancer patients whose tumors carry these genetic alterations.
BAY2927088 formulation A is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting the clinical trials for this investigational drug candidate.
BAY2927088 formulation A is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants.
BAY2927088 formulation A is being studied in a single Phase 1 first-in-human clinical trial registered as NCT05099172. This trial is recruiting approximately 400 participants with advanced non-small cell lung cancer who have EGFR or HER2 mutations, and is being conducted across multiple countries including the United States, Belgium, Brazil, China, and Japan.