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BAY3498264 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | During dose escalation, at each dose level BAY3498264 monotherapy will be administered for 7 days as a safety run-in, prior to introduction of a combination agent (sotorasib) for 21-day treatment cycles. Intra-participant dose escalation will be implemented: participants will be able to move to a cohort offering a higher dose level of BAY3498264 provided protocol-specified criteria are met. |
| Backfill cohorts | EXPERIMENTAL | Backfill cohorts may be initiated concurrently with dose escalation cohorts to generate additional safety, PK, and PD data to facilitate the selection of the optimal doses for use in further development. |
| Exploratory expansion cohorts | EXPERIMENTAL | Exploratory expansion cohorts may be recruited to provide additional safety, PK/PD, and efficacy data. |
| Name | Type | Description |
|---|---|---|
| BAY3498264 | DRUG | Oral |
Inclusion Criteria: * Histologically confirmed solid tumor malignancy with documented KRAS\^G12C mutation as assessed by an appropriately accredited laboratory. * Documented disease progression after treatment with at least 1 prior standard of care (SoC) systemic therapy other than a G12C inhibitor...
BAY3498264 is an investigational small molecule being studied for the treatment of advanced solid tumors that harbor a KRAS G12C mutation. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BAY3498264 is being studied in patients with advanced solid tumors that have a specific genetic change called the KRAS G12C mutation. It is given together with sotorasib, another KRAS G12C-targeted therapy, in a Phase 1 clinical trial.
BAY3498264 is being developed by Bayer AG, a multinational pharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug in combination with sotorasib for advanced solid tumors with the KRAS G12C mutation.
BAY3498264 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is currently recruiting participants.
BAY3498264 is being studied in a Phase 1 clinical trial registered as NCT06659341. This trial evaluates BAY3498264 in combination with sotorasib in participants with advanced solid cancers harboring the KRAS G12C mutation. The trial is recruiting 104 participants across Australia, Denmark, Italy, Spain, and the United Kingdom.
No, BAY3498264 is not the same as sotorasib. BAY3498264 is an investigational drug being developed by Bayer AG, while sotorasib is a separate KRAS G12C inhibitor. In the ongoing Phase 1 trial, BAY3498264 is being studied in combination with sotorasib.