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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 advanced solid tumors that harbor a KRAS G12C mutation. It is given in combination with sotorasib in a Phase 1 trial enrolling adults with these genetically defined cancers. It is not approved for any use and remains in clinical development.
BAY3498264 targets KRAS G12C, a mutated form of the KRAS protein found in certain solid tumors. By acting on this specific mutation, the small molecule is designed to address cancers driven by KRAS G12C. It is being evaluated together with sotorasib, another KRAS G12C-directed agent.
BAY3498264 is being developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer is the sponsor of the Phase 1 study evaluating the compound in KRAS G12C-mutated advanced solid tumors.
BAY3498264 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The single ongoing study is a Phase 1 trial, and no Phase 2 or Phase 3 trials of BAY3498264 have been completed.
BAY3498264 is being studied in one active trial, NCT06659341, a Phase 1 study combining BAY3498264 with sotorasib in participants with advanced solid cancers carrying KRAS G12C mutations. The trial is recruiting, plans to enroll 104 participants, and sites are in Australia, Denmark, Italy, Spain, and the United Kingdom.
Yes. The Phase 1 trial NCT06659341 evaluates BAY3498264 given together with sotorasib in participants who have advanced solid tumors with KRAS G12C mutations. The study is controlled, is not randomized or double blinded, and is enrolling adults aged 18 years and older across five countries.