Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 3771249 · 1 trial · 1 indication
Hematology, serum chemistry, urinalysis and coagulation tests. Applicable in Dosage escalation and expansion
Applicable in Dosage escalation and expansion
Applicable in Dosage escalation and expansion
Applicable in Dosage escalation and expansion
Applicable in Dosage escalation and expansion
Applicable in Dosage escalation and expansion
Applicable in Dose escalation part
Applicable in Dosage escalation and expansion
Applicable in Dosage escalation and expansion
Applicable in Dosage escalation and expansion
| Arm | Type | Description |
|---|---|---|
| Dosage escalation | EXPERIMENTAL | In the dosage escalation part, different dose levels of BAY 3771249 administered as monotherapy and in combination with cetuximab are planned. |
| Dosage expansion | EXPERIMENTAL | In the dosage expansion part, participants will receive BAY 3771249 either as monotherapy or in combination with cetuximab until disease progression as defined by RECIST v1.1, the occurrence of unacceptable toxicity, or the fulfillment of any other withdrawal criteria. |
| Name | Type | Description |
|---|---|---|
| BAY 3771249 | DRUG | Oral |
| Cetuximab | DRUG | Intravenous (IV) infusion |
Inclusion Criteria: * KRAS G12D mutated solid tumor * Participant must be ≥18 years old or the legal age of consent in the jurisdiction in which the study is taking place when signing the screening ICF * At least one measurable lesion as per RECIST v1.1. outside the CNS * Eastern Cooperative Oncolo...
BAY 3771249 is an investigational small molecule being studied for the treatment of advanced or metastatic colorectal adenocarcinoma, specifically in patients whose tumors have a KRAS G12D mutation. It is not yet approved for any indication and remains in clinical development.
BAY 3771249 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating the compound in KRAS G12D mutant colorectal cancer.
BAY 3771249 is in Phase 1 clinical development. The single ongoing trial is a Phase 1 study, and no Phase 2 or Phase 3 trials have been initiated. The drug is investigational and has not received FDA approval.
BAY 3771249 is being evaluated in one recruiting Phase 1 trial, NCT07535112, titled a study of safety and efficacy in people with advanced or metastatic colorectal cancer that has a KRAS G12D mutation. The trial plans to enroll 130 participants across the United States, Australia, Belgium, Denmark, Finland, Italy, the Netherlands, Singapore, Spain, and Sweden.
Yes. BAY 3771249 is being studied in a biomarker-selected population. The Phase 1 trial enrolls only patients with advanced or metastatic colorectal adenocarcinoma whose tumors carry a KRAS G12D mutation, as stated in the trial title and eligibility criteria.