Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 3771249 · 1 trial · 1 indication
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 Dosage escalation and expansion
Hematology, serum chemistry, urinalysis and coagulation tests. Applicable in Dosage escalation and expansion
Applicable in Dose escalation part
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. It is currently in Phase 1 clinical development, and it is being evaluated in patients whose tumors have a KRAS G12D mutation.
BAY 3771249 targets the KRAS G12D mutation, a specific genetic alteration found in some colorectal cancers. The drug is designed to act on this mutation, which is the focus of the ongoing clinical trial in patients with advanced or metastatic colorectal adenocarcinoma.
BAY 3771249 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is listed on the stock exchange under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
BAY 3771249 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the drug's safety and how well it works in patients with advanced or metastatic colorectal cancer.
BAY 3771249 is being studied in a Phase 1 clinical trial registered as NCT07535112. This trial is recruiting 130 participants with advanced or metastatic colorectal adenocarcinoma that has a KRAS G12D mutation. The study is being conducted in multiple countries, including the United States, Australia, and several European nations.