Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY2701439 · 1 trial · 1 indication
TEAE: Treatment-emergent adverse event TESAE: Treatment-emergent serious adverse event
DLT:Dose limiting toxicity
ORR: Objective response rate
| Arm | Type | Description |
|---|---|---|
| Dose escalation of BAY2701439 | EXPERIMENTAL | The target population consists of participants with advanced HER2-expressing/amplified breast, gastric or gastroesophageal cancer. |
| HER2 overexpressing breast cancer | EXPERIMENTAL | Dose expansion of BAY2701439 |
| HER2 low expressing breast cancer | EXPERIMENTAL | Dose expansion of BAY2701439 |
| Other HER2 overexpressing advanced carcinomas | EXPERIMENTAL | Dose expansion of BAY2701439 |
| Name | Type | Description |
|---|---|---|
| BAY2701439 | DRUG | Intravenous (IV) injection on Day 1 of each cycle.The duration of each cycle will be 6 weeks (42 days). |
Inclusion Criteria: * Male or female participants at least 18 years of age on the day of signing informed consent. * Participants must meet the study phase-specific disease requirements: Dose escalation: Pathologically documented, HER2-expressing (IHC3+, 2+, or 1+ and/or ISH+), unresectable local...
BAY2701439 is an investigational small molecule developed by Bayer AG for cancers that express the HER2 protein. It has been studied in a single Phase 1 first-in-human trial in participants with advanced HER2-expressing cancer. It is not an approved medicine and remains in clinical development.
BAY2701439 is being studied for the treatment of advanced cancers that express the HER2 protein. The Phase 1 trial enrolled adults aged 18 years and older with HER2-expressing advanced cancer. Because the drug is investigational, no approved use has been established.
BAY2701439 is developed by Bayer AG, the German pharmaceutical and life sciences company whose shares trade over the counter in the United States under the ticker BAYRY. Bayer sponsored the first-in-human Phase 1 study of the compound in participants with advanced HER2-expressing cancer.
BAY2701439 is in Phase 1 development. One Phase 1 first-in-human study has been completed, and it enrolled 14 participants with advanced cancer expressing the HER2 protein. The drug is investigational and has not been approved by the FDA for any indication.
BAY2701439 has been evaluated in one clinical trial, NCT04147819, titled a first-in-human study of BAY2701439 to look at safety, how the body absorbs, distributes and excretes the drug, and how well it works in participants with advanced cancer expressing the HER2 protein. The Phase 1 study is completed and enrolled 14 participants in the United States and United Kingdom.
Yes. BAY2701439 was studied in a biomarker-selected population, enrolling only participants whose advanced cancers expressed the HER2 protein. The Phase 1 trial NCT04147819 required HER2 expression for enrollment, and it included 14 participants across sites in the United States and the United Kingdom.