Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY2416964 · 1 trial · 1 indication
MTD:defined as the dose level that can be given such that the estimated Dose limiting toxicity (DLT) probability is closest to approximately 25%.
Integration of all available safety, PK and PD data
| Arm | Type | Description |
|---|---|---|
| Dose escalation of BAY2416964 | EXPERIMENTAL | Approximately 8 dose levels of BAY2416964 are planned |
| Dose expansion of BAY2416964 in tumor type specific | EXPERIMENTAL | Patients with NSCLC, HNSCC |
| Name | Type | Description |
|---|---|---|
| BAY2416964 | DRUG | Oral application of study drug daily in a predefined dose escalation scheme. |
Inclusion Criteria: * Participants must be ≥18 years of age inclusive, at the time of signing the informed consent. * Participants with following histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BAY2416964 is an investigational small molecule developed by Bayer AG for the treatment of advanced solid tumors. It is an aryl hydrocarbon receptor inhibitor, or AhRi, and has been studied in a first-in-humans Phase 1 dose finding trial in patients with advanced cancer.
BAY2416964 is being developed for advanced solid tumors. It was evaluated in a Phase 1 first-in-humans dose finding study in patients with advanced cancer across sites in the United States, Canada, Germany, Spain, and the United Kingdom. It is investigational and has not been approved for any indication.
BAY2416964 works as an aryl hydrocarbon receptor inhibitor, also called an AhRi. By inhibiting the aryl hydrocarbon receptor, the drug targets a pathway implicated in cancer biology. This mechanism was the basis for its first-in-humans dose finding study in patients with advanced cancer.
BAY2416964 is being developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer sponsored the Phase 1 first-in-humans dose finding study of the aryl hydrocarbon receptor inhibitor in patients with advanced cancer.
BAY2416964 is in Phase 1 development. Its single first-in-humans dose finding study in advanced solid tumors is listed as completed, with 78 patients enrolled. The drug remains investigational and has not been approved by the FDA for any indication.
BAY2416964 was studied in one Phase 1 trial, NCT04069026, titled a first-in-humans dose finding study for an aryl hydrocarbon receptor inhibitor in patients with advanced cancer. The trial enrolled 78 patients aged 18 years and older across the United States, Canada, Germany, Spain, and the United Kingdom, and is completed.