Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1217389 · 1 trial · 1 indication
The MTD is defined as the highest dose that can be given such that the dose-limiting toxicity (DLT) rate of the combination treatment is not more than 10% higher than the cumulative DLT rate of the standard single-agent treatment across all previous and the current cohort.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Experimental Treatment (combination of BAY1217389 with paclitaxel in an intermittent dosing schedule) Expansion Cohort - Maximum tolerated dose of BAY1217389 and Paclitaxel |
| Arm 2 | PLACEBO_COMPARATOR | Standard Treatment (Single-agent Paclitaxel ) |
| Name | Type | Description |
|---|---|---|
| BAY1217389 | DRUG | BAY1217389 will be given orally, with a starting dose of 0.25 mg twice daily, on D1, D2, D8, D9, D15 and D16 of a 28 day cycle. BAY1217389 will be dosed in combination with paclitaxel in Arm 1 (Experimental Treatment) and from Cycle 2 onwards in Arm 2 (Standard Treatment). After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort. In a higher dose level Cohort 4 \> (or equal to) a relative bioavailability assessment of BAY1217389 liquid capsule formulation compared to BAY1217389 oral solution will be performed. |
| Paclitaxel | DRUG | Paclitaxel will be given once per week IV at 90 mg/m\^2 on D1, D8, and D15 of a 28 day cycle. Paclitaxel will be dosed as a single-agent in Cycle 1 of Arm 2 (Standard Treatment Arm), and in combination with BAY1217389 in Arm 1 (Experimental Treatment Arm) and from Cycle 2 onwards in Arm 2 (Standard Treatment Arm). After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort. |
Inclusion Criteria: * Male or female subjects aged \>/= 18 years. * Study population: * For the dose-escalation cohorts: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors), refractory to any standard therapy, have no standard therapy available * For th...
BAY1217389 is an investigational small molecule being studied in medical oncology, specifically in solid tumor settings. It has been evaluated in a Phase 1 clinical trial in combination with intravenous paclitaxel. It is not approved for any indication and remains in clinical development.
BAY1217389 targets TTK, also known as monopolar spindle 1 (MPS1), a kinase involved in the spindle assembly checkpoint during cell division. BAY1217389 is a TTK inhibitor. By inhibiting TTK, the compound interferes with mitotic checkpoint control, which is being explored as an anticancer strategy.
BAY1217389 is being developed by Bayer AG, whose ticker is BAYRY. Bayer sponsored the Phase 1 study of the compound in combination with paclitaxel.
BAY1217389 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory authority. The Phase 1 trial evaluating it in combination with intravenous paclitaxel has been completed.
BAY1217389 has been studied in one clinical trial, NCT02366949, titled Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel. The trial enrolled 75 participants, was placebo-controlled and randomized, and was conducted in the United States and the Netherlands. It is now completed.