Approval Probability
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BAY1436032 · 2 trials · 2 indications
If the MTD is not reached during dose escalation, the primary variable will be the recommended phase 2 dose (RP2D) of BAY1436032
As a measure of safety and tolerability
MTD is defined as the maximum dose at which the predicted incidence of DLTs during Cycle 1 (DLT evaluation period) is ≤25%.
Safety and tolerability variables will include AEs, laboratory safety tests, ECGs, and vital signs.
If the MTD is not reached, the primary variable will be the RP2D, defined based on all available safety, PK, PD, biomarker, and efficacy data collected after the start of BAY1436032 treatment.
| Arm | Type | Description |
|---|---|---|
| BAY1436032 | EXPERIMENTAL | Dose escalation: Various doses of study drug will be tested on a small number of patients/dose with the goal of identifying the most appropriate dose(s) for further evaluation in dose expansion. The MTD of the study drug may or may not be identified. It is anticipated that 3-4 patients will be treated at each dose of study drug to be tested and that 15-20 total patients will be treated in this part of the trial. Dose expansion: Up to 2 different doses of study drug will be tested on up to 30 patients/dose with the goal of identifying the most appropriate RP2D for further clinical development. The doses to be evaluated in this part of the trial will be selected based on information obtained during dose escalation. |
| Name | Type | Description |
|---|---|---|
| BAY1436032 | DRUG | BAY1436032 administered continuously as a single agent dosed twice a day orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with BAY1436032 until disease progression, development of other unacceptable toxicity or Investigator discretion. |
Inclusion Criteria: * Patients with advanced AML that harbors IDH1 mutation * Patients are relapsed from or refractory to at least 1 previous line of therapy * Good kidney and liver function * Male or female patients * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Wome...
BAY1436032 is an investigational small molecule being studied for the treatment of IDH1-mutant advanced solid tumors and IDH1-mutant advanced acute myeloid leukemia (AML). It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
BAY1436032 targets mutant IDH1, an enzyme involved in cellular metabolism that can drive tumor growth when mutated. By inhibiting mutant IDH1, the drug aims to interfere with cancer cell proliferation in IDH1-mutant solid tumors and acute myeloid leukemia.
BAY1436032 is being developed by Bayer AG, a German pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the over-the-counter market.
BAY1436032 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in advanced solid tumors and one in acute myeloid leukemia. The drug remains investigational and has not received FDA approval.
BAY1436032 has been studied in two completed Phase 1 trials. NCT02746081 enrolled 81 patients with IDH1-mutant advanced solid tumors across the United States, Denmark, Germany, and Japan. NCT03127735 enrolled 27 patients with IDH1-mutant acute myeloid leukemia in the United States and Germany.
BAY1436032 is a distinct investigational agent targeting mutant IDH1. It is not the same as approved IDH1 inhibitors such as ivosidenib, which are separate drugs with different chemical structures and development histories.