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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...
| 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 |
BAY1436032 is an investigational small molecule developed by Bayer AG for the treatment of IDH1-mutant cancers. It has been studied in acute myeloid leukemia and advanced solid tumors. It is a Phase 1 agent and is not approved for any indication.
BAY1436032 was studied in adults with mutant IDH1 advanced acute myeloid leukemia. The Phase 1 trial NCT03127735 enrolled 27 patients with AML in the United States and Germany. The study is completed, and BAY1436032 remains an investigational therapy rather than an approved AML treatment.
BAY1436032 is an inhibitor of IDH1, the isocitrate dehydrogenase 1 enzyme. It is designed to target the mutant IDH1 form found in certain tumors. Trials of BAY1436032 selected patients whose cancers carried IDH1 mutations, making it a biomarker-selected therapy.
Bayer AG is developing BAY1436032. Bayer trades on the OTC market in the United States under the ticker BAYRY. The company sponsored the Phase 1 clinical program evaluating the compound in IDH1-mutant acute myeloid leukemia and advanced solid tumors.
BAY1436032 is in Phase 1 development. Two Phase 1 trials have been completed: NCT03127735 in mutant IDH1 advanced acute myeloid leukemia and NCT02746081 in IDH1-mutant advanced solid tumors. No later-phase trials are active, and the drug is not FDA approved.
BAY1436032 has been evaluated in two completed Phase 1 trials. NCT03127735 tested it in 27 patients with mutant IDH1 advanced acute myeloid leukemia in the United States and Germany. NCT02746081 tested it in 81 patients with IDH1-mutant advanced solid tumors across the United States, Denmark, Germany, and Japan.